DigiHealthAccess

Global DTx reimbursement explorer

Digital therapeutics currently reimbursed across Europe, Japan and the USA -- plus recommended-but-not-reimbursed libraries (Denmark, UK regional ORCHA, South Korea) for context. Start at the country level or search by therapeutic area.

Search in:
ICD-10-GM codes work too — e.g. F41
Each entry is traced back, wherever possible, to a primary source rather than vendor marketing: national statutory registries (e.g. Germany's BfArM DiGA directory, France's HAS/LPPR, Belgium's mHealthBELGIUM, Switzerland's MiGeL), national tariffs & fee schedules (US Medicare HCPCS/CPT, Japan's Chuikyo NHI list, Germany's EBM), payer & insurer publications, official app-assessment directories (UK NICE & ORCHA, Denmark's Sundhedsapps Council, Korea's MFDS/HIRA), and company or regulator pages for founding, ownership and pricing detail -- pulled live from this project's own continuously-updated product database, cross-checked by category and reimbursement scope.

National reimbursement = nationwide/universal entitlement (statutory listing, tariff, or agreement -- coverage doesn't depend on which insurer the patient belongs to). Regional/Selective = named-insurer-specific contract.

Markets are grouped into three regions; each country tile's colour reflects its maturity tier (see legend). Selecting a country opens its reimbursement one-pager -- how coverage began, the reimbursement pathways, a pricing snapshot and the outlook -- built from web-verified primary sources. A further 30+ countries were researched but carry no reimbursed product yet -- including ambition markets (Australia, New Zealand, Singapore, the Gulf, Brazil, India) shown on the world map by pipeline status. This overview is non-exhaustive; see the disclaimer in the footer.

Global adoption at a glance

Colour = reimbursement maturity. Hover a country for its status and the major areas it reimburses; click a researched market to jump to its one-pager.

Loading world map…

Non-exhaustive research snapshot — hover for status & major reimbursement areas. Ambition markets (e.g. Australia, New Zealand, Gulf, Brazil, India) are shown by pipeline status. Toggle Startup hubs to overlay 61 global MedTech / digital-health ecosystems — ranks from StartupBlink's Global Startup Ecosystem Index 2026, with each city's digital-health anchor (an ecosystem overlay, not a reimbursement signal; focus Europe to separate the closely-clustered German hubs). Based on current research as of October 2026.

This country summary is a non-exhaustive research snapshot and may omit products or pathways; verify against primary sources.1

These totals are a non-exhaustive research snapshot, not an official register.1

Filter by therapeutic area -- by body system

Click a region of the body to filter to that therapeutic area. Male and female bodies carry the sex-specific areas (urology, gynaecology); shared organs appear on both. Areas that aren't tied to one body region are below.

Body-system areas
Not tied to one body region

Filter by country, delivery model & payer

Country
Delivery
Platform
Reimbursement
Evidence
Germany-only filters

These two apply to German statutory schemes and have no effect on products from other countries. No product sits on both routes, so picking from both groups shows the combined set rather than the overlap.

Germany is not in your current country selection, so these filters would return no products.

DiGA listing status
§20 SGB V chapter

Results

326 of 326

1 Minute pour mon Coeur

🇧🇪 Belgium

1 Minute pour mon Coeur is a remote-monitoring / digital health platform, developed by Newcard, used for chronic heart failure remote monitoring. Physiological parameters (weight, blood pressure, heart rate) collected via a patient kit and reviewed by the treating care team. It is reimbursed nationally in Belgium.

MonitoringApp + clinician platformNational reimbursement
🫀 Heart & Circulatory
Newcard · mhealthbelgium.be/apps/app-details/1-minute-pour-mon-cur
Entry last updated 10 Oct 2026

6 additional Hainan Class II-approved DTx products (#1-3 pre-Feb-2024, #8-11 during 2025 -- not individually named or dated in this pass)

🇨🇳 China

6 additional Hainan Class II-approved DTx products (#1-3 pre-Feb-2024, #8-11 during 2025 -- not individually named or dated in this pass) is a digital therapeutic (DTx), used for aggregate reference row. Hainan's provincial regulator had approved 11 DTx products under its Class II fast-track as of its own Nov 2025 press release (up from the 10-product Aug 2025 trade-press figure used elsewhere in this tab); this row stands in for the 6 beyond the 5 named/dated above (Xinjing plus approvals #4-7), spanning chronic-disease management, psychiatric/cognitive, ophthalmology, oncology and...

DTxNative appProvincial fee-schedule (Hainan)💳 Co-pay applies
⚕️ Not indication-specific
Company not recorded · dongmaipai/vbdata.cn (Aug 2025, '73 companies, 10 approved DTx products')
Entry last updated 30 Jul 2026

Abbott Merlin.net

🇩🇪 Germany

Abbott Merlin.net is a connected medical device (with companion software), developed by Abbott Laboratories (legacy St. Jude Medical), used for pacemaker / ICD / CRT follow-up. It is reimbursed nationally in Germany via nationwide EBM remote-monitoring/telemonitoring billing codes. Reimbursed since 1 April 2016.

MedTech deviceConnected device / hardwareNational reimbursementPublished RCT (this product)
🫀 Heart & Circulatory
Abbott Laboratories (legacy St. Jude Medical) · kbv.de
Entry last updated 30 Jul 2026

Abbott Merlin.net

🇫🇷 France

Abbott Merlin.net is the remote-monitoring platform through which recordings from the manufacturer’s implanted cardiac devices reach the treating cardiology team between in-person checks. France reimburses the implantable-cardiac-monitor follow-up activity through a product-specific code per platform, all at an identical rate; the clinical service is the same across vendors and the French tariff reflects that.

Ongoing

MonitoringConnected device with companion softwareNational reimbursement
🫀 Heart & Circulatory
Abbott Laboratories (legacy St. Jude Medical) · Legifrance: Arrete du 23 June 2025 (JORFTEXT000051795508, inscription LATM)
Entry last updated 24 Oct 2026

actensio

🇩🇪 Germany

actensio is a digital therapeutic (DTx), developed by mementor DE GmbH (same manufacturer as the still-active DiGA 'somnio'), used for hypertension (high blood pressure). It is available in Germany on a self-pay basis -- a reimbursement-eligible pathway may exist, but the patient currently pays out of pocket rather than an insurer or employer.

N/A (delisted); self-pay commercial pricing was quoted per 90 days

DTxNative appSelf-payPublished RCT (this product)💳 No co-pay
⚕️ Not indication-specific
mementor DE GmbH · diga.bfarm.de/de/verzeichnis (Gestrichen-Filter)
Entry last updated 18 Oct 2026

ACTICORE1

🇩🇪 Germany

ACTICORE1 is a digital therapeutic (DTx), developed by ACTICORE AG (Basel, Switzerland), used for stress urinary incontinence (ICD-10 N39.3). It consists of a pelvic-floor pressure sensor (hardware, placed under the patient rather than inserted) connected via Bluetooth to a companion app that runs a biofeedback-based pelvic-floor training programme. It is reimbursed nationally in Germany via the DiGA Sec.139e SGB V pathway, provisionally listed (Erprobungszeitraum 16 Sep 2026 - 15 Sep 2027). Manufacturer price EUR 795.00, includes the sensor hardware; no contracted-physician service required; available in German only.

DTx🇩🇪 DiGA PreliminaryNative app + connected pelvic-floor sensorNational reimbursementOngoing trial, unpublished💳 No co-pay
💧 Urogenital
ACTICORE AG · acticore.com
Entry last updated 19 Oct 2026

ActiveTEP (Hüfte / Knie)

🇩🇪 Germany

ActiveTEP (Hüfte / Knie) is a digital therapeutic (DTx), developed by DORA Digitale Orthopädie Anwendungen GmbH (Leipzig); part of the EU-co-funded 'Health Labs4Value' research project, also co-financed by the Free State of Saxony, used for total hip replacement (ActiveTEP Hüfte) and total knee replacement (ActiveTEP Knie). 24-week companion (12 weeks pre-op + 12 weeks post-op): 60+ knowledge modules, training plans, diary/progress tracking; the knee version followed the hip version to market. It is reimbursed in Germany through regional or insurer-specific contracts rather than a...

24 weeks (12 weeks pre-op + 12 weeks post-op)

DTxNative appRegional/SelectiveOngoing trial, unpublished💳 No co-pay
🦴 Musculoskeletal
DORA Digitale Orthopädie Anwendungen GmbH (Leipzig) · activetep.de
Entry last updated 8 Aug 2026

Ahead Health

🇨🇭 Switzerland

Ahead Health is a digital prevention programme, developed by Ahead Health AG, used for early detection of cancer, cardiovascular disease and other conditions via preventive full-body screening. Not indication-specific. It is offered in Switzerland as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate healthReal-world evidence only
⚕️ Not indication-specific
Ahead Health AG · startupticker.ch/en/news (funding round)
Entry last updated 30 Jul 2026

Allara Health

🇺🇸 USA

Allara Health is a virtual women's health clinic focused on PCOS and related hormonal and metabolic conditions, combining clinician visits with dietitian support, prescriptions and supplements. The company names its in-network payers rather than claiming blanket coverage, and states the coverage is state-by-state: Aetna (including Meritain), Blue Cross Blue Shield (including Anthem, CareFirst and affiliated plans), Cigna, UnitedHealthcare (including Oxford and UMR) and GEHA. Where a plan is not in network it offers a paid membership instead. Even with in-network coverage, patients remain responsible for copayments, coinsurance and deductibles. Checked Oct 2026.

Ongoing

Blended careNative app + virtual clinic (video visits)Regional/SelectiveMedicaid
Allara Health, Inc. · allarahealth.com/insurance-pricing
Entry last updated 14 Oct 2026

Alvie

🇩🇪 Germany

Alvie is a digital therapeutic (DTx), developed by Anker Health GmbH (Bayreuth, Germany, founded 2022), used for nonspecific pain of the cervical, thoracic and lumbar spine (ICD-10 M54). A CE-marked Class I medical device delivering an algorithm-personalised daily exercise plan plus pain education and relaxation content, adapted to the user's self-reported pain level. It is currently available in Germany only on a self-pay basis (EUR 135 for a 90-day licence, introductory price) while the company pursues DiGA (Sec.139e SGB V) listing; Alvie has already obtained BSI TR-03161 certification (the DiGA cybersecurity/IT-security requirement) without conditions, and a completed two-arm RCT (BackCare, DRKS00036874, n=143) is awaiting publication. Once listed as a DiGA, the manufacturer expects a price of roughly EUR 220-240, reimbursable by statutory health insurance.

90-day self-pay licence; 12-week programme

DTxNative app (iOS/Android)Self-payCompleted trial, unpublished💳 No co-pay
🦴 Musculoskeletal
Anker Health GmbH · alvie.app
Entry last updated 10 Oct 2026

AnyHand (LIME medical)

🇩🇪 Germany

AnyHand (LIME medical) is a connected medical device (with companion software), developed by LIME medical GmbH, used for post-injury hand/finger rehabilitation aftercare (bone, tendon, ligament injuries). Robotic-assisted motion therapy. It is reimbursed in Germany case-by-case through statutory accident insurance.

MedTech deviceConnected device / hardwareAccident insurance (BG, SGB VII)Ongoing trial, unpublished
🦴 Musculoskeletal
LIME medical GmbH · lime-medical.de
Entry last updated 30 Jul 2026

attexis - digitale Therapie bei ADHS im Erwachsenenalter

🇩🇪 Germany

attexis - digitale Therapie bei ADHS im Erwachsenenalter is a digital therapeutic (DTx), developed by GAIA AG, used for ADHD (adults). It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA §139e SGB V; manufacturer price EUR599.40/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentWeb appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
GAIA AG · diga.bfarm.de
Entry last updated 18 Oct 2026

Axia - für axiale Spondyloarthritis (axSpA)

🇩🇪 Germany

Axia - für axiale Spondyloarthritis (axSpA) is a digital therapeutic (DTx), developed by Applimeda GmbH, used for axial spondyloarthritis. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR599.00/90-day Rx (diga-verzeichnis.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
🦴 Musculoskeletal
Applimeda GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

Axomove Therapy

🇫🇷 France

Axomove Therapy is a digital rehabilitation and telemonitoring platform, developed by Axomove SAS, used for chronic/subacute low back pain rehabilitation follow-up after hospital-based functional rehabilitation. It is reimbursed nationally in France via the PECAN/LATM pathway. PECAN favourable CNEDiMTS/HAS opinion 22 Oct 2024; favourable CNEDiMTS/HAS opinion for permanent LATM listing published 7 May 2026 -- first PECAN-origin musculoskeletal/rehabilitation product to reach durable reimbursement.

MonitoringWeb app / mobile app (exercise prescription + telemonitoring)National reimbursementPublished RCT (this product)
🦴 Musculoskeletal
Axomove SAS · has-sante.fr (avis CNEDiMTS 22 Oct 2024 & 7 May 2026)
Entry last updated 11 Oct 2026

bauchgefuehl

🇩🇪 Germany

bauchgefuehl is a digital prevention programme, developed by bauchgefuehl, used for online course on gut health and digestion (Darmgesundheit). It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). Zertifiziert nach Sec.20 SGB V; bis zu 100% Zuschuss der gesetzlichen Krankenkasse.

PreventionWeb appNational reimbursement🇩🇪 §20 Chapter 5
🦠 Digestive
bauchgefuehl · bauchgefuehl-praevention.de
Entry last updated 4 Sep 2026

Beating the Blues

🇬🇧 United Kingdom

Beating the Blues is a digital therapeutic (DTx), used for depression and generalised anxiety disorder (GAD). Its earlier NICE guidance (TA97) was withdrawn in 2018. It was named in NICE's 2023 draft process for a new depression/anxiety Early Value Assessment pathway, but does not appear in either of the resulting final guidances (HTG675 for depression, HTG676 for anxiety) -- unlike SilverCloud, Koa Health's iCT-PTSD/iCT-SAD and Spring, which are named in those final guidances. No active NICE backing for this product was found as of this research.

DTxNative appN/A (reimbursement status unconfirmed)Published RCT (this product)💳 No co-pay
💭 Mental Health
Company not recorded · nice.org.uk/news/articles/nice-recommends-8-digitally-enabled-therapies-to-treat-depression-and-anxiety (1 Mar 2023)
Entry last updated 10 Oct 2026

BeWell Well@Home

🇧🇪 Belgium

BeWell Well@Home is a remote-monitoring / digital health platform, developed by BeWell Innovations, used for chronic heart failure remote monitoring. Questionnaires, connected vital-sign measurement, education, diary, secure messaging and video consultation with the care team. It is reimbursed nationally in Belgium.

MonitoringApp + clinician platformNational reimbursement
🫀 Heart & Circulatory
BeWell Innovations · mhealthbelgium.be/apps/app-details/bewell-wellhome
Entry last updated 23 Oct 2026

BIOTRONIK Home Monitoring

🇩🇪 Germany

BIOTRONIK Home Monitoring is a connected medical device (with companion software), developed by BIOTRONIK SE & Co. KG, used for pacemaker / ICD / CRT follow-up (cardiac implantable electronic devices). It is reimbursed nationally in Germany via nationwide EBM remote-monitoring/telemonitoring billing codes. Reimbursed since 1 April 2016.

MedTech deviceConnected device / hardwareNational reimbursementPublished RCT (this product)
🫀 Heart & Circulatory
BIOTRONIK SE & Co. KG · biotronik.com
Entry last updated 30 Jul 2026

Biotronik Home Monitoring Service Center

🇫🇷 France

Biotronik Home Monitoring Service Center is the remote-monitoring platform through which recordings from the manufacturer’s implanted cardiac devices reach the treating cardiology team between in-person checks. France reimburses the implantable-cardiac-monitor follow-up activity through a product-specific code per platform, all at an identical rate; the clinical service is the same across vendors and the French tariff reflects that.

Ongoing

MonitoringConnected device with companion softwareNational reimbursement
🫀 Heart & Circulatory
BIOTRONIK SE & Co. KG · Legifrance: Arrete du 23 June 2025 (JORFTEXT000051806217, inscription LATM)
Entry last updated 24 Oct 2026

BlueStar

🇺🇸 USA

BlueStar is an FDA-cleared digital therapeutic, developed by Welldoc, Inc. (Columbia, MD), used for type 1 and type 2 diabetes management. One of the earliest FDA-cleared DTx products (original clearance 2013, with 10+ subsequent clearances), it combines a patient-facing coaching app with connected glucose-meter/CGM data for the prescribing clinician. It is reimbursed today primarily through Medicare and commercial Remote Patient Monitoring billing (CPT 99453/99454/99457), billed by the treating clinician -- a different code family from the Medicare DMHT G-codes used by behavioral-health digital therapeutics -- and is also distributed via employer and health-plan contracts.

Ongoing chronic-care management

MonitoringNative app + connected glucose meter/CGM dataNational reimbursementPublished RCT (this product)💳 Co-pay applies
🩸 Metabolic Diseases
Welldoc, Inc. · welldoc.com
Entry last updated 30 Jul 2026

Boston Scientific LATITUDE Clarity (LUX-Dx ICM)

🇫🇷 France

Boston Scientific LATITUDE Clarity is a remote-monitoring data-management system for the LUX-Dx insertable cardiac monitor (ICM), developed by Boston Scientific Corporation, used for remote monitoring and programming of patients with an implantable cardiac monitor. It is reimbursed nationally in France via the LATM telemonitoring pathway. Listed on France's LATM list via Arrete du 3 mars 2026, for remote monitoring of LUX-Dx ICM patients.

MonitoringConnected device / hardwareNational reimbursementReal-world evidence only
🫀 Heart & Circulatory
Boston Scientific Corporation · legifrance.gouv.fr (Arrete du 3 mars 2026)
Entry last updated 11 Oct 2026

Boston Scientific LATITUDE NXT

🇩🇪 Germany

Boston Scientific LATITUDE NXT is a connected medical device (with companion software), developed by Boston Scientific Corporation, used for pacemaker / ICD / CRT follow-up. It is reimbursed nationally in Germany via nationwide EBM remote-monitoring/telemonitoring billing codes. Reimbursed since 1 April 2016.

MedTech deviceConnected device / hardwareNational reimbursementPublished RCT (related product)
🫀 Heart & Circulatory
Boston Scientific Corporation · kbv.de
Entry last updated 30 Jul 2026

Breathment

🇩🇪 Germany

Breathment is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, used for COPD (also asthma). AI-guided breathing/stretching/mobilisation exercises via phone camera with live audio/visual form feedback, plus a physiotherapist-staffed chat/video-consultation layer (app + human hybrid, not software-only). It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

3, 6, or 12 months (tiered -- EUR100/EUR200/EUR400 respectively)

Blended careNative appRegional/SelectiveReal-world evidence only
🫁 Respiratory
Breathment GmbH · breathment.com
Entry last updated 30 Jul 2026

brite (XO Life, formerly ImpactMonitor)

🇩🇪 Germany

brite (XO Life, formerly ImpactMonitor) is a manufacturer-sponsored digital therapy-support platform, developed by XO Life GmbH (Munich, Germany), used for asthma and COPD digital therapy support funded via a biosyn partnership, alongside a broader medication-adherence and side-effect-tracking service spanning 30+ condition areas with various pharmaceutical partners. Unlike this dataset's other entries, funding comes from the drug/device manufacturer paying XO Life directly, rather than a statutory health insurer or employer.

Blended careApp + clinician platformManufacturer-sponsoredReal-world evidence only
🫁 Respiratory
XO Life GmbH · xo-life.com
Entry last updated 30 Jul 2026

Calorymama Plus (Karo Mama Purasu)

🇯🇵 Japan

Calorymama Plus (Karo Mama Purasu) is a digital prevention programme, developed by Wellmira Inc. / Link and Communication Co., Ltd., used for general nutrition, exercise and sleep health management via AI photo-based food logging. Not indication-specific. It is offered in Japan as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
Wellmira Inc. / Link and Communication Co., Ltd. · plus.calomama.com
Entry last updated 30 Jul 2026

Cara Care für Reizdarm

🇩🇪 Germany

Cara Care für Reizdarm is a digital therapeutic (DTx), developed by HiDoc Technologies GmbH, used for irritable bowel syndrome. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR248.00/90-day Rx (diga-verzeichnis.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementCompleted trial, unpublished💳 No co-pay
🦠 Digestive
HiDoc Technologies GmbH (owned by Bayer since spring 2025; previously acquired by Mahana Therapeutics in 2024) · diga.bfarm.de
Entry last updated 18 Oct 2026

CardioSignal

🇫🇮 Finland

CardioSignal is a CE Class IIa-certified digital health monitoring app, developed by Precordior Oy (Turku, Finland), used for atrial fibrillation detection via a 60-second smartphone-based chest measurement using the phone's accelerometer and gyroscope. It is sold self-pay direct-to-consumer in 15+ countries. Precordior is separately one of 10 companies selected for Finland's DigiFinland pilot (Oct 2025), a government evaluation programme testing how digital therapies should integrate into the healthcare system -- the pilot itself carries no reimbursement mechanism yet.

60-second measurement

MonitoringNative app (smartphone accelerometer/gyroscope)Self-payPublished RCT (this product)
🫀 Heart & Circulatory
Precordior Oy · cardiosignal.com
Entry last updated 30 Jul 2026

Careline

🇫🇷 France

Careline Solutions is a French telemonitoring provider for chronic heart failure, working as a Medtronic partner. Patients are followed remotely between consultations and signals of deterioration are relayed to the cardiology team. Unlike Satelia Cardio, which holds its own higher-rated code for the same condition, Careline is reimbursed through the generic heart-failure telemonitoring activity -- a reminder that in France a reimbursed service does not always mean a separately listed product.

MonitoringClinician-facing platformNational reimbursementReal-world evidence only
🫀 Heart & Circulatory
Careline Solutions · careline.fr (abgerufen 23.10.2026)
Entry last updated 23 Oct 2026

CareLink System

🇧🇪 Belgium

CareLink System is a remote-monitoring / digital health platform, developed by Medtronic Belgium (Medtronic plc), used for pacemaker / ICD / CRT-D / CRT-P follow-up (cardiac implantable electronic devices), via the MyCareLink Heart app or a bedside monitor. It is reimbursed nationally in Belgium.

MonitoringApp + clinician platformNational reimbursementPublished RCT (this product)
🫀 Heart & Circulatory
Medtronic Belgium (Medtronic plc) · mhealthbelgium.be/apps/app-details/carelink-system
Entry last updated 30 Jul 2026

Caspar Health (digitale Reha-Nachsorge)

🇩🇪 Germany

Caspar Health (digitale Reha-Nachsorge) is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Caspar Health GmbH, used for general post-rehabilitation aftercare (multi-indication). Structured digital follow-on care after orthopaedic, cardiac, oncological, psychosomatic and other rehab stays, intended to sustain therapy gains after discharge. It is reimbursed in Germany through the statutory pension/care-insurance system rather than standard health insurance.

Not fixed (duration tied to individual DRV aftercare period)

Blended careNative appPension/care insurance
🦴 Musculoskeletal🫀 Heart & Circulatory🎗️ Cancer💭 Mental Health
Caspar Health GmbH · caspar-health.de/en
Entry last updated 30 Jul 2026

Caterna Vision

🇩🇪 Germany

Caterna Vision is a digital therapeutic (DTx), developed by Caterna Vision GmbH (Berlin), used for amblyopia ('lazy eye'), children aged 4-12. Online vision-training games using a background wave pattern intended to stimulate the brain-eye connection, ~30-45 min/day, ophthalmologists can monitor progress online. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

3 months (fixed therapy period)

DTxNative appRegional/SelectivePublished RCT (related product)💳 No co-pay
👁️ Eyes/Vision🧸 Pediatric
Caterna Vision GmbH · caterna.de
Entry last updated 30 Jul 2026

Champion Health

🇬🇧 United Kingdom

Champion Health is a digital prevention programme, developed by Champion Health Ltd., used for mental health and musculoskeletal risk, plus physical and financial wellbeing. Not indication-specific. It is offered in the United Kingdom as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
💭 Mental Health🦴 Musculoskeletal
Champion Health Ltd. · championhealth.co.uk
Entry last updated 30 Jul 2026

CodeThera

🇰🇷 South Korea

CodeThera is a digital therapeutic (DTx), developed by EmocoG (이모코크), used for mild cognitive impairment (MCI). It is available in South Korea on a self-pay basis -- a reimbursement-eligible pathway may exist, but the patient currently pays out of pocket rather than an insurer or employer.

DTxNative appSelf-payPublished RCT (this product)
🧠 Nervous System🧑‍🦳 Geriatric
EmocoG (이모코크) · themedical.kr (2025-06-10)
Entry last updated 30 Jul 2026

Cogthera App

🇩🇪 Germany

Cogthera App is a digital therapeutic (DTx), developed by Cogthera GmbH (Munich, Germany), used for mild cognitive impairment (MCI, ICD-10 F06.7) and mild Alzheimer's dementia. A personalised multimodal intervention combining cognitive training, dual-task movement exercises, audio-guided meditation and educational content. Cogthera GmbH states it is provisionally listed as a DiGA and reimbursed by statutory health insurance; a CE-marked Class I medical device since December 2023. However, Cogthera App does not appear anywhere in BfArM's official DiGA-Verzeichnis as of this research (checked including the delisted/"Gestrichen" filter), so the DiGA-listing claim could not be independently verified. Cogthera GmbH reports that a multicenter randomized controlled trial in Germany showed positive effects on cognitive ability in people with MCI; this has not been published, so the claim could not be independently verified.

DTxNative appN/A (reimbursement status unconfirmed)Completed trial, unpublished💳 No co-pay
🧠 Nervous System🧑‍🦳 Geriatric
Cogthera GmbH · cogthera.de
Entry last updated 10 Oct 2026

Comarch HomeHealth 2.0

🇧🇪 Belgium

Comarch HomeHealth 2.0 is a remote-monitoring / digital health platform, developed by Comarch AG - Belgian Branch, used for chronic heart failure and other chronic-disease remote monitoring. It is reimbursed nationally in Belgium.

MonitoringApp + clinician platformNational reimbursement
🫀 Heart & Circulatory
Comarch AG - Belgian Branch · mhealthbelgium.be/apps/app-details/comarch-homehealth-20
Entry last updated 30 Jul 2026

companion patella powered by medi

🇩🇪 Germany

companion patella powered by medi is a digital therapeutic (DTx), developed by medi GmbH & Co. KG, used for patellar conditions / knee pain. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR223.49/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentWeb appNational reimbursementCompleted trial, unpublished💳 No co-pay
🦴 Musculoskeletal
medi GmbH & Co. KG · diga.bfarm.de
Entry last updated 19 Oct 2026

companion(R) shoulder

🇩🇪 Germany

companion(R) shoulder is a digital therapeutic (DTx), developed by medi GmbH & Co. KG, used for shoulder lesions/pain. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA (provisional); manufacturer price EUR419.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PreliminaryWeb appNational reimbursementOngoing trial, unpublished💳 No co-pay
🦴 Musculoskeletal
medi GmbH & Co. KG · diga.bfarm.de
Entry last updated 19 Oct 2026

Comunicare

🇫🇷 France

Comunicare is a remote-monitoring / digital health platform, developed by Comunicare, used for cardiac & renal remote monitoring. It is reimbursed nationally in France via the PECAN pathway. PECAN: EUR435 first 3 months then EUR38.30/month, max EUR780/yr (standard PECAN telesurveillance tariff, same schedule as Implicity).

MonitoringClinician-facing platformNational reimbursement
🫀 Heart & Circulatory
Comunicare · healthandtech.eu
Entry last updated 30 Jul 2026

Comunicare

🇧🇪 Belgium

Comunicare is a remote-monitoring / digital health platform, developed by Comunicare Solutions, used for chronic-disease communication and self-management. Cancer, heart failure, COPD, multiple myeloma and other chronic conditions (multi-indication digital care companion, not heart-failure-specific). It is reimbursed nationally in Belgium.

MonitoringApp + clinician platformNational reimbursementReal-world evidence only
🎗️ Cancer🫀 Heart & Circulatory🫁 Respiratory
Comunicare Solutions · mhealthbelgium.be/apps/app-details/comunicare
Entry last updated 30 Jul 2026

Cordiva

🇫🇷 France

Cordiva is a digital therapeutic, developed by CDM e-Health, used for remote home monitoring of chronic heart failure patients -- symptom questionnaire plus connected weighing scale, with alerts to the care team. A 2016 CNEDiMTS opinion did not recommend Cordiva for standard LPP listing, citing insufficient/non-transposable evidence of therapeutic benefit.

MonitoringConnected scale + web questionnaireRegional/SelectivePublished RCT (this product)
🫀 Heart & Circulatory
CDM e-Health (company website no longer resolves, Oct 2026) · has-sante.fr (CNEDiMTS opinion, 2016)
Entry last updated 10 Oct 2026

CoreHealth (now CoreHealth by Carebook)

🇨🇦 Canada

CoreHealth (now CoreHealth by Carebook) is a digital prevention programme, developed by CoreHealth Technologies Inc., used for general corporate wellness programme administration. Flexible/white-label, not indication-specific. It is offered in Canada as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
CoreHealth Technologies Inc. · cbinsights.com/company/corehealth-technologies
Entry last updated 30 Jul 2026

CorinRPM (Corin -- Connected Orthopaedic Insight)

🇬🇧 United Kingdom

CorinRPM (Corin -- Connected Orthopaedic Insight) is a remote-monitoring / digital health platform, developed by Corin Group (Corin Limited), used for hip and knee replacement (joint arthroplasty) perioperative patient engagement, PROMs collection, and progressive post-op exercise videos, feeding the surgeon-facing CorinConnect analytics platform. It is provided free in the United Kingdom by the treating hospital or device manufacturer as part of the care episode itself -- not billed to any insurer, employer or the patient.

MonitoringNative appProvider-bundled
🦴 Musculoskeletal
Corin Group (Corin Limited) · coringroup.com/healthcare-professionals/products/corin-rpm
Entry last updated 30 Jul 2026

Curable

🇺🇸 USA

Curable is a direct-to-consumer mobile app, developed by Curable Inc. (Chicago, IL), used for chronic pain -- back pain, migraine, fibromyalgia, sciatica, neck/joint/pelvic/hip pain -- via a biopsychosocial, mind-body pain-reprocessing program (pain education, CBT, meditation, expressive writing, somatic tracking). Sold purely direct-to-consumer on a self-pay annual-subscription basis (no Medicare DMHT, commercial-payer, or employer-sponsored channel identified); HSA/FSA-eligible, and clinicians can refer patients to 6 weeks of free access via the "Curable Connect" portal. No FDA clearance identified -- marketed as a general wellness/self-management program rather than a regulated medical device. Its core program is supported by a published randomized controlled trial (Thomson et al 2024, Canadian Journal of Pain; n=198, 6-week intervention vs. wait-list control, improved pain severity and interference; the paper won the journal's 2024 Paper of the Year award).

6-week core program (ongoing self-paced use thereafter)

DTxNative app (iOS/Android) + webSelf-payPublished RCT (this product)💳 Co-pay applies
🦴 Musculoskeletal
Curable Inc. · curablehealth.com
Entry last updated 10 Oct 2026

Curafida (ZTM Bad Kissingen)

🇩🇪 Germany

Curafida (ZTM Bad Kissingen) is a remote-monitoring / digital health platform, developed by ZTM Bad Kissingen GmbH (Zentrum für Telemedizin e.V. / Stiftung Innovative Gesundheitsversorgung), used for chronic heart-failure remote monitoring (vital-sign telemonitoring); platform also used for other indications e.g. Multiple sclerosis ('MS-intakt'). It is reimbursed nationally in Germany via nationwide EBM remote-monitoring/telemonitoring billing codes. Reimbursed since Jan 2022 where a contracted physician bills the national HFTM codes; the sekTOR-HF Innovationsfonds pilot itself (Jun...

MonitoringNative appNational reimbursement💳 No co-pay
🫀 Heart & Circulatory
ZTM Bad Kissingen GmbH (Zentrum für Telemedizin e.V. / Stiftung Innovative Gesundheitsversorgung) · ztm.de (sekTOR-HF blog, Feb 2025)
Entry last updated 30 Jul 2026

CureApp AUD (marketed as HAUDY)

🇯🇵 Japan

CureApp AUD (marketed as HAUDY) is a digital therapeutic (DTx), developed by CureApp, Inc. (developer); Sawai Pharmaceutical (commercial distribution), used for alcohol use disorder / drinking-reduction treatment. It is reimbursed nationally in Japan via an NHI Chuikyo (Central Social Insurance Medical Council) listing. Reimbursed since 1 Sept 2025 -- NHI-listed; 3rd CureApp product to reach reimbursement, commercialised in partnership with Sawai Pharmaceutical as 'HAUDY'.

DTxNative appNational reimbursementPublished RCT (this product)💳 Co-pay applies
💭 Mental Health
CureApp, Inc. · prtimes.jp (CureApp release)
Entry last updated 30 Jul 2026

CureApp HT

🇯🇵 Japan

CureApp HT is a digital therapeutic (DTx), developed by CureApp, Inc., used for hypertension, adjunct to lifestyle-modification therapy. It is reimbursed nationally in Japan via an NHI Chuikyo (Central Social Insurance Medical Council) listing. Reimbursed since 1 Sept 2022 -- NHI reimbursement price: JPY7,010.

DTxNative appNational reimbursementPublished RCT (this product)💳 Co-pay applies
🫀 Heart & Circulatory
CureApp, Inc. · cureapp.co.jp/productsite/ht/insurance.html
Entry last updated 30 Jul 2026

CureApp SC

🇯🇵 Japan

CureApp SC is a digital therapeutic (DTx), developed by CureApp, Inc., used for nicotine dependence / smoking cessation, used alongside varenicline. It is reimbursed nationally in Japan via an NHI Chuikyo (Central Social Insurance Medical Council) listing. Reimbursed since 1 Dec 2020 -- NHI reimbursement price: 2,540 points (~JPY25,400) per course of treatment.

DTxNative appNational reimbursementPublished RCT (this product)💳 Co-pay applies
💭 Mental Health
CureApp, Inc. · mhlw.go.jp
Entry last updated 30 Jul 2026

Cureety Techcare

🇫🇷 France

Cureety Techcare is a remote-monitoring platform for people undergoing cancer treatment. Patients complete follow-up questionnaires at set intervals, organised by therapeutic class for systemic treatments and by anatomical site for radiotherapy; questions and answers follow the CTCAE standard, so symptom grading rests on objective criteria rather than free text. Responses are triaged automatically and only those crossing a threshold are escalated to the care team. The same product is listed in Belgium under the mHealthBELGIUM cancer-telemonitoring pathway.

Ongoing during anticancer treatment

MonitoringWeb platform plus clinician dashboardNational reimbursement
🎗️ Cancer
Cureety SAS · Legifrance: Arrete du 25 octobre 2023 (PECAN)
Entry last updated 23 Oct 2026

Cureety Techcare

🇧🇪 Belgium

Cureety Techcare is a remote-monitoring platform for people undergoing cancer treatment. Patients complete follow-up questionnaires at set intervals -- organised by therapeutic class for systemic treatments and by anatomical site for radiotherapy -- whose questions and answers follow the CTCAE standard (Common Terminology Criteria for Adverse Events), so grading rests on objective criteria rather than a free-form scale. Each answer carries a score; the total places the patient in a clinical classification (correct, fragile, to be monitored, critical). Amber and red cases both alert the care team and prompt the patient to contact the hospital, while lower grades return self-management advice for grade 1 and 2 adverse events. A telephone module covers patients who cannot or prefer not to use the app: a team member enters their answers during a call and the same analysis runs, so the whole cohort stays in remote follow-up rather than only its digital-capable part. In Belgium the product sits at level M3 of the mHealthBELGIUM validation pyramid -- the reimbursed tier.

Ongoing during anticancer treatment

MonitoringWeb platform (patient-facing questionnaires plus a clinician dashboard)National reimbursementPublished RCT (this product)
🎗️ Cancer
Cureety SAS · mhealthbelgium.be/apps (accessed 23 Oct 2026)
Entry last updated 23 Oct 2026

CyberHealth

🇩🇪 Germany

CyberHealth is a digital prevention programme, developed by CyberHealth, used for platform of 11 certified 8-week online prevention courses (weight loss, back coaching, yoga, pilates, diabetes prevention, PMR relaxation, smoking cessation, nutrition). Video modules plus downloadable materials and a short weekly questionnaire, on-demand via app or browser. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). Certified Sec.20 SGB V online courses meeting the GKV-Spitzenverband's Leitfaden Praevention requirements; most statutory insurers...

8 weeks

PreventionNative appNational reimbursement🇩🇪 §20 Chapter 5
⚕️ Not indication-specific
CyberHealth · cyberhealth.de
Entry last updated 10 Oct 2026

Das Lab (DasLab)

🇩🇪 Germany

Das Lab (DasLab) is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, used for colorectal cancer screening. At-home stool test, digital lab report, and (for positive results) a video consultation with a telemedicine physician plus onward referral. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

One-time screening (not an ongoing programme)

Blended careNative appRegional/Selective
🎗️ Cancer🦠 Digestive
Das Lab GmbH · healthy-hub.de (4th-round winner announcement, Nov 2022)
Entry last updated 30 Jul 2026

Daylight (DaylightRx)

🇺🇸 USA

Daylight (DaylightRx) is a digital therapeutic (DTx), developed by Big Health, used for generalised anxiety disorder. It is reimbursed nationally in the USA via Medicare's HCPCS G0552-G0554 digital mental health treatment codes. Reimbursed since 1 Jan 2025 -- Billed by the prescribing clinician: G0552 + G0553/G0554.

DTxNative appNational reimbursementMedicarePublished RCT (this product)💳 Co-pay applies
💭 Mental Health
Big Health · aapc.com
Entry last updated 30 Jul 2026

DBLG1 System (Diabeloop)

🇩🇪 Germany

DBLG1 System (Diabeloop) is an automated insulin delivery (AID) system: an insulin pump coupled to a real-time CGM (Dexcom G6), with the DBLG1 algorithm automatically adjusting the basal rate and delivering automatic correction boluses while leaving manual adjustment available. In Germany it is listed in the Hilfsmittelverzeichnis under § 33 SGB V as "Variante 3" of product types 30.29.05/30.29.06 — the category defined by exactly that combination of automatic basal adjustment and automatic correction boluses — and is supplied nationwide on prescription.

Continuous use for as long as the indication persists

MedTech device🇩🇪 HilfsmittelConnected device / hardwareNational reimbursementPublished RCT (this product)💳 Co-pay applies
🩸 Metabolic Diseases
Diabeloop SA · GKV Hilfsmittelverzeichnis, product types 30.29.05 and 30.29.06 (queried 20 Oct 2026)
Entry last updated 20 Oct 2026

DE-RENA / DE-RENA 2.0

🇩🇪 Germany

DE-RENA / DE-RENA 2.0 is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Binacon GmbH (Mannheim, Germany), used for psychosomatic Reha-Nachsorge for depressive disorders. (smartphone) app supporting individual daily-structure planning to help patients sustain newly-learned coping behaviours after psychosomatic rehab, with regular contact to an assigned aftercare therapist. It is reimbursed in Germany through the statutory pension/care-insurance system rather than standard health insurance.

Not fixed (duration tied to individual DRV aftercare period)

Blended careNative appPension/care insuranceReal-world evidence only
💭 Mental Health
Binacon GmbH · nachderreha.de (DRV's official digital Reha-Nachsorge portal, describing DE-RENA/DE-RENA 2.0)
Entry last updated 30 Jul 2026

Deep Care (Isa)

🇩🇪 Germany

Deep Care (Isa) is a digital prevention programme, developed by Deep Care GmbH, used for workplace ergonomics, posture, stress and indoor air-quality monitoring. Not indication-specific. It is offered in Germany as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
🦴 Musculoskeletal💭 Mental Health
Deep Care GmbH · deep-care.com/en/hi-im-isa
Entry last updated 30 Jul 2026

deprexis

🇩🇪 Germany

deprexis is a digital therapeutic (DTx), developed by GAIA AG, used for depression. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR228.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentWeb appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
GAIA AG · diga-verzeichnis.de
Entry last updated 19 Oct 2026

deprexis (CH)

🇨🇭 Switzerland

deprexis (CH) is a digital therapeutic (DTx), developed by GAIA AG, used for mild-to-moderate depression, recurrent depressive disorders. It is reimbursed nationally in Switzerland via the MiGeL/dGA listing (OKP compulsory insurance). OKP (Obligatorische Krankenpflegeversicherung, compulsory health insurance) covers a Höchstvergütungsbetrag (HVB, max. reimbursement amount) of CHF193.32 out of a CHF271.32 total price; the remaining Selbstbehalt (co-payment) is often covered by supplementary insurance (Zusatzversicherung); requires prescription by a psychiatry/psychotherapy specialist or a...

DTxWeb appNational reimbursementPublished RCT (this product)💳 Co-pay applies
💭 Mental Health
GAIA AG · gaia-group.com (press release, 30 Jun 2026)
Entry last updated 30 Jul 2026

dermanostic

🇩🇪 Germany

dermanostic is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by dermanostic GmbH, used for skin conditions incl. acne, eczema, psoriasis, suspicious moles. Photo + questionnaire teledermatology, reviewed by a board-certified dermatologist. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

Blended careNative appRegional/SelectiveReal-world evidence only
🩹 Skin/Dermatology
dermanostic GmbH · dermanostic.de
Entry last updated 30 Jul 2026

detoxi Health App

🇩🇪 Germany

detoxi Health App is a digital prevention programme, developed by detoxi Health GmbH, used for digital stress management. App-blocking, focus sessions and 300+ "life hacks" to reduce screen time and digital stress. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). SHI-reimbursed up to 100% of EUR99.99 course fee after completing 40 missions over 9 weeks and submitting a participation certificate; ZPP-certified under Sec.20 Abs.1 SGB V, course ID KU-ST-4JDL2F.

9 weeks

PreventionNative appNational reimbursement🇩🇪 §20 Chapter 7
💭 Mental Health
detoxi Health GmbH · detoxi.info
Entry last updated 4 Sep 2026

Dexcom Clarity (Dexcom G6/G7, GB)

🇬🇧 United Kingdom

Dexcom Clarity (Dexcom G6/G7, GB) is a connected medical device (with companion software), developed by Dexcom Inc., used for type 1 diabetes (all ages); insulin-treated type 2 diabetes meeting local eligibility criteria. It is reimbursed nationally in the United Kingdom via the NICE NG17 pathway. Reimbursed (NHS-funded sensor; companion app free) -- Same NICE NG17 national pathway as FreeStyle LibreLink above; Dexcom G6/G7 sensors prescribed via NHS diabetes services, Dexcom Clarity is the free companion analytics app (also has a clinician-facing web platform).

MedTech deviceConnected device / hardwareNational reimbursementPublished RCT (related product)
🩸 Metabolic Diseases
Dexcom Inc. · nice.org.uk/guidance/ng17
Entry last updated 30 Jul 2026

Dexcom G6 / G7

🇩🇪 Germany

Dexcom G6 / G7 is a connected medical device (with companion software), developed by Dexcom Inc., used for insulin-treated diabetes. It is reimbursed nationally in Germany via nationwide EBM remote-monitoring/telemonitoring billing codes. Reimbursed (individual case approval by Krankenkasse).

MedTech device🇩🇪 HilfsmittelConnected device / hardwareNational reimbursementPublished RCT (this product)💳 Co-pay applies
🩸 Metabolic Diseases
Dexcom Inc. · dexcom.com/de-de/fachpersonal/kostenuebernahme
Entry last updated 20 Oct 2026

Diabeloop DBLG1

🇫🇷 France

Diabeloop DBLG1 is a connected medical device (with companion software), developed by Diabeloop SA, used for type 1 diabetes (inadequate control on insulin pump). It is reimbursed nationally in France via the LPPR pathway. LPPR codes 1177410 (terminal) & 1102872 (daily algorithm licence); limited to adults with >6 months intensive insulin pump therapy and insufficient glycaemic control.

MedTech deviceConnected device / hardwareNational reimbursementPublished RCT (this product)
🩸 Metabolic Diseases
Diabeloop SA · vidal.fr
Entry last updated 30 Jul 2026

Diabeo

🇫🇷 France

Diabeo is a digital therapeutic, developed by Voluntis, used for insulin-dose titration support for insulin-treated diabetes patients -- mobile app calculates bolus/basal dose recommendations from blood-glucose and carbohydrate data, with an optional clinician web portal for telemonitoring. Reimbursed on France's LPP since a September 2016 HAS opinion -- reported as the first digital health app reimbursed by French statutory health insurance (Assurance Maladie).

DTxNative app + clinician web portalNational reimbursementPublished RCT (this product)
🩸 Metabolic Diseases
Aptar Digital Health (formerly Voluntis; voluntis.com now redirects there) · has-sante.fr (2016 opinion
Entry last updated 10 Oct 2026

EasyBreath

🇰🇷 South Korea

EasyBreath is a digital therapeutic (DTx), developed by Share&Service (쉐어앤서비스), used for COPD, asthma, lung-cancer-related. Respiratory rehabilitation. It is available in South Korea on a self-pay basis -- a reimbursement-eligible pathway may exist, but the patient currently pays out of pocket rather than an insurer or employer.

DTxNative appSelf-payPublished RCT (this product)
🫁 Respiratory
Share&Service (쉐어앤서비스) · themedical.kr (2025-06-10)
Entry last updated 30 Jul 2026

eatappie

🇩🇪 Germany

eatappie is a digital therapeutic (DTx), developed by Mind Generation GmbH (Heidelberg, founded Sept 2023 -- EXIST-Gründerstipendium spin-off; founders Dr. med. Larissa Niemeyer and Dr. med. Szarah Sanchez Roman, ex-Zentralinstitut für Seelische Gesundheit), used for anorexia and bulimia nervosa in adolescents (12-18); digital CBT-based companion, bridges waiting times and supports post-inpatient follow-up. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

Not specified (ongoing access while TK-insured)

DTxNative appRegional/SelectiveOngoing trial, unpublished💳 No co-pay
💭 Mental Health🧸 Pediatric
Mind Generation GmbH · eatappie.de
Entry last updated 30 Jul 2026

eCovery - Therapie bei Schmerzen im unteren Rücken

🇩🇪 Germany

eCovery - Therapie bei Schmerzen im unteren Rücken is a digital therapeutic (DTx), developed by eCovery GmbH, used for lower back pain. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA (provisional); manufacturer price EUR574.00/90-day Rx (diga-verzeichnis.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementOngoing trial, unpublished💳 No co-pay
🦴 Musculoskeletal
eCovery GmbH · diga.bfarm.de
Entry last updated 27 Oct 2026

eCovery (AOK PLUS Satzungsleistung -- non-DiGA indications)

🇩🇪 Germany

eCovery (AOK PLUS Satzungsleistung -- non-DiGA indications) is a digital therapeutic (DTx), developed by eCovery GmbH (same manufacturer as the lower-back DiGA), used for upper back pain, hip pain, knee pain (incl. Osteoarthritis/cartilage wear, meniscus issues) and pre-/post-operative care for total hip or knee replacement (TEP); TEP patients pay a EUR99 co-payment out of a EUR399 total, all other indications fully covered up to the EUR300 cap. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

12 months (annual benefit cap)

DTxNative appRegional/SelectiveReal-world evidence only💳 No co-pay
🦴 Musculoskeletal
eCovery GmbH · ecovery.de/aok-plus
Entry last updated 30 Jul 2026

eduMovo

🇩🇪 Germany

eduMovo is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, used for multimodal digital rehabilitation aftercare. Interactive learning units, individual training plans, task management, chat/video contact with the aftercare team. It is reimbursed in Germany through the statutory pension/care-insurance system rather than standard health insurance.

Not fixed (duration tied to individual DRV aftercare period)

Blended careNative appPension/care insurancePublished RCT (related product)
⚕️ Not indication-specific
eduMovo (FAU Erlangen-Nürnberg spin-off, Lehrstuhl Bewegung und Gesundheit; distributed via ZTM Bad Kissingen GmbH) · nachderreha.de (DRV's official digital Reha-Nachsorge provider list)
Entry last updated 30 Jul 2026

edupression.com

🇩🇪 Germany

edupression.com is a digital therapeutic (DTx), developed by edupression GmbH, used for depression. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR224.80/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentWeb appNational reimbursementCompleted trial, unpublished💳 No co-pay
💭 Mental Health
edupression GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

EGYM Wellpass (formerly qualitrain)

🇩🇪 Germany

EGYM Wellpass (formerly qualitrain) is a digital prevention programme, developed by EGYM Wellpass GmbH (part of EGYM GmbH), used for general fitness and wellness access. Not indication-specific. It is offered in Germany as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
EGYM Wellpass GmbH · fitness-news-germany.de/qualitrain-wird-zu-egym-wellpass (rebrand)
Entry last updated 30 Jul 2026

elevida

🇩🇪 Germany

elevida is a digital therapeutic (DTx), developed by GAIA AG, used for multiple sclerosis (fatigue/mental health support). It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR243.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentWeb appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health🧠 Nervous System
GAIA AG · diga.bfarm.de
Entry last updated 19 Oct 2026

elona explore - für die mentale Gesundheit

🇩🇪 Germany

elona explore - für die mentale Gesundheit is a digital therapeutic (DTx), developed by Elona Health GmbH, used for depression. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA (provisional); manufacturer price EUR535.49/90-day Rx (diga-verzeichnis.de).

DTx🇩🇪 DiGA PreliminaryNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
Elona Health GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

elona therapy Depression

🇩🇪 Germany

elona therapy Depression is a digital therapeutic (DTx), developed by Elona Health GmbH, used for depression. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR229.50/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
Elona Health GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

EndeavorOTC

🇺🇸 USA

EndeavorOTC is an FDA-cleared, over-the-counter digital therapeutic, developed by Akili Interactive Labs, Inc. (Boston, MA), used for ADHD-related inattention in adults. It uses the same game-based mechanism as Akili's prescription product EndeavorRx (tracked separately for children ages 8-12), cleared in Jun 2024 as a distinct, adult-facing, non-prescription SKU. It is sold direct-to-consumer through app stores on a self-pay basis, independent of Medicare DMHT billing or commercial-payer contracts.

4 weeks minimum (25 min/day, 5 days/week)

DTxNative app (game-based), sold OTCSelf-payPublished RCT (related product)💳 Co-pay applies
💭 Mental Health
Akili Interactive Labs, Inc. · akiliinteractive.com
Entry last updated 30 Jul 2026

ENDEAVORRIDE

🇯🇵 Japan

ENDEAVORRIDE is a digital therapeutic (DTx), developed by Shionogi & Co., Ltd. (Japan rights; underlying technology from Akili Interactive, USA), used for paediatric ADHD, ages 6-17, when environmental/psychosocial interventions are insufficient. It is reimbursed nationally in Japan via an NHI Chuikyo (Central Social Insurance Medical Council) listing. Approval 13 Feb 2025; reimbursement effective 5 Jun 2026 -- NHI reimbursement: material fee 1,450 points for the app + guidance-management fee (B005-14: 90 points) + induction-phase add-on (50 points); limited to 2 prescriptions per patient.

DTxNative appNational reimbursementPublished RCT (this product)💳 Co-pay applies
🧠 Nervous System🧸 Pediatric
Shionogi & Co., Ltd. · shionogi.com press release (18 Feb 2025)
Entry last updated 30 Jul 2026

EndeavorRx

🇺🇸 USA

EndeavorRx is a digital therapeutic (DTx), developed by Akili Interactive Labs, Inc. (Boston, MA; a wholly-owned subsidiary of Virtual Therapeutics since a July 2024 tender offer), used for ADHD -- inattention in children and teens (ages 8-17). Delivered as a video-game-based intervention played roughly 25 minutes a day, 5 days a week, for a minimum of 4 weeks, it received FDA De Novo clearance in 2020 as the first prescription treatment delivered through a video game (label expanded from ages 8-12 to 8-17 in Dec 2023). It is reimbursed nationally in the US via Medicare's DMHT G-codes (G0552-G0554) since 1 Jan 2026, after CMS's CY2026 Physician Fee Schedule Final Rule extended DMHT payment eligibility to ADHD digital-therapy devices under 21 CFR 882.5803 -- the device classification created for EndeavorRx's own clearance. It remains selectively covered by some commercial payers and state Medicaid plans via outcome-based contracts (e.g. Highmark BCBS, Molina Medicaid Ohio) alongside the new Medicare pathway; other payers still classify it as investigational. A self-pay, non-prescription OTC version (EndeavorOTC, for adults) is also available independent of insurance.

4 weeks minimum (25 min/day, 5 days/week)

DTxNative app (game-based)National reimbursementMedicarePublished RCT (this product)💳 Co-pay applies
💭 Mental Health🧸 Pediatric
Akili Interactive Labs, Inc. · sidley.com (CMS CY2026 PFS Final Rule)
Entry last updated 10 Oct 2026

Endo-App

🇩🇪 Germany

Endo-App is a digital therapeutic (DTx), developed by Endo Health GmbH, used for endometriosis. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR235.80/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
♀️ Gynaecology
Endo Health GmbH · diga.bfarm.de
Entry last updated 18 Oct 2026

endogApp

🇩🇪 Germany

endogApp is a hospital patient-information and care-pathway companion app, developed by endogap Klinik für Gelenkersatz (Klinikum Garmisch-Partenkirchen GmbH), used for perioperative patient information and individual treatment timeline for hip and knee joint replacement surgery at endogap Klinik für Gelenkersatz (Klinikum Garmisch-Partenkirchen). It is provided free in Germany by the treating hospital or device manufacturer as part of the care episode itself -- not billed to any insurer, employer or the patient.

Patient informationNative appProvider-bundled
🦴 Musculoskeletal
endogap Klinik für Gelenkersatz (Klinikum Garmisch-Partenkirchen GmbH) · play.google.com/store/apps/details?id=de.endogap.endogap
Entry last updated 30 Jul 2026

enna care

🇩🇪 Germany

enna care combines a home emergency call system with a voice assistant for older people living alone, plus an app for relatives. Beyond the emergency button it offers reminders, orientation and spoken everyday assistance, which the manufacturer gives as the reason a co-payment remains rather than the system being fully covered: "Weil enna mehr kann als ein reines Notrufgerät, bleibt ein Eigenanteil von 9,90 EUR im Monat". Funding runs through the long-term care insurance: enna joined the GKV framework contract for home emergency call services and announced the first confirmed Pflegekasse approvals on 9 September 2026. A care level of Pflegegrad 1 or above and living largely alone at home are the stated conditions -- about 80% of its users according to the company -- and enna files the application digitally during ordering. Pricing: EUR 9.90/month with the subsidy on a 12-month term, EUR 39.90/month as a self-payer, EUR 4.90 shipping, 30-day free trial. Notable as a reimbursement pattern: the provider is licensed through a framework contract, so a product listing in the Hilfsmittelverzeichnis is not required -- and enna appears in neither of the two groups that would otherwise apply (52.40.01 home emergency call systems, 52.40.05 modular assistance systems).

Subscription, 12-month term on the subsidised tariff; a monthly cancellable tariff is also offered

MonitoringHardware (wearable emergency button plus voice assistant) and a companion app foPension/care insurance💳 Co-pay applies
🧑‍🦳 Geriatric
enna systems GmbH · enna.care (Start, Hausnotruf, Preise, Impressum, accessed 19 Oct 2026)
Entry last updated 19 Oct 2026

EvoCare

🇩🇪 Germany

EvoCare is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by EvoCare Telemedizin ECT eG (Nuremberg/Erlangen area, Germany; own site states founded 2018, though the underlying telemedicine methodology traces to DRV-funded research at Fachklinik Herzogenaurach from ~1999-2004), used for multimodal digital rehabilitation aftercare across orthopaedics (chronic back pain, joint-replacement aftercare), cardiology (coronary heart disease secondary prevention), neurology (aphasia, stroke, cognitive/attention training) and general...

Not fixed (duration tied to individual DRV aftercare period)

Blended careNative appPension/care insurance
🦴 Musculoskeletal🫀 Heart & Circulatory🧠 Nervous System🧑‍🦳 Geriatric
EvoCare Telemedizin ECT eG · nachderreha.de (DRV's official digital Reha-Nachsorge provider list)
Entry last updated 30 Jul 2026

FEMNA Care

🇩🇪 Germany

FEMNA Care is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Femna Health M.E. GmbH (Berlin, founded 2016 by Maxie Matthiessen and Emily Casey), used for endometriosis, PCOS, PMS/PMDD, menstrual pain/cycle complaints, menopause. Includes 3 individual coaching sessions with medical professionals per programme. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

12 months (VIACTIV); duration at other partner funds not centrally published

Blended careNative appRegional/Selective
♀️ Gynaecology
Femna Health M.E. GmbH · femnacare.de
Entry last updated 10 Oct 2026

FibriCheck

🇧🇪 Belgium

FibriCheck is a remote-monitoring / digital health platform, developed by FibriCheck NV, used for atrial fibrillation / arrhythmia detection (smartphone PPG). It is reimbursed nationally in Belgium.

MonitoringApp + clinician platformNational reimbursementPublished RCT (this product)
🫀 Heart & Circulatory
FibriCheck NV · agoria.be
Entry last updated 30 Jul 2026

Fimo Health

🇩🇪 Germany

Fimo Health is a digital therapeutic (DTx), developed by Fimo Health GmbH (Bonn, founded 30 Dec 2019), used for long Covid, ME/CFS, cancer, multiple sclerosis, fibromyalgia, rheumatoid arthritis (chronic-disease companion, not single-indication). It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

6 months (mhplus Krankenkasse); duration at other partner funds not centrally published

DTxNative appRegional/SelectiveReal-world evidence only💳 No co-pay
🎗️ Cancer🧠 Nervous System🦴 Musculoskeletal
Fimo Health GmbH · fimohealth.com/en/insurances
Entry last updated 30 Jul 2026

FIT UND GESUND COACH

🇩🇪 Germany

FIT UND GESUND COACH is a digital prevention programme, developed by FIT UND GESUND COACH, used for starke Beine (Kniekrafttraining), Vom Walken zum Laufen and Rueckenfit. Movement-focused online prevention courses. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). ZPP-zertifiziert nach Sec.20 SGB V; EUR119, bis zu 100% Erstattung durch die gesetzliche Krankenkasse.

PreventionWeb appNational reimbursement🇩🇪 §20 Chapter 5
🦴 Musculoskeletal
FIT UND GESUND COACH · mobilo.coach
Entry last updated 10 Oct 2026

Flowzone

🇩🇪 Germany

Flowzone is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Flow Technologies (Oslo, Norway -- not a German company, but operates as a DRV-recognised aftercare provider in Germany), used for digital rehabilitation aftercare with 600+ exercises/seminars for orthopaedic and cardiac indications. It is reimbursed in Germany through the statutory pension/care-insurance system rather than standard health insurance.

Not fixed (duration tied to individual DRV aftercare period)

Blended careNative appPension/care insurance
🦴 Musculoskeletal🫀 Heart & Circulatory
Flow Technologies AS · nachderreha.de (DRV's official digital Reha-Nachsorge provider list)
Entry last updated 30 Jul 2026

ForPatientApp (B. Braun)

🇩🇪 Germany

ForPatientApp (B. Braun) is a remote-monitoring / digital health platform, developed by B. Braun Melsungen AG, used for perioperative guidance for hip and knee replacement, spine surgery, hernia surgery and colorectal surgery. Pre-op preparation, post-op recovery information, an assignable exercise programme (ForPatientApp Move), and PROM/PREM (patient-reported outcome/experience measure) data collection. It is provided free in Germany by the treating hospital or device manufacturer as part of the care episode itself -- not billed to any insurer, employer or the patient.

MonitoringApp + clinician platformProvider-bundled💳 No co-pay
🦴 Musculoskeletal🦠 Digestive
B. Braun Melsungen AG · bbraun.com/en/products-and-solutions/therapies/orthopaedic-surgery/pheno4u/forpatientapp.html
Entry last updated 30 Jul 2026

Freespira

🇺🇸 USA

Freespira is an FDA-cleared digital therapeutic, developed by Freespira, Inc. (Menlo Park, CA), used for panic attacks (panic disorder) and PTSD. It pairs a home-use breathing-sensor device with a 28-day program of twice-daily sessions to normalize respiration patterns linked to panic and hyperarousal symptoms. Cleared by the FDA since 2018 for adults, with a 2025 expansion to adolescents (13-17), it is reimbursed by several named commercial health plans and is eligible for Medicare billing under the DMHT G-codes (G0552-G0554), the same reimbursement family used by Akili, Big Health and Otsuka's prescription digital therapeutics.

28-day program (2 sessions/day)

DTxHome-use breathing-sensor device + 28-day programNational reimbursementMedicarePublished RCT (this product)💳 Co-pay applies
💭 Mental Health
Freespira, Inc. · freespira.com
Entry last updated 30 Jul 2026

FreeStyle Libre (2 / 3)

🇩🇪 Germany

FreeStyle Libre (2 / 3) is a connected medical device (with companion software), developed by Abbott Diabetes Care, used for insulin-treated diabetes (type 1 and insulin-treated type 2). It is reimbursed nationally in Germany via nationwide EBM remote-monitoring/telemonitoring billing codes. Reimbursed since 2016 (Libre); Libre 2 added 2019.

MedTech device🇩🇪 HilfsmittelConnected device / hardwareNational reimbursementPublished RCT (this product)💳 Co-pay applies
🩸 Metabolic Diseases
Abbott Diabetes Care · pro.freestyle.abbott
Entry last updated 20 Oct 2026

FreeStyle Libre Flash Glucose Monitoring System (BE)

🇧🇪 Belgium

FreeStyle Libre Flash Glucose Monitoring System (BE) is a connected medical device (with companion software), developed by Abbott SA/NV, used for interstitial glucose measurement for people (4+) with diabetes mellitus, including pregnant women; replaces blood-glucose testing for insulin dosing. It is reimbursed nationally in Belgium.

MedTech deviceConnected device / hardwareNational reimbursementPublished RCT (related product)
🩸 Metabolic Diseases
Abbott SA/NV · mhealthbelgium.be/apps/app-details/freestyle-libre-flash-glucose-monitoring-system
Entry last updated 30 Jul 2026

FreeStyle LibreLink (GB)

🇬🇧 United Kingdom

FreeStyle LibreLink (GB) is a connected medical device (with companion software), developed by Abbott Diabetes Care, used for type 1 diabetes (all ages); insulin-treated type 2 diabetes meeting local eligibility criteria. It is reimbursed nationally in the United Kingdom via the NICE NG17 pathway. Reimbursed (NHS-funded sensor; companion app free) -- NICE NG17 recommends offering rtCGM or isCGM to ALL adults/children with type 1 diabetes based on individual preference and device functionality; insulin-treated type 2 diabetes covered under narrower local-ICB criteria (typically multiple...

MedTech deviceConnected device / hardwareNational reimbursementPublished RCT (related product)
🩸 Metabolic Diseases
Abbott Diabetes Care · nice.org.uk/guidance/ng17
Entry last updated 30 Jul 2026

Frieda Menova

🇩🇪 Germany

Frieda Menova is a digital therapeutic (DTx), developed by Frieda Health GmbH, used for menopause and climacteric symptoms (vasomotor symptoms, sleep disturbance, psychological distress). A 12-week cognitive behavioral therapy (CBT) programme covering psychoeducation, cognitive restructuring, breathing/relaxation techniques, sleep hygiene and symptom tracking, developed with an interdisciplinary team spanning gynaecology, psychology and technology under the medical direction of Prof. Dr. med. Petra Stute (chief physician for gynaecological endocrinology; president of the European Menopause and Andropause Society). It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway, provisionally listed as of 7 Sep 2026.

12 weeks

DTx🇩🇪 DiGA PreliminaryNative appNational reimbursementPublished RCT (this product)💳 No co-pay
♀️ Gynaecology
Frieda Health GmbH · diga.bfarm.de/de/verzeichnis/02895
Entry last updated 18 Oct 2026

Gesundheitskurs.de (Plattform)

🇩🇪 Germany

Gesundheitskurs.de (Plattform) is a digital prevention programme, developed by Gesundheitskurs.de, used for platform hosting multiple ZPP-certified online prevention courses across movement, nutrition and stress/resilience, recognised by German statutory insurers. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). Platform for ZPP-certified prevention courses; all listed courses are certified under §20 SGB V; reimbursement of up to 100% depending on the statutory health insurer.

PreventionWeb appNational reimbursement🇩🇪 §20 Chapter 5
⚕️ Not indication-specific
umove GmbH · gesundheitskurs.de
Entry last updated 11 Sep 2026

Glooko XT (Candiss)

🇫🇷 France

Glooko XT (Candiss) is a remote-monitoring platform for diabetes management, developed by Glooko SAS (a French subsidiary of Glooko, Inc.), used for gestational diabetes monitoring in non-insulin-treated patients. It is reimbursed nationally in France via the LATM telemonitoring pathway. Listed on France's LATM list, Journal Officiel 26 Dec 2024; base tariff approx. EUR28/month per patient; indication limited to non-insulin-treated gestational diabetes (positive OGTT weeks 24-28, or fasting glucose >=0.92 g/L in the first trimester with a risk factor).

MonitoringMobile app + connected glucose meter/CGM integrationNational reimbursementReal-world evidence only
🩸 Metabolic Diseases
Glooko SAS · glooko.com
Entry last updated 23 Oct 2026

glucura Diabetestherapie

🇩🇪 Germany

glucura Diabetestherapie is a digital therapeutic (DTx), developed by Perfood GmbH, used for type 2 diabetes. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR499.80/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
🩸 Metabolic Diseases
Perfood Laboratories GmbH (successor to Perfood GmbH, which became insolvent in 2024) · diga.bfarm.de
Entry last updated 19 Oct 2026

GoJoe

🇬🇧 United Kingdom

GoJoe is a digital prevention programme, developed by GoJoe Ltd., used for general social/team fitness challenges and physical, mental and social wellbeing. Not indication-specific. It is offered in the United Kingdom as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
GoJoe Ltd. · gojoe.com/about
Entry last updated 30 Jul 2026

Grokker

🇺🇸 USA

Grokker is a digital prevention programme, developed by Grokker, Inc., used for general physical, emotional and financial wellbeing via video content. Not indication-specific. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate healthReal-world evidence only
⚕️ Not indication-specific
Grokker, Inc. · grokker.com
Entry last updated 30 Jul 2026

Gymlib

🇫🇷 France

Gymlib is a digital prevention programme, developed by Gymlib SAS, used for general fitness and wellness facility access. Not indication-specific. It is offered in France as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
Gymlib SAS · us.egym.com/en-us/blog/gymlib (EGYM acquires Gymlib)
Entry last updated 10 Oct 2026

Gymondo Praeventionskurse

🇩🇪 Germany

Gymondo Praeventionskurse is a digital prevention programme, developed by Gymondo GmbH, used for rueckenfit, Laufen and Funktionelle Ganzkoerperkraeftigung. Movement-based online prevention courses guided by physiotherapists/Reha-Trainer. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). Offiziell nach Sec.20 Abs.1 SGB V durch die ZPP zertifiziert; bis zu 100% Kostenerstattung durch die gesetzliche Krankenkasse; EUR99 je Kurs.

10 weeks

PreventionWeb appNational reimbursement🇩🇪 §20 Chapter 5
🦴 Musculoskeletal
Gymondo GmbH · prevention.gymondo.com
Entry last updated 10 Oct 2026

Hainan Class II DTx #4 -- Exercise/Cardiopulmonary Rehab Training Software (运动康复训练软件)

🇨🇳 China

Hainan Class II DTx #4 -- Exercise/Cardiopulmonary Rehab Training Software (运动康复训练软件) is a digital therapeutic (DTx), used for cardiopulmonary rehabilitation. Structured exercise-training programme to aid clinicians guiding patients through cardiopulmonary function rehab. It is billable in China (Hainan province) under a provincial fee-schedule, not yet nationwide health insurance.

DTxApp + clinician platformProvincial fee-schedule (Hainan)💳 Co-pay applies
🫀 Heart & Circulatory🫁 Respiratory
Company not recorded · amr.hainan.gov.cn, '海南省药监局批准一款数字疗法产品上市' (published 9 Feb 2024)
Entry last updated 30 Jul 2026

Hainan Class II DTx #5 -- Pulmonary Function Rehab Training Software (肺功能康复训练软件)

🇨🇳 China

Hainan Class II DTx #5 -- Pulmonary Function Rehab Training Software (肺功能康复训练软件) is a digital therapeutic (DTx), used for pulmonary (lung) function rehabilitation. Structured training programme to aid clinicians guiding patients through pulmonary rehab. It is billable in China (Hainan province) under a provincial fee-schedule, not yet nationwide health insurance.

DTxApp + clinician platformProvincial fee-schedule (Hainan)💳 Co-pay applies
🫁 Respiratory
Company not recorded · amr.hainan.gov.cn, '海南省药监局批准一款数字疗法产品上市' (published 13 Jun 2024)
Entry last updated 30 Jul 2026

Hainan Class II DTx #6 -- Cardiopulmonary Walking-Test Data Analysis Software (心肺步行试验数据分析软件)

🇨🇳 China

Hainan Class II DTx #6 -- Cardiopulmonary Walking-Test Data Analysis Software (心肺步行试验数据分析软件) is a digital therapeutic (DTx), used for exercise cardiopulmonary function assessment. Analyses walking-test data to assist medical staff (no automated diagnosis). It is billable in China (Hainan province) under a provincial fee-schedule, not yet nationwide health insurance.

DTxNative appProvincial fee-schedule (Hainan)💳 Co-pay applies
🫀 Heart & Circulatory🫁 Respiratory
Company not recorded · amr.hainan.gov.cn, '新增1个、累计6个!海南省药监局批准一款数字疗法产品上市' (published 24 Sep 2024)
Entry last updated 30 Jul 2026

Hainan Class II DTx #7 -- Cognitive Impairment Assessment & Training Software (认知功能障碍评估与训练软件)

🇨🇳 China

Hainan Class II DTx #7 -- Cognitive Impairment Assessment & Training Software (认知功能障碍评估与训练软件) is a digital therapeutic (DTx), used for mild cognitive impairment. Adjunct assessment and training aid. It is billable in China (Hainan province) under a provincial fee-schedule, not yet nationwide health insurance.

DTxNative appProvincial fee-schedule (Hainan)Ongoing trial, unpublished💳 Co-pay applies
🧠 Nervous System🧑‍🦳 Geriatric
Company not recorded · amr.hainan.gov.cn, '海南省药监局批准一款数字疗法产品上市' (published 12 Oct 2024)
Entry last updated 30 Jul 2026

Hansefit

🇩🇪 Germany

Hansefit is a digital prevention programme, developed by Hansefit GmbH (part of Epassi Group), used for general fitness and wellness access, plus individually rewarded health activities. Not indication-specific. It is offered in Germany as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
Hansefit GmbH · hansefit.de/presse/uebernahme-initiative-gesunder-betrieb (i-gb acquisition)
Entry last updated 30 Jul 2026

Headspace for Work / Headspace Care (incl. Ginger)

🇺🇸 USA

Headspace for Work / Headspace Care (incl. Ginger) is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Headspace Health, Inc. (Headspace + Ginger), used for mindfulness, stress, anxiety, depression and general mental-health support. Not indication-specific. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careNative appCorporate healthPublished RCT (this product)
💭 Mental Health
Headspace Health, Inc. (Headspace + Ginger) · forbes.com/sites/forrester/2021/09/07 (Ginger/Headspace merger)
Entry last updated 30 Jul 2026

Healabs

🇫🇷 France

Healabs is a remote-monitoring / digital health platform, developed by Healabs, used for cardiac & renal remote monitoring. It is reimbursed nationally in France via the PECAN pathway. PECAN: EUR435 first 3 months then EUR38.30/month, max EUR780/yr (standard PECAN telesurveillance tariff, same schedule as Implicity).

MonitoringClinician-facing platformNational reimbursementOngoing trial, unpublished
🫀 Heart & Circulatory
Healabs · healthandtech.eu
Entry last updated 30 Jul 2026

Health Hero (Long-COVID-Service)

🇩🇪 Germany

Health Hero (Long-COVID-Service) is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by HealthHero Germany GmbH (formerly Fernarzt; part of the pan-European HealthHero group since 2020), used for long-COVID / Post-COVID syndrome. Digital symptom-checker followed by a specialist video consultation with Long-COVID-trained doctors, plus an optional independent-rehabilitation coaching track. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

Not specified (symptom-check + consultation, plus optional coaching track)

Blended careNative appRegional/Selective
⚕️ Not indication-specific
HealthHero Germany GmbH · healthy-hub.de (4th-round winner announcement, Nov 2022)
Entry last updated 30 Jul 2026

Healthclapp

🇩🇪 Germany

Healthclapp is a digital prevention programme, developed by Healthclapp (Schuljahr & Putz), used for general workplace physical activity motivation. Not indication-specific. It is offered in Germany as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
Healthclapp · healthclapp.de
Entry last updated 30 Jul 2026

Healthentia

🇧🇪 Belgium

Healthentia is a remote-monitoring / digital health platform, developed by Innovation Sprint, used for digital biomarkers / remote monitoring (multi-pathology, incl. Heart failure). It is reimbursed nationally in Belgium.

MonitoringApp + clinician platformNational reimbursementPublished RCT (this product)
🫀 Heart & Circulatory
Innovation Sprint · agoria.be
Entry last updated 23 Oct 2026

hedy Telemonitoring

🇩🇪 Germany

hedy Telemonitoring is a connected medical device (with companion software), developed by Health Care Systems GmbH (HCSG), used for chronic heart failure remote monitoring (external measurement devices). It is reimbursed nationally in Germany via nationwide EBM remote-monitoring/telemonitoring billing codes. Reimbursed since Jan 2022.

MedTech deviceConnected device / hardwareNational reimbursement
🫀 Heart & Circulatory
Health Care Systems GmbH (HCSG) · hedy.de
Entry last updated 30 Jul 2026

HelloBetter Chronische Schmerzen

🇩🇪 Germany

HelloBetter Chronische Schmerzen is a digital therapeutic (DTx), developed by HelloBetter GmbH (GET.ON Institut), used for chronic pain. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR235.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
HelloBetter GmbH (GET.ON Institut) · diga.bfarm.de
Entry last updated 18 Oct 2026

HelloBetter Diabetes

🇩🇪 Germany

HelloBetter Diabetes is a digital therapeutic (DTx), developed by HelloBetter GmbH (GET.ON Institut), used for type 1 and type 2 diabetes (psych. comorbidity). It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR222.99/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
🩸 Metabolic Diseases💭 Mental Health
HelloBetter GmbH (GET.ON Institut) · diga.bfarm.de
Entry last updated 18 Oct 2026

HelloBetter Panik

🇩🇪 Germany

HelloBetter Panik is a digital therapeutic (DTx), developed by HelloBetter GmbH (GET.ON Institut), used for panic disorder. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR230.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
HelloBetter GmbH (GET.ON Institut) · diga.bfarm.de
Entry last updated 19 Oct 2026

HelloBetter Schlafen

🇩🇪 Germany

HelloBetter Schlafen is a digital therapeutic (DTx), developed by HelloBetter GmbH (GET.ON Institut), used for insomnia. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR241.25/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementCompleted trial, unpublished💳 No co-pay
💭 Mental Health
HelloBetter GmbH (GET.ON Institut) · diga.bfarm.de
Entry last updated 19 Oct 2026

HelloBetter Stress und Burnout

🇩🇪 Germany

HelloBetter Stress und Burnout is a digital therapeutic (DTx), developed by HelloBetter GmbH (GET.ON Institut), used for stress & burnout. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR235.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
HelloBetter GmbH (GET.ON Institut) · diga.bfarm.de
Entry last updated 19 Oct 2026

HelloBetter Vaginismus Plus

🇩🇪 Germany

HelloBetter Vaginismus Plus is a digital therapeutic (DTx), developed by HelloBetter GmbH (GET.ON Institut), used for vaginismus. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR235.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health♀️ Gynaecology
HelloBetter GmbH (GET.ON Institut) · diga.bfarm.de
Entry last updated 19 Oct 2026

HELP (HELP Schmerztherapie)

🇩🇪 Germany

HELP (HELP Schmerztherapie) is a digital therapeutic (DTx), developed by HELP Mee Schmerztherapie GmbH (founder/CEO Dr. med. Antje Kallweit, specialist in anaesthesiology / special pain therapy), used for chronic 'nociplastic' pain (i.e. pain sustained by nervous-system processing rather than ongoing tissue damage). Fibromyalgia, chronic back/neck pain, persistent pelvic pain, or pain that persists after an injury/surgery has otherwise healed; 90-day, 24-module programme covering pain-neuroscience education, neuroplasticity-based exercises, and behavioural-medicine techniques; earmarked...

90 days (24-module programme); 5-day trial option also available

DTxNative appRegional/Selective💳 No co-pay
🧠 Nervous System
HELP Mee Schmerztherapie GmbH · help-app.de
Entry last updated 30 Jul 2026

Herodikos (Herodikos App / Herakles)

🇩🇪 Germany

Herodikos (Herodikos App / Herakles) is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Herodikos GmbH (Varel, Niedersachsen, 2019), used for back pain, neck pain, knee pain. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

Ongoing (no fixed programme length found)

Blended careNative appRegional/SelectiveReal-world evidence only
🦴 Musculoskeletal
Herodikos GmbH · herodikos.de/versorgungsvertraege
Entry last updated 30 Jul 2026

Hinge Health (core MSK programme)

🇺🇸 USA

Hinge Health (core MSK programme) is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Hinge Health, Inc., used for musculoskeletal pain. Back, joint, knee, shoulder and general chronic pain. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careNative appCorporate healthPublished RCT (this product)
🦴 Musculoskeletal
Hinge Health, Inc. · hingehealth.com/resources/organizations
Entry last updated 9 Oct 2026

Hinge Health Global -- Germany

🇩🇪 Germany

Hinge Health Global -- Germany is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Hinge Health, Inc., used for musculoskeletal pain (same core programme as the US employer offering). It is offered in Germany as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careNative appCorporate healthPublished RCT (this product)
🦴 Musculoskeletal
Hinge Health, Inc. · hingehealth.com/product/global
Entry last updated 9 Oct 2026

Hinge Health Global -- United Kingdom

🇬🇧 United Kingdom

Hinge Health Global -- United Kingdom is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Hinge Health, Inc., used for musculoskeletal pain (same core programme as the US employer offering). It is offered in the United Kingdom as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careNative appCorporate healthPublished RCT (related product)
🦴 Musculoskeletal
Hinge Health, Inc. · hingehealth.com/product/global
Entry last updated 18 Sep 2026

Hinge Health Migraine Care Program

🇺🇸 USA

Hinge Health Migraine Care Program is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Hinge Health, Inc., used for migraine. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careNative appCorporate health
🧠 Nervous System
Hinge Health, Inc. · hingehealth.com/resources/organizations (recent programme expansions, migraine care)
Entry last updated 18 Sep 2026

Hinge Health Women's Pelvic Health

🇺🇸 USA

Hinge Health Women's Pelvic Health is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Hinge Health, Inc., used for pelvic-floor disorders. Prolapse, diastasis recti (abdominal separation), bladder/bowel problems, chronic pelvic pain; across pregnancy, postpartum and menopause. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careNative appCorporate healthReal-world evidence only
💧 Urogenital♀️ Gynaecology
Hinge Health, Inc. · hingehealth.com/blog/introducing-a-nationally-accessible-womens-pelvic-health-program-from-hinge
Entry last updated 30 Jul 2026

HingeSelect

🇺🇸 USA

HingeSelect is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Hinge Health, Inc., used for musculoskeletal conditions requiring in-person/specialist follow-up (surgical candidates, high-risk members). It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careNative appCorporate health
🦴 Musculoskeletal
Hinge Health, Inc. · fiercehealthcare.com (HingeSelect launch, provider network)
Entry last updated 30 Jul 2026

hiToco(R): ADHS Elterntraining

🇩🇪 Germany

hiToco(R): ADHS Elterntraining is a digital therapeutic (DTx), developed by Medigital GmbH (MEDICE Health Family), used for ADHD (parent training, children). It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA (provisional); manufacturer price EUR479.20/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PreliminaryNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health🧸 Pediatric
Medigital GmbH (MEDICE Health Family) · diga.bfarm.de
Entry last updated 18 Oct 2026

Humanoo

🇩🇪 Germany

Humanoo is a digital prevention programme, developed by Humanoo GmbH (trading as eTherapists GmbH), used for general workplace fitness, physiotherapy, yoga, meditation, nutrition and sleep. Not indication-specific. It is offered in Germany as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
Humanoo GmbH (trading as eTherapists GmbH) · businessinsider.de/gruenderszene/health/humanoo-fitness-boni-arbeitgeber-a (Humanoo funding, business model)
Entry last updated 30 Jul 2026

Hyperhero (brainjo)

🇩🇪 Germany

Hyperhero (brainjo) is a digital therapeutic (DTx), developed by brainjo (Regensburg, Germany, founded 2022), used for ADHD (children, ages 8-13). A VR-based therapy delivered across 24 sessions in 5 modules over roughly 3 months (~40 minutes per session), developed in partnership with MEDICE and backed by EUR2M HTGF seed funding (Apr 2026). It is available in Germany on a self-pay basis while the company pursues DiGA listing, targeted for 2028.

3 months (24 sessions across 5 modules, ~40 min/session)

DTxVR (headset-based)Self-pay💳 No co-pay
💭 Mental Health🧸 Pediatric
brainjo · brainjo.de/adhd
Entry last updated 30 Jul 2026

ieso Digital Health (Mindler)

🇬🇧 United Kingdom

ieso Digital Health (Mindler) is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by ieso Digital Health (trading as Mindler), used for depression, anxiety and related common mental health conditions. It is reimbursed in the United Kingdom through regional or insurer-specific contracts rather than a nationwide scheme.

Blended careNative appRegional/SelectivePublished RCT (this product)
💭 Mental Health
ieso Digital Health (trading as Mindler) · iesohealth.com
Entry last updated 30 Jul 2026

Implicity

🇫🇷 France

Implicity is a remote-monitoring platform from Implicity SAS (Paris, founded 2016 by Dr Arnaud Rosier) for patients with cardiac implantable electronic devices. It aggregates data from implanted defibrillators, pacemakers and implantable cardiac monitors across manufacturers into a single clinician-facing view, with alert triage intended to reduce the review burden on cardiology teams. In France it moved in 2026 from the PECAN early-access scheme to the standard télésurveillance list under Article L. 162-52 of the Code de la sécurité sociale, across three indications: implantable defibrillators, pacemakers, and implantable cardiac monitors.

MonitoringClinician-facing platformNational reimbursementReal-world evidence only
🫀 Heart & Circulatory
Implicity SAS · Légifrance: Arrêté du 20 mai 2026 (JORFTEXT000054122358)
Entry last updated 23 Oct 2026

IncentFit

🇺🇸 USA

IncentFit is a digital prevention programme, developed by IncentFit, Inc., used for general fitness, wellness benefits and reimbursements. Not indication-specific. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
IncentFit, Inc. · incentfit.com
Entry last updated 30 Jul 2026

INKA

🇩🇪 Germany

INKA is a digital therapeutic (DTx), developed by nextec medical GmbH, used for urinary incontinence. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA (provisional); manufacturer price EUR670.49/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PreliminaryNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💧 Urogenital
nextec medical GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

InTandem

🇺🇸 USA

InTandem is an FDA-cleared, home-use digital therapeutic device, developed by MedRhythms, Inc. (Portland, ME), used for gait and mobility impairment after chronic stroke. It combines wearable movement sensors with auditory rhythmic cueing to guide walking rehabilitation. Following a 2020 FDA Breakthrough Device designation and 2023 Class II clearance, CMS finalized a dedicated Medicare Durable Medical Equipment billing code (HCPCS E3200) in Jan 2025, giving an estimated 15 million Medicare beneficiaries and roughly 800,000 chronic-stroke patients a reimbursement pathway to access it.

Ongoing home-use therapy

MedTech deviceWearable sensors + auditory rhythmic cueing (home-use device)National reimbursementMedicareOngoing trial, unpublished
🧠 Nervous System
MedRhythms, Inc. · medrhythms.com
Entry last updated 30 Jul 2026

Invirto - Die Therapie gegen Angst

🇩🇪 Germany

Invirto - Die Therapie gegen Angst is a digital therapeutic (DTx), developed by Sympatient GmbH, used for anxiety disorder. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR220.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
Sympatient GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

isi PMS App

🇩🇪 Germany

isi PMS App is a digital therapeutic (DTx), developed by Endo Health GmbH, used for premenstrual syndrome (PMS). It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA (provisional); manufacturer price EUR598.95/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PreliminaryNative appNational reimbursementOngoing trial, unpublished💳 No co-pay
♀️ Gynaecology
Endo Health GmbH · diga.bfarm.de/de/verzeichnis/02857 (listing and Fachkreise pages, checked Oct 2026)
Entry last updated 18 Oct 2026

JawBuddy

🇩🇪 Germany

JawBuddy is a jaw-exercise and tracking app, developed by JawBuddy GmbH (Leipzig, Germany) with dentists and physiotherapists, used for jaw pain, bruxism (teeth grinding) and temporomandibular joint (TMJ/CMD) tension. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified): a standalone "Progressive Muskelentspannung" course (Jacobson PMR technique), 8 weeks at 8x45 minutes, delivered entirely within the JawBuddy app (ZPP course ID KU-ST-73WY6K). SHI-reimbursed up to EUR59.99 course fee after completion and submission of a participation certificate; manufacturer states completion also includes 6 months of full app access.

PreventionNative appNational reimbursement🇩🇪 §20 Chapter 7
🦴 Musculoskeletal
JawBuddy GmbH · jawbuddy.com
Entry last updated 1 Oct 2026

JOE (Digital Therapy JOE)

🇫🇷 France

JOE (Digital Therapy JOE) is a connected medical device (with companion software), developed by Ludocare SAS, used for persistent paediatric asthma (ages 7-11). It is reimbursed nationally in France via the LPPR pathway. Pending: CEPS price negotiation, then publication in Journal Officiel before reimbursement is active.

MedTech deviceConnected device / hardwareNational reimbursementCompleted trial, unpublished
🫁 Respiratory🧸 Pediatric
Ludocare SAS · maddyness.com
Entry last updated 10 Oct 2026

kaarloApp

🇩🇪 Germany

kaarloApp is a digital therapeutic, developed by kaarlo health GmbH (Essen, Germany), used for somatoform and functional bodily disorders (ICD-10 F45.-) -- symptoms such as fatigue, dizziness, headache, back pain and exhaustion that are not sufficiently explained by organic causes. It combines a modular digital self-therapy programme with on-demand human support by video call (kaarloDoc), and is certified as a medical device. It is not a DiGA: it does not appear in BfArM's DiGA-Verzeichnis, listed or struck, as of Oct 2026. Access today is free of charge via a study; a selective-contract route with statutory insurers is in preparation following the GWQ ServicePlus / HAEVG innovation process of 2026, but no contract or start date has been published.

DTxNative app (iOS/Android) plus on-demand clinician video supportN/A (not yet reimbursed)Ongoing trial, unpublished💳 No co-pay
💭 Mental Health
kaarlo health GmbH · kaarlo.de (Impressum and patient site, Sep 2026)
Entry last updated 7 Oct 2026

Kaia COPD: Meine aktive COPD Therapie

🇩🇪 Germany

Kaia COPD: Meine aktive COPD Therapie is a digital therapeutic (DTx), developed by Kaia Health Software GmbH (acquired by Sword Health, Jan 2026), used for COPD (chronic obstructive pulmonary disease). Breathing/relaxation/movement exercise programme with an AI-based camera exercise coach. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

90 days (per activation code)

DTxNative appRegional/SelectivePublished RCT (this product)💳 No co-pay
🫁 Respiratory
Kaia Health Software GmbH · diga.bfarm.de/de/verzeichnis (Gestrichen-Filter)
Entry last updated 19 Oct 2026

Kaia Rückenschmerzen

🇩🇪 Germany

Kaia Rückenschmerzen is a digital therapeutic (DTx), developed by Kaia Health Software GmbH, used for back pain. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR221.49/90-day Rx (diga-verzeichnis.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
🦴 Musculoskeletal
Kaia Health Software GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

Kalmeda

🇩🇪 Germany

Kalmeda is a digital therapeutic (DTx), developed by Pohl-Boskamp Digital Health GmbH, used for chronic tinnitus. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR189.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
👂 Ears
Pohl-Boskamp Digital Health GmbH · diga.bfarm.de
Entry last updated 18 Oct 2026

Kira-App

🇩🇪 Germany

Kira-App is a digital therapeutic (DTx), developed by Endo Health GmbH (Chemnitz, Germany, founded 2020 as Endo Health UG by Nadine Rohloff), used for people coping with an unfulfilled desire to have children. A multimodal self-management companion (symptom/cycle/treatment diary, learning modules from reproductive medicine, psychology and nutrition, interactive exercises) addressing both the physical and emotional dimensions of fertility struggles. It is a CE-marked Class I medical device, free to download, but not yet listed in BfArM's DiGA directory. Any cost to unlock full content was not confirmed from public sources.

DTxNative appN/A (reimbursement status unconfirmed)💳 No co-pay
💧 Urogenital
Endo Health GmbH · apps.apple.com Kira-App (trackId 6670159048)
Entry last updated 19 Sep 2026

Kiso Mind

🇩🇪 Germany

Kiso Mind is a digital therapeutic, developed by Kiso Health GmbH (Berlin), a spin-off of Charite Universitaetsmedizin Berlin, used for schizophrenia and psychotic disorders. It delivers exercises from cognitive behavioural therapy alongside symptom self-monitoring, psychoeducation, reminders and a crisis plan, and is built with psychologists, psychotherapists and people with lived experience of psychosis; a companion app, Kiso Care, addresses relatives. It is a CE-marked Class I medical device under MDR. It is not reimbursed: the basic version is free, a Plus version is paid, and the company describes statutory cost coverage as in preparation. A randomised pilot trial runs at the Charite (NCT07395206).

DTxNative app (iOS/Android)N/A (not yet reimbursed)Ongoing trial, unpublished💳 No co-pay
💭 Mental Health
Kiso Health GmbH · kisohealth.de (patient site, Fuer Fachkreise page and Impressum, Oct 2026)
Entry last updated 7 Oct 2026

klariva

🇩🇪 Germany

klariva is a digital therapeutic (DTx), developed by GAIA AG (Hamburg, Germany, founded 2002 as GAIA Gesundheitsmanagement GmbH), used for psoriasis. A web-based, psychologically-oriented programme addressing the mental and emotional burden of psoriasis (self-esteem, mindfulness, sleep, weight, habit-building) alongside regular medical treatment. It is not yet self-pay or DiGA-reimbursed -- the public site only offers a login for existing study participants, with no purchase path found; GAIA has described Germany as the planned first launch market ahead of international expansion.

DTxWeb applicationPilotOngoing trial, unpublished💳 No co-pay
🩹 Skin/Dermatology
GAIA AG · klariva.de
Entry last updated 18 Sep 2026

Klenico

🇨🇭 Switzerland

Klenico is a web-based diagnostic support system for mental health. Patients complete a structured self-report module; the system maps the responses onto disorder domains and presents the clinician with a structured diagnostic picture before the first consultation, which the company positions as a way to reduce lengthy test batteries. It is a CE-marked medical device and is unusually well validated for this category: three peer-reviewed validation studies, including a comparison against the SCID diagnostic gold standard and a large psychotherapeutic inpatient sample. In Switzerland it is not on the MiGeL and not covered by mandatory basic insurance -- it reaches patients through agreements with individual insurers (Sanitas and KPT are named), and is sold directly to therapists and clinics.

Per assessment, no fixed programme length

Blended careWeb-based (no installation; self-report module sent to the patient, results reviRegional/SelectivePublished RCT (this product)
💭 Mental Health
Klenico Health AG · klenico.com (home, /versicherer, /unternehmen, /health-professionals, accessed 22 Oct 2026)
Entry last updated 22 Oct 2026

Koa Health iCT-PTSD

🇬🇧 United Kingdom

Koa Health iCT-PTSD is a digital therapeutic (DTx), developed by Koa Health, used for post-traumatic stress disorder (PTSD). It is reimbursed nationally in the United Kingdom via the NHS Talking Therapies DET pathway. NHS England DET-compliant, nationally usable within NHS Talking Therapies -- Commissioned locally by individual NHS Talking Therapies services, drawn from NICE's nationally-vetted DET list.

DTxNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
Koa Health · nice.org.uk/news/articles/nice-recommends-8-digitally-enabled-therapies-to-treat-depression-and-anxiety (1 Mar 2023)
Entry last updated 30 Jul 2026

Koa Health iCT-SAD

🇬🇧 United Kingdom

Koa Health iCT-SAD is a digital therapeutic (DTx), developed by Koa Health, used for social anxiety disorder (SAD). It is reimbursed nationally in the United Kingdom via the NHS Talking Therapies DET pathway. NHS England DET-compliant, nationally usable within NHS Talking Therapies -- Commissioned locally by individual NHS Talking Therapies services, drawn from NICE's nationally-vetted DET list.

DTxNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
Koa Health · nice.org.uk/news/articles/nice-recommends-8-digitally-enabled-therapies-to-treat-depression-and-anxiety (1 Mar 2023)
Entry last updated 30 Jul 2026

Kranus Edera

🇩🇪 Germany

Kranus Edera is a digital therapeutic (DTx), developed by Kranus Health GmbH, used for erectile dysfunction. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR235.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💧 Urogenital
Kranus Health GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

Kranus Lutera

🇩🇪 Germany

Kranus Lutera is a digital therapeutic (DTx), developed by Kranus Health GmbH, used for prostate enlargement / urinary urgency. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR240.50/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💧 Urogenital🧑‍🦳 Geriatric
Kranus Health GmbH · diga.bfarm.de
Entry last updated 18 Oct 2026

Kranus Mictera

🇩🇪 Germany

Kranus Mictera is a digital therapeutic (DTx), developed by Kranus Health GmbH, used for urinary incontinence. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR681.30/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💧 Urogenital🧑‍🦳 Geriatric
Kranus Health GmbH · diga.bfarm.de
Entry last updated 18 Oct 2026

levidex

🇩🇪 Germany

levidex is a digital therapeutic (DTx), developed by GAIA AG, used for multiple sclerosis (mental health support). It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR247.81/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentWeb appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health🧠 Nervous System
GAIA AG · diga.bfarm.de
Entry last updated 18 Oct 2026

Lifton D (リフトンD)

🇯🇵 Japan

Lifton D (リフトンD) is a digital therapeutic (program medical device / SaMD), developed by DT-Axis Co., Ltd., used for depression -- specifically relief of moderate-to-severe depressive symptoms that persist despite ongoing pharmacotherapy. It delivers a 20-week cognitive-behavioural-therapy programme alongside antidepressant treatment, and is built on research from Kyoto University. It received manufacturing and marketing approval on 25 Sep 2025 as Japan's first program medical device for depression. From 1 Jun 2026 it is designated 評価療養 (evaluation therapy) through 31 May 2030 -- a mixed-billing framework rather than reimbursement: the patient pays for the app on top of the normal insurance co-payment while real-world data is collected toward a possible future NHI listing.

20 weeks

DTxNative app (smartphone)Self-payCompleted trial, unpublished💳 Co-pay applies
💭 Mental Health
DT-Axis Co., Ltd. (DTアクシス株式会社) · dt-axis.co.jp (press release 2 Jun 2026)
Entry last updated 4 Oct 2026

Limeade

🇺🇸 USA

Limeade is a digital prevention programme, developed by Limeade, Inc., used for general employee wellbeing and organisational-listening/survey tools. Not indication-specific. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
Limeade, Inc. · sec.gov/Archives/edgar/data/1381507 (Limeade DEFM14A/PREM14A merger filings)
Entry last updated 30 Jul 2026

Lina-App

🇩🇪 Germany

Lina-App is a digital therapeutic (DTx), developed by Endo Health GmbH (Chemnitz, Germany, founded 2020 as Endo Health UG by Nadine Rohloff), used for lipedema (Lipödem). A multimodal self-management companion combining a symptom/pain diary with learning modules and exercises drawn from lymphology, phlebology, physiotherapy, pain medicine, nutrition and psychology. It is a CE-marked Class I medical device, free to download, but not yet listed in BfArM's DiGA directory -- a direct search of the official registry returns no lipedema DiGA at all as of this research. Any cost to unlock full content was not confirmed from public sources.

DTxNative appN/A (reimbursement status unconfirmed)💳 No co-pay
🩸 Metabolic Diseases
Endo Health GmbH · apps.apple.com Lina-App (trackId 6670159232)
Entry last updated 19 Sep 2026

Lindera Mobilitätsanalyse (Sturz-App)

🇩🇪 Germany

Lindera Mobilitätsanalyse (Sturz-App) is a digital prevention programme, developed by Lindera GmbH, used for fall-risk assessment / mobility analysis in older adults. AI analyses gait from a short smartphone-camera video to calculate individual fall risk, used mainly in nursing/care settings by staff, with results reviewed by clinicians/therapists for fall-prevention planning; Charite-affiliated study cites up to 15-20% fall-risk reduction. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

Not specified (ongoing access in care setting)

PreventionNative appRegional/SelectiveReal-world evidence only
🦴 Musculoskeletal🧑‍🦳 Geriatric
Lindera GmbH · lindera.ai/home
Entry last updated 30 Jul 2026

LipoAlly

🇩🇪 Germany

LipoAlly is a digital therapeutic (DTx), used for 12-month lipedema (Lipödem) companion programme. Video modules with medicine/therapy/psychology experts, monthly live courses, movement units, progress documentation. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

12 months

DTxNative appRegional/Selective💳 No co-pay
🩸 Metabolic Diseases
LipoCheck GmbH · lipocheck.de/unsere-apps/lipoally
Entry last updated 30 Jul 2026

lipodia

🇩🇪 Germany

lipodia is a digital therapeutic (DTx), developed by GAIA AG (Hamburg, Germany, founded 2002 as GAIA Gesundheitsmanagement GmbH), intended for adults with hypercholesterolemia as part of cardiovascular risk management. Daiichi Sankyo Europe holds exclusive commercialisation rights, with Germany as the initial launch market. It is not yet accessible to patients in any form -- a pivotal Phase III randomized controlled trial is currently enrolling, and GAIA plans to submit lipodia for DiGA (Sec.139e SGB V) reimbursement once the trial data are available.

DTxNative appPilotOngoing trial, unpublished💳 No co-pay
🫀 Heart & Circulatory
GAIA AG · gaia-group.com/en/news/digitale-unterstuetzung-lipidmanagement.html
Entry last updated 18 Sep 2026

Luma Life

🇩🇪 Germany

Luma Life is a voice-based AI companion for people living with dementia and their family carers at home. A friendly avatar provides reminders, spoken conversation and cognitive games, with the stated aim of more structure and independence in daily life and relief for carers. It is paid for entirely out of pocket in Germany: a permanently free tier (10 min conversation/day, 3 calendar entries, up to 2 carers), Solo at EUR 30/month or EUR 300/year, Familie at EUR 50/month or EUR 500/year (30-day trial, no card required), and an Unbegrenzt tier at EUR 200/month. It is not a medical device and not a detection or screening tool.

Subscription, no fixed programme length

Patient informationNative app (iOS/Android), voice-based AI assistantSelf-pay
🧠 Nervous System🧑‍🦳 Geriatric
Luma Life GmbH · lumalife.de (Start, Produkt, Impressum, accessed 19 Oct 2026)
Entry last updated 19 Oct 2026

Lumi Nova

🇬🇧 United Kingdom

Lumi Nova is a digital therapeutic (DTx), developed by BFB Labs, used for mild-to-moderate anxiety, ages 7-12. It is available in the United Kingdom through a regional or time-limited pilot commissioning arrangement, not (yet) an established national or ongoing regional/selective contract.

DTxNative appPilotReal-world evidence only💳 No co-pay
💭 Mental Health🧸 Pediatric
BFB Labs · luminova.app
Entry last updated 18 Sep 2026

Luminopia

🇺🇸 USA

Luminopia is an FDA-cleared digital therapeutic, developed by Luminopia, Inc. (Boston, MA), used to treat amblyopia ("lazy eye") in children. Delivered through a VR headset streaming modified television and video content that trains the amblyopic eye during normal at-home viewing, it received FDA De Novo clearance in Oct 2021 for ages 4-7, expanded to ages 8-12 in Apr 2025. It is actively covered by named commercial payers including Anthem Blue Cross Blue Shield and CareFirst BlueCross BlueShield.

Prescribed course, typically several months

DTxVR headset + streaming video contentRegional/SelectiveMedicaidPublished RCT (this product)💳 Co-pay applies
👁️ Eyes/Vision🧸 Pediatric
Luminopia, Inc. · luminopia.com
Entry last updated 30 Jul 2026

Luscii

🇳🇱 Netherlands

Luscii is a remote patient monitoring platform, developed by Luscii Healthtech B.V. (Amsterdam, Netherlands; an OMRON Healthcare company since its April 2024 acquisition), used for chronic-disease monitoring including heart failure, COPD and hypertension. Founded in 2013 by Ronald Scheffer, Joris Janssen and Daan Dohmen, it combines a patient-facing app with connected monitoring devices and clinician dashboards. The Netherlands has no DiGA-style dedicated digital-therapeutics reimbursement code; instead, Luscii is billed under the general Zvw basic health insurance rules whenever the clinical activity it supports is already covered. Despite the lack of a dedicated pathway, adoption is substantial: reimbursed by an estimated 94% of Dutch insurers and used across the majority of Dutch hospitals.

Ongoing chronic-care management

MonitoringNative app + connected monitoring devicesNational reimbursementReal-world evidence only💳 Co-pay applies
🫀 Heart & Circulatory🫁 Respiratory
Luscii Healthtech B.V. · luscii.com
Entry last updated 30 Jul 2026

MamaLift Plus

🇺🇸 USA

MamaLift Plus is a digital therapeutic (DTx), developed by Curio Digital Therapeutics, used for postpartum / maternal mental health. It is reimbursed nationally in the USA via Medicare's HCPCS G0552-G0554 digital mental health treatment codes. Reimbursed since 1 Jan 2025 -- Billed by the prescribing clinician: G0552 + G0553/G0554.

DTxNative appNational reimbursementMedicarePublished RCT (this product)💳 Co-pay applies
💭 Mental Health♀️ Gynaecology
Curio Digital Therapeutics · Digital Therapeutics Alliance G-code product list (Apr 2025)
Entry last updated 30 Jul 2026

MANN is(s)t smart

🇩🇪 Germany

MANN is(s)t smart is a digital prevention programme, developed by Mann-isst-smart / ESG, used for 10-week digital nutrition course for men, covering diet basics, heart health, metabolism and everyday-compatible eating habits. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). Zertifiziertes Praeventionsangebot nach Sec.20 SGB V; 80-100% Erstattung durch die gesetzliche Krankenkasse; EUR89.

10 weeks

PreventionWeb appNational reimbursement🇩🇪 §20 Chapter 5
🩸 Metabolic Diseases
Mann-isst-smart / ESG · mann-isst-smart.de
Entry last updated 4 Sep 2026

Mawendo

🇩🇪 Germany

Mawendo is a digital therapeutic (DTx), developed by Mawendo GmbH, used for patellar conditions / knee pain. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA (one-off licence); manufacturer price EUR119.00 one-off licence (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentWeb appNational reimbursementPublished RCT (this product)💳 No co-pay
🦴 Musculoskeletal
Mawendo GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

Medcle (formerly Med CBT-i)

🇯🇵 Japan

Medcle (formerly Med CBT-i) is a digital therapeutic (DTx), developed by SUSMED, Inc. (developer); Shionogi (commercialisation partner), used for insomnia disorder. 9-week CBT-I (cognitive behavioural therapy for insomnia) programme. It is reimbursed nationally in Japan via an NHI Chuikyo (Central Social Insurance Medical Council) listing. Approved for reimbursement 13 May 2026, effective 1 Jun 2026 -- NHI reimbursement price JPY24,100, plus guidance-management fee (B005-14: 90 points) and induction-phase add-on (50 points).

DTxNative appNational reimbursementPublished RCT (this product)💳 Co-pay applies
💭 Mental Health
SUSMED, Inc. · release.tdnet.info (13 May 2026 reimbursement-approval notice)
Entry last updated 30 Jul 2026

medicalmotion

🇩🇪 Germany

medicalmotion is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by medicalmotion GmbH (Munich, 2017, founders Sven & Tobias Klimpel), used for back and knee pain. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

Ongoing (no fixed programme length found)

Blended careNative appRegional/Selective
🦴 Musculoskeletal
medicalmotion GmbH · medicalmotion.com/de/uber-uns
Entry last updated 30 Jul 2026

Medtronic CareLink Network

🇩🇪 Germany

Medtronic CareLink Network is a connected medical device (with companion software), developed by Medtronic plc, used for pacemaker / ICD / CRT follow-up. It is reimbursed nationally in Germany via nationwide EBM remote-monitoring/telemonitoring billing codes. Reimbursed since 1 April 2016.

MedTech deviceConnected device / hardwareNational reimbursementPublished RCT (this product)
🫀 Heart & Circulatory
Medtronic plc · kbv.de
Entry last updated 30 Jul 2026

Medtronic CareLink Network

🇫🇷 France

Medtronic CareLink Network is the remote-monitoring platform through which recordings from the manufacturer’s implanted cardiac devices reach the treating cardiology team between in-person checks. France reimburses the implantable-cardiac-monitor follow-up activity through a product-specific code per platform, all at an identical rate; the clinical service is the same across vendors and the French tariff reflects that.

Ongoing

MonitoringConnected device with companion softwareNational reimbursement
🫀 Heart & Circulatory
Medtronic plc · Legifrance: Arrete du 24 July 2025 (JORFTEXT000052053609, inscription LATM)
Entry last updated 24 Oct 2026

Medtrum TouchCare System

🇩🇪 Germany

Medtrum TouchCare System is an automated insulin delivery (AID) system: an insulin pump coupled to a real-time CGM (the integrated Medtrum rtCGM), with the TouchCare algorithm automatically adjusting the basal rate and delivering automatic correction boluses while leaving manual adjustment available. In Germany it is listed in the Hilfsmittelverzeichnis under § 33 SGB V as "Variante 3" of product types 30.29.05/30.29.06 — the category defined by exactly that combination of automatic basal adjustment and automatic correction boluses — and is supplied nationwide on prescription.

Continuous use for as long as the indication persists

MedTech device🇩🇪 HilfsmittelConnected device / hardwareNational reimbursementReal-world evidence only💳 Co-pay applies
🩸 Metabolic Diseases
Medtrum Technologies Inc. / Medtrum GmbH · GKV Hilfsmittelverzeichnis, product types 30.29.05 and 30.29.06 (queried 20 Oct 2026)
Entry last updated 20 Oct 2026

Meine Tinnitus App

🇩🇪 Germany

Meine Tinnitus App is a digital therapeutic (DTx), developed by BAYOOCARE GmbH and operated by InfectoPharm Digital Health GmbH (Hamburg), used for tinnitus counselling. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA (one-off licence); manufacturer price EUR260.00 one-off licence (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
👂 Ears
BAYOOCARE GmbH (for InfectoPharm Digital Health GmbH) · diga.bfarm.de
Entry last updated 18 Oct 2026

MeineSana (Sana Kliniken)

🇩🇪 Germany

MeineSana (Sana Kliniken) is a hospital patient-information and care-pathway companion app, developed by Sana Kliniken AG, used for perioperative and general-treatment patient information across the Sana Kliniken hospital network. Live variants include hip/knee surgery preparation (Sana Kliniken Sommerfeld), obesity-centre patients (Karl-Olga Hospital Stuttgart), and general hospital-stay guidance (Sana Klinikum Munich, Rummelsberg, Baumann Klinik). It is provided free in Germany by the treating hospital or device manufacturer as part of the care episode itself -- not billed to any...

Patient informationNative appProvider-bundled
⚕️ Not indication-specific
Sana Kliniken AG · sana.de/sommerfeld/medizin-pflege/operative-orthopaedie/meine-sana-kliniken-sommerfeld-app
Entry last updated 30 Jul 2026

memodio

🇩🇪 Germany

memodio is a digital therapeutic (DTx), developed by memodio GmbH, used for Alzheimer's dementia, vascular dementia, and mild cognitive impairment (MCI). It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA (provisional); manufacturer price EUR595.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PreliminaryNative appNational reimbursementOngoing trial, unpublished💳 No co-pay
🧠 Nervous System🧑‍🦳 Geriatric
memodio GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

MENO!

🇩🇪 Germany

MENO! is a digital therapeutic (DTx), developed by Sidekick Health ehf (Reykjavik, Iceland; operated in Germany as Sidekick Health Germany GmbH -- the same corporate family behind PINK! Coach and zanadio), used for menopause symptoms. A CE-marked, CBT-based 12-week programme covering symptom tracking, coping strategies and lifestyle guidance. It is currently free to use for patients while the company pursues DiGA listing; the company reports that a German randomized controlled trial (ages 40-65, 12 weeks, vs. standard care) was completed successfully; this has not been published, so the claim could not be independently verified.

12-week programme

DTxNative appN/A (pilot, not reimbursed)Completed trial, unpublished💳 No co-pay
♀️ Gynaecology
Sidekick Health ehf · meno-app.com/de
Entry last updated 19 Sep 2026

mentalis

🇩🇪 Germany

mentalis is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by mentalis GmbH (Nuremberg, founded 2018; founders Alexander Ploner, Leonhard Glomann, Dr. Christian A. Lukas, Hans-Jürgen Stein), used for depression (programme 'Phoenix'), eating disorders ('MyJourney'), borderline personality disorder ('InBalance'), emotional-competence training ('TEK'). Algorithm-based therapy app + tele-coaching, set up on the patient's phone before hospital discharge, 26 weeks active + 6 months read-only. It is reimbursed in Germany through...

26 weeks active access + 6 months read-only follow-up

Blended careNative appRegional/SelectiveReal-world evidence only
💭 Mental Health
mentalis GmbH · aok.de (Rheinland/Hamburg)
Entry last updated 30 Jul 2026

MHComm

🇫🇷 France

MHComm is a remote-monitoring / digital health platform, developed by MHComm, used for cardiac & renal remote monitoring platform (multi-pathology). It is reimbursed nationally in France via the PECAN pathway. PECAN: EUR435 first 3 months then EUR38.30/month, max EUR780/yr (standard PECAN telesurveillance tariff, same schedule as Implicity).

MonitoringClinician-facing platformNational reimbursement
🫀 Heart & Circulatory
MHComm · healthandtech.eu
Entry last updated 30 Jul 2026

Midi Health

🇺🇸 USA

Midi Health is a virtual clinic for menopause and perimenopause: video visits with women's health clinicians, prescriptions and a care plan. Reimbursement attaches to the clinician visit, not to a listed product. Midi states it is in-network with most major plans nationwide and specifically with most PPO plans, while deductibles, coinsurance and copays vary by plan; HSA and FSA funds can be used. Two exclusions are stated plainly by the company: Medicare is out of network (beneficiaries are welcome as self-pay but cannot submit claims for visits, medications or associated services), and Medicaid/Medi-Cal patients are not accepted. Self-pay is USD250 for a 30-minute first visit and USD150 for a 15-minute returning visit. Closest comparator in this directory is Stella, which charges USD200/USD90 self-pay. Checked Oct 2026.

Ongoing

Blended careNative app + virtual clinic (video visits)Regional/SelectiveMedicaid
Midi Health, Inc. · joinmidi.com/pricing-insurance
Entry last updated 14 Oct 2026

Mika (Krebs Therapie Assistent)

🇩🇪 Germany

Mika (Krebs Therapie Assistent) is a digital health solution, developed by Fosanis GmbH, used for psycho-oncology support, initially ovarian/cervical/endometrial cancer. It is not currently reimbursed in Germany -- WITHDRAWN.

N/A (delisted)

DTxNative appRegional/Selective💳 No co-pay
⚕️ Not indication-specific
Fosanis GmbH · ptaheute.de
Entry last updated 18 Oct 2026

Mindable: Panik & Agoraphobie

🇩🇪 Germany

Mindable: Panik & Agoraphobie is a digital therapeutic (DTx), developed by Mindable Health GmbH, used for panic disorder / agoraphobia. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR245.50/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
Mindable Health GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

Mindable: Soziale Phobie

🇩🇪 Germany

Mindable: Soziale Phobie is a digital therapeutic (DTx), developed by Mindable Health GmbH, used for social phobia. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR765.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
Mindable Health GmbH · diga.bfarm.de
Entry last updated 18 Oct 2026

Minddistrict

🇳🇱 Netherlands

Minddistrict is a blended e-mental-health platform, developed by Minddistrict B.V. (Amsterdam, Netherlands; founded 2008), used by Dutch GGZ (mental health and addiction care) providers to deliver online modules, care plans and questionnaires alongside standard therapy for conditions including depression, anxiety and addiction. Described as the market leader in e-mental health in the Netherlands, it has no dedicated digital-therapeutics reimbursement code of its own -- it is billed as part of the standard GGZ treatment course it supports, reimbursed under the same general Zvw basic health insurance rules as that underlying care.

Ongoing -- part of a standard GGZ treatment course

Blended careWeb app + clinician-facing platformNational reimbursementPublished RCT (related product)
💭 Mental Health
Minddistrict B.V. · minddistrict.com
Entry last updated 30 Jul 2026

MindDoc Auf Rezept

🇩🇪 Germany

MindDoc Auf Rezept is a digital health solution, developed by MindDoc Health GmbH, used for depression. It is not currently reimbursed in Germany -- WITHDRAWN by MindDoc's own decision.

N/A (delisted)

DTxNative appRegional/Selective💳 No co-pay
⚕️ Not indication-specific
MindDoc Health GmbH · diga.bfarm.de/de/verzeichnis (Gestrichen-Filter)
Entry last updated 19 Oct 2026

MindDoc: Psychotherapie per Video

🇩🇪 Germany

MindDoc: Psychotherapie per Video is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by MindDoc Health GmbH (a Schön Klinik online offering since 2015, effectiveness researched with LMU Munich), used for depression, eating disorders, anxiety disorders, obsessive-compulsive disorder. Initial diagnostic assessment at one of 200+ partner practices nationwide, then a fixed weekly video therapy slot with a licensed psychotherapist (full outpatient behavioural therapy, not just self-help content), plus a crisis hotline and access...

Not fixed (ongoing outpatient psychotherapy; duration set by clinical need)

Blended careNative appRegional/SelectivePublished RCT (this product)
💭 Mental Health
MindDoc Health GmbH (a Schön Klinik online offering since 2015, effectiveness researched with LMU Munich) · barmer.de/unsere-leistungen/leistungen-a-z/psychische-gesundheit/minddoc-psychotherapie-per-video-1004076
Entry last updated 30 Jul 2026

MiniMed 780G

🇩🇪 Germany

MiniMed 780G is an automated insulin delivery (AID) system: an insulin pump coupled to a real-time CGM (Guardian 4 or Simplera Sync), with the SmartGuard algorithm automatically adjusting the basal rate and delivering automatic correction boluses while leaving manual adjustment available. In Germany it is listed in the Hilfsmittelverzeichnis under § 33 SGB V as "Variante 3" of product types 30.29.05/30.29.06 — the category defined by exactly that combination of automatic basal adjustment and automatic correction boluses — and is supplied nationwide on prescription.

Continuous use for as long as the indication persists

MedTech device🇩🇪 HilfsmittelConnected device / hardwareNational reimbursementPublished RCT (this product)💳 Co-pay applies
🩸 Metabolic Diseases
Medtronic MiniMed · GKV Hilfsmittelverzeichnis, product types 30.29.05 and 30.29.06 (queried 20 Oct 2026)
Entry last updated 20 Oct 2026

mom2be

🇩🇪 Germany

mom2be is a digital prevention programme, developed by mom2be, used for online courses covering pregnancy and the postpartum period (Beckenbodentraining, Pilates, Yoga). It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). Von den gesetzlichen Krankenkassen gefoerderte, zertifizierte Online-Kurse nach Sec.20 SGB V.

PreventionWeb appNational reimbursement🇩🇪 §20 Chapter 5
♀️ Gynaecology
mom2be · mom2be-praevention.de
Entry last updated 4 Sep 2026

MoovCare Poumon

🇫🇷 France

MoovCare Poumon is a digital therapeutic, developed by Sivan France, used for post-treatment follow-up for lung cancer patients -- early detection of relapse and complications via a weekly web-based patient symptom questionnaire, analysed by an algorithm that alerts the care team. Listed on France's LPP (reimbursable products list) since a 2019 CNEDiMTS opinion (Service Rendu Suffisant, ASA level III/moderate).

MonitoringWeb applicationNational reimbursementPublished RCT (this product)
🎗️ Cancer
Sivan France · has-sante.fr (CNEDiMTS opinions, 2019 and 2024)
Entry last updated 10 Oct 2026

moveUp

🇧🇪 Belgium

moveUp is a remote-monitoring / digital health platform, developed by moveUP NV, used for multi-domain digital care platform, NOT heart-failure-specific. Per the product's own mHealthBELGIUM listing: orthopaedics (arthroplasty and conservative treatment), cardiology (surgery and heart failure), oncology (haematology), abdominal surgery, obesity, respiratory (COPD, asthma) and neurology; personalised care plans, education and monitoring tools across all of these. It is reimbursed nationally in Belgium.

MonitoringApp + clinician platformNational reimbursementReal-world evidence only
🦴 Musculoskeletal🫀 Heart & Circulatory🎗️ Cancer🦠 Digestive🩸 Metabolic Diseases🫁 Respiratory🧠 Nervous System
moveUP NV · mhealthbelgium.be/apps/app-details/moveup
Entry last updated 23 Oct 2026

MOVEVO App

🇦🇹 Austria

MOVEVO App is a digital prevention programme, developed by Movevo Technologies GmbH, used for general workplace movement and physical-activity motivation. Not indication-specific. It is offered in Austria as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
Movevo Technologies GmbH · movevo.app
Entry last updated 30 Jul 2026

My Dose Coach

🇩🇪 Germany

My Dose Coach is a digital health solution, developed by METEDA s.r.l. (Italy); marketed in Germany by Sanofi, used for type 2 diabetes on long-acting basal insulin (or basal insulin + GLP-1 fixed combination). Physician sets a dosing plan via a portal, patient logs fasting blood glucose and receives daily insulin-dose guidance. It is not currently reimbursed in Germany -- Delisted.

N/A (delisted)

DTxNative appRegional/Selective💳 No co-pay
⚕️ Not indication-specific
METEDA s.r.l. (Italy) · diga.bfarm.de/de/verzeichnis (Gestrichen-Filter)
Entry last updated 19 Oct 2026

My7steps App

🇩🇪 Germany

My7steps App is a digital therapeutic (DTx), developed by My7steps gGmbH, used for depression. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR207.00/60-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentWeb appNational reimbursementCompleted trial, unpublished💳 No co-pay
💭 Mental Health
My7steps gGmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

myCOPD

🇬🇧 United Kingdom

myCOPD is a digital therapeutic, developed by My mHealth Limited, used for cOPD self-management -- digital pulmonary rehabilitation, symptom tracking, inhaler-technique training, education and medication support, with clinician communication. Formally recognised in two NICE Early Value Assessments (HTE18 for pulmonary rehabilitation, HTE19 for broader self-management), giving conditional NHS commissioning approval until December 2027 while further outcomes evidence is generated.

DTxNative app / webNational reimbursementPublished RCT (this product)💳 No co-pay
🫁 Respiratory
My mHealth Limited · nice.org.uk/guidance/htg736 and /htg718 (checked Oct 2026)
Entry last updated 10 Oct 2026

myDiabby Healthcare

🇫🇷 France

myDiabby Healthcare is a French diabetes-monitoring platform. Patients record blood-glucose readings in the app and the data reaches the diabetology team through a clinician-facing web dashboard, so follow-up during pregnancy can run between appointments instead of only at them. France reimburses the gestational-diabetes indication through a product-specific code on the telemonitoring list; the same platform is also used outside that indication, which is not covered by this listing.

Duration of the pregnancy

MonitoringWeb platform plus native appNational reimbursement
🩸 Metabolic Diseases
MDHC (myDiabby Healthcare) · Legifrance: Arrete du 19 aout 2024 (JORFTEXT000050126205)
Entry last updated 23 Oct 2026

mylife YpsoPump mit CamAPS FX

🇩🇪 Germany

mylife YpsoPump mit CamAPS FX is an automated insulin delivery (AID) system: an insulin pump coupled to a real-time CGM (Abbott FreeStyle Libre 3 or Dexcom G6), with the CamAPS FX (CamDiab) algorithm automatically adjusting the basal rate and delivering automatic correction boluses while leaving manual adjustment available. In Germany it is listed in the Hilfsmittelverzeichnis under § 33 SGB V as "Variante 3" of product types 30.29.05/30.29.06 — the category defined by exactly that combination of automatic basal adjustment and automatic correction boluses — and is supplied nationwide on prescription.

Continuous use for as long as the indication persists

MedTech device🇩🇪 HilfsmittelConnected device / hardwareNational reimbursementPublished RCT (this product)💳 Co-pay applies
🩸 Metabolic Diseases
Ypsomed AG · GKV Hilfsmittelverzeichnis, product types 30.29.05 and 30.29.06 (queried 20 Oct 2026)
Entry last updated 20 Oct 2026

MyMEDIAN@Home

🇩🇪 Germany

MyMEDIAN@Home is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by MEDIAN Kliniken (major German rehabilitation-clinic operator group; in-house developed), used for all somatic rehabilitation conditions (24 training/wellbeing/knowledge modules) plus a dedicated neurological track (36 modules). It is reimbursed in Germany through the statutory pension/care-insurance system rather than standard health insurance.

Up to 12 months post-rehab

Blended careNative appPension/care insurance
🧠 Nervous System⚕️ Not indication-specific
MEDIAN Kliniken · nachderreha.de (DRV's official digital Reha-Nachsorge provider list)
Entry last updated 30 Jul 2026

mymobility (Zimmer Biomet)

🇺🇸 USA

mymobility (Zimmer Biomet) is a remote-monitoring / digital health platform, developed by Zimmer Biomet Holdings, Inc., used for hip and knee replacement (joint arthroplasty) perioperative care management. Pre/post-op education, PROMs, and passive step-count/mobility tracking via a connected Apple Watch, feeding a surgeon-facing dashboard. It is reimbursed nationally in the USA via Medicare's Remote Therapeutic Monitoring CPT codes (98975-98981). Live -- widely deployed across US orthopaedic practices using Zimmer Biomet hip/knee implants -- App is free for the patient; the enrolling...

MonitoringNative appNational reimbursementReal-world evidence only💳 Co-pay applies
🦴 Musculoskeletal
Zimmer Biomet Holdings, Inc. · zimmerbiomet.com/en/patients-caregivers/mymobility-patient-care-app.html
Entry last updated 30 Jul 2026

myReha

🇩🇪 Germany

myReha is a digital therapeutic (DTx), developed by nyra health GmbH (Vienna, Austria, founded 2020; founders Moritz Schöllauf, Mario Zusag, Philipp Schöllauf; EUR20m Series A), used for speech, cognition, memory and everyday-skills therapy for neurological conditions: aphasia, stroke, traumatic brain injury, dementia; 65,000+ adaptive exercises. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

6 months (per licence)

DTxNative appRegional/Selective💳 No co-pay
🧠 Nervous System
nyra health GmbH · nyra.health
Entry last updated 30 Jul 2026

myReha (DRV Reha-Nachsorge)

🇩🇪 Germany

myReha (DRV Reha-Nachsorge) is a digital therapeutic (DTx), developed by nyra health GmbH (Vienna, Austria, founded 2020; founders Moritz Schöllauf, Mario Zusag, Philipp Schöllauf; EUR20m Series A), used for same speech, cognition, memory and everyday-skills therapy for neurological conditions (aphasia, stroke, traumatic brain injury, dementia, Parkinson's, MS) as the GKV-Selektivvertrag offering, delivered as DRV-funded post-rehab aftercare instead. ~50,000 patients across 100+ clinics, ~98% satisfaction reported in a DRV pilot. It is reimbursed in Germany through the statutory...

Not fixed (duration tied to individual DRV aftercare period)

DTxNative appPension/care insuranceReal-world evidence only💳 No co-pay
🧠 Nervous System
nyra health GmbH · nachderreha.de (DRV's official digital Reha-Nachsorge provider list)
Entry last updated 30 Jul 2026

myWEIGHTcoach / myHEALTHcoach

🇩🇪 Germany

myWEIGHTcoach / myHEALTHcoach is a digital prevention programme, developed by ESG, used for 8-week digital nutrition and weight-management courses (myWEIGHTcoach for weight loss, myHEALTHcoach for general healthy eating) offered through multiple statutory insurers. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). ZPP-zertifiziert nach Sec.20 SGB V; EUR89, 71-89% Erstattung je nach Krankenkasse; gelistet u.a. bei KKH, Novitas-BKK, meine krankenkasse.

8 weeks

PreventionWeb appNational reimbursement🇩🇪 §20 Chapter 5
🩸 Metabolic Diseases
ESG · my-weightcoach.de
Entry last updated 4 Sep 2026

Nacken-Athlet / MOBIFIT / Stickletics

🇩🇪 Germany

Nacken-Athlet / MOBIFIT / Stickletics is a digital prevention programme, developed by Ramin Waraghai, used for neck/shoulder strength (Nacken-Athlet), mobility (MOBIFIT) and pole training (Stickletics). Movement-based online prevention courses by DSHS-Koeln-credentialed trainer Ramin Waraghai, hosted on gesundheitskurs.de. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). ZPP-zertifiziert nach Sec.20 SGB V; EUR119, bis zu 100% Erstattung durch die gesetzliche Krankenkasse.

PreventionWeb appNational reimbursement🇩🇪 §20 Chapter 5
🦴 Musculoskeletal
Ramin Waraghai · raminwaraghai.de
Entry last updated 4 Sep 2026

neolexon Aphasie

🇩🇪 Germany

neolexon Aphasie is a digital therapeutic (DTx), developed by neolexon GmbH (formerly Limedix GmbH), used for aphasia (post-stroke). It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR223.01/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
🧠 Nervous System🧑‍🦳 Geriatric
neolexon GmbH · diga.bfarm.de
Entry last updated 18 Oct 2026

neolexon Aphasie-App

🇩🇪 Germany

neolexon Aphasie-App is a digital therapeutic (DTx), developed by neolexon GmbH, used for aphasia therapy. Home-training app for adults with aphasia (post-stroke or other acquired brain injury), used to supplement, not replace, in-person speech-language-pathology (Logopädie) sessions. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

Not specified (ongoing supplement to in-person speech therapy)

DTxNative appRegional/SelectivePublished RCT (this product)💳 No co-pay
🗣️ Speech/Communication🧠 Nervous System
neolexon GmbH · healthy-hub.de (2nd-round winner announcement, 30 Oct 2019, 'zwei Lösungen von Neolexon')
Entry last updated 30 Jul 2026

neolexon Artikulations-App

🇩🇪 Germany

neolexon Artikulations-App is a digital therapeutic (DTx), developed by neolexon GmbH, used for articulation-disorder home-training app for children aged 3-7 already in speech-language-pathology (Logopädie) treatment; used to supplement, not replace, in-person SLP sessions. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

3 or 6 months (licence; pricing scales with duration)

DTxNative appRegional/SelectivePublished RCT (related product)💳 No co-pay
🗣️ Speech/Communication🧸 Pediatric
neolexon GmbH · neolexon.de/kostenerstattung
Entry last updated 30 Jul 2026

neotivCare

🇩🇪 Germany

neotivCare is a remote-monitoring / digital health platform, used for 3 validated cognitive/memory tests over 12 weeks, tablet/smartphone-based, distinguishes age-related from disease-related memory decline. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

12 weeks (3 cognitive/memory tests)

MonitoringNative appRegional/SelectiveReal-world evidence only💳 No co-pay
🧠 Nervous System🧑‍🦳 Geriatric
neotiv GmbH · neotiv.com
Entry last updated 30 Jul 2026

NeuroNation MED

🇩🇪 Germany

NeuroNation MED is a digital therapeutic (DTx), developed by Synaptikon GmbH, used for mild cognitive impairment. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR229.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
🧠 Nervous System🧑‍🦳 Geriatric
Synaptikon GmbH · diga.bfarm.de
Entry last updated 18 Oct 2026

Newcard

🇫🇷 France

Newcard is a remote-monitoring / digital health platform, developed by Newcard, used for cardiac remote monitoring. It is reimbursed nationally in France via the PECAN pathway. PECAN: EUR435 first 3 months then EUR38.30/month, max EUR780/yr (standard PECAN telesurveillance tariff, same schedule as Implicity).

MonitoringClinician-facing platformNational reimbursementReal-world evidence only
🫀 Heart & Circulatory
Newcard · healthandtech.eu
Entry last updated 30 Jul 2026

Nia

🇩🇪 Germany

Nia is a digital therapeutic (DTx), developed by Nia Health GmbH (Berlin; spun out of Charite Berlin, 2019; partnered with Sanofi/Sanofi Genzyme), used for atopic dermatitis / neurodermitis (ICD L20). AI-based skin-condition documentation, flare-trigger identification, personalised recommendations, follows the AGNES neurodermitis-training curriculum. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

6 or 12 months (package-dependent -- 'Digitale Begleitung' vs 'Tagebuch PLUS')

DTxNative appRegional/Selective💳 No co-pay
🩹 Skin/Dermatology
Nia Health GmbH · nia-health.de
Entry last updated 30 Jul 2026

NichtraucherHelden-App

🇩🇪 Germany

NichtraucherHelden-App is a digital therapeutic (DTx), developed by NichtraucherHelden GmbH, used for smoking cessation. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR211.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
Sanero Medical GmbH (formerly NichtraucherHelden GmbH) · diga.bfarm.de
Entry last updated 19 Oct 2026

NielsApp (Mein Kunstgelenk)

🇩🇪 Germany

NielsApp (Mein Kunstgelenk) is a hospital patient-information and care-pathway companion app, developed by Niels-Stensen-Kliniken GmbH, used for perioperative patient information for hip and knee joint replacement surgery at Niels-Stensen-Kliniken. It is provided free in Germany by the treating hospital or device manufacturer as part of the care episode itself -- not billed to any insurer, employer or the patient.

Patient informationNative appProvider-bundled
🦴 Musculoskeletal
Niels-Stensen-Kliniken GmbH · play.google.com/store/apps/details?id=de.nielsstensenkliniken.nielsapp
Entry last updated 30 Jul 2026

NightWatch+

🇩🇪 Germany

NightWatch+ detects motor epileptic seizures during sleep and alerts carers. A wireless sensor worn on the arm continuously monitors heart rate (photoplethysmography), movement and body position (3D accelerometer); when a potentially dangerous seizure is detected the sensor signals a separate alarm station. It is intended for people aged 4 and over with diagnosed epilepsy and nocturnal motor seizures, living at home or in assisted-living settings, and alarms can be forwarded to nurse call systems. The NightWatch Portal, included free of charge, lets carers review detailed sensor data after the fact -- the course of the night and why an alarm fired. The detection algorithm was developed by the Dutch TeleEpilepsy Consortium and validated against manual video review in multicentre home-setting trials: median sensitivity for the main motor seizure types was 86% in adults and 100% in children, rising to 96% and 100% for tonic-clonic seizures specifically, at a mean false-alarm rate of 0.04 per hour. In Germany it is reimbursed as a Hilfsmittel under § 33 SGB V.

Continuous nightly use for as long as the indication persists

Monitoring🇩🇪 HilfsmittelWearable wireless arm sensor (PPG heart rate plus 3D accelerometer) with a separNational reimbursementPublished RCT (this product)💳 Co-pay applies
🧠 Nervous System
LivAssured B.V. · nightwatchepilepsy.com (product and scientific-evidence pages, accessed 19 Oct 2026)
Entry last updated 20 Oct 2026

nilo

🇩🇪 Germany

nilo is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Likenilo GmbH (trading as nilo; formerly Nilo Health, merged with Likeminded Feb 2025), used for mental health. Stress, burnout prevention, and general psychological wellbeing support for employees and managers. It is offered in Germany as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careNative appCorporate healthReal-world evidence only
💭 Mental Health
Likenilo GmbH · nilohealth.com
Entry last updated 30 Jul 2026

Noctua Care

🇫🇷 France

Noctua Care is a digital therapeutic, developed by Noctua Care SAS (Paris, France) with cardiologists, used for coronary artery disease -- after a heart attack, acute coronary syndrome, stent or bypass, and in stable disease. It runs a twelve-week guided secondary-prevention programme across five areas: stress and sleep, movement, nutrition, medication adherence and personalised planning, with daily action plans, an AI chat for questions, tracking of appointments, medications and readings, and guided meditation and exercise sessions. The company states the programme follows European Society of Cardiology secondary-prevention guidance, and describes it on its German site as a CE-marked Class I medical device under MDR 2017/745. It is free for patients and not nationally reimbursed in France, reaching them instead through clinical and patient-side partners -- CHU de Bordeaux, the College National des Cardiologues des Hopitaux and Alliance du Coeur. A German market entry is in preparation and a US launch is announced as coming soon.

DTxNative app (iOS/Android)N/A (not yet reimbursed)Real-world evidence only
🫀 Heart & Circulatory
Noctua Care SAS · noctua.care/en and noctua.care/de (incl. the Krankenkassen page, which carries the Class I MDR statement) and Impressum, Oct 2026
Entry last updated 8 Oct 2026

Noona

🇧🇪 Belgium

Noona is a remote-monitoring / digital health platform, developed by Varian Medical Systems Belgium (Siemens Healthineers group), used for oncology patient-reported outcomes. Symptom tracking and secure messaging with the cancer care team during treatment, recovery and post-treatment care. It is reimbursed nationally in Belgium.

MonitoringApp + clinician platformNational reimbursementReal-world evidence only
🎗️ Cancer
Varian Medical Systems Belgium (Siemens Healthineers group) · mhealthbelgium.be/apps/app-details/noona
Entry last updated 30 Jul 2026

Novego: Ängste überwinden

🇩🇪 Germany

Novego: Ängste überwinden is a digital therapeutic (DTx), developed by IVPNetworks GmbH, used for anxiety disorder. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA (one-off licence); manufacturer price EUR189.00 one-off licence (diga-verzeichnis.de).

DTx🇩🇪 DiGA PermanentWeb appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
IVPNetworks GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

Novego: Depressionen bewältigen

🇩🇪 Germany

Novego: Depressionen bewältigen is a digital therapeutic (DTx), developed by IVPNetworks GmbH, used for depression. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA (one-off licence); manufacturer price EUR199.00 one-off licence (diga-verzeichnis.de).

DTx🇩🇪 DiGA PermanentWeb appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
IVPNetworks GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

Novio Hand

🇩🇪 Germany

Novio Hand is a digital therapeutic (DTx), developed by LIME medical GmbH (Mainz, Germany) in partnership with Bauerfeind, used for hand injuries and degenerative hand conditions in postoperative or post-treatment rehabilitation. Delivers dynamically-adjusted, feedback-guided exercise training intended to improve range of motion, hand function and pain. Its current market/reimbursement status is unclear from public sources -- a registered RCT (DRKS00033768) is comparing it to standard aftercare, but no confirmed DiGA listing or public self-pay purchase option was found, unlike its sibling product Novio Rücken (back pain), which is already a reimbursed DiGA.

DTxNative appPilotOngoing trial, unpublished💳 No co-pay
🦴 Musculoskeletal
LIME medical GmbH · lime-medical.de
Entry last updated 18 Sep 2026

Novio Rücken

🇩🇪 Germany

Novio Rücken is a digital therapeutic (DTx), developed by LIME medical GmbH (Mainz, Germany) in partnership with Bauerfeind, used for nonspecific back pain in patients aged 16 and older. LIME medical states it is reimbursed 100% by statutory health insurance with no co-payment, and that many private insurers reimburse fully or largely. However, Novio Rücken does not appear anywhere in BfArM's official DiGA-Verzeichnis as of this research (checked including the delisted/"Gestrichen" filter), so the reimbursement claim could not be independently verified.

DTxNative appN/A (reimbursement status unconfirmed)💳 No co-pay
🦴 Musculoskeletal
LIME medical GmbH · dev-novio.webflow.io
Entry last updated 19 Sep 2026

Nukkuaa (aka sleep(2))

🇩🇪 Germany

Nukkuaa (aka sleep(2)) is a digital therapeutic (DTx), developed by Nukkuaa GmbH (Salzburg, Austria, founded 2022; spin-off of Paris-Lodron-Universität Salzburg; founders Prof. Manuel Schabus and Dr. Thomas Winkler), used for insomnia / sleep-quality improvement. Overnight heart-rate sensor (Polar strap or Apple Health/Google Fit) + algorithmic sleep-stage analysis + evidence-based sleep training. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

12 months (1 year, free for TK-insured)

DTxNative appRegional/SelectiveOngoing trial, unpublished💳 No co-pay
💭 Mental Health
Nukkuaa GmbH · presseportal.de
Entry last updated 30 Jul 2026

Odysight

🇫🇷 France

Odysight is a mobile application from Tilak Healthcare that lets people with a chronic retinal condition test their own vision at home between hospital appointments. The visual tests are embedded in a casual puzzle game, which is the design idea behind the product: the measurement happens as a by-product of play rather than as a chore. Results go to the treating ophthalmologist through a web platform, so a deterioration can bring an appointment forward instead of waiting for the next scheduled visit. France reimburses it through the early-access PECAN scheme rather than the permanent list.

Ongoing, reassessed at renewal

MonitoringNative app plus clinician web platformNational reimbursement
👁️ Eyes/Vision
Tilak Healthcare SAS · Legifrance: Arrete du 27 novembre 2025 (JORFTEXT000052869690, PECAN)
Entry last updated 23 Oct 2026

Okeiro (formerly Predict4Health)

🇫🇷 France

Okeiro (formerly Predict4Health, renamed per company LinkedIn) is a remote-monitoring / digital health platform, developed by Okeiro, used for cardiac & renal deterioration prediction (AI). It is reimbursed nationally in France via the PECAN pathway. PECAN: EUR435 first 3 months then EUR38.30/month, max EUR780/yr (standard PECAN telesurveillance tariff, same schedule as Implicity).

MonitoringClinician-facing platformNational reimbursementOngoing trial, unpublished
🫀 Heart & Circulatory
Okeiro · predict4health.com
Entry last updated 19 Sep 2026

Omada Cardiometabolic Suite (Prevention, Diabetes, Hypertension, GLP-1 support)

🇺🇸 USA

Omada Cardiometabolic Suite (Prevention, Diabetes, Hypertension, GLP-1 support) is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Omada Health, Inc., used for prediabetes, type 1 & 2 diabetes, hypertension, and support for members on GLP-1/anti-obesity medications. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careNative appCorporate healthPublished RCT (this product)
🩸 Metabolic Diseases
Omada Health, Inc. · omadahealth.com
Entry last updated 9 Oct 2026

Omada for Joint & Muscle Health

🇺🇸 USA

Omada for Joint & Muscle Health is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Omada Health, Inc., used for musculoskeletal pain. Joint and muscle conditions. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careNative appCorporate healthReal-world evidence only
🦴 Musculoskeletal
Omada Health, Inc. · omadahealth.com/musculoskeletal
Entry last updated 9 Oct 2026

Omnipod 5

🇩🇪 Germany

Omnipod 5 is an automated insulin delivery (AID) system: an insulin pump coupled to a real-time CGM (Dexcom G6 or G7), with the SmartAdjust algorithm automatically adjusting the basal rate and delivering automatic correction boluses while leaving manual adjustment available. In Germany it is listed in the Hilfsmittelverzeichnis under § 33 SGB V as "Variante 3" of product types 30.29.05/30.29.06 — the category defined by exactly that combination of automatic basal adjustment and automatic correction boluses — and is supplied nationwide on prescription.

Continuous use for as long as the indication persists

MedTech device🇩🇪 HilfsmittelConnected device / hardwareNational reimbursementPublished RCT (this product)💳 Co-pay applies
🩸 Metabolic Diseases
Insulet Corporation · GKV Hilfsmittelverzeichnis, product types 30.29.05 and 30.29.06 (queried 20 Oct 2026)
Entry last updated 20 Oct 2026

Online-Hautcheck (OnlineDoctor)

🇩🇪 Germany

Online-Hautcheck (OnlineDoctor) is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by OnlineDoctor AG, used for skin conditions / suspicious moles. Asynchronous photo-based dermatology consultation. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

Blended careNative appRegional/Selective
🩹 Skin/Dermatology
OnlineDoctor AG · onlinedoctor.de
Entry last updated 30 Jul 2026

onyo

🇩🇪 Germany

onyo is a digital prevention programme, developed by onyo GmbH, used for home-office/remote-work ergonomics and statutory workplace risk assessment. Not indication-specific. It is offered in Germany as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
🦴 Musculoskeletal
onyo GmbH · onyo.io
Entry last updated 30 Jul 2026

OpenUp

🇳🇱 Netherlands

OpenUp is an employer-funded mental well-being platform for the workplace, positioned by the company as "a modern EAP". Employees of subscribing organisations can book 1:1 sessions with psychologists, and the service extends to lifestyle and financial coaching, group sessions and self-guided material, with a 24/7 support line included. The company reports 600,000+ employees across 2,000+ organisations and support in 45 languages, and states that sessions require no referral or approval. In the Netherlands this sits entirely outside the Zorgverzekeringswet: the employer pays, so there is no deductible (eigen risico) and no GP/POH-GGZ gatekeeping -- but equally no coverage for anyone whose employer does not subscribe. OpenUp is not a medical device; its ISMS is certified to ISO 27001 and NEN 7510.

Ongoing access while the employer subscribes

Blended careNative appCorporate healthReal-world evidence only
💭 Mental Health
OpenUp B.V. · openup.com (home, /privacy-policy-and-imprint, accessed 22 Oct 2026)
Entry last updated 22 Oct 2026

ORIKO ADHS-Therapie

🇩🇪 Germany

ORIKO ADHS-Therapie is a digital therapeutic (DTx), developed by Oriko GmbH, used for ADHD (adults). It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA (provisional); manufacturer price EUR360.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PreliminaryNative appNational reimbursementOngoing trial, unpublished💳 No co-pay
💭 Mental Health
Oriko GmbH · diga.bfarm.de
Entry last updated 18 Oct 2026

Orthopy bei Knieverletzungen

🇩🇪 Germany

Orthopy bei Knieverletzungen is a digital health solution, developed by Orthopy Health GmbH, used for knee injuries / rehabilitation. It is not currently reimbursed in Germany -- WITHDRAWN 9 Sep 2025. Since its September 2023 launch, it has been marketed in Germany via an exclusive distribution/marketing partnership with Enovis, a global orthopedics/medtech company ("Orthopy powered by Enovis"); Enovis handles sales and marketing while Orthopy Health GmbH retains product development and medical content.

N/A (delisted)

DTxNative appRegional/Selective💳 No co-pay
⚕️ Not indication-specific
Orthopy Health GmbH · diga.bfarm.de/de/verzeichnis (Gestrichen-Filter)
Entry last updated 19 Oct 2026

Oshi Health

🇺🇸 USA

Oshi Health is a virtual multidisciplinary GI clinic covering IBS, Crohn's disease, ulcerative colitis, GERD, SIBO and undiagnosed GI symptoms, combining gastroenterology care with dietitians and gut-brain specialists. The company states it is in-network with most major health plans, so that many patients pay little to nothing out of pocket depending on plan, and that it is not in-network with Medicare or Medicaid; remaining out-of-pocket costs can be spread over payment plans and the services are HSA-eligible. Unlike the other virtual clinics recorded here it runs three channels at once -- direct to patient, employer partnerships and value-based contracts with health plans. Checked Oct 2026.

Ongoing

Blended careNative app + virtual clinic (video visits)Regional/SelectiveMedicaidReal-world evidence only
Oshi Health, Inc. · oshihealth.com (pricing/insurance FAQ)
Entry last updated 14 Oct 2026

OsteoCoach

🇩🇪 Germany

OsteoCoach is a mobile app for people aged 65 and over whose fear of falling limits everyday life. Its stated intended purpose, taken from the electronic instructions for use (QBM-OSTEOCOACH-IFU-001 of 25 Feb 2026), is "Software zur Verringerung des Sturzrisikos bei Personen ab 65 Jahren": a guided entry test records physical fitness and fall-related anxiety, from which the app builds a personalised modular training programme aimed at improving strength and balance and reducing fear of falling. Four modules are offered -- Fitness, Mental, Tai Chi and Wissen (knowledge). The company says its clinical pilot study is complete and evaluated but that the results are not yet published, and that the app holds a BSI TR-03161 certificate for version 1.1.0. It is a medical device pursuing DiGA listing under § 139e SGB V; the BfArM application was in preparation as of October 2026. Note three company names appear around the product: Osteoconnect GmbH (Berlin) operates the site, QuickBird Market GmbH (Munich) is named as manufacturer in the instructions for use, and the App Store seller is OSTEOCONNECT IP LTD.

Self-paced, no fixed programme length

DTxNative app (iOS)Self-payCompleted trial, unpublished💳 No co-pay
🧑‍🦳 Geriatric🦴 Musculoskeletal
Osteoconnect GmbH · osteocoach.eu (home, /diga, /eIFU, /impressum, accessed 22 Oct 2026)
Entry last updated 22 Oct 2026

Oviva Direkt Bluthochdruck

🇩🇪 Germany

Oviva Direkt Bluthochdruck is a digital therapeutic (DTx), developed by Oviva AG, used for hypertension. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA (provisional); manufacturer price EUR599.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PreliminaryNative appNational reimbursementPublished RCT (this product)💳 No co-pay
🫀 Heart & Circulatory
Oviva AG · diga.bfarm.de
Entry last updated 18 Oct 2026

Oviva Direkt für Adipositas

🇩🇪 Germany

Oviva Direkt für Adipositas is a digital therapeutic (DTx), developed by Oviva AG, used for obesity. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR243.00/90-day Rx (diga-verzeichnis.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
🩸 Metabolic Diseases
Oviva AG · diga.bfarm.de
Entry last updated 19 Oct 2026

OvulaRing

🇩🇪 Germany

OvulaRing is a remote-monitoring / digital health platform, used for cycle/ovulation tracking for women with irregular menstruation or unfulfilled desire to have children. Wearable vaginal-ring hormone sensor + companion app; NOTE: this is hardware + app, closer to the RPM/telemonitoring category than a pure software DTx, included here because its reimbursement mechanism (per-insurer Kostenerstattung) matches this sheet's other entries. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

12 months (annual reimbursement cap, renewable)

MonitoringNative appRegional/SelectivePublished RCT (related product)💳 No co-pay
♀️ Gynaecology
VivoSensMedical GmbH · ovularing.com/schwanger-werden/kostenuebernahme-ovularing
Entry last updated 30 Jul 2026

Patient Journey App (platform)

🇩🇪 Germany

Patient Journey App (platform) is a hospital patient-information and care-pathway companion app, developed by Patient Journey App, used for perioperative and general hospital-stay information across surgical and non-surgical care pathways, department- and procedure-configurable per hospital. It is provided free in Germany by the treating hospital or device manufacturer as part of the care episode itself -- not billed to any insurer, employer or the patient.

Patient informationNative appProvider-bundledPublished RCT (this product)
⚕️ Not indication-specific
Patient Journey App (Interactive Studios B.V.) · patientjourneyapp.com
Entry last updated 30 Jul 2026

Paula-App

🇩🇪 Germany

Paula-App is a digital therapeutic (DTx), developed by Endo Health GmbH (Chemnitz, Germany, founded 2020 as Endo Health UG by Nadine Rohloff), used for polycystic ovary syndrome (PCOS). A multimodal self-management companion (symptom diary, learning modules from psychology, nutrition and physiotherapy, interactive exercises) addressing cycle irregularity, fertility concerns, hirsutism, weight management and psychological burden. It is a CE-marked medical device, free to download, but not yet listed in BfArM's DiGA directory. Endo Health reports that a randomized study with over 200 participants is evaluating the app, with results expected in Q3 2025; this has not been published, so the claim could not be independently verified.

DTxNative appN/A (reimbursement status unconfirmed)Ongoing trial, unpublished💳 No co-pay
♀️ Gynaecology🩸 Metabolic Diseases
Endo Health GmbH · apps.apple.com Paula-App (trackId 6670159420)
Entry last updated 19 Sep 2026

PBC Begleiter

🇩🇪 Germany

PBC Begleiter supports people living with primary biliary cholangitis (PBC) in managing the condition day to day, with the stated aim of strengthening disease literacy and active self-management. It was co-developed with PBC patients. Users who consent can log symptoms, test results and quality of life; those data are analysed anonymously by Prof. Dr. Dr. Andreas Teufel (Greifswald) so that care gaps and the burden of PBC can be published and put before health policymakers -- the company states the documentation is anonymous with no possibility of tracing it back, and GDPR-compliant. A patient advisory board can propose questions for future analyses. The app is free; it is funded by Ipsen Pharma GmbH, so no payer reimburses it. Project lead is the non-profit Kautz5 gUG (Cologne); the software was built by Quickbird Medical GmbH (Munich).

Ongoing use, no fixed programme length

Blended careNative app (iOS/Android)Manufacturer-sponsored
🦠 Digestive
Kautz5 gUG · Apple App Store DE, app ID 6781680909 (released 19 Sep 2026
Entry last updated 22 Oct 2026

Peppy

🇬🇧 United Kingdom

Peppy is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Peppy Health Ltd., used for menopause, fertility, and men's health (including prostate and mental health). Specialist life-stage health support for employees. It is offered in the United Kingdom as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careNative appCorporate healthReal-world evidence only
💧 Urogenital♀️ Gynaecology
Peppy Health Ltd. · peppy.health
Entry last updated 30 Jul 2026

Personify Health

🇺🇸 USA

Personify Health is a digital prevention programme, developed by Personify Health, Inc. (formerly Virgin Pulse + HealthComp), used for general employee wellbeing, health-plan navigation and personalised health journeys. Not indication-specific. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
Personify Health, Inc. · fiercehealthcare.com (Personify Health formation)
Entry last updated 30 Jul 2026

Pia-App bei Regelschmerzen

🇩🇪 Germany

Pia-App bei Regelschmerzen is a digital therapeutic (DTx), developed by Endo Health GmbH (Chemnitz, Germany, founded 2020 as Endo Health UG by Nadine Rohloff), used for menstrual pain (primary dysmenorrhea, ICD-10 N94.4). A multimodal self-management companion (symptom diary, learning modules from medicine, physiotherapy, nutrition and pain management, guided in-app exercises, SOS list). It is reimbursed nationally in Germany via the DiGA (provisional) pathway. SHI-reimbursed, DiGA (provisional); manufacturer price EUR598.95/90-day Rx, no extra costs (diga.bfarm.de).

DTx🇩🇪 DiGA PreliminaryNative appNational reimbursementOngoing trial, unpublished💳 No co-pay
♀️ Gynaecology
Endo Health GmbH · diga.bfarm.de/de/verzeichnis/02883
Entry last updated 18 Oct 2026

PINK! Coach

🇩🇪 Germany

PINK! Coach is a digital therapeutic (DTx), developed by PINK! gegen Brustkrebs GmbH, used for breast cancer (psycho-oncology). It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR234.50/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
🎗️ Cancer♀️ Gynaecology
PINK! gegen Brustkrebs GmbH · diga.bfarm.de
Entry last updated 18 Oct 2026

Plateforme Maela

🇧🇪 Belgium

Plateforme Maela is a remote-monitoring / digital health platform, developed by Medtronic Belgium (Medtronic plc), used for multi-specialty surgical patient engagement and monitoring. Configurable digital care protocols for colorectal, bariatric, spine, AFS and thoracic surgery pathways, among others. It is reimbursed nationally in Belgium.

MonitoringNative appNational reimbursement
🦠 Digestive🦴 Musculoskeletal🫁 Respiratory
Medtronic Belgium (Medtronic plc) · mhealthbelgium.be/apps/app-details/plateforme-maela
Entry last updated 23 Oct 2026

platoniq

🇩🇪 Germany

platoniq is a digital prevention programme, developed by SHS Social Health Solutions UG (Berlin) under the brand platoniq, used for loneliness and stress. It treats social support as the central coping resource and works on it with methods from cognitive behavioural therapy: building and maintaining a network, recognising and changing unhelpful thinking about one's social life, and integrated relaxation exercises. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway as a ZPP-certified course (ID KU-ST-RB7DXE), priced at EUR99 for six weeks and 61 units, with reimbursement claimed after 49 units are completed. It was developed with psychologists at Humboldt-Universität zu Berlin and co-financed by Berlin and the European Union.

6 weeks (61 units)

PreventionNative app (iOS/Android)National reimbursementOngoing trial, unpublished
💭 Mental Health
SHS Social Health Solutions UG (haftungsbeschränkt) -- brand: platoniq · platoniq.health
Entry last updated 9 Oct 2026

Poppins Clinical

🇫🇷 France

Poppins Clinical is a digital therapeutic (DTx), developed by BMOTION Technologies (brand: Poppins; formerly Mila until Oct 2023), used for dyslexia and related learning disorders, children 7-11. It is reimbursed nationally in France via the PECAN pathway. PECAN tariff: EUR435 flat fee first 3 months, then EUR38.30/month, max EUR780/yr. The arrete was published in the Journal Officiel on 21 Jul 2026 and reimbursement took effect on 3 Aug 2026.

DTxNative appNational reimbursement
🧠 Nervous System🧸 Pediatric
BMOTION Technologies · fno.fr
Entry last updated 4 Oct 2026

Prevencer

🇩🇪 Germany

Prevencer is a digital prevention programme, developed by Prevencer, used for krafttraining ohne Geraete. Equipment-free strength-training online prevention course. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). ZPP-zertifizierter Online-Praeventionskurs nach Sec.20 SGB V; bis zu 100% Kostenerstattung durch die gesetzliche Krankenkasse.

PreventionWeb appNational reimbursement🇩🇪 §20 Chapter 5
🦴 Musculoskeletal
Prevencer · prevencer.de
Entry last updated 4 Sep 2026

Prevenio (R)

🇩🇪 Germany

Prevenio (R) is a digital prevention programme, developed by TransGate GmbH, used for statutory occupational-medical fitness/eligibility examinations and preventive check-ups. Administrative/compliance tool, not indication-specific. It is offered in Germany as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
TransGate GmbH · transgate.de/prevenio/medizinische-vorsorge
Entry last updated 30 Jul 2026

Preventicus Heartbeats

🇩🇪 Germany

Preventicus Heartbeats is a digital prevention programme, developed by Preventicus GmbH, used for atrial fibrillation screening (stroke prevention), insured persons 55+. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

PreventionNative appRegional/SelectivePublished RCT (this product)
🫀 Heart & Circulatory
Preventicus GmbH · preventicus.com
Entry last updated 30 Jul 2026

priovi

🇩🇪 Germany

priovi is a digital therapeutic (DTx), developed by GAIA AG, used for borderline personality disorder. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR244.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentWeb appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
GAIA AG · diga.bfarm.de
Entry last updated 18 Oct 2026

ProHerz

🇩🇪 Germany

ProHerz is a digital therapeutic (DTx), developed by ProCarement GmbH, used for heart failure. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR235.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
🫀 Heart & Circulatory
ProCarement GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

Prothera Fit

🇩🇪 Germany

Prothera Fit is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, used for multimodal and training-therapy digital rehabilitation aftercare, prevention and rehabilitation content (app-based, iOS/Android); specific indication breadth not independently itemised in this pass. It is reimbursed in Germany through the statutory pension/care-insurance system rather than standard health insurance.

Not fixed (duration tied to individual DRV aftercare period)

Blended careNative appPension/care insurance
⚕️ Not indication-specific
Profession Fit GmbH · nachderreha.de (DRV's official digital Reha-Nachsorge provider list)
Entry last updated 30 Jul 2026

re.flex

🇩🇪 Germany

re.flex is a digital health solution, developed by Kineto Tech Rehab SRL (Romania), used for knee osteoarthritis (gonarthrosis). Sports/movement therapy, developed with Sporlastic Medizinische Produkte GmbH. It is not currently reimbursed in Germany -- Delisted.

N/A (delisted)

DTxNative appRegional/Selective💳 No co-pay
⚕️ Not indication-specific
Kineto Tech Rehab SRL (Romania) · diga.bfarm.de/de/verzeichnis (Gestrichen-Filter)
Entry last updated 19 Oct 2026

Rejoyn

🇺🇸 USA

Rejoyn is a digital therapeutic (DTx), developed by Otsuka Precision Health / Click Therapeutics, used for major depressive disorder (adjunct, ages 22+). It is reimbursed nationally in the USA via Medicare's HCPCS G0552-G0554 digital mental health treatment codes. Medicare-billable since 1 Jan 2025; broader commercial-payer coverage NOT confirmed -- Billed by the prescribing clinician: G0552 + G0553/G0554; as of Apr 2025 no commercial insurer publicly confirmed on board -- still largely self-pay/discounted cash (~$50) or Medicare-billed only.

DTxNative appNational reimbursementMedicarePublished RCT (this product)💳 Co-pay applies
💭 Mental Health
Otsuka Precision Health / Click Therapeutics · statnews.com (13 Aug 2024, pricing)
Entry last updated 30 Jul 2026

RelieVRx

🇺🇸 USA

RelieVRx is an FDA-authorized virtual-reality digital therapeutic, developed by AppliedVR, Inc. (Los Angeles, CA), used for chronic lower back pain. It delivers an 8-week program of cognitive-behavioral and pain-education skills through an immersive VR headset. Authorized by the FDA via the De Novo pathway in Nov 2021, it became the first VR therapeutic to receive its own Medicare billing code when CMS assigned HCPCS Level II code E1905 (effective Apr 2023), classified as Durable Medical Equipment. CMS has not yet finalized the payment rate for this code, so real-world coverage remains uneven and payer-dependent in the meantime.

8-week program (skills-based sessions)

MedTech deviceVR headset + 8-week behavioral-therapy programNational reimbursementMedicarePublished RCT (this product)
🦴 Musculoskeletal
AppliedVR, Inc. · appliedvr.io
Entry last updated 30 Jul 2026

Remecare

🇧🇪 Belgium

Remecare is a remote-monitoring / digital health platform, developed by Newexo / Remecare, used for chronic heart failure remote monitoring & coaching. It is reimbursed nationally in Belgium.

MonitoringApp + clinician platformNational reimbursement
🫀 Heart & Circulatory
Newexo / Remecare · agoria.be
Entry last updated 23 Oct 2026

Remi Health (HPV-Heimtest)

🇩🇪 Germany

Remi Health (HPV-Heimtest) is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Remi Health GmbH (myremi.com), used for cervical cancer screening. At-home HPV self-sampling kit (tests HPV 16, HPV 18 plus 12 further high-risk types), digital result delivery, and telephone consultation with a Remi-network gynaecologist for abnormal results. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

One-time screening (not an ongoing programme)

Blended careNative appRegional/Selective
♀️ Gynaecology🎗️ Cancer
Remi Health GmbH · healthy-hub.de (5th-round winner announcement, Mar 2024)
Entry last updated 30 Jul 2026

reSET

🇺🇸 USA

reSET is a digital therapeutic (DTx), developed by PursueCare (acquired Pear Therapeutics' reSET/reSET-O assets, 2023), used for substance use disorder. It is reimbursed nationally in the USA via Medicare's HCPCS G0552-G0554 digital mental health treatment codes. Reimbursed since 1 Jan 2025 (Medicare); commercial coverage via Cigna PDT policy -- Billed by the prescribing clinician: G0552 + G0553/G0554.

DTxNative appNational reimbursementMedicarePublished RCT (this product)💳 Co-pay applies
💭 Mental Health
PursueCare · statnews.com (22 Aug 2024)
Entry last updated 30 Jul 2026

reset U

🇩🇪 Germany

reset U is a digital prevention programme, developed by reset U, used for online courses for burnout prevention and depression prevention. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). Zertifiziert nach Sec.20 SGB V (ZPP); EUR99, 79-99% Erstattung durch die gesetzliche Krankenkasse.

PreventionWeb appNational reimbursement🇩🇪 §20 Chapter 5
💭 Mental Health
reset U · resetu-praevention.de
Entry last updated 4 Sep 2026

reSET-O

🇺🇸 USA

reSET-O is a digital therapeutic (DTx), developed by PursueCare (acquired Pear Therapeutics' reSET/reSET-O assets, 2023), used for opioid use disorder. It is reimbursed nationally in the USA via Medicare's HCPCS G0552-G0554 digital mental health treatment codes. Reimbursed since 1 Jan 2025 (Medicare); commercial coverage via Cigna PDT policy -- Billed by the prescribing clinician: G0552 + G0553/G0554.

DTxNative appNational reimbursementMedicarePublished RCT (this product)💳 Co-pay applies
💭 Mental Health
PursueCare · statnews.com (22 Aug 2024)
Entry last updated 30 Jul 2026

RESILIENCE PRO

🇫🇷 France

RESILIENCE PRO is a remote-monitoring / digital health platform, developed by Resilience, used for oncology remote monitoring and supportive care. Helps patients cope with treatment side effects and improves quality of life during and after cancer treatment. It is reimbursed nationally in France via the PECAN pathway. Reimbursed under the French telesurveillance framework since Oct 2023; exact CEPS tariff not independently confirmed in this pass.

MonitoringApp + clinician platformNational reimbursementReal-world evidence only
🎗️ Cancer
Resilience · mhealthbelgium.be/apps/app-details/resilience-pro (company's own 'Adoption abroad' statement)
Entry last updated 23 Oct 2026

RESILIENCE PRO

🇧🇪 Belgium

RESILIENCE PRO is a remote-monitoring / digital health platform, developed by Resilience, used for oncology remote monitoring and supportive care. Helps patients cope with treatment side effects and improves quality of life during and after cancer treatment. It is reimbursed nationally in Belgium.

MonitoringApp + clinician platformNational reimbursement
🎗️ Cancer
Resilience · mhealthbelgium.be/apps/app-details/resilience-pro
Entry last updated 30 Jul 2026

SaniQ HERZ

🇩🇪 Germany

SaniQ HERZ is a connected medical device (with companion software), developed by Qurasoft GmbH, used for chronic heart failure remote monitoring (external measurement devices). It is reimbursed nationally in Germany via nationwide EBM remote-monitoring/telemonitoring billing codes. Reimbursed since Jan 2022 (G-BA resolution 2020).

MedTech deviceConnected device / hardwareNational reimbursementOngoing trial, unpublished
🫀 Heart & Circulatory
Qurasoft GmbH · qurasoft.de
Entry last updated 30 Jul 2026

Sanum Entspannungskurs

🇩🇪 Germany

Sanum Entspannungskurs is a digital prevention programme, developed by Sanum, used for online audio-guided relaxation and stress-management course, 8 sessions of 45 minutes each. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). Zertifizierter Praeventionskurs (ZPP), entspricht dem Leitfaden Praevention (Sec.20 Abs.1 SGB V); wird von allen gesetzlichen Krankenkassen erstattet; EUR99.

8 x 45 min

PreventionWeb appNational reimbursement🇩🇪 §20 Chapter 5
💭 Mental Health
Sanum · sanum-entspannungskurs.de
Entry last updated 4 Sep 2026

Satelia Cardio

🇫🇷 France

Satelia Cardio is a French remote-monitoring service for chronic heart failure. Patients answer a short recurring questionnaire about symptoms and weight; deterioration signals are relayed to the cardiology team so an intervention can happen before a hospital admission. It is one of the few products on the French telemonitoring list to hold a product-specific tariff distinctly higher than the generic rate for the same condition, which is what makes its listing worth reading closely: the French system usually pays one rate per care activity, not per product.

Ongoing

MonitoringWeb platform (no app install required)National reimbursement
🫀 Heart & Circulatory
Satelia SAS · Legifrance: Arrete du 28 mars 2025 (JORFTEXT000051401301, inscription LATM)
Entry last updated 23 Oct 2026

Schlank ohne Diaet

🇩🇪 Germany

Schlank ohne Diaet is a digital prevention programme, developed by Fitnessdoc.net, used for certified online course for sustainable weight loss without dieting. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). Zertifizierter Praeventionskurs nach Sec.20 SGB V; Kosten koennen von der gesetzlichen Krankenkasse uebernommen werden.

PreventionWeb appNational reimbursement🇩🇪 §20 Chapter 5
🩸 Metabolic Diseases
Fitnessdoc.net · fitnessdoc.net
Entry last updated 4 Sep 2026

Selfapys Online-Kurs bei Binge-Eating-Störung

🇩🇪 Germany

Selfapys Online-Kurs bei Binge-Eating-Störung is a digital therapeutic (DTx), developed by Selfapy GmbH, used for binge eating disorder. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR232.00/90-day Rx (diga-verzeichnis.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
Selfapy GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

Selfapys Online-Kurs bei Bulimia Nervosa

🇩🇪 Germany

Selfapys Online-Kurs bei Bulimia Nervosa is a digital therapeutic (DTx), developed by Selfapy GmbH, used for bulimia nervosa. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR232.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
Selfapy GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

Selfapys Online-Kurs bei chronischen Schmerzen

🇩🇪 Germany

Selfapys Online-Kurs bei chronischen Schmerzen is a digital health solution, developed by Selfapy GmbH, used for chronic pain. CBT-based methods and techniques. It is not currently reimbursed in Germany -- WITHDRAWN 28 May 2025.

N/A (delisted)

DTxNative appRegional/Selective💳 No co-pay
⚕️ Not indication-specific
Selfapy GmbH · diga.bfarm.de/de/verzeichnis (Gestrichen-Filter)
Entry last updated 19 Oct 2026

Selfapys Online-Kurs bei Depression

🇩🇪 Germany

Selfapys Online-Kurs bei Depression is a digital therapeutic (DTx), developed by Selfapy GmbH, used for depression. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR217.18/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
Selfapy GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

Selfapys Online-Kurs bei Generalisierter Angststörung

🇩🇪 Germany

Selfapys Online-Kurs bei Generalisierter Angststörung is a digital therapeutic (DTx), developed by Selfapy GmbH, used for generalised anxiety disorder. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR228.50/90-day Rx (diga-verzeichnis.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
Selfapy GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

Selfapys Online-Kurs bei Panikstörung

🇩🇪 Germany

Selfapys Online-Kurs bei Panikstörung is a digital health solution, developed by Selfapy GmbH, used for panic disorder. It is not currently reimbursed in Germany -- WITHDRAWN by end of Sept 2023.

N/A (delisted)

DTxNative appRegional/Selective💳 No co-pay
⚕️ Not indication-specific
Selfapy GmbH · e-health-com.de (DiGA-versum)
Entry last updated 19 Oct 2026

Semeia

🇫🇷 France

Semeia is a remote-monitoring / digital health platform, developed by Semeia, used for chronic kidney disease remote monitoring. It is reimbursed nationally in France via the PECAN pathway. PECAN: EUR435 first 3 months then EUR38.30/month, max EUR780/yr (standard PECAN telesurveillance tariff, same schedule as Implicity).

MonitoringClinician-facing platformNational reimbursement
🫘 Renal
Semeia · healthandtech.eu
Entry last updated 30 Jul 2026

SilentCloud

🇩🇪 Germany

SilentCloud is a digital therapeutic (DTx), developed by Aureliym GmbH (Bad Neuenahr-Ahrweiler, Germany; part of the Sonova hearing-care group), used for tinnitus. Combines patient education, validated assessments, internet-based cognitive behavioural therapy (iCBT) and sound therapy on a subscription basis. It is not yet available in Germany -- currently live only in Belgium and Italy -- but has obtained BSI TR-03161 certification, the German cybersecurity prerequisite for DiGA listing, suggesting a German launch may follow.

DTxNative appN/A (not yet reimbursed)💳 No co-pay
👂 Ears
Aureliym GmbH · sonova.com/en/sonova-introduces-silentcloudtm-medical-app-enabling-people-actively-manage-their-tinnitus
Entry last updated 18 Sep 2026

SilverCloud (Space from Depression / Space from Anxiety)

🇬🇧 United Kingdom

SilverCloud (Space from Depression / Space from Anxiety) is a digital therapeutic (DTx), developed by SilverCloud Health, used for depression and anxiety/GAD. It is reimbursed nationally in the United Kingdom via the NHS Talking Therapies DET pathway. NHS England DET-compliant, nationally usable within NHS Talking Therapies -- Commissioned locally by individual NHS Talking Therapies services, drawn from NICE's nationally-vetted DET list; NOTE -- distinct from this same company's separate 'SilverCloud - Making Space for Healthy Minds' listing on the 'UK - ORCHA Recommended Apps' tab (a...

DTxNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
SilverCloud Health · nice.org.uk/news/articles/nice-recommends-8-digitally-enabled-therapies-to-treat-depression-and-anxiety (1 Mar 2023)
Entry last updated 30 Jul 2026

sinCephalea Migräneprophylaxe (marketed as "M-sense by Sincephalea")

🇩🇪 Germany

sinCephalea Migräneprophylaxe (now marketed via m-sense.de) is a digital therapeutic (DTx), developed by Perfood GmbH (Lübeck, founded 2017 -- same manufacturer as glucura), used for migraine prophylaxis via personalised nutrition, based on continuous glucose monitoring (CGM) + headache diary; RCT with 800+ patients showed significant reduction in monthly migraine days. It is available in Germany on a self-pay basis -- a reimbursement-eligible pathway may exist, but the patient currently pays out of pocket rather than an insurer or employer. Following withdrawal from the DiGA directory on 22 Jan 2026 the product remains available as a self-pay offer, marketed under the M-sense name: m-sense.de is branded "M-sense by Sincephalea" and is operated by Perfood GmbH, not by Newsenselab, which built the original M-sense app. Former users of that original app have in effect been moved to a different product.

12 weeks (self-pay commercial product; no longer SHI-reimbursed)

DTxNative appSelf-payPublished RCT (this product)💳 No co-pay
⚕️ Not indication-specific
Perfood GmbH (Lübeck, founded 2017 · Currently offered as a free e-book (lighter, non-reimbursed alternative) or as the full 12-week app for EUR420 self-pay, with no GKV reimbursement path. Sources: diga.bfarm.de/de/verzeichnis (Gestrichen-Filter, delisting date/reason)
Entry last updated 19 Oct 2026

Skinapy Akne

🇩🇪 Germany

Skinapy Akne is a digital therapeutic (DTx), developed by Dermafy Group GmbH (Schorndorf, Germany), used for acne vulgaris. The programme covers nutrition, skin care and cleansing routines, and psychological support for a holistic approach alongside dermatological treatment. Dermafy Group states that statutory health insurers reimburse it 100% on a doctor's prescription (3-month cycle) and private insurers reimburse per individual tariff; a self-pay access code is also sold directly via the manufacturer's own shop. However, Skinapy Akne does not appear anywhere in BfArM's official DiGA-Verzeichnis as of this research (checked including the delisted/"Gestrichen" filter), so the reimbursement claim could not be independently verified.

3-month prescription cycle

DTxNative appN/A (reimbursement status unconfirmed)💳 No co-pay
🩹 Skin/Dermatology
Dermafy Group GmbH · skinapy.de
Entry last updated 19 Sep 2026

Skinuvita

🇩🇪 Germany

Skinuvita is a digital therapeutic (DTx), developed by Skinuvita GmbH (Bremen, founded 2021; backed by High-Tech Gründerfonds and private investors incl. Stefan Bellinger; EUR1.8m raised), used for digital therapy SYSTEM: smart home UV-irradiation device (hardware) + telemonitoring by participating dermatologists. Moves UV phototherapy, previously clinic/practice-only, into the home. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

Not specified (pilot phase, ongoing)

DTxNative appRegional/SelectiveReal-world evidence only💳 No co-pay
🩹 Skin/Dermatology
Skinuvita GmbH · gwq-serviceplus.de (pilot launch, Apr 2025)
Entry last updated 30 Jul 2026

Skleo Augenvorsorge-Check

🇩🇪 Germany

Skleo Augenvorsorge-Check is an AI-supported preventive eye screening service, operated by Skleo Health GmbH (Düsseldorf), used to look for signs of conditions such as glaucoma and diabetic retinopathy. A retinal image taken at a partner optician or drugstore is analysed by an AI for 12 retinal markers and then validated in every case by a German-licensed ophthalmologist, with a report within 24 hours and, on an abnormal finding, a specialist appointment booked through the platform. The AI is CE-marked as a medical device under MDR class IIa, and the company cites a scientific collaboration with Charité Universitätsmedizin Berlin. It is a self-pay service: not reimbursed, not a §20 prevention course and not a DiGA, though some partner sites are designated insurance partners.

MedTech deviceIn-person screening at partner opticians and drugstores, AI analysis plus ophthaSelf-pay
👁️ Eyes/Vision
Skleo Health GmbH · skleo.de (patient site and Impressum, Oct 2026)
Entry last updated 9 Oct 2026

Sleepio

🇬🇧 United Kingdom

Sleepio is a digital therapeutic (DTx), developed by Big Health, used for insomnia and insomnia symptoms. It is available in the United Kingdom through a regional or time-limited pilot commissioning arrangement, not (yet) an established national or ongoing regional/selective contract.

DTxNative appPilotPublished RCT (this product)💳 No co-pay
💭 Mental Health
Big Health · nice.org.uk/guidance/mtg70
Entry last updated 30 Jul 2026

SleepioRx

🇺🇸 USA

SleepioRx is a digital therapeutic (DTx), developed by Big Health, used for chronic insomnia. It is reimbursed nationally in the USA via Medicare's HCPCS G0552-G0554 digital mental health treatment codes. Reimbursed since 1 Jan 2025 -- Billed by the prescribing clinician: G0552 (device supply/onboarding) + G0553/G0554 (monthly treatment-management time, ~$20/20min).

DTxNative appNational reimbursementMedicarePublished RCT (this product)💳 Co-pay applies
💭 Mental Health
Big Health · aapc.com
Entry last updated 30 Jul 2026

SleepQ (formerly WELT-I)

🇰🇷 South Korea

SleepQ (formerly WELT-I) is a digital therapeutic (DTx), developed by WELT Corp (웰트) / Handok (한독, commercial partner), used for chronic insomnia. CBT-i programme. It is available in South Korea on a self-pay basis -- a reimbursement-eligible pathway may exist, but the patient currently pays out of pocket rather than an insurer or employer.

DTxNative appSelf-payPublished RCT (this product)
💭 Mental Health
WELT Corp (웰트) · themedical.kr (2025-06-10)
Entry last updated 30 Jul 2026

Smoke Free - Rauchen aufhören

🇩🇪 Germany

Smoke Free - Rauchen aufhören is a digital therapeutic (DTx), developed by Smoke Free 23 GmbH (parent: 23 Ltd, UK), used for smoking cessation. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR231.25/90-day Rx (diga-verzeichnis.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
Smoke Free 23 GmbH · diga.bfarm.de
Entry last updated 18 Oct 2026

somnio

🇩🇪 Germany

somnio is a digital therapeutic (DTx), developed by mementor DE GmbH, used for insomnia. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR224.99/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
mementor DE GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

somnovia

🇩🇪 Germany

somnovia is a digital therapeutic (DTx), developed by GAIA AG, used for chronic insomnia. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR236.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentWeb appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
GAIA AG · diga.bfarm.de
Entry last updated 18 Oct 2026

Somryst

🇺🇸 USA

Somryst is a digital therapeutic (DTx), developed by Nox Health (acquired the Somryst asset from Pear Therapeutics' bankruptcy estate), used for chronic insomnia. It is reimbursed nationally in the USA via Medicare's HCPCS G0552-G0554 digital mental health treatment codes. Reimbursed since 1 Jan 2025 (Medicare); added to Serve You Rx/OptumRx pharmacy-benefit formularies for select commercial/self-insured employer plans -- Billed by the prescribing clinician: G0552 + G0553/G0554; formulary listing separately covers the device cost for enrolled plan members.

DTxNative appNational reimbursementMedicarePublished RCT (related product)💳 Co-pay applies
💭 Mental Health
Nox Health · sleepreviewmag.com (Somryst/Serve You Rx formulary)
Entry last updated 30 Jul 2026

Somzz

🇰🇷 South Korea

Somzz is a digital therapeutic (DTx), developed by AIMMED (에임메드), used for chronic insomnia. CBT-i (cognitive behavioural therapy for insomnia) programme. It is available in South Korea on a self-pay basis -- a reimbursement-eligible pathway may exist, but the patient currently pays out of pocket rather than an insurer or employer.

DTxNative appSelf-payPublished RCT (this product)
💭 Mental Health
AIMMED (에임메드) · themedical.kr (2025-06-10)
Entry last updated 30 Jul 2026

Sooma tDCS

🇫🇮 Finland

Sooma tDCS is an EU MDR-certified transcranial direct current stimulation (tDCS) device, developed by Sooma Oy (Helsinki, Finland), used for depression and chronic pain via a non-invasive brain-stimulation headset worn for 30-minute sessions, 5 days a week, for a minimum of 4 weeks. It is sold direct-to-patient (self-pay) in Finland and Germany, ordered online with no referral required. Sooma is separately one of 10 companies selected for Finland's DigiFinland pilot (Oct 2025), a government evaluation programme -- the pilot itself carries no reimbursement mechanism yet.

4 weeks minimum (30 min/session, 5 days/week)

MedTech deviceWearable device (tDCS headset) + treatment protocolSelf-payPublished RCT (related product)
💭 Mental Health
Sooma Oy · soomamedical.com
Entry last updated 30 Jul 2026

SoriCLEAR

🇰🇷 South Korea

SoriCLEAR is a digital therapeutic (DTx), developed by NuLive (뉴라이브), used for tinnitus. It is available in South Korea on a self-pay basis -- a reimbursement-eligible pathway may exist, but the patient currently pays out of pocket rather than an insurer or employer.

DTxNative appSelf-pay
👂 Ears
NuLive (뉴라이브) · themedical.kr (2025-06-10)
Entry last updated 30 Jul 2026

Spring

🇬🇧 United Kingdom

Spring is a digital therapeutic (DTx), used for post-traumatic stress disorder (PTSD). It is reimbursed nationally in the United Kingdom via the NHS Talking Therapies DET pathway. NHS England DET-compliant, nationally usable within NHS Talking Therapies -- Commissioned locally by individual NHS Talking Therapies services, drawn from NICE's nationally-vetted DET list.

DTxNative appNational reimbursementOngoing trial, unpublished💳 No co-pay
💭 Mental Health
Company not recorded · nice.org.uk/news/articles/nice-recommends-8-digitally-enabled-therapies-to-treat-depression-and-anxiety (1 Mar 2023)
Entry last updated 30 Jul 2026

Stella

🇺🇸 USA

Stella is a virtual menopause clinic from Vira Health Limited: video visits with board-certified clinicians licensed in all 50 states, prescriptions (including HRT) sent to the patient's pharmacy, plus a companion app with coaching and lifestyle programmes. Reimbursement attaches to the clinician visit, not to a listed product -- Stella states it is in-network with hundreds of commercial plans, naming Aetna, Anthem, BlueCross BlueShield and UnitedHealthcare, with an average copay of about USD45 and coverage varying by plan. Patients without in-network coverage pay USD200 for the initial visit and USD90 per follow-up and receive a superbill to submit themselves. Medications are FDA-regulated and typically run through pharmacy benefits rather than through this service. The company is UK-based and also operates Stella UK (fully private, explicitly not NHS: GBP85 initial appointment plus GBP10 per prescription) and Stella South Africa. Checked Oct 2026.

Ongoing

Blended careNative app + virtual clinic (video visits)Regional/SelectiveMedicaid
Vira Health Limited · us.onstella.com (insurance and pricing pages)
Entry last updated 14 Oct 2026

Sword Bloom

🇺🇸 USA

Sword Bloom is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Sword Health, Inc., used for women's health across every life stage. Incl. pregnancy, postpartum and menopause-related conditions. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careApp + clinician platformCorporate healthReal-world evidence only
♀️ Gynaecology
Sword Health, Inc. · swordhealth.com/business/employers
Entry last updated 9 Oct 2026

Sword Mind

🇺🇸 USA

Sword Mind is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Sword Health, Inc., used for anxiety, depression and other common mental-health conditions. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careApp + clinician platformCorporate health
💭 Mental Health
Sword Health, Inc. · swordhealth.com/business/employers
Entry last updated 30 Jul 2026

Sword Pulse

🇺🇸 USA

Sword Pulse is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Sword Health, Inc., used for cardiometabolic health. E.g. hypertension, high cholesterol, weight-related risk. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careApp + clinician platformCorporate health
🩸 Metabolic Diseases🫀 Heart & Circulatory
Sword Health, Inc. · swordhealth.com/business/employers
Entry last updated 30 Jul 2026

Sword Thrive

🇺🇸 USA

Sword Thrive is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Sword Health, Inc., used for musculoskeletal pain. Back, joint, neck, shoulder and repetitive-strain conditions. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careNative appCorporate healthPublished RCT (this product)
🦴 Musculoskeletal
Sword Health, Inc. · swordhealth.com/business/employers
Entry last updated 9 Oct 2026

t:slim X2 mit Control-IQ

🇩🇪 Germany

t:slim X2 mit Control-IQ is an automated insulin delivery (AID) system: an insulin pump coupled to a real-time CGM (Dexcom G6 or G7), with the Control-IQ algorithm automatically adjusting the basal rate and delivering automatic correction boluses while leaving manual adjustment available. In Germany it is listed in the Hilfsmittelverzeichnis under § 33 SGB V as "Variante 3" of product types 30.29.05/30.29.06 — the category defined by exactly that combination of automatic basal adjustment and automatic correction boluses — and is supplied nationwide on prescription.

Continuous use for as long as the indication persists

MedTech device🇩🇪 HilfsmittelConnected device / hardwareNational reimbursementPublished RCT (this product)💳 Co-pay applies
🩸 Metabolic Diseases
Tandem Diabetes Care, Inc. · GKV Hilfsmittelverzeichnis, product types 30.29.05 and 30.29.06 (queried 20 Oct 2026)
Entry last updated 20 Oct 2026

taozen

🇩🇪 Germany

taozen is a digital prevention programme, developed by Tao Zen, used for tai-Chi- and Qigong-based online movement courses (fernoestliche Bewegungslehren) for stress reduction. It is reimbursed nationally in Germany via the §20 SGB V Leitfaden Prävention pathway (ZPP-certified). Zertifiziert nach Sec.20 SGB V (ZPP); Erstattung bis zu 100% durch die gesetzliche Krankenkasse, zweimal jaehrlich bezuschusst.

PreventionWeb appNational reimbursement🇩🇪 §20 Chapter 5
💭 Mental Health
Tao Zen · taozen-praevention.de
Entry last updated 4 Sep 2026

teamfit

🇩🇪 Germany

teamfit is a digital prevention programme, developed by Teamfit GmbH, used for general workplace movement, motivation and vital-sign wellness. Not indication-specific. It is offered in Germany as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
Teamfit GmbH · teamfit.eu/en/corporate-health-platform
Entry last updated 30 Jul 2026

telecor (SHL Telemedizin)

🇩🇪 Germany

telecor (SHL Telemedizin) is a connected medical device (with companion software), developed by SHL Telemedizin GmbH (part of SHL Group), used for chronic heart failure remote monitoring, TMZ-as-a-service for cardiologists. It is reimbursed nationally in Germany via nationwide EBM remote-monitoring/telemonitoring billing codes. Reimbursed since Jan 2022.

MedTech deviceConnected device / hardwareNational reimbursement
🫀 Heart & Circulatory
SHL Telemedizin GmbH · shl-telemedizin.de
Entry last updated 30 Jul 2026

TheraKey (Berlin-Chemie)

🇩🇪 Germany

TheraKey (Berlin-Chemie) is a manufacturer-sponsored patient-education and therapy-support platform, developed and funded by Berlin-Chemie AG (Berlin, Germany; part of the Menarini Group), launched in 2012, used for patient education and therapy support across 8 chronic conditions including Type 1/Type 2 diabetes, hypertension, COPD, asthma, angina pectoris, dyslipidemia, gout and premature ejaculation. Unlike this dataset's other entries, funding comes from the drug manufacturer directly, rather than a statutory health insurer or employer.

Blended careWeb appManufacturer-sponsoredReal-world evidence only
🩸 Metabolic Diseases🫀 Heart & Circulatory🫁 Respiratory💧 Urogenital
Berlin-Chemie AG · therakey.de
Entry last updated 30 Jul 2026

Thieme TeleCare (Thieme TeleCoach App)

🇩🇪 Germany

Thieme TeleCare (Thieme TeleCoach App) is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Thieme TeleCare GmbH (subsidiary of the Thieme Verlagsgruppe medical-publishing group; telemedicine coaching provider active since 2000, company states 75,000+ people supported to date), used for multi-condition telemedical coaching: respiratory disease, hypertension/heart health, Long Covid/fatigue, diabetes, overweight, chronic pain, mental health/stress, sleep and more. It is reimbursed in Germany through regional or...

Blended careNative appRegional/Selective
🫁 Respiratory🫀 Heart & Circulatory🩸 Metabolic Diseases🦴 Musculoskeletal💭 Mental Health
Thieme TeleCare GmbH · gesundheitswelt.allianz.de
Entry last updated 30 Jul 2026

TK-Doc

🇩🇪 Germany

TK-Doc is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Techniker Krankenkasse (TK) -- operated in-house, not a separate vendor company, used for general/primary-care consultation via live chat or phone, in lieu of a waiting-room visit. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

Blended careNative appRegional/Selective
⚕️ Not indication-specific
Techniker Krankenkasse (TK) · tk.de/techniker/gesundheit-foerdern/digitale-gesundheit/gesundheits-apps-2000212
Entry last updated 30 Jul 2026

Una Health für Diabetes

🇩🇪 Germany

Una Health fuer Diabetes is a digital therapeutic (DTx), developed by Una Health GmbH, used for type 2 diabetes. It is not currently reimbursed in Germany -- struck from the DiGA directory on 28 Sep 2026 via a Hamburg regional social court order (Landessozialgericht Hamburg), the second delisting of 2026 after an earlier evidence-deadline strike (30 Mar 2026) was reversed on 22 Jun 2026.

DTxNative appRegional/SelectiveOngoing trial, unpublished💳 No co-pay
🩸 Metabolic Diseases
Una Health GmbH · diga.bfarm.de
Entry last updated 18 Oct 2026

Unmind

🇬🇧 United Kingdom

Unmind is a digital prevention programme, developed by Unmind Ltd., used for workplace mental health. Stress, anxiety, depression, sleep and general psychological wellbeing -- not indication-specific. It is offered in the United Kingdom as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate healthReal-world evidence only
⚕️ Not indication-specific
Unmind Ltd. · unmind.com
Entry last updated 30 Jul 2026

Untire(R)

🇩🇪 Germany

Untire(R) is a digital therapeutic (DTx), developed by Tired of Cancer B.V. (Untire), used for breast cancer-related fatigue (ICD-10 C50). It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR240.50/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
🎗️ Cancer
Tired of Cancer B.V. · diga.bfarm.de
Entry last updated 19 Oct 2026

Uroletics

🇩🇪 Germany

Uroletics is a digital therapeutic (DTx), developed by Rocketlane Medical Ventures GmbH (majority stake acquired by APOGEPHA Arzneimittel GmbH, Dec 2022), used for pre- and post-operative care for prostate surgery. 3D pelvic-floor training, mental-coaching content for surgery preparation and coping, and validated patient information, aimed at preventing/treating post-operative incontinence and erectile dysfunction. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

Not specified (ongoing access under the active Barmenia PKV contract)

DTxNative appRegional/SelectiveReal-world evidence only💳 No co-pay
💧 Urogenital
Rocketlane Medical Ventures GmbH · diga.bfarm.de/de/verzeichnis (Gestrichen-Filter)
Entry last updated 18 Oct 2026

Vantage Fit

🇺🇸 USA

Vantage Fit is a digital prevention programme, developed by Vantage Circle (Intellicorp Consulting Pvt. Ltd.), used for general fitness tracking, mood, heart-rate and workout gamification. Not indication-specific. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
Vantage Circle (Intellicorp Consulting Pvt. Ltd.) · vantagefit.io
Entry last updated 30 Jul 2026

velibra

🇩🇪 Germany

velibra is a digital therapeutic (DTx), developed by GAIA AG, used for anxiety disorder. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR230.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentWeb appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
GAIA AG · diga.bfarm.de
Entry last updated 19 Oct 2026

Vera-App für Wechseljahresbeschwerden

🇩🇪 Germany

Vera-App für Wechseljahresbeschwerden is a digital therapeutic (DTx), developed by Endo Health GmbH, used for menopause symptoms. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA (provisional); manufacturer price EUR598.95/90-day Rx (diga-verzeichnis.de).

DTx🇩🇪 DiGA PreliminaryNative appNational reimbursementOngoing trial, unpublished💳 No co-pay
♀️ Gynaecology
Endo Health GmbH · diga.bfarm.de
Entry last updated 18 Oct 2026

Vertidisan

🇮🇹 Italy

Vertidisan (VH90D) is a 90-day sensorimotor exercise therapy for vestibular vertigo, delivered as a mobile app and used daily at home. It is published by Digitineers GmbH & Co. KG in Tübingen and sold directly as a paid activation code rather than through any listing. Notably, it holds BSI TR-03161 -- the security certification German DiGA listing requires -- without being listed as a DiGA or stating an intention to apply.

90 exercise days; the activation code stays valid for 180 days

DTxNative app (iOS, Android)Self-pay
👂 Ears
Digitineers GmbH & Co. KG · vertidisan.de and vertidisan.com including the country pages and the Freischaltcode/reimbursement page (retrieved 27 October 2026)
Entry last updated 27 Oct 2026

Vertidisan

🇨🇭 Switzerland

Vertidisan (VH90D) is a 90-day sensorimotor exercise therapy for vestibular vertigo, delivered as a mobile app and used daily at home. It is published by Digitineers GmbH & Co. KG in Tübingen and sold directly as a paid activation code rather than through any listing. Notably, it holds BSI TR-03161 -- the security certification German DiGA listing requires -- without being listed as a DiGA or stating an intention to apply.

90 exercise days; the activation code stays valid for 180 days

DTxNative app (iOS, Android)Self-pay💳 Co-pay applies
👂 Ears
Digitineers GmbH & Co. KG · vertidisan.de and vertidisan.com including the country pages and the Freischaltcode/reimbursement page (retrieved 27 October 2026)
Entry last updated 27 Oct 2026

Vertidisan

🇱🇺 Luxembourg

Vertidisan (VH90D) is a 90-day sensorimotor exercise therapy for vestibular vertigo, delivered as a mobile app and used daily at home. It is published by Digitineers GmbH & Co. KG in Tübingen and sold directly as a paid activation code rather than through any listing. Notably, it holds BSI TR-03161 -- the security certification German DiGA listing requires -- without being listed as a DiGA or stating an intention to apply.

90 exercise days; the activation code stays valid for 180 days

DTxNative app (iOS, Android)Self-pay
👂 Ears
Digitineers GmbH & Co. KG · vertidisan.de and vertidisan.com including the country pages and the Freischaltcode/reimbursement page (retrieved 27 October 2026)
Entry last updated 27 Oct 2026

Vertidisan

🇧🇪 Belgium

Vertidisan (VH90D) is a 90-day sensorimotor exercise therapy for vestibular vertigo, delivered as a mobile app and used daily at home. It is published by Digitineers GmbH & Co. KG in Tübingen and sold directly as a paid activation code rather than through any listing. Notably, it holds BSI TR-03161 -- the security certification German DiGA listing requires -- without being listed as a DiGA or stating an intention to apply.

90 exercise days; the activation code stays valid for 180 days

DTxNative app (iOS, Android)Self-pay
👂 Ears
Digitineers GmbH & Co. KG · vertidisan.de and vertidisan.com including the country pages and the Freischaltcode/reimbursement page (retrieved 27 October 2026)
Entry last updated 27 Oct 2026

Vertidisan

🇫🇷 France

Vertidisan (VH90D) is a 90-day sensorimotor exercise therapy for vestibular vertigo, delivered as a mobile app and used daily at home. It is published by Digitineers GmbH & Co. KG in Tübingen and sold directly as a paid activation code rather than through any listing. Notably, it holds BSI TR-03161 -- the security certification German DiGA listing requires -- without being listed as a DiGA or stating an intention to apply.

90 exercise days; the activation code stays valid for 180 days

DTxNative app (iOS, Android)Self-pay
👂 Ears
Digitineers GmbH & Co. KG · vertidisan.de and vertidisan.com including the country pages and the Freischaltcode/reimbursement page (retrieved 27 October 2026)
Entry last updated 27 Oct 2026

Vertidisan

🇦🇹 Austria

Vertidisan (VH90D) is a 90-day sensorimotor exercise therapy for vestibular vertigo, delivered as a mobile app and used daily at home. It is published by Digitineers GmbH & Co. KG in Tübingen and sold directly as a paid activation code rather than through any listing. Notably, it holds BSI TR-03161 -- the security certification German DiGA listing requires -- without being listed as a DiGA or stating an intention to apply.

90 exercise days; the activation code stays valid for 180 days

DTxNative app (iOS, Android)Self-pay
👂 Ears
Digitineers GmbH & Co. KG · vertidisan.de and vertidisan.com including the country pages and the Freischaltcode/reimbursement page (retrieved 27 October 2026)
Entry last updated 27 Oct 2026

Vertidisan

🇩🇪 Germany

Vertidisan (VH90D) is a 90-day sensorimotor exercise therapy for vestibular vertigo, delivered as a mobile app and used daily at home. It is published by Digitineers GmbH & Co. KG in Tübingen and sold directly as a paid activation code rather than through any listing. Notably, it holds BSI TR-03161 -- the security certification German DiGA listing requires -- without being listed as a DiGA or stating an intention to apply.

90 exercise days; the activation code stays valid for 180 days

DTxNative app (iOS, Android)Self-pay💳 No co-pay
👂 Ears
Digitineers GmbH & Co. KG · vertidisan.de and vertidisan.com including the country pages and the Freischaltcode/reimbursement page (retrieved 27 October 2026)
Entry last updated 27 Oct 2026

viatolea

🇩🇪 Germany

viatolea is a digital therapeutic (DTx), developed by PYRA MEDI GmbH (Nuremberg, Germany, founded 2024), used for food intolerances (fructose, sorbitol, lactose, wheat sensitivity). A digital nutrition journal plus an algorithm identifies likely intolerances from logged meals/symptoms and guides users through guideline-compliant dietary changes over a 10-week programme. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

10-week programme

DTxNative appRegional/SelectiveReal-world evidence only💳 No co-pay
🦠 Digestive
PYRA MEDI GmbH · viatolea.de
Entry last updated 30 Jul 2026

Vigo

🇱🇻 Latvia

Vigo is a digital therapeutic (DTx), developed by Vigo Health, used for post-stroke rehabilitation (multimodal: physical therapy, activities-of-daily-living guidance, CBT-based tools), for patients who have not entirely lost cognitive ability. It is currently self-pay only (approx. EUR49/month per Latvian press coverage). Vigo has obtained an NVD (National Health Service) manipulation-list code. Uncertain / not independently confirmed for 2025-2026 -- see note above.

DTxNative appSelf-pay
🧠 Nervous System
Vigo Health · vigo.health
Entry last updated 19 Sep 2026

Vila RaVie

🇩🇪 Germany

Vila RaVie is a digital therapeutic (DTx), developed by Vila Health GmbH (Berlin, Germany), used for inflammatory rheumatic diseases including rheumatoid arthritis (ICD-10 M05/M06), psoriatic arthropathy (L40.5) and systemic lupus erythematosus (M32), targeting disease-related psychological burden and quality of life rather than the underlying disease activity itself. A 12-week, browser-based cognitive-behavioural-therapy programme (no app installation required) covering self-image, daily life, thoughts/feelings, body/symptoms, family/friends, acceptance and health empowerment, guided by a psychotherapist persona. It is currently available in Germany only on a self-pay basis (EUR 149 for a 12-week access code); not yet DiGA-listed. Vila Health reports that effectiveness in reducing psychological burden and improving quality of life was shown in a randomized controlled trial led by the University Hospital Giessen and Marburg (UKGM); this has not been published, so the claim could not be independently verified.

12-week programme

DTxWeb applicationSelf-payCompleted trial, unpublished💳 No co-pay
🦴 Musculoskeletal
Vila Health GmbH · vila-health.com
Entry last updated 19 Sep 2026

Virdio Health

🇺🇸 USA

Virdio Health is a digital therapeutic (DTx), developed by Virdio Health, Inc. (Vienna, Virginia, USA, founded April 2019 by Arjun Rishi and Ty Bordner), used for musculoskeletal (MSK) pain such as back, hip and knee pain. Delivered as "Myra", a conversational AI recovery coach accessible from any browser (no app download, no equipment) that builds a personalized recovery program through open-ended dialogue rather than tap-through intake forms, and adapts the plan as the user's condition changes. It is offered as a self-funded-employer benefit at a flat $99 all-in cost per engaged employee (the company also cites "sub $1 PEPM" pricing), with no co-pays or scheduled appointments. Virdio Health reports a 24x return on investment for employers and that 73% of members report significant pain reduction; these are company-reported figures with no independent citation found.

DTxWeb applicationCorporate healthReal-world evidence only💳 Co-pay applies
🦴 Musculoskeletal
Virdio Health, Inc. · virdiohealth.com
Entry last updated 19 Sep 2026

Vitadio

🇩🇪 Germany

Vitadio is a digital therapeutic (DTx), developed by Vitadio, used for type 2 diabetes. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR224.01/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
🩸 Metabolic Diseases
Vitadio s.r.o., Czech Republic (German subsidiary Vitadio Health Technologies GmbH insolvent 2024, in liquidation) · diga.bfarm.de
Entry last updated 18 Oct 2026

VIVID Brain

🇰🇷 South Korea

VIVID Brain is a digital therapeutic (DTx), developed by Nunaps (뉴냅스), used for hemianopia (visual field loss following brain lesion/stroke). Cognitive/visual-perceptual training. It is available in South Korea on a self-pay basis -- a reimbursement-eligible pathway may exist, but the patient currently pays out of pocket rather than an insurer or employer.

DTxNative appSelf-pay
🧠 Nervous System👁️ Eyes/Vision
Nunaps (뉴냅스) · themedical.kr (2025-06-10)
Entry last updated 30 Jul 2026

Vivira

🇩🇪 Germany

Vivira is a digital therapeutic (DTx), developed by Vivira Health Lab GmbH, used for back pain. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR206.79/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
🦴 Musculoskeletal
Vivira Health Lab GmbH · diga.bfarm.de
Entry last updated 19 Oct 2026

vorvida

🇩🇪 Germany

vorvida is a digital therapeutic (DTx), developed by GAIA AG, used for alcohol use disorder. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR185.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentWeb appNational reimbursementPublished RCT (this product)💳 No co-pay
💭 Mental Health
GAIA AG · diga.bfarm.de
Entry last updated 19 Oct 2026

Wellhub (formerly Gympass)

🇺🇸 USA

Wellhub (formerly Gympass) is a digital prevention programme, developed by Wellhub, Inc. (formerly Gympass), used for general fitness, mental wellness, nutrition and sleep. Not indication-specific. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
Wellhub, Inc. · en.wikipedia.org/wiki/Wellhub
Entry last updated 30 Jul 2026

Wellnow -- Smart Corporate Health

🇩🇪 Germany

Wellnow -- Smart Corporate Health is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Wellnow Health GmbH, used for general workplace physical and mental wellbeing. On-site massage, physiotherapy, yoga, back-training, mindfulness -- not indication-specific. It is offered in Germany as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

Blended careNative appCorporate healthReal-world evidence only
🦴 Musculoskeletal💭 Mental Health
Wellnow Health GmbH · en.wellnow.de
Entry last updated 18 Sep 2026

WellSteps

🇺🇸 USA

WellSteps is a digital prevention programme, developed by WellSteps, LLC, used for general wellness behavior change across six health pillars. Not indication-specific. It is offered in the USA as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate healthReal-world evidence only
⚕️ Not indication-specific
WellSteps, LLC · wellsteps.com
Entry last updated 30 Jul 2026

WundFit

🇩🇪 Germany

WundFit is a digital therapeutic (DTx), developed by 4L Health GmbH (Karlsruhe, Germany), used for chronic wounds such as diabetic, venous or arterial circulatory-disorder wounds. A patient-education and daily-routine companion (structured diary, guided instructions, reminders) intended to strengthen patients' active role in wound self-care alongside clinical treatment. It is currently free to use for participants in the company's clinical study, which is preparatory to a planned DiGA submission; not yet self-pay or DiGA-listed. A Class IIa medical device.

DTxNative appPilotOngoing trial, unpublished💳 No co-pay
🩹 Skin/Dermatology
4L Health GmbH · 4l.health
Entry last updated 18 Sep 2026

Xinjing Technology VR Insomnia-Disorder Therapy Software (心景科技)

🇨🇳 China

Xinjing Technology VR Insomnia-Disorder Therapy Software (心景科技) is a connected medical device (with companion software), developed by Xinjing Technology (心景科技), used for insomnia disorder. VR-based cognitive-behavioural/relaxation therapy. It is billable in China (Hainan province) under a provincial fee-schedule, not yet nationwide health insurance.

MedTech deviceConnected device / hardwareProvincial fee-schedule (Hainan)Real-world evidence only💳 Co-pay applies
💭 Mental Health
Xinjing Technology (心景科技) · Chinese-language trade press (2024-2025) reporting Hainan's first/only VR-based insomnia-treatment device registration
Entry last updated 30 Jul 2026

YoniCare (Micado)

🇩🇪 Germany

YoniCare (Micado) is a blended-care digital health programme, combining software with ongoing clinician or coach involvement, developed by Micado Health Care GmbH (Hamburg, founded 13 Aug 2004), used for genitourinary syndrome of menopause (GSM). Vaginal dryness, tissue/mucosal changes, itching, incontinence and recurrent UTIs from declining oestrogen; laser therapy revitalises the vaginal epithelium, typically 1-3 sessions 4-8 weeks apart, hormone-free. It is reimbursed in Germany through regional or insurer-specific contracts rather than a nationwide scheme.

1-3 sessions, spaced 4-8 weeks apart

Blended careNative appRegional/Selective
♀️ Gynaecology
Micado Health Care GmbH · healthy-hub.de (5th-round winner announcement, Mar 2024)
Entry last updated 30 Jul 2026

YuMuuv

🇪🇪 Estonia

YuMuuv is a digital prevention programme, developed by YuMuuv OU, used for general team fitness and step/activity challenges. Not indication-specific. It is offered in Estonia as an employer-sponsored corporate-health benefit, paid for by the employer or health plan rather than a statutory or private insurer.

PreventionNative appCorporate health
⚕️ Not indication-specific
YuMuuv OU · yumuuv.com
Entry last updated 30 Jul 2026

zanadio

🇩🇪 Germany

zanadio is a digital therapeutic (DTx), developed by aidhere GmbH, used for obesity. It is reimbursed nationally in Germany via the DiGA §139e SGB V pathway. SHI-reimbursed, DiGA; manufacturer price EUR218.00/90-day Rx (diga.bfarm.de).

DTx🇩🇪 DiGA PermanentNative appNational reimbursementPublished RCT (this product)💳 No co-pay
🩸 Metabolic Diseases
Sidekick Health Germany GmbH (acquired the zanadio business from aidhere GmbH, which became insolvent in 2023) · diga.bfarm.de
Entry last updated 19 Oct 2026

Zio XT

🇬🇧 United Kingdom

Zio XT is a digital therapeutic, developed by iRhythm Technologies, Inc., used for ambulatory ECG monitoring (>24 hours) for people with suspected cardiac arrhythmias -- wearable single-lead ECG patch, algorithmic analysis, and clinician report. NICE Medical Technologies Guidance MTG52 recommends Zio XT as an option for ambulatory ECG monitoring beyond 24 hours, replacing standard Holter monitors in eligible NHS pathways.

MedTech deviceWearable ECG patch + algorithm + clinician reportNational reimbursementReal-world evidence only
🫀 Heart & Circulatory
iRhythm Technologies, Inc. · nice.org.uk/guidance/htg562 (formerly MTG52
Entry last updated 10 Oct 2026

Country dossiers

How reimbursement began in each country, which pathway dominates today, what it costs — and which laws are changing.

🇦🇺 Australia
No DiGA-style single DTx pathway. The TGA regulates DTx as software-based medical devices (ARTG listing, tightened for AI/software in 2025), and reimbursement is fragmented across MBS, PBS, the National Diabetes Services Scheme and the NDIS rather than a dedicated digital-therapeutics scheme. Active HTA modernisation but no standing DTx line yet.
🇦🇹 Austria Statutory pathway in pilot — corporate channel live now.

How reimbursement began

  • 2021: MOVEVO (Villach) is founded, launching an employer-paid corporate workplace-movement app -- Austria's first reimbursed product of any kind.
  • Jun 2023: Digital Austria Act adopted by the Council of Ministers -- a 117-measure digitalisation package that lays the groundwork for a future DiGA-style statutory pathway.
  • 2025: MOVEVO's annual MOVE DAYS company health challenge draws 100+ companies.
  • Nov 2025: A statutory DiGA/DiPA-style framework is confirmed in pilot, testing psychiatry and cardiovascular apps.
  • End of 2026 (targeted): A standardised evaluation process is due to be completed.
  • Early 2027 (expected): Prescribing under the statutory pathway is expected to begin.

Reimbursement pathways

The only live reimbursement route today is the employer-sponsored corporate-health channel: MOVEVO (Villach) sells a workplace movement/BGF app directly to Austrian employers — non-statutory, but real payment.

Pricing snapshot

Employer-paid corporate-wellness pricing rather than a statutory tariff.

Trend & outlook

The statutory pathway is the one to watch: if the 2026 evaluation model lands, Austria could move from a single corporate-channel product to a genuine national scheme in 2027.
🇧🇪 Belgium A graduated on-ramp, not one big gate.

How reimbursement began

  • 2019: mHealthBELGIUM, run by beMedTech and Agoria, launches its three-level validation pyramid (M1/M2/M3).
  • 29 Jan 2021: Level M3, the reimbursement tier, is activated for the first time, funded by INAMI-RIZIV.
  • Jan 2025: A chronic heart-failure telemonitoring convention brings hospitals onto the pathway.
  • 1 Jan 2026: An oncology telemonitoring pathway opens under circular OMZ.ZH.2026/04, adding five new apps.
  • Jul 2026: The platform's live count reaches 32 apps in total, with 12 at the reimbursement-eligible Level 3+.

Reimbursement pathways

Apps climb M1 (CE + GDPR + registration) → M2 (interoperability/security) → M3, where INAMI-RIZIV funds those proving clinical and socio-economic value. Coverage spans heart-failure and cancer telemonitoring, knee/hip rehab, Holter and sleep-apnoea pathways.

Pricing snapshot

Reimbursement is pathway-specific rather than a single tariff — funding attaches to the care trajectory the app supports (e.g. heart-failure telemonitoring), not to the software licence itself.

Trend & outlook

Belgium now tracks ~13 reimbursed products, on par with France, and January 2026 added cancer telemonitoring. The model's strength is its graduated on-ramp; proving M3 clinical value remains the bottleneck.
🇧🇷 Brazil

Reimbursement pathways

No DTx-specific route exists, so a digital therapeutic would have to travel the general incorporation path. The SUS (Sistema Único de Saúde) is Brazil's public health system: universal, free at the point of use, and run jointly by the federal government, the states and the municipalities -- at national scale, the only payer that matters. Getting a technology into it is a defined administrative act under Law 12.401/2011, which inserted articles 19-Q and 19-R into the health act. The Ministry of Health decides, advised by CONITEC (Comissão Nacional de Incorporação de Tecnologias no SUS), which runs a health-technology assessment including a public consultation; the process must conclude within 180 days of filing, extendable by 90. ANVISA registration is a precondition -- the same law prohibits paying for or reimbursing an unregistered product. A favourable decision then has to reach the lists that make a service billable, above all SIGTAP (the unified table of SUS procedures, medicines and devices), and the three levels of government settle who funds it in the Comissão Intergestores Tripartite. Private health plans are a separate system, regulated by ANS through its Rol de Procedimentos rather than by CONITEC. No digital therapeutic has completed any of this.
🇧🇬 Bulgaria
NHIF (National Health Insurance Fund) digital initiatives found in this pass covered an electronic health-insurance card and pharmaceutical cost-recovery agreements -- no digital-therapeutics-specific mechanism identified.
🇨🇦 Canada Reimbursement is provincial — so the count is corporate.

How reimbursement began

  • 2004: CoreHealth Technologies is founded in Kelowna, British Columbia.
  • 9 Aug 2021: CoreHealth is acquired by Montreal's Carebook Technologies, becoming CoreHealth by Carebook.
  • Present: No statutory DTx reimbursement pathway has been identified in any province -- Canada's only tracked route remains this employer-paid corporate-wellness channel.

Reimbursement pathways

The tracked route is corporate-health: CoreHealth (Kelowna, BC; now CoreHealth by Carebook) is a Canadian white-label corporate-wellness platform serving large employers and wellness providers.

Pricing snapshot

Employer/provider-paid platform pricing rather than a public tariff.

Trend & outlook

Public reimbursement would need provincial action; for now Canada's presence here is via the employer channel rather than any medicare-style listing.
🇨🇳 China One province pays for DTx; the rest of China does not.

How reimbursement began

  • Jan 2022: Hainan Province's 14th Five-Year Plan creates the legal basis for a provincial DTx fast-track, kept deliberately separate from China's national NMPA/NHSA system.
  • Oct 2022: The fast-track Class II device-approval channel formally launches, averaging a 29-day review (79% faster than the statutory limit).
  • Sep 2023 (Beijing): Anding Hospital and Brain Aurora unveil 心灵岛屿Aurora, a gamified depression app, heading into clinical trials -- a real product, but with no reimbursement mechanism attached.
  • Mar 2024 (Shanghai): A Shanghai official's national CPPCC proposal states plainly that very few DTx products are reimbursed anywhere in China yet, citing Hainan as the model other regions should copy.
  • May 2024 (Guangdong): Shenzhen launches a free cognitive-screening pilot for over-65 residents, funded via the public-health-service budget rather than medical insurance.
  • Feb-Oct 2024: Four more Hainan approvals follow -- exercise/cardiopulmonary rehab (Feb), pulmonary-function rehab (Jun), cardiopulmonary walking-test analysis (Sep) and cognitive-impairment assessment (Oct) software.
  • May 2025: Hainan launches its own province-level billing framework, with three fee models -- patient self-pay, hospital add-on fee, or bundled family-doctor contracts.
  • May 2025 (Shanghai): A pediatric digital-diagnostics R&D center opens in Pudong with 8 initial research projects -- an incubation center, not a payment mechanism.
  • Jun 2025 (Guangdong): The provincial regulator grants Tencent's cognitive-training app a Class II device clearance -- a regulatory approval, not an insurance decision.
  • Jul 2025 (Beijing): Beijing Hospital of Traditional Chinese Medicine launches a cognitive-impairment digital-therapeutics research platform -- a clinical-research initiative, not an insurance pathway.
  • Nov 2025: Hainan's regulator revises its headline count to 11 approved products.
  • Jul 2026: Independent counts put Hainan's total at 14 -- still the only region with a real payment mechanism, and no national pathway has been announced.

Reimbursement pathways

This is a single-province mechanism — Hainan MPA approvals plus a provincial fee schedule — deliberately kept distinct from China's national NMPA/NHSA insurance system. Beijing, Shanghai and Guangdong are routinely named as parallel 'pilots' in Chinese trade press, but none has a documented province/city-level medical-insurance notice for DTx: Beijing's own insurance bureau returns zero hits for '数字疗法'; Shanghai's 2024 CPPCC proposal states plainly that 'very few' DTx products are reimbursed anywhere in China; Guangdong's one concrete 2025 event (Tencent's cognitive-training app) is a device clearance, not a payment decision. Elsewhere, DTx reimbursement is decided ad hoc by hospital groups.

Pricing snapshot

Provincial fee-schedule pricing rather than national insurance; several approvals are named only by generic device type, not a commercial brand.

Trend & outlook

Hainan is the only region in China with a documented DTx payment mechanism. Beijing, Shanghai and Guangdong each show adjacent activity -- R&D platforms, a named clinical product, one device clearance, a free public-health pilot -- but none has published a DTx-specific insurance-payment mechanism of its own. No national pathway has been announced, so scale depends on whether other provinces adopt Hainan's model or a national rule follows.

Regulatory changes · 30 Jul 2025 · NMPA 2025/27

Classification Guideline for Rehabilitation Digital Therapeutics Software (康复类数字疗法软件产品分类界定指导原则)

  • Issued by the NMPA as Announcement No. 27 of 2025, in force from the day of publication (30 Jul 2025).
  • Covers software that uses digital technology to relieve a patient's functional impairment, or to compensate for or rebuild lost function.
  • Tells applicants how to determine both the regulatory attribute of a product (whether it counts as a medical device at all) and its risk class, weighing factors such as the indication, the data being processed and the core algorithm.
Market impact: Until this guideline, DTx in China were handled under general medical-device rules, with the only DTx-specific machinery sitting one level down, in Hainan province. This is a regulatory step rather than a reimbursement one: it clarifies how a rehabilitation DTx gets approved, while who pays remains a provincial question — Hainan is still the only province with its own DTx payment mechanism. NMPA guidance covering DTx indications beyond rehabilitation is expected to follow.

Source: NMPA / NIFDC (Announcement 2025 No. 27)

🇭🇷 Croatia
HZZO's digital push (e-invoicing, e-Zdravstveno portal, a new file-exchange portal live since Apr 2025) is entirely administrative digitisation -- no digital-therapeutics reimbursement mechanism found.
🇨🇾 Cyprus
Named among 11 EU states with no dedicated digital-therapeutics reimbursement framework (Rabiei & Almasi, DIGITAL HEALTH, Apr 2026). GESY (the national health system, marking 7 years in 2026) recently added physiotherapy and cross-border-care reimbursement -- nothing DTx-specific found.
🇨🇿 Czech Republic
New telemedicine legislation (2024 Act amendment, Decree 30/2025) defines how telemedicine services must be delivered, but a dedicated reimbursement framework is still described as 'under discussion' -- insurers reimbursed remote consultations ad hoc during COVID with no lasting legal basis.
🇩🇰 Denmark Curation on purpose — not reimbursement.

How reimbursement began

  • 2024: Denmark establishes Naevnet for Sundhedsapps (the Health Apps Council), deliberately choosing curation over reimbursement.
  • 1 Jul 2025: The first recommendation round lists five apps -- Min Laege, Mine Knogler, Stress Autism Mate, Hedia Diabetes Assistant and SelfBack.
  • Sep 2025: A second round adds Meta Learn and MinSpiral.
  • Nov-Dec 2025: A third round adds MinSundhed, Kulhydrattaelleren and Mit liv - min sundhed -- still a quality signal, with no payment mechanism behind any listing.

Reimbursement pathways

Recommendation-only: apps are assessed and listed for citizens and clinicians to trust, not funded as a prescribed therapy.

Pricing snapshot

No reimbursement tariff — recommended apps are free or self-pay.

Trend & outlook

Denmark's bet is that trusted curation plus a strong public-health digital backbone drives adoption without DiGA-style spend. A shift to reimbursement isn't currently signalled.
🇪🇪 Estonia e-government leader, no DTx tariff yet.

How reimbursement began

  • 2019: YuMuuv, an Estonian wearable-data team-challenge platform, is founded -- Estonia's first reimbursed product, via the employer-paid corporate channel.
  • 2019-2026: YuMuuv scales to 600+ companies worldwide, still the country's only live reimbursement route.
  • Jan 2026: Tervisekassa (the Estonian Health Insurance Fund) adds 55 new devices to its medical-devices reimbursement list -- still with no digital-therapeutics-specific category.

Reimbursement pathways

The live route is the corporate-health channel: YuMuuv, an Estonian wearable-data team-challenge platform, sells to 600+ companies globally — non-statutory reimbursement.

Pricing snapshot

Employer-paid corporate-wellness pricing; no statutory DTx tariff exists.

Trend & outlook

Given Estonia's digital-health infrastructure, a statutory pathway would be a natural next step — but none is defined yet, so the count rests on the corporate channel.
🇫🇮 Finland
No standalone national reimbursement pathway for digital therapeutics. What exists is an explicit experiment rather than a framework: the Ministry of Social Affairs and Health, Kela, Sitra and FinCCHTA have run a nationwide digital-therapeutics experiment since 2025 with 10 selected solutions, with a proposal for a permanent operating model due by the end of 2026 and a final report in Feb 2027. The pilot is coordinated by DigiFinland and tests how prescribed, evidence-based digital applications could be integrated into the Finnish health insurance reimbursement system -- the model already used in several European countries, where a physician prescribes an application and the insurer reimburses it as it would a medicine. Sitra reported the call for participants on 10 Jun 2025, open until 6 Aug 2025. Treat this as a pipeline signal: a reimbursement experiment is not a reimbursement route, and no permanent reimbursement system exists today. Checked Oct 2026.
🇫🇷 France Telemonitoring first, therapeutics next.

How reimbursement began

  • 2014-2022: France runs the ETAPES telemonitoring experiment, the forerunner to today's framework.
  • Sept 2021: Diabeloop's DBLG1 becomes one of the first digital-linked devices reimbursed via the standard LPPR listing route.
  • Apr 2023: PECAN (Prise en Charge Anticipee Numerique) launches, inspired by Germany's DiGA, a one-year early-access route for digital medical devices pending full HAS evaluation.
  • Oct 2023: Telemonitoring products like RESILIENCE PRO begin reimbursement via the LATM line.
  • 2025: Ludocare's JOE is rejected under PECAN for insufficient data.
  • Apr 2026: JOE re-files via the standard LPPR route and wins the first-ever favourable HAS/CNEDiMTS opinion for a digital therapy in France.
  • Jun 2026: Poppins Clinical secures a PECAN listing.

Reimbursement pathways

Two doors: PECAN for fast, temporary access, then permanent listing via the LPPR (digital therapeutics) or the LATM telemonitoring line. HAS assesses clinical benefit; Assurance Maladie pays. Most live volume today is cardiac and renal remote monitoring.

Pricing snapshot

PECAN telemonitoring is set at ~€50/patient/month; individual-use DTx use a front-loaded first-quarter package plus capped monthly fees (e.g. ~€435 then €38.30/month, max €780/yr).

Trend & outlook

Uptake has trailed the 50-application target — only ~11 dossiers by early 2025. The pipeline is broadening from telemonitoring into paediatric DTx (e.g. Poppins), and the LPPR permanent pathway is the real prize companies are now chasing.
🇩🇪 Germany The template the rest of the world copied.

How reimbursement began

  • Apr 2016: EBM remote monitoring for pacemakers, ICDs and CRTs becomes reimbursable nationwide -- years before DiGA existed, this is Germany's first digital-health billing line.
  • Dec 2019: The Digital Healthcare Act (DVG) takes effect, creating the DiGA fast-track under Section 139e SGB V -- the world's first national DTx reimbursement law.
  • Oct 2020: The first DiGA go live -- velibra, Kalmeda and somnio become the fast-track's first real, prescribable products.
  • 2020-Jan 2022: Following a 2020 G-BA resolution, heart-failure telemonitoring with external devices becomes reimbursable nationwide under its own EBM codes (13583-13587 plus 03325/03326) -- a second, DiGA-independent digital-health pathway.
  • 2022-2023: The legal basis for DiPA (Digitale Pflegeanwendungen) is established -- a sister pathway to DiGA, funded via long-term-care insurance (Pflegeversicherung, SGB XI) rather than statutory health insurance, for digital care rather than medical-treatment apps.
  • 2024: The Digital Act (DigiG) streamlines DiGA activation codes and opens the door to higher-risk class IIb devices, while a wave of delistings (Kaia COPD, optimune and others) shows the evidence bar starting to bite.
  • Jan 2026: The BEEP-Gesetz enters into force, giving DiPA a simplified pilot listing procedure, a trial year and a higher monthly cap -- though BfArM has yet to list a single DiPA product.
  • Jul 2026: The Anwendungsbegleitende Erfolgsmessung (AbEM) starts: manufacturers of permanently listed DiGA with a proven medical benefit must collect outcome data from 1 Jul 2026 and report it to BfArM every six months, on 15 April and 15 October -- the first report falls due 15 Apr 2027 and covers Q3 and Q4 2026 together.
  • Jul 2026: deprexis becomes the first German DiGA to also be reimbursed abroad, listed on Switzerland's new MiGeL dGA chapter.

Reimbursement pathways

Germany runs several statutory routes side by side, and the best-known is not the biggest. DiGA (§ 139e SGB V) is the dedicated DTx pathway and the part other countries copied: manufacturers apply to BfArM, which decides within three months; an app may list provisionally on a “positive healthcare effect” trial, then convert to a permanent listing. Physicians and psychotherapists prescribe, and statutory insurers pay the manufacturer directly. It is the only route built for software as such — but it carries roughly as many products in this directory as selective contracts and reimbursement-by-claim (§ 140a SGB V), where a single named insurer covers an app for its own members. Alongside both run certified prevention courses (§ 20 SGB V), approved through the Zentrale Prüfstelle Prävention and reimbursed per completed course; physician-billed telemonitoring via the EBM, which predates DiGA by three years and covers cardiac implants since 2016 and heart failure since 2022; Hilfsmittel (§ 33 SGB V), the route for devices with software — CGM systems, automated insulin delivery, seizure detection — supplied on prescription from the Hilfsmittelverzeichnis; and the long-term care insurance (SGB XI), which pays toward home emergency call systems for people with a care level. Employer-funded corporate health sits outside the statutory system entirely. For scale: cumulative DiGA spending passed €234m by the end of 2024, across all products and four years.

Pricing snapshot

Manufacturers set their own price for the first 12 months, then negotiate a rate with the GKV-Spitzenverband. Typical prices run ~€200–600 per 90-day prescription; cumulative DiGA spending passed €234m by the end of 2024. From 1 Jan 2026 the reimbursement agreement under §134 SGB V must also contain at least 20 percent outcome-dependent price components; BfArM notes that exactly how the AbEM results feed into that share is still to be settled between the parties.

Trend & outlook

The 2024 Digital Act (DigiG) streamlined activation codes and opened the door to higher-risk (class IIb) apps. From 2026 the Anwendungsbegleitende Erfolgsmessung (AbEM) -- the mandatory outcome measurement that accompanies everyday use -- and outcome-linked pricing begin — the market is shifting from merely “listed” to “proven,” with price caps and performance clauses tightening.

Regulatory changes · 19 Dec 2019 · DVG

Digital Healthcare Act (DVG)

  • Creates §139e SGB V, the legal basis for the DiGA ("app on prescription") pathway.
  • Gives ~73 million statutorily insured people a legal entitlement to prescribed, reimbursed digital health applications.
Market impact: The DVG is the model international regulators have repeatedly copied — France, Belgium and others explicitly cite the DiGA fast-track as their reference when designing their own digital-therapeutics pathways.

Source: Bundesministerium für Gesundheit (BMG)

Regulatory changes · 21 Apr 2020 · DiGAV

DiGA Ordinance (DiGAV)

  • Defines the BfArM fast-track procedure enabled by the DVG.
  • Sets the 3-month assessment clock for complete applications.
  • Establishes the review criteria: safety, data protection, interoperability and a "positive healthcare effect".
Market impact: Turns the DVG's legal entitlement into an operable process — without the DiGAV, manufacturers would have no defined route or timeline to get a product listed.

Source: Bundesministerium für Gesundheit (BMG)

Regulatory changes · 26 Mar 2024 · DigiG

Digital Act (DigiG)

  • Simplifies the DiGA activation-code process for prescribers and patients.
  • Opens the DiGA pathway to class IIb medical devices, previously out of scope.
  • Lays the legal groundwork for mandatory performance/success reporting and outcome-linked pricing (see the Jul 2026 entry below).
Market impact: Widens the addressable market to more complex, higher-risk software (class IIb) and signals the shift from "listed" to "proven" that later provisions (outcome-based pricing, BStabG) build on.

Source: Bundesministerium für Gesundheit (BMG)

Regulatory changes · 1 Jul 2026 · DigiG / AbEM

Anwendungsbegleitende Erfolgsmessung (AbEM) and outcome-based pricing take effect

Manufacturers of all permanently listed DiGA that have demonstrated at least one medical benefit must collect AbEM data from 1 Jul 2026. Results go to BfArM every six months, on 15 April and 15 October; the first report is due 15 Apr 2027 and covers Q3 and Q4 2026 together. Stage I captures usage data, stage II adds patient satisfaction and PGI-C with first reports due 15 Apr 2028. Pricing becomes tied to demonstrated benefit rather than the manufacturer's free first-year price alone.
Market impact: Market shifts from simply "listed" to "proven" -- price caps and performance clauses tighten, foreshadowing the volume-based discounts BStabG introduces from 2027. Since 1 Jan 2026 the §134 SGB V agreement must already carry at least 20 percent outcome-dependent price components, though BfArM notes that how AbEM results feed into that share is still to be settled.

Source: BfArM -- DiGA-Leitfaden (AbEM)

Regulatory changes · From 1 Jan 2027 · BStabG DRAFT

GKV Contribution-Rate Stabilisation Act (BStabG)

  • Mandatory quantity-based discount, tiered by annual delivery volume: a minimum 2% discount from 3,000 deliveries/year, rising in steps to a minimum 30% discount from 100,000+ deliveries/year.
  • New fallback valuation rule for products without a comparable reference group — priced at a weighted-average reimbursement value instead.
  • Restructures the framework-agreement system with standardised thresholds and performance-dependent maximum amounts.
Market impact: Creates what the source article calls a "paradoxical incentive structure": successful, high-volume products face systematically shrinking margins precisely as they scale — a structural ceiling on the growth the DiGA model was designed to reward.

Source: Forvis Mazars, Newsletter Healthcare 2/2026

Regulatory changes · Draft bill, no date set · GeDIG DRAFT

Digital Infrastructure Act (GeDIG) — draft bill

  • Explicitly extends the DiGA definition to cover telemonitoring/remote-monitoring applications, closing a gap in the current regulatory treatment.
  • Requires DiGA to transmit data into the electronic patient record (ePA) with patient consent, including access to medication data — the same requirement already reflected in this site's DiGA data-protection checklist (see the National Checklists page).
  • Replaces today's separate reporting burdens with a single flow: GKV reports annual utilisation data to the health ministry, which publishes it on the open internet.
Market impact: Enables true scalability for monitoring scenarios by improving data connectivity and care continuity — but the source article flags an open gap: no clear proof requirements ("Nachweisanforderungen") yet exist for telemonitoring validity, unlike the established DiGA evidence bar.

Source: Forvis Mazars, Newsletter Healthcare 2/2026

🇬🇷 Greece
EOPYY's digital transformation (a new digital insured-persons file launched May 2026, funded via the 'Greece 2.0' EU recovery plan) digitises claims and records -- no digital-therapeutics-specific reimbursement mechanism found.
🇭🇺 Hungary
NEAK (National Health Insurance Fund Administration) runs a general health-technology assessment process for admission into statutory financing, but no DTx-specific application or listing was found under it.
🇮🇸 Iceland
Sjukratryggingar Islands (Icelandic Health Insurance) reimburses digital health services 'on the same basic principles as other healthcare' -- folded into general rules, not a dedicated DTx pathway. A broader health-insurance-law overhaul took effect Aug 2025 with no DTx-specific provisions identified.
🇮🇳 India
Pilot projects with digital-CBT platforms (e.g. SilverCloud and local startups) run alongside the National Mental Health Programme, but no large-scale reimbursement pathway exists yet.
🇮🇪 Ireland
HSE's 'Digital for Care 2024-2030' framework explicitly names digital therapeutics as a future-focus area, and a national e-prescribing service is due to complete procurement by end of 2026 -- but no DTx-specific line exists yet on the HSE Reimbursement List (assessed case-by-case by the National Centre for Pharmacoeconomics, same as any other medical device).
🇮🇱 Israel
A strong digital-health startup ecosystem and HMO-driven innovation, but no dedicated statutory DTx reimbursement pathway was identified in this research pass.
🇮🇹 Italy
No product has been listed for reimbursement yet. The enabling law recognizing DTx as reimbursable medical devices under the SSN passed the Chamber of Deputies unanimously (May 2026) and now awaits Senate approval; implementing decrees and a national DTx list would follow final passage. Regulation otherwise follows the EU MDR, with the SSN devolved across 20 regions of varying autonomy.
🇯🇵 Japan DTx folded straight into the drug-pricing machinery.

How reimbursement began

  • 1 Dec 2020: CureApp SC (nicotine dependence) becomes Japan's first reimbursed DTx, listed by Chuikyo on the NHI fee schedule.
  • 1 Sep 2022: CureApp HT (hypertension) is reimbursed -- the world's first reimbursed hypertension DTx.
  • 13 Feb 2025: ENDEAVORRIDE (paediatric ADHD, based on Akili's EndeavorRx, Shionogi in Japan) is approved.
  • 1 Sep 2025: CureApp AUD, marketed as HAUDY (alcohol-use disorder), is reimbursed, commercialised with Sawai Pharmaceutical.
  • 13 May 2026: Medcle (insomnia, 9-week CBT-I) wins reimbursement approval after a 2024 setback and resubmission.
  • 1-5 Jun 2026: Medcle and ENDEAVORRIDE both go live for reimbursement, bringing Japan's NHI-listed set to five products.

Reimbursement pathways

A DTx clears PMDA device approval, then Chuikyo assigns an NHI point/price like any reimbursed medical technology. There is no separate “app pathway” — both a strength (established rails) and a constraint (software has to fit a device mould).

Pricing snapshot

Prices are set per product in NHI points — e.g. CureApp HT at ~¥7,010, and CureApp SC at ~2,540 points per treatment course.

Trend & outlook

The listed set is growing fast -- hypertension (2022), alcohol-use disorder (2025), then insomnia and paediatric ADHD both listed on 1 Jun 2026. A second track opened alongside it: from 1 Jun 2026 Japan's first depression app runs under 評価療養 (evaluation therapy), a mixed-billing arrangement in which the patient pays for the app while evidence is gathered -- access without reimbursement. Applications are rising, and Japan is increasingly cited as the model for folding DTx into an existing national fee schedule.
🇱🇻 Latvia An early code that never became a framework.

How reimbursement began

  • 2018: Vigo Health is founded, developed with NRC Vaivari (Latvia's largest rehabilitation centre) and EU EIT Health support.
  • Sep 2021: Latvia's NVD assigns Vigo an official manipulation-list reimbursement code -- the first in the Baltics -- rather than passing a dedicated DTx law.
  • 2022 (expected): Full state reimbursement was anticipated, but the code's live-reimbursement status for 2025-2026 could not be confirmed.

Reimbursement pathways

Coverage rides on an NVD manipulation-list code rather than a DiGA-style standalone pathway.

Pricing snapshot

The specific current tariff could not be confirmed for 2025–26, and the code's live-reimbursement status is uncertain.

Trend & outlook

Latvia was an early mover but hasn't built a broader framework around that first code. Whether it grows into a repeatable pathway remains an open question.
🇱🇹 Lithuania
Named among 11 EU states with no dedicated digital-therapeutics reimbursement framework in a peer-reviewed scoping review (Rabiei & Almasi, DIGITAL HEALTH, Apr 2026). VLK's (Valstybine ligoniu kasa) published compensation price lists cover medicines and medical devices only -- nothing DTx-specific found.
🇱🇺 Luxembourg
CNS's digitalisation programme (mandatory e-invoicing for doctors/dentists rolling out through 2026) is about claims processing and administrative digitisation, not a therapeutics reimbursement pathway. No DTx-specific route found.
🇲🇹 Malta
Named among 11 EU states with no dedicated digital-therapeutics reimbursement framework (Rabiei & Almasi, DIGITAL HEALTH, Apr 2026). A EUR100m, 10-year digital-health investment announced May 2025 targets electronic patient records, not DTx reimbursement.
🇳🇱 Netherlands
Flagged as a likely fast follower to Germany's DiGA model back in 2022, but no dedicated assessment-and-listing pathway has materialised since. Digital health is reimbursable under the standard basisverzekering only when it substitutes an already-reimbursable in-person service -- not a DiGA-equivalent standalone route. Two developments qualify that picture without changing it: Zorginstituut Nederland published a handbook for assessing digital and hybrid care on 31 Mar 2025, setting out how providers, insurers and developers can judge whether such care belongs in the basic package -- assessment guidance, not a listing procedure with its own entry route; and in July 2026 the Dutch government allocated EUR 102.5 million to the national MedTech ecosystem under the MedTech Growth Plan, aimed at innovation and implementation rather than at reimbursing any specific product. Checked Oct 2026.

Regulatory changes · Announced 12 Oct 2026 · Beleidsagenda passende zorg DRAFT

Parliamentary letter on the policy agenda for appropriate care (beleidsagenda passende zorg)

  • Abolition of reimbursement for non-contracted care (niet-gecontracteerde zorg) -- today insurers typically reimburse 60-80% of their own negotiated rate for such providers.
  • Clarification of health insurers' statutory duty of care (zorgplicht).
  • A proposed escalation mechanism.
  • Changes to disciplinary law (tuchtrecht).
  • Wider access to information for health insurers.

Sent on 12 October 2026 by the Minister of Health, Welfare and Sport together with the Minister for Long-Term Care, Welfare and Youth. The agenda builds on the Integral Care Agreement (IZA) and the Supplementary Care and Welfare Agreement (AZWA).

Market impact: Still an announcement, not law: the government says it will inform both chambers of parliament in early 2027 about the legislative changes needed, and the legal and practical implications are described as not yet clear. If the non-contracted route does close, it removes the pathway through which a share of English-language and digital care in the Netherlands is currently accessed -- patients would be limited to contracted providers or pay in full. The stated rationale is systemic rather than individual: the government argues decisions about available care can no longer be made solely from the individual patient's perspective, but must also weigh staff shortages, affordability and long-term sustainability.

Source: Loyens & Loeff, 20 Oct 2026 (law-firm summary of the Kamerbrief of 12 Oct 2026)

🇳🇿 New Zealand
Early-stage. Pharmac's medical-device programme is still being built out (a March 2025 minister briefing set out the plan), and Budget 2025 gave only modest digital-infrastructure funding. No dedicated DTx reimbursement pathway yet; cost-effectiveness evidence is the stated barrier.
🇳🇴 Norway
Helsedirektoratet's Helseteknologiordningen funds general health-technology and telehomecare projects (NOK 152m granted in 2026), and Helfo's Blue Prescription scheme covers medicines/medical supplies -- but no DTx-specific assessment or reimbursement route was found on either agency's site.
🇵🇱 Poland
The one major market checked here confirmed to have NO reimbursement mechanism for digital health solutions at all -- a 2023 academic review found reimbursement present 'to some extent' in every other studied EU country except Poland. E-health modernisation (e-prescriptions, e-referrals) is progressing under Recovery Plan (KPO) funding, but nothing DTx-specific is in development.
🇵🇹 Portugal
Earliest-stage of all markets tracked here. Decreto-Lei 118/2026 (17 Jun 2026) just revised SiNATS, the national health-technology-assessment system, to formally bring digital solutions into its scope for the first time -- a first legislative step, not yet a live reimbursement pathway or any listed product.
🇷🇴 Romania
Named among 11 EU states with no dedicated digital-therapeutics reimbursement framework (Rabiei & Almasi, DIGITAL HEALTH, Apr 2026). CNAS (national health insurance house) publications found in this pass covered only pharmaceutical reimbursement.
🇸🇦 Saudi Arabia
The SFDA is among the most active GCC regulators, classifying DTx by risk and issuing MDMA guidance; the Ministry of Health launched a Regulatory Healthcare Sandbox in 2024 to test digital-health/AI solutions. Vision-2030-driven momentum, but no live reimbursement pathway yet.
🇸🇬 Singapore
Building regulatory infrastructure via HSA, with international mutual-recognition arrangements (e.g. with South Korea) trimming certification timelines. A frequently-cited APAC front-runner on process, but no standing national DTx reimbursement scheme identified yet.
🇸🇰 Slovakia
Named among 11 EU states with no dedicated digital-therapeutics reimbursement framework (Rabiei & Almasi, DIGITAL HEALTH, Apr 2026). The Ministry of Health's current reform push is focused on faster market entry for medicines, not digital therapeutics.
🇸🇮 Slovenia
Named among 11 EU states with no dedicated digital-therapeutics reimbursement framework (Rabiei & Almasi, DIGITAL HEALTH, Apr 2026). ZZZS's electronic services (zVEM portal, e-claims) cover administrative processes, not a DTx pathway.
🇰🇷 South Korea Approved and coded — but patients still pay.

How reimbursement began

  • Feb 2023: MFDS approves Somzz (AIMMED, insomnia CBT-I), Korea's first approved DTx.
  • Weeks later, 2023: WELT-I (later renamed SleepQ) is approved second.
  • Aug 2023: Revised insurance rules allow temporary NHI reimbursement for up to three years while full evidence is gathered.
  • Feb-Mar 2024: EasyBreath (respiratory rehab) and VIVID Brain (hemianopia visual rehab) are approved.
  • Aug 2024: Somzz's formal HIRA non-covered billing code and reference price (KRW 25,390) are set.
  • Jan 2025: The Digital Medical Products Act takes effect, putting clinical-evidence requirements on a statutory footing.
  • Feb 2025: SleepQ's temporary HIRA reference price (KRW 21,660) is set.
  • 2025: SoriCLEAR (tinnitus) and CodeThera (mild cognitive impairment) are approved.

Reimbursement pathways

Products clear MFDS, undergo NECA new-health-technology assessment and HIRA review. Somzz holds a formal HIRA non-covered (“bigeubyeo”) billing code with a reference price inside the NHI claims framework — a provisional listing, not yet full coverage.

Pricing snapshot

Somzz's reference price is ~₩25,390, but hospitals actually charge patients roughly ₩200,000–250,000 out of pocket, since the reference price sits far below delivery cost — so in practice these count as self-pay.

Trend & outlook

The Digital Medical Products Act (effective Jan 2025) put clinical-evidence requirements on a statutory footing. No DTx has yet moved from temporary listing to formal NHI reimbursement -- products remain self-pay (비급여) in practice. The groundwork is underway: HIRA published a commissioned study in Apr 2026 on reimbursement-adequacy evaluation criteria and a formal listing scheme for digital therapeutics. Trade press expects formal listing to be settled around the turn of 2026/27 as the temporary listings expire, though no decision has been published. Provider awareness and durable reimbursement remain the open questions.
🇪🇸 Spain
No dedicated DTx regulation yet -- the public reimbursement route (via the standard medical-device pharmaceutical allowance) has been on hold pending new rules since at least 2023. The Spanish DTx Consortium (formed Dec 2022) is pushing industry/Administration co-creation of a financing model, but no framework or listed product has emerged from it as of this research pass.
🇸🇪 Sweden
A 2023 academic policy review found digital health 'reimbursable to some extent', but decisions are made regionally across Sweden's 21 self-governing regions rather than through a unified national framework -- no DiGA-equivalent pathway or specific product identified in this pass.
🇨🇭 Switzerland Just switched on — in evaluation mode.

How reimbursement began

  • 6 Nov 2024: Ada Health partners with insurer Groupe Mutuel -- a non-statutory precedent that predates any formal digital-health billing line.
  • Dec 2025: FOPH confirms a new MiGeL Chapter 40 for digital health applications (dGA), effective 1 July 2026, naming deprexis (GAIA's depression CBT) as the first listed product.
  • 1 Jul 2026: Chapter 40 takes effect -- Switzerland's first statutory DTx reimbursement route goes live, under a coverage-with-evidence-development status running through the end of 2026.

Reimbursement pathways

A prescribed, CE-marked dGA listed on MiGeL is covered by compulsory basic insurance (OKP/AOS). The first listing runs under a “coverage with evidence development” status — in evaluation until the end of 2026.

Pricing snapshot

deprexis reimbursement is set within the MiGeL framework (~CHF 193–271 depending on configuration), prescribed for mild-to-moderate depression in adults.

Trend & outlook

One product live makes this genuinely emerging, not established. The evaluation-until-2026 flag signals Switzerland is testing the mechanism before scaling — expect the dGA chapter to widen if the first listings perform.
🇦🇪 United Arab Emirates
Regulatory pathways for digital health are forming, with a growing emphasis on clinical validation and EMR/HIE integration and payer/provider partnerships. No dedicated national DTx reimbursement scheme identified yet.
🇬🇧 United Kingdom No single law — capacity relief drives adoption.

How reimbursement began

  • 20 May 2022: NICE issues guidance MTG70, recommending Sleepio (Big Health) for insomnia -- the first-ever positive NICE guidance for a digital therapeutic, and the template for the Early Value Assessment (EVA) route.
  • Aug 2022: NICE updates NG17 to recommend CGM for every Type 1 diabetes patient.
  • 1 Mar 2023: NICE publishes draft EVA guidance (HTE8/HTE9) conditionally recommending eight digitally-enabled therapies for NHS Talking Therapies covering depression and anxiety.
  • 2023: SilverCloud Health is acquired by Amwell; ieso Digital Health is acquired by Sweden's Mindler.
  • 2025: NICE's HealthTech guidance merger renumbers MTG70 as HTE624.

Reimbursement pathways

Two live national mechanisms: NICE NG17 funds CGM companion apps (device-linked), and NHS Talking Therapies commissions six DET-compliant CBT programmes for depression and anxiety. Regional ICBs run their own ORCHA-curated libraries for everything else.

Pricing snapshot

Funding flows through NHS commissioning and service contracts rather than a per-prescription tariff; Talking Therapies apps are bought at service level to stretch limited therapist capacity.

Trend & outlook

Demand pressure (1.2m+ Talking Therapies referrals a year) is the engine — digital therapy is framed as capacity relief. Expect more EVA-routed approvals, but national mandates stay the exception; most products still live on regional pilots.
🇺🇸 USA Medicare opened a route in 2025; the employer channel was already larger.

How reimbursement began

  • 2020-2022: Pear Therapeutics' reSET, reSET-O and Somryst reach the market on commercial-insurer-only coverage, years before Medicare has any DTx billing line.
  • 2023: Pear Therapeutics ceases operations; reSET/reSET-O assets are acquired by PursueCare and Somryst by Nox Health.
  • Nov 2024: CMS finalises the 2025 Physician Fee Schedule, creating HCPCS codes G0552-G0554 for FDA-cleared digital mental-health treatment (DMHT) -- Medicare's first explicit DTx billing line.
  • 1 Jan 2025: The G-codes take effect; SleepioRx, Daylight/DaylightRx, Rejoyn and MamaLift Plus become reimbursable under the CMS CY2025 fee schedule.
  • 2026: Remote Therapeutic Monitoring (RTM) CPT codes join the DMHT G-codes for Medicare's second adoption year.

Reimbursement pathways

Two channels: Medicare DMHT (G-codes, billed by the prescribing clinician alongside a behavioural plan) and Remote Therapeutic Monitoring (RTM) CPT codes. Separately, a large employer / self-insured channel pays vendors directly (Sword, Omada, Hinge).

Pricing snapshot

G0553/G0554 pay ~$20 per 20-minute monthly management increment; the device-supply code G0552 is contractor-priced given cost variability. Rates are clinician-billed, not paid to the vendor.

Trend & outlook

2025 is a Phase-1 adoption curve: CMS has tied the new codes to documentation and outcome reporting before any broadening. The employer channel remains the larger commercial route; full prescription-DTx coverage is an active industry objective, not a published CMS plan.

Do you miss anything, or have a recommendation? Please let us know via email or the contact form.