Reimbursement & market-access updates

🇩🇪 Germany’s DiGA directory reaches 51 permanent listings

Germany's DiGA directory now lists 51 permanently admitted digital health applications, up from 50. The change took effect on 27 October 2026, when eCovery — Therapie bei Schmerzen im unteren Rücken (eCovery GmbH) moved from a provisional listing to a permanent one.

BfArM's change history for the entry records the whole sequence: admitted to the directory on 27 December 2024 with the status Vorläufig aufgenommen, and Dauerhaft aufgenommen from 27 October 2026. The trial period therefore ran about 22 months — past the standard twelve, so an extension was used, but inside the maximum of 24. The app treats lower back pain, carries a manufacturer price of EUR 574.00 and states an application period of 84 days.

The directory as a whole stands at 63 active entries of 82 ever listed: 51 permanent and 12 still provisional. The total did not change — eCovery moved between the two buckets rather than joining or leaving.

BfArM DiGA-Verzeichnis, entry 02173 (eCovery - Therapie bei Schmerzen im unteren Rücken) including its Änderungshistorie, and the directory listing at diga.bfarm.de/de/verzeichnis showing 63 of 82 entries. Both retrieved 27 October 2026.

🇫🇷 What a French tariff table reveals: seven reimbursed products we were missing

A tariff order is an odd place to find a product list, but in France it is the most complete one there is. The arrete of 14 September 2026 sets a rate for every code on the telemonitoring list, and a code only exists where a named device holds one. Run a directory against that table and it works as a census.

We did, and it changed ten entries here and added seven more.

Ten products we already listed are touched by the new rates. The sharpest is cardiac: Implicity and Newcard sit on the defibrillator and pacemaker activity, cut 30 per cent to EUR 35.52 a month. Glooko XT falls 19 per cent on gestational diabetes, RESILIENCE PRO about 8 per cent across its two cancer stages, Diabeloop DBLG1 and Diabeo 3.9 per cent on insulin-treated diabetes. Careline, Cordiva and Comunicare bill the generic heart-failure rate, down 0.2 per cent. Boston Scientific LATITUDE Clarity joins the implantable-cardiac-monitor line at EUR 90.60.

Seven products held a French code and were missing from this directory. Four we already carried for another country without noticing they were reimbursed in France too: myDiabby and Cureety Techcare (listed here for Belgium), Abbott Merlin.net and Medtronic CareLink (listed for Germany). Three were absent entirely: Satelia Cardio, Biotronik Home Monitoring Service Center and Odysight. All seven are now entered with their inscription arrete.

Two of those are worth a second look. Satelia Cardio is paid EUR 71.78 a month for chronic heart failure against EUR 38.87 on the generic code for the same condition — nearly double, in a system that normally pays per care activity rather than per product. Odysight, a Tilak Healthcare app that hides a visual acuity test inside a puzzle game, is reimbursed under PECAN for a tightly drawn group: adults with chronic maculopathy, corrected binocular acuity of at least 3/10, who confirm after a trial period of no more than three months that they want this kind of follow-up.

The table also draws a line that is easy to miss. A code of one’s own is not the only way to be paid. The generic activity codes — insulin-treated diabetes, chronic kidney failure, chronic heart failure — are open to any provider meeting the conditions, and they name nobody. Careline is one of those providers: a heart-failure telemonitoring service and Medtronic partner that holds no code and appears in no arrete, yet bills the generic activity at EUR 38.87 a month. Reimbursed in France therefore does not always mean separately listed, and a product census built from the tariff table will miss exactly these providers.

Legifrance: Arrete du 14 septembre 2026, JORFTEXT000054838783; Arrete du 17 septembre 2026, JORFTEXT000054855376; Arrete du 31 mars 2026, JORFTEXT000053743387; Arrete du 10 septembre 2024, JORFTEXT000050212622 (Continuum+ Connect); Arrete du 19 aout 2024, JORFTEXT000050126205 (myDiabby); Arrete du 31 mars 2025, JORFTEXT000051427339 (Cureety); Arrete du 28 mars 2025, JORFTEXT000051401301 (Satelia Cardio); Arrete du 23 juin 2025, JORFTEXT000051795508 and JORFTEXT000051806217 (Merlin.net, Home Monitoring Service Center); Arrete du 24 juillet 2025, JORFTEXT000052053609 (CareLink); Arrete du 27 novembre 2025, JORFTEXT000052869690 (Odysight). careline.fr, odysight.fr, tilakhealthcare.com. Retrieved October 2026.

🇧🇪 How Belgium reimburses health apps: by care pathway, not by product

In Belgium, reimbursement of a health app attaches to a care pathway rather than to the product itself. mHealthBELGIUM states this on its financing page: “The intention is not to reimburse applications per se, but their use within the context of a specific care process.”

The M3 tier of the validation pyramid comes in two grades: M3 light, where funding is temporary, and M3 plus, where the use is integrated into how the care process is financed. Three pathways are currently active, all at M3 plus:

• Telemonitoring and therapy guidance in chronic heart failure — 10 apps, hospitals under Convention since January 2025
• Telemonitoring by a physiotherapist — 1 app
• Telemonitoring of cancer patients — 8 apps

Rehabilitation after knee or hip prosthesis and COVID-19 home telemonitoring are listed as inactive. Holter recording for cardiac patients and telemonitoring for sleep apnoea are in preparation.

All three active pathways grew over the autumn. An Internet Archive capture of the same page from 8 September 2026 shows the heart-failure pathway with nine apps rather than ten, the cancer pathway with six rather than eight — Cureety Techcare and Healthentia were added after that date — and no physiotherapy pathway at all.

Five apps appear in more than one pathway: moveUP in all three, Remecare, BeWell Well@Home, Healthentia and Plateforme Maela in two each. The question is better framed as for which care process, and at which grade — that is what determines an app's reach, since reimbursement applies only to patients treated within the pathway it is listed for.

Trial data from the oncology pathway

One of the eight apps in that pathway, Cureety Techcare, has published trial data. Patients complete questionnaires built on the CTCAE adverse-event grading criteria; responses are scored and mapped to a clinical class, with amber and red alerting the care team and prompting the patient to contact the hospital.

OPTIMACURE — prospective, randomised 2:1, multicentre, open-label, 192 patients across three French centres between April and August 2024 — measured telephone workload. The endpoint is organisational rather than clinical.

• Total outgoing calls fell (adjusted difference 1.20 calls, 95% CI 0.53 to 1.89, p < 0.001)
• Preparation calls: 73.2% of patients needed none, against 12.3% in the control arm; three or more calls fell from 69.2% to 3.2%
• Calls about toxicity rose (+1.6, 95% CI 1.14 to 2.05, p < 0.01)
• Grade 3–4 non-haematological adverse events were reported earlier (hazard ratio 4.06, p < 0.001)

A separate randomised phase III trial, ALTERNATIVE, is running in metastatic triple-negative breast cancer. The published abstract covers the design only and reports no results. A conference abstract on radiotherapy patients submitted to ESMO 2025 was withdrawn, with neither text nor reason deposited.

mHealthBELGIUM, financing page and app list, accessed 23 October 2026. Faveyrial A, Gernier F, Rouzier R, Grellard JM, et al., OPTIMACURE multicentric French prospective randomized study, BMC Health Services Research 2025, PMID 41462241, doi:10.1186/s12913-025-13661-1; results also presented at ASCO 2025, Journal of Clinical Oncology 2025;43(16_suppl):11017, doi:10.1200/jco.2025.43.16_suppl.11017. Babau B, Joly F, Fiteni F, et al., ALTERNATIVE trial design abstract P3-08-25, Clinical Cancer Research 2025 (SABCS), doi:10.1158/1557-3265.sabcs24-p3-08-25. Withdrawn abstract 2899P, Annals of Oncology 2025, doi:10.1016/j.annonc.2025.08.3511. Product and regulatory detail from cureety.com, accessed 23 October 2026. Internet Archive capture of mhealthbelgium.be/financing, 8 September 2026.

🇫🇷 France cuts every telemonitoring tariff — cardiac implants by 30%

France repriced its entire medical-telemonitoring list this autumn. The arrete of 14 September 2026 restates the flat rates for every activity on the list under Article L. 162-52; a second arrete three days later moved the start date to 1 October 2026.

Compared with the previous consolidated schedule of 31 March 2026, every one of the thirteen codes present in both came down. The median cut is 8.4 per cent, but the range is wide.

The deepest cut lands on telemonitoring of implanted defibrillators and pacemakers, down 30 per cent — from EUR 50.77 to EUR 35.52 per patient per month, and from EUR 304.63 to EUR 213.10 for the half-yearly equivalent. Gestational-diabetes monitoring falls 19 per cent, from EUR 48.85 to EUR 39.58, which applies to the generic code and to the two product-specific ones (Glooko XT and myDiabby) alike. Oncology monitoring falls about 8 per cent in both its stages, affecting RESILIENCE PRO and Cureety equally.

At the other end, two rates barely moved: the generic chronic-heart-failure flat rate went from EUR 38.95 to EUR 38.87, and Satelia’s product-specific heart-failure rate from EUR 71.93 to EUR 71.78 — cuts of 0.2 per cent. Satelia remains an outlier worth noticing: at EUR 71.78 it is paid nearly twice the generic rate for the same condition.

The same arrete also brings the cardiac-implant monitoring platforms onto one line. Merlin.net, Home Monitoring Service Center, CareLink, LATITUDE Clarity and Implicity each hold their own billing code for implantable-cardiac-monitor follow-up, and all five are paid the identical EUR 90.60 per patient per month. That is the French design in miniature: the tariff attaches to the care activity, and a manufacturer’s own code is an accounting handle, not a price negotiation.

The arrete explains itself, and the reason is not austerity. Article L. 162-54 of the social-security code provides for the flat-rate base to be modulated, and the order of 16 May 2023 requires the technical flat rates to be revised every six months; the PECAN compensation follows the same cycle under the order of 25 October 2023. The September text states the trigger for each group of codes in the same words: the rates are revised au regard de la progression de la file active mensuelle moyenne — in light of the growth in the average monthly caseload of telemonitored patients actually billed.

So the cuts are a volume mechanism working as designed. The 30 per cent fall on cardiac-implant telemonitoring is the largest because that caseload grew fastest, not because the service was devalued. Read the other way round, the two rates that barely moved — generic chronic heart failure and Satelia — are the ones whose patient numbers were closest to flat.

Legifrance: Arrete du 14 septembre 2026 fixant le montant forfaitaire des activites de telesurveillance medicale, JORFTEXT000054838783, JORF n°0215 du 15 septembre 2026; Arrete du 17 septembre 2026, JORFTEXT000054855376, JORF n°0218 du 18 septembre 2026 (entree en vigueur au 1er octobre 2026); Arrete du 31 mars 2026, JORFTEXT000053743387 (tarifs anterieurs). Retrieved October 2026. Note on the comparison: individual arretes in May, July and August 2026 set rates for single codes between the two consolidated schedules, so for a few lines the September figure is the second step of a change rather than a fresh cut from March.

🇫🇮 Finland’s digital-therapeutics experiment reaches its decision year

This is a status entry rather than a news item, and it is dated accordingly: the Finnish developments on the record are from 2025, while the decision point falls in 2026.

The Ministry of Social Affairs and Health, Kela, Sitra and FinCCHTA have run a nationwide digital-therapeutics experiment since 2025, with 10 selected solutions. 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 June 2025, open until 6 August 2025.

The dates that matter now are ahead: a proposal for a permanent operating model is due by the end of 2026, and the final report in February 2027.

Sitra, “Use of digital applications in healthcare – reimbursement experiment launched”, 10 June 2025, https://www.sitra.fi. Pilot coordinated by DigiFinland. Status checked October 2026.

🇧🇷 Brazil signs an AI cooperation with Sword Health — across the SUS, and not a reimbursement route

On 28 September 2026, announced by Health Minister Alexandre Padilha at the CBIS'26 congress in Brasília, Brazil's Ministry of Health and Sword Health signed a Technology Cooperation Agreement to deploy AI across the Sistema Único de Saúde: voice and text clinical triage, intelligent prioritisation of waiting lists and scheduling, clinical decision support, and prevention work.

It is framed as system-wide across federal, state and municipal levels rather than as a pilot, reaching a population of more than 210 million, and marks Sword's entry into Latin America after Portugal, Greece, the UK and Germany. Technical work is to begin in early 2027, when the SUS and Sword teams define the first projects and an implementation plan. No financial terms have been published.

Announcement by Health Minister Alexandre Padilha at the CBIS'26 congress, Brasília, 28 September 2026. Procedural framework: Law 12.401/2011, arts. 19-Q to 19-U (planalto.gov.br).

What a DiGA delisting actually costs — startups, health systems and payers after Una Health

Una Health für Diabetes left the DiGA directory on 28 Sep 2026 following a Landessozialgericht Hamburg ruling. Beyond the individual case, it is a useful moment to ask a harder question: when a digital therapeutic fails during its provisional listing, who actually carries the cost?

Germany lets a DiGA be prescribed and reimbursed before its benefit is proven by listing it provisionally for a one-year trial period — the Erprobung. Statutory insurers pay the manufacturer's price throughout. If the evidence then falls short, the listing is removed.

What a delisting actually does. It is worth being precise here, because the effect is narrower — and more mechanical — than it sounds. A DiGA prescription does not activate itself: it has to be processed by the patient's health insurer first, and only then is an activation code issued. A removal cuts that chain at the insurer. Prescriptions that arrive there after the removal date are rejected, even where the physician wrote them beforehand. People who are already mid-therapy, with a code and a running application, are not affected by this. For those holding a prescription that has not yet been redeemed, vendors who run their own prescription service can stop forwarding prescriptions to insurers and instead offer goodwill access to the product. New activations then taper rather than stop dead, because prescribing software in practices is updated on a quarterly cycle, after which the DiGA can no longer be issued at all. Vendors commonly arrange some form of continuation: Mika carried on free of charge after its removal, and sinCephalea moved to a self-pay model. The cliff is therefore sharper for the company's revenue than for the individual patient.

That still matters for startups and for the care system. For a young company the provisional listing was often not one revenue line among several but the entire business case, and losing it can end the company — and with it any chance that the evidence question ever gets answered, or that the product stays available at all.

For payers, there is a fair counter-argument. During the trial period, statutory insurers pay while proof of a positive care effect is still outstanding. If that proof fails to materialise, the money bought no demonstrated clinical benefit. Una Health shows the sharp end: the usage costs from the interim reinstatement (22 Jun - 28 Sep 2026) are not clawed back, even though the case ultimately went against the listing. That risk sits with the payer, not the manufacturer.

So how often does the bet pay off? We counted it directly out of BfArM's own catalogue rather than relying on a headline figure. Of the 82 DiGA ever listed since 2020, 16 were admitted straight to a permanent listing and 66 entered provisionally. Of those 66: 34 are permanently listed today, 19 have been removed, and 13 are still inside their trial period. Among the cases actually decided, that is a conversion rate of 64 % — somewhat below the "just under 70 %" the industry association's DiGA-Report 2025 reports.

The chart shows the shift behind the headline. In 2020 and 2021 the directory was mostly a directory of provisional listings — 6 of 10 at the end of 2020. From 2023 onwards permanent listings are the clear majority, and today they account for 50 of 63. The provisional route did not become a permanent parking space; it drained into permanent listings. One further detail for the payer side: all 19 DiGA removed so far had originally entered provisionally — not one had been admitted directly as a permanently listed product.

The number counts products, not prescriptions. This is the most important caveat, and it cuts in favour of the route. A 64 % success rate by headcount says nothing about where the money and the patients actually are, and the two are nowhere near proportional: per the GKV-Spitzenverband's DiGA-Bericht 2025, the top ten DiGA accounted for about three quarters of all dispensings (522,300 of roughly 690,000 in 2025) and two thirds of statutory spending. Products that clear the evidence bar tend to be the ones that then scale steeply. The single most-dispensed DiGA, Oviva Direkt für Adipositas with roughly 306,700 dispensings in 2025, is permanently listed today — and it came in provisionally, as did zanadio. The failures are counted at their smallest, during a trial period; the successes are counted before most of their growth.

Own analysis of the BfArM DiGA-Verzeichnis catalogue (diga.bfarm.de FHIR API, CatalogEntry/HealthAppCatalogEntry, 82 entries retrieved 03.10.2026): listing status at a given date derived from each entry's validityPeriod (listing start / strike date) and TrialPeriod extension. Year-end totals for 2020-2025 can run slightly below counts published at the time, as the catalogue reflects each entry's record as it stands today; the present-day total (63) matches the live directory. Dispensing volumes and the top-10 concentration: DiGA-Bericht 2025 des GKV-Spitzenverbandes (§33a Abs. 6 SGB V). Comparison conversion figure: DiGA-Report 2025 (Spitzenverband Digitale Gesundheitsversorgung). Una Health case: diga.bfarm.de/de/verzeichnis/02286/fachkreise (Az. L 1 KR 68/26 B ER).

Germany's DiGA directory shrinks to 63 — Una Health für Diabetes struck again after a Hamburg court ruling

BfArM has struck Una Health für Diabetes (type 2 diabetes) from the DiGA directory again -- this time because of a court ruling, not a new evidence check.

Here's what happened: BfArM first struck the app on 30 Mar 2026, saying the evidence wasn't strong enough. Una Health took that decision to court. While the case was open, the app came back onto the list on 22 Jun 2026 and insurers kept paying for it. The Landessozialgericht Hamburg (a regional social court) has now ruled, and BfArM struck the app again on 28 Sep 2026 to match that ruling. A larger trial (EVALUNA, 188 patients planned) was underway to prove the app works well enough for a permanent listing.

Right now, there is no statutory reimbursement for Una Health für Diabetes in Germany. A self-pay option might exist, but the manufacturer's own site doesn't confirm one yet.

diga.bfarm.de/de/verzeichnis/02286/fachkreise (Bewertungsentscheidung, Az. L 1 KR 68/26 B ER); unahealth.de/fachkreise (not yet updated as of this research)

Germany's DiGA directory adds Pia-App bei Regelschmerzen — a new digital therapeutic for primary dysmenorrhea

BfArM has provisionally listed Pia-App bei Regelschmerzen, a new DiGA for primary dysmenorrhea (ICD-10 N94.4), developed by Endo Health GmbH — a Chemnitz-based company (founded 2020 as Endo Health UG by Nadine Rohloff) already behind three other DiGA-track products: the permanently listed Endo-App (endometriosis) and the provisionally listed Vera-App für Wechseljahresbeschwerden (menopause) and isi PMS App (PMS).

The app is a multimodal self-management companion — a symptom diary, content modules drawn from medicine, physiotherapy, nutrition and pain management, guided in-app exercises, and an SOS list of personal coping methods — listed at a manufacturer price of €598.95 per 90-day prescription, with no extra patient costs. An open, controlled (though not randomised, due to randomisation deficiencies) 12-week pilot study submitted for admission enrolled 187 women; the primary-dysmenorrhea subgroup relevant to this listing numbered 59 (27 intervention / 32 control) and showed nominally significant improvements in pain self-efficacy (FESS) and everyday impairment (PDI) favouring the intervention group, alongside a favourable change in menstrual pain (VAS). A confirmatory open-label RCT (WirPA), running through the Erprobung period (23 Sep 2026 – 22 Sep 2027), will test the same three measures at 12 and 24 weeks against a waitlist control.

diga.bfarm.de/de/verzeichnis/02883 (Fachkreise-Informationen); endometriose.app; diga.pia.app

Germany's DiGA directory adds ACTICORE1 — a new digital therapeutic for stress urinary incontinence

BfArM has provisionally listed ACTICORE1, a new DiGA for stress urinary incontinence (ICD-10 N39.3), developed by ACTICORE AG, a company based in Basel, Switzerland (registered 2017). The product has been reimbursed in Switzerland since 2022 via the supplementary insurers Helsana, CSS and Sympany.

ACTICORE1 consists of a pelvic-floor pressure sensor (hardware, placed under the patient rather than inserted) connected via Bluetooth to a companion smartphone app that runs a biofeedback-based pelvic-floor training programme. It is listed at a manufacturer price of €795.00, which includes the sensor hardware; no contracted-physician service is required. A multicenter randomized pilot trial in Germany (n=40, published in Annals of Medicine and Surgery, 2023) reported a statistically significant reduction in incontinence symptoms (ICIQ score) after 12 weeks of use compared with no training.

acticore.com; moneyhouse.ch; pubmed.ncbi.nlm.nih.gov/37811051; diga.bfarm.de/de/verzeichnis/02940 (verified directly, 23 Sep 2026)

Germany's directory now tracks §20 SGB V prevention courses — and what five years of GKV spending show

DigiHealthAccess now tracks Germany's §20 SGB V prevention courses (Präventionskurse, certified under the GKV-Spitzenverband's Leitfaden Prävention) alongside DiGA, DiPA and telemonitoring — the fourth parallel German reimbursement pathway now fully represented in the product database.

A review of the past five years of official GKV/MD Präventionsbericht data puts the category in context. Statutory health insurers spent €218.4 million on individual behavioural prevention courses in 2024 — up 43 % from €152.3 million in 2020. A pandemic-driven decline to €143.3 million occurred in 2021 in between. Participation grew even more sharply: 1.89 million course enrolments in 2024 represent a 63 % increase over 2020.

Set against total GKV spending on prevention and health promotion (€686.2 million in 2024, across all three categories combined), §20 individual prevention's share has fluctuated between 27 % and 37 % over the period — highest in 2020, when overall spending collapsed during the pandemic, and lowest in 2021, before recovering to roughly a third of the total by 2024. Set against total GKV expenditure of all kinds (€327.4 billion in 2024), however, prevention and health promotion combined never exceeded roughly 0.21 % — up only marginally from 0.16 % in 2020.

The average cost per course enrolment swings more than the headline totals suggest: it peaked at €179.86 in 2021 — the pandemic year with the fewest enrolments — and has fallen steadily since, to €115.54 in 2024 as participation scaled back up.

Browse the individual §20 courses and other German pathways side by side in the Explorer — select the “Prevention” category there to filter down to this dataset.

Figures for the 2025 reporting year are not yet available. The GKV/MD Präventionsbericht is compiled from each insurer's annual documentation forms and carries a structural lag of roughly one year: the 2024 figures cited above were only published in December 2025. A report covering 2025 is not expected before the fourth quarter of 2026.

GKV-Spitzenverband & Medizinischer Dienst Bund, Praeventionsbericht 2025 (Berichtsjahr 2024), published Dec 2025, gkv-spitzenverband.de/media/dokumente/krankenversicherung_1/praevention__selbsthilfe__beratung/praevention/praeventionsbericht/2025_GKV_MD_Praventionsbericht_barrierefrei.pdf (Kennziffern table, p.134); GKV-Spitzenverband & MDS, Praeventionsbericht 2022 (Berichtsjahr 2021), gkv-spitzenverband.de/media/dokumente/krankenversicherung_1/praevention__selbsthilfe__beratung/praevention/praeventionsbericht/2022_GKV_MDS_Praeventionsbericht_barrierefrei.pdf (Kennziffern table, p.156).

Germany's DiGA directory adds Frieda Menova — a new digital therapeutic for menopause symptoms

BfArM has provisionally listed Frieda Menova, a new DiGA for menopause and climacteric symptoms (ICD-10 N95.1), developed by Frieda Health GmbH — a Hamburg-based femtech company founded in 2020 (originally as Loba Health GmbH).

The app delivers a 12-week cognitive behavioral therapy (CBT) programme — psychoeducation, cognitive restructuring, breathing/relaxation exercises, sleep hygiene and symptom tracking — developed under the medical direction of Prof. Dr. med. Petra Stute, president of the European Menopause and Andropause Society. It is provisionally listed from 7 Sep 2026 to 6 Sep 2027 at a manufacturer price of €490.00 per 90-day prescription, backed by a completed 100-patient pilot RCT (DRKS00036152) showing a statistically significant reduction in hot-flash/night-sweat burden versus standard care (Cohen's d=0.74, p<0.001).

Based on the Frieda Menova BfArM DiGA-Verzeichnis listing, vorlaeufig aufgenommen 07 Sep 2026 (diga.bfarm.de/de/verzeichnis/02895); DRKS00036152 trial registry; Monitor Versorgungsforschung, 11 Dec 2025.

🇧🇪 Belgium keeps extending remote-care reimbursement — oncology, physio, midwives, speech therapy

Belgium's route for digital care is not an app listing but the nomenclature: a service becomes reimbursable when it gets a code and conditions. On that measure 2026 was a busy year, and the national institute's own page records the steps.

Since 1 January 2026, patients treated with certain oncological therapies qualify for reimbursed telemonitoring, aimed at picking up side effects and complications early. That followed the equivalent step for chronic heart failure, reimbursed since 1 January 2025 for recently hospitalised patients.

Since 1 July 2026, physiotherapy can be partly delivered as remote provision or telemonitoring, and care by midwives can again take place remotely. From 1 September 2026, speech and language therapy can again be delivered remotely.

One more step is approved but not yet in force: on 9 February 2026 the Insurance Committee approved tele-expertise in dermatology, letting a GP consult a dermatologist remotely. The service becomes available only once the proposal completes the full royal-decree publication procedure, which the institute expected to allow use from autumn 2026.

RIZIV/INAMI, “Telegeneeskunde en mHealth-toepassingen”, https://www.riziv.fgov.be. Retrieved October 2026.

Circle Health winds down — every reimbursement model carries its own overhead

Circle Health, a Berlin-based preventive-medicine startup, is winding down after three-plus years. It ran three clinics (Berlin, Munich and Düsseldorf) with a team of 50 at peak, built its own AI-native platform (CircleOS) to run holistic, diagnostics-plus-treatment preventive care, and treated over 12,000 patients at a 4.9★ Google rating. Announcing the wind-down, founder and CEO Jannik Tiedemann put the outcome plainly: “in venture terms: fail fast.”

The company closed a €9 million seed round — combining equity and debt — in February 2026 to fund expansion across Germany. In the same post, Tiedemann cited a final equity raise of €3 million roughly a year earlier, likely a different slice of the same fundraising history. Either way, the message was consistent: the clinical model worked, the business case around it didn't.

Self-pay isn't the only model that carries this risk, either. Several reimbursed DiGA makers — Aidhere (Zanadio), Vitadio Health Technologies and Perfood among them — have filed for insolvency over the past three years. A common thread across these cases: an organisation plans around a higher post-negotiation price than the arbitration board ultimately sets, and scales faster than the market that actually materialises can support — or underestimates what mandatory regulatory compliance costs, which operating revenue alone often can't carry. The full mechanics are their own story.

Jannik Tiedemann, Circle Health wind-down announcement, LinkedIn, https://www.linkedin.com/posts/jannik-tiedemann_after-more-than-3-years-circle-health-is-share-7499764140098650112--SmU/ (Aug 2026); Circle Health €9M seed-round announcement, circle.health newsroom, 11 Feb 2026; Ahead Health €8.7M funding-round coverage, eu-startups.com, Jul 2026; Aidhere/Zanadio preliminary insolvency, aerzteblatt.de, May 2023; Vitadio Health Technologies preliminary insolvency, verbraucherschutzforum.berlin, 23 Dec 2024; Perfood GmbH preliminary insolvency, der-indat.de, Nov 2024.

Germany's DiGA directory adds isi PMS App — a new digital therapeutic for premenstrual syndrome

BfArM has provisionally listed isi PMS App, a new DiGA for premenstrual syndrome (PMS, ICD-10 N94.3), developed by Endo Health GmbH — the Chemnitz-based company already behind Endo-App (endometriosis) and Vera-App (menopause symptoms). It is their third DiGA in the reproductive-health space.

The app delivers guideline-based, multimodal self-management content — mindfulness and relaxation exercises, movement and physiotherapy-style routines, psychological techniques, and nutrition guidance — as a companion to standard PMS care. It is provisionally listed from 10 Aug 2026 to 9 Aug 2027 at a manufacturer price of €598.95 per 90-day prescription, while Endo Health runs the MIPSI study (a waitlist-controlled RCT measuring symptom severity, quality of life and patient activation over 24 weeks) to support permanent listing.

Based on the isi PMS App BfArM DiGA-Verzeichnis listing, vorlaeufig aufgenommen 10 Aug 2026 (diga.bfarm.de/de/verzeichnis/02857).

🇳🇱 The Netherlands puts EUR 102.5m into MedTech — and still has no DTx listing route

In July 2026 the Dutch government allocated EUR 102.5 million to strengthen the national MedTech ecosystem, responding to the MedTech Growth Plan. The money is aimed at innovation, implementation and closer cooperation between industry, providers and research institutions — a response to workforce shortages and rising demand for care, not to any particular product's reimbursement case.

It lands on top of a second development from the year before: on 31 March 2025 Zorginstituut Nederland published a handbook for assessing digital and hybrid care, setting out how providers, insurers and developers can judge whether such care belongs in the basic package.

Zorginstituut Nederland, “Handleiding – Beoordeling digitale en hybride zorg”, 31 March 2025. MedTech funding: Med Tech Reimbursement Consulting, “Dutch government commitment to MedTech ecosystem (2026–2036)”, 3 August 2026.

🇵🇹 INFARMED draws the line: when a health app is a medical device in Portugal

Portugal's medicines and health products authority has put out guidance on a question that decides everything downstream for a digital therapeutic: is this thing a medical device at all? On 29 July 2026 INFARMED published Circular Informativa N.º 078/CD/100.20.200, accompanied by a Nota Informativa, clarifying the regulatory framework for digital solutions used in health — software, mobile applications, and solutions based on artificial intelligence.

The test it sets out turns on the manufacturer's stated purpose. A digital solution counts as a medical device when its intended purpose is medical — prevention, diagnosis, monitoring or treatment of disease. Applications aimed at administrative or wellbeing purposes, as a rule, fall outside that definition. Where a solution does qualify, it must meet the European requirements, including CE marking and the conformity assessment procedures.

The stated audience is broad: manufacturers, purchasing entities, health professionals and other parties, with the aim of correct application of medical device legislation and safe use of the technologies. INFARMED frames the timing around the growing use of digital and AI-based solutions in care delivery.

INFARMED, I.P., Circular Informativa N.º 078/CD/100.20.200 of 29 July 2026, with accompanying Nota Informativa (infarmed.pt). Content as reported by Ordem dos Farmacêuticos, 10 August 2026.

China's DTx tracking now covers Hainan, Beijing, Shanghai and Guangdong

Our China coverage now tracks four regions instead of one: alongside Hainan's established provincial pilot, the timeline adds Beijing, Shanghai and Guangdong, each shown with what's documented for that region today.

Hainan runs China's only DTx-specific payment mechanism: a provincial Class II device fast-track (since Oct 2022) plus its own province-level billing framework (since May 2025), now covering 14 products under Hainan's own count.

Beijing has a hospital-backed depression app (Anding Hospital, since Sep 2023) and a TCM digital-therapeutics research platform (since Jul 2025); no DTx-specific notice has been published by the Beijing Medical Insurance Bureau.

Shanghai's 2024 CPPCC proposal on DTx cites Hainan as the model to follow, and the city's National Children's Medical Center opened a pediatric digital-diagnostics research centre in May 2025 — no Shanghai-specific reimbursement notice exists yet.

Guangdong's provincial regulator cleared Tencent's cognitive-training app as a Class II device in Jun 2025, and Shenzhen runs a free, public-health-funded cognitive-screening pilot for residents over 65 — neither carries an insurance-payment code.

Hainan regulator counts (amr.hainan.gov.cn); Beijing Municipal Medical Insurance Bureau site search (数字疗法); Shanghai CPPCC proposal, Mar 2024; Guangdong Provincial Medical Products Administration device registration, Jun 2025; Shenzhen Municipal Health Commission pilot notices, 2024-2025.

🇮🇳 India’s CDSCO names digital therapeutics as regulated software — by example, in writing

India's Central Drugs Standard Control Organisation published a guidance document on Medical Device Software under the Medical Devices Rules 2017 on 21 July 2026, listed under its own public notices. It runs to a dozen sections: purpose and scope, definitions, key features and examples of medical device software, software covered and not covered by the rules, the intended-use statement, risk-based classification, applicable standards, quality-management requirements, the regulatory pathway to market, licensing authorities, and submission requirements.

The detail that matters here sits in the worked examples of covered software. Example 10 is “a behaviour-change and digital therapeutics platform intended to mitigate the progression of chronic diseases (e.g. Type 2 diabetes, hypertension, etc.) through remote coaching and digital tracking.” That is a digital therapeutic described in the regulator's own words and placed inside the regulated category, not left to inference.

The boundary is drawn on the other side too. The document does not apply to software merely intended for general wellness, for promoting a healthy lifestyle, or for measuring body parameters only for routine tracking and fitness — provided it is not intended for any medical purpose as the document defines one. General wellness software is defined separately, as software meant to maintain or encourage a general state of health, or to relate healthy lifestyle to reducing the risk or impact of certain chronic conditions.

CDSCO, “Guidance document on Medical Device Software under MDR-2017”, listed in the agency's public notices with the date 21 July 2026 (cdsco.gov.in). Quotations from the document text; earlier software classification notice dated 13 September 2021 from the same listing.

Switzerland's digital-health chapter goes live — the dGA route is now open

The MiGeL Chapter 40 for digital health applications (dGA) took effect on 1 July 2026, turning last December's announcement into a live reimbursement route. Prescribed, CE-marked dGAs listed by the Federal Office of Public Health are now covered by compulsory basic insurance (OKP/AOS), with GAIA's deprexis as the first listed product.

The chapter opens under a “coverage with evidence development” status running to the end of 2026 — a deliberately gated start while Switzerland watches how the first listings perform.

Based on MiGeL Chapter 40 taking effect, 1 July 2026.

DiGA turns outcome-based — a fifth of the price now rides on results

From 1 July 2026, Germany's DiGA scheme puts real money on performance: at least 20% of a DiGA's reimbursement price is contingent on success measures, backed by mandatory outcomes monitoring. Eligibility also extends to higher-risk class IIb applications, and the G-BA (Federal Joint Committee) takes over benefit evaluations — a signal that evidence standards are tightening.

Based on the DiGA outcome-based-pricing rules taking effect, 1 July 2026.

Denmark folds four national bodies into Digital Health Denmark — infrastructure, not a reimbursement route

Denmark is establishing a new national organisation, Digital Health Denmark, as part of a healthcare reform aimed at strengthening digital development and coherence across the health sector. It merges the Danish Health Data Authority, sundhed.dk, MedCom and the National Genome Center, together with several shared national tasks currently carried by the regions. A few selected functions and regulatory responsibilities of the Danish Health Data Authority stay with the Ministry of the Interior and Health.

The new body will be jointly owned by municipalities, regions and the state, and governed by a board appointed by those owners in the second half of 2026. Its stated aims are improving the use of health data, strengthening digital infrastructure, and accelerating the rollout of shared digital solutions across the health system.

A preparatory phase is running through 2026 under an interim structure called Preparatory Digital Health Denmark, with full establishment planned for 1 January 2027. The consequence for anyone who tracks Danish digital health by institution is concrete: sundhed.dk, the Danish Health Data Authority and MedCom cease to exist as independent organisations on 31 December 2026.

Med Tech Reimbursement Consulting, “Establishing Digital Health Denmark”, 24 June 2026 (https://mtrconsult.com/news/establishing-digital-health-denmark).

🇮🇹 Italy’s Chamber passes a digital-therapeutics law — after three years, and it is not law yet

Italy has spent three years on a dedicated law for digital therapeutics, and the first chamber has now finished with it. The parliamentary record is precise about the course: bill C. 1208 (Loizzo and others), Disposizioni in materia di terapie digitali, was presented on 7 June 2023 and assigned to the XII Social Affairs Committee on 22 September 2023. Committee examination ran from 2 October 2024 to 7 May 2026. Floor debate opened on 11 May 2026 and closed on 27 May 2026 with approval, in a unified text merging C. 1208 with C. 2095 and C. 2220.

It was transmitted to the Senate on 28 May 2026, where it is now DDL 1918 and awaits its first reading there.

Camera dei deputati, Atto Camera 1208, bill record, https://www.camera.it/leg19/126?idDocumento=1208. Page as of 11 October 2026.

🇫🇷 France: Axomove Therapy becomes the first PECAN musculoskeletal product to reach permanent LATM reimbursement

France's Haute Autorite de Sante (HAS/CNEDiMTS) has given Axomove Therapy, developed by the Lille-based startup Axomove SAS, a favourable opinion for permanent listing on the LATM (telesurveillance medicale) reimbursement line -- published 7 May 2026. The digital rehabilitation and telemonitoring platform prescribes personalised exercise programmes and remotely monitors adults with subacute or chronic low back pain (lombalgie) after hospital-based functional rehabilitation.

Axomove first entered French reimbursement via PECAN (Prise En Charge Anticipee Numerique), with a favourable CNEDiMTS opinion on 22 Oct 2024. To convert that one-year, provisional access into durable reimbursement, the company ran a prospective, multicentre, randomised controlled trial across 8 rehabilitation centres (including 4 CHU teaching hospitals) with roughly 190 randomised patients (NCT05910463): the Axomove arm improved on the Oswestry Disability Index by -9 points, versus -4.4 points for the conventional-care control arm.

Axomove Therapy is now tracked in our directory alongside France's other PECAN and LATM-listed products -- browse them all in the Explorer.

has-sante.fr (avis CNEDiMTS 22 Oct 2024 & 7 May 2026); clinicaltrials.gov/NCT05910463; ticpharma.com; mind.eu.com; eurasante.com

🇰🇷 South Korea does the groundwork for formal DTx listing — while every product still bills as self-pay

South Korea approved its first digital therapeutic in 2023 and put clinical-evidence requirements on a statutory footing with the Digital Medical Products Act, effective January 2025. What has not happened since is the step that matters commercially: no DTx has moved from temporary listing to formal National Health Insurance reimbursement, and products remain self-pay (비급여) in practice.

The groundwork is visibly underway. In April 2026 the Health Insurance Review and Assessment Service (HIRA) published a commissioned study on reimbursement-adequacy evaluation criteria and on a formal listing scheme for digital therapeutics.

HIRA, commissioned study on reimbursement-adequacy criteria and a formal listing scheme for digital therapeutics, April 2026. Digital Medical Products Act, in force since January 2025.

France's PECAN hits its three-year mark — first therapeutics head for permanent LPPR listing

Three years after PECAN launched, France's early-access scheme has reached the point where its first cohort must convert to permanent reimbursement. Digital therapeutics that entered via PECAN now pursue listing on the LPPR (manufacturers must file the follow-up dossier within six months of their PECAN decision), while telemonitoring products route to the LATM line.

Uptake has stayed measured — around eleven dossiers over the cycle, weighted toward telemonitoring — but the transition to LPPR is the real test: temporary access becoming durable, priced reimbursement.

Based on the PECAN framework reaching its three-year milestone, spring 2026.

🇨🇦 Health Canada refreshes its evidence guidance — and no, the SaMD rules are not new

Health Canada ran a substantial refresh of its medical device guidance through spring 2026. On 1 April 2026 three documents appeared together under safety and effectiveness evidence requirements: guidance on clinical evidence requirements for medical devices, pre-market guidance for machine learning-enabled medical devices, and guidance on terms and conditions for class II to IV devices. A day earlier came guidance on how to interpret a “significant change” to a device; on 9 April, guidance on summary reports; and on 24 April, three more on licence applications, the regulatory enrolment process and private-label devices.

For a digital therapeutic the first of these is the one that bites. Evidence is the gate a therapeutic app has to pass in every market that regulates one, and Canada has just restated what it expects.

Health Canada, Guidance documents on medical devices (canada.ca), listing dates as shown: 2026-04-01 for clinical evidence requirements, machine learning pre-market guidance and terms and conditions; 2019-12-18 for both SaMD guidance documents. Retrieved October 2026.

🇮🇱 Israel closes its 2026 basket round — an annual, budgeted gate that digital therapeutics are not visibly using

Israel updates its health services basket once a year through a public committee under the National Health Insurance Law of 1994. The 2026 round is complete: the committee finished its deliberations on 19 February 2026, recommending 107 medicines and technologies for roughly 86,450 people at a total cost of 650 million shekels, and the government approved the recommendations on 4 March 2026.

What makes this worth recording in a reimbursement directory is the shape of the process rather than this year's contents. The committee operates a published procedure for including a medical technology that is not a medicine, maintains a separate public list of non-drug technologies submitted for the round, scores every application from A10 down to C1 on evidence of efficacy, safety and clinical acceptability alongside disease characteristics, treatment sequence, alternatives and social and ethical considerations, and runs an appeals window — for the 2026 round, until 5 January 2026. That is a defined, annual, budgeted gate with a documented entry route, which is more than most markets classified as pipeline can show.

Israeli Ministry of Health, committee conclusion announcement 19 February 2026 (gov.il/he/pages/19022026-02) and the 2026 basket committee page (gov.il/he/pages/hbs2026). Government approval announcement 4 March 2026 (gov.il/en/pages/04032026-06) — note its figures are transposed; the Hebrew release is authoritative.

🇯🇵 Japan’s FY2026 fee revision lands — with a notice aimed at program medical devices

Japan revises its medical fee schedule every two years, and the FY2026 (令和8年度) round is now complete. The sequence on the record: a ministerial agreement on 24 December 2025, publication of the accumulated discussion and the minister's referral to the Central Social Insurance Medical Council (中央社会保険医療協議会, Chuikyo) on 14 January 2026, and the Chuikyo's report back to the minister on 13 February 2026, alongside publication of the individual revision items.

One of the notices issued that day is directly on topic for this directory: プログラム医療機器に係る評価療養及び選定療養の手続きについて — procedures for evaluation treatment and selected treatment relating to program medical devices (産情発0213第7号、保発0213第10号).

Japanese Ministry of Health, Labour and Welfare (MHLW), “令和8年度診療報酬改定について” (FY2026 medical fee revision), https://www.mhlw.go.jp/stf/newpage_67729.html. Retrieved October 2026.

🇦🇺 Australia’s TGA defines digital therapeutics — a regulatory line, not a payment one

Australia's medicines and devices regulator now has a page of its own for digital therapeutics, carrying a last-updated stamp of 30 January 2026. It defines DTx as evidence-based software products delivering medical interventions intended to prevent, manage or treat a disease, disorder or injury, usable alone or alongside medicines, devices or other therapies, and classifies them as a type of software as a medical device.

The regulatory consequence is stated plainly: DTx fall under the medical device framework by virtue of meeting the device definition in section 41BD of the Therapeutic Goods Act 1989, and must be included in the Australian Register of Therapeutic Goods before they can be supplied, unless excluded or exempt.

A good part of the guidance exists to draw a boundary. Wellness apps — fitness trackers, meditation tools, calorie counters — are not intended to treat, diagnose or manage medical conditions and are not regulated by the TGA. DTx, by contrast, must be supported by clinical evidence. The agency lists categories it counts in, including digital behavioural interventions such as CBT apps for substance use disorders, sensor-linked apps, and game- or VR-based therapy.

Therapeutic Goods Administration, “Digital therapeutics”, last updated 30 January 2026, https://www.tga.gov.au.

🇬🇧 NICE clears Overcoming Bulimia Online for NHS use — conditionally, and on core NHS money

NICE published HTG768, early value assessment guidance on digital self-help for eating disorders, on 22 January 2026. It separates three technologies into two groups, and the split is the whole point of the document.

Overcoming Bulimia Online can be used in the NHS during a two-year evidence generation period, in adults, for binge eating disorder, bulimia nervosa, other specified feeding or eating disorder with similar features, and disordered eating with similar features. Two conditions attach: the evidence set out in its evidence generation plan must actually be generated, and it must hold appropriate regulatory approval including NHS England's Digital Technology Assessment Criteria (DTAC). Use is placed after an initial eating disorder assessment in primary care or a further assessment by specialist services, and alongside usual waiting-list care such as regular check-ins and routine physical monitoring.

Digital CBTe and Worth Warrior fall on the other side: NICE states more research is needed before they can be funded by the NHS for those conditions.

The obligations run to the company, not just the service. It is responsible for ensuring data collection and analysis take place and must confirm that agreements are in place; NICE contacts it annually and may revise or withdraw the guidance if the conditions are not met. At the end of the two years the company submits the evidence, and NICE decides whether the technology can be routinely adopted.

NICE, HealthTech guidance HTG768, “Digital self-help for eating disorders: early value assessment”, published 22 January 2026 (https://www.nice.org.uk/guidance/htg768).

US sharpens digital-therapeutics billing for 2026

Entering their second year, Medicare's digital mental-health treatment (DMHT) G-codes are joined by four additional Remote Therapeutic Monitoring (RTM) codes for 2026 — 98984, 98985, 98986 and 98979, introduced in CMS's CY2026 Physician Fee Schedule Final Rule (released 31 Oct 2025). They lower the billing threshold for shorter-duration monitoring from 16 days/20 minutes to as little as 2 days/10 minutes per 30-day period, giving clinicians flexibility for shorter monitoring periods and briefer interactions. Momentum also continues behind federal efforts to formalise broader prescription-digital-therapeutic coverage under Medicare and Medicaid.

The practical picture is unchanged for now: clinician-billed codes plus a fast-growing employer/self-insured channel, rather than a single DiGA-style national tariff.

CMS CY2026 Physician Fee Schedule Final Rule (released 31 Oct 2025); tenovi.com; limberhealth.com; forcetherapeutics.com; nixonlawgroup.com

Switzerland switches on digital-health reimbursement — deprexis goes first

The Swiss Federal Office of Public Health has confirmed a new Chapter 40 for “digital health applications (dGA)” on the MiGeL medical-aids list, effective 1 July 2026. GAIA's depression programme deprexis is the first listed product, covered by compulsory basic insurance (OKP/AOS) for adults with mild-to-moderate depression.

The listing runs under a “coverage with evidence development” status — in evaluation until the end of 2026 — signalling that Switzerland wants to test the mechanism on a single, proven product before widening the chapter.

Based on the official FOPH announcement of 3 December 2025.

🇦🇦 Saudi Arabia’s SFDA gives digital therapeutics a category of their own

The Saudi Food and Drug Authority issued MDS-G27, Guidance on Digital Health Products, as version 1.0 dated 11 August 2025. Its stated purpose is to clarify which categories of digital health products fall within the SFDA's regulatory scope, to outline the regulatory approach for them, and to draw the line between what qualifies as a regulated medical device and what counts as a general wellness product.

The structure is the interesting part. Across sixteen pages the guidance sorts the field into eight named categories: software as a medical device, mobile health applications, digital therapeutics (DTx), health information technology, telemedicine, wearable devices, virtual and augmented reality, artificial intelligence and machine learning, and general wellness devices. Digital therapeutics get their own numbered section rather than being folded into software as a medical device or treated as an example of it.

SFDA, MDS-G27 “Guidance on Digital Health Products”, version 1.0, version date 11 August 2025, document code MDS-G-027-V1/250811, 16 pages (sfda.gov.sa). Quotations and category list from the document text.

GKV-SV's DiGA-Bericht 2024: €234m and 861,000 prescriptions since 2020

The GKV-Spitzenverband's DiGA-Bericht 2024 puts hard numbers on four years of Germany's “apps on prescription” scheme: €234 million reimbursed and 861,000 prescriptions, cumulatively, since the DiGA pathway opened on 1 September 2020 through the end of 2024.

Growth has accelerated sharply: spending on health apps rose 71% from 2023 to 2024 alone, reflecting both a growing catalogue of listed DiGA and rising prescriber familiarity with the pathway.

GKV-Spitzenverband DiGA-Bericht 2024 (published 31 March 2025); cumulative figures, 1 September 2020 to 31 December 2024.

🇫🇷 France: Glooko XT (Candiss) secures the country's first gestational-diabetes telemonitoring reimbursement

Glooko XT, marketed in France under the brand Candiss by Glooko SAS (the Paris-based French subsidiary of Glooko, Inc., Mountain View, USA), has been listed on France's LATM (telesurveillance medicale) reimbursement line -- published in the Journal Officiel on 26 Dec 2024. The remote-monitoring platform is reimbursed for non-insulin-treated gestational diabetes: pregnant women with a positive oral glucose tolerance test between weeks 24-28, or a fasting glucose of >=0.92 g/L in the first trimester alongside a risk factor.

The listing carries a base tariff of roughly EUR28 per patient per month. It makes Glooko XT one of only two solutions currently reimbursed in France specifically for gestational-diabetes telemonitoring -- a narrower, and until now largely uncovered, corner of France's PECAN/LATM landscape, which has so far been dominated by cardiac and renal remote monitoring.

Glooko XT (Candiss) is now tracked in our directory -- browse it alongside France's other PECAN and LATM-listed products in the Explorer.

glooko.com; ticpharma.com; prnewswire.com; legifrance.gouv.fr (Arrete du 26 decembre 2024)

US Medicare creates its first digital mental-health treatment codes

CMS's 2025 Physician Fee Schedule final rule established HCPCS codes G0552–G0554 for FDA-cleared digital mental-health treatment (DMHT) devices — Medicare's first explicit line for a prescription digital therapeutic. The codes are billed by the prescribing clinician alongside a behavioural-health treatment plan, effective January 2025.

G0553/G0554 pay roughly $20 per 20-minute monthly management increment; the device-supply code G0552 is contractor-priced, reflecting how much device costs still vary.

Based on the CMS CY2025 Medicare Physician Fee Schedule final rule (1 November 2024).

🇧🇪 mHealthBELGIUM 2.0: the app register continues without government support

At the end of 2023 the arrangement under which RIZIV/INAMI, beMedTech and Agoria jointly ran mHealthBELGIUM came to an end. The two sector federations — beMedTech for medical technology, Agoria for the technology industry — continue the platform on their own. The site now presents itself as mHealthBelgium 2.0 and states the consequence plainly: it carries on without government support.

The register began in 2018 as a federal initiative, after then health minister Maggie De Block funded 24 pilot projects to test what mHealth was worth in Belgian care. Three agencies each built one level of the validation pyramid: the FAMHP the M1 criteria, the eHealth platform the ICT criteria that originally defined M2, and RIZIV/INAMI the financing decisions behind M3.

The pyramid survives the handover, but M2 changes meaning. Where it used to certify that an app met the ICT criteria, it now marks an application that has submitted a reimbursement request that RIZIV/INAMI declared admissible — aligned with the procedure renewed on 1 October 2023. For every app below M2 the register also shows the date of the request and, once available, the outcome of the evaluation. Apps that held M2 under the old system without a pending request kept their [2] marker only until 1 October 2024.

M1 and M3 are filled exactly as before, but M3 is now reported in more detail per app: whether the funding is temporary or definitive — the register writes these M3- and M3+ — for which care path or paths it applies, and what that financing looks like, with a link to the relevant RIZIV/INAMI page. The care processes themselves are labelled under construction, active or inactive, which makes it possible to see that a listed pathway is not currently funding anything.

mHealthBELGIUM, home page, sections mHealthBelgium 2.0 as of 2024 and Management by beMedTech and Agoria, mhealthbelgium.be. mHealthBELGIUM, Validation pyramid, including the transitional note on level 2 listings until 1 October 2024. RIZIV/INAMI, Mobiele medische toepassingen: uw aanvraag indienen. All retrieved October 2026. mHealthBELGIUM publishes no day-level date for the 2.0 relaunch; Internet Archive captures place the change between 3 December 2023 and 24 February 2024, and the statement itself dates the handover to the end of 2023.

🇧🇪 Belgium rebuilds its mHealth reimbursement procedure — and adds a temporary funding route

Belgium has had a dedicated route for reimbursing mobile medical applications since level M3 of the mHealthBELGIUM pyramid opened in January 2021. From 1 October 2023 the national institute RIZIV/INAMI applies a rebuilt procedure for those applications, and the consequential change is that there are now two destinations rather than one.

Definitive reimbursement is the established outcome. Temporary reimbursement is new: an early-access route for applications with an innovative character, where evidence already indicates clinical value (mortality, morbidity, quality of life) or organisational value (staff time, avoided procedures or devices), but uncertainties remain. The standard duration is three years, from which the working group may depart with reasons. An interim report is due every 18 months, and at the latest six months before the end the applicant must file for definitive reimbursement together with an evaluation report. A negative evaluation at that point ends the funding; a timely filing that takes longer than six months to process gets a transitional arrangement.

Two conditions are easy to overlook. A manufacturer, hospital or working-group member cannot file alone: the dossier needs the backing of a scientific or professional association, which has to state its support for the application and the proposed care process. And the remaining uncertainties must be named in the dossier, with a workable plan for removing them — a study already under way counts, provided the applicant argues why international data will be usable in the Belgian context.

The applicant pool is wider than manufacturers. Scientific associations, professional organisations, hospitals and members of the multidisciplinary working group may all submit. That group meets monthly. Its fixed core is drawn from care providers, physicians, paramedical staff, hospital managers, insurers and health economists; beMedTech, Agoria, the federal health service, eHealth and the FAMHP sit as observers without a vote. Per dossier it is completed by thirteen ad hoc members — including at least three independent experts in the proposed care process or technology, and one representative of the patient associations concerned — who all do have a vote.

The indicative timelines are published: 30 days to rule a dossier admissible, then 270 days for the evaluation and any integration proposal, with the institute stating it aims for 180 once the field matures. The consultation bodies and the Insurance Committee add 90 days. Implementation adds two months for a convention, or six if a royal decree proves necessary.

RIZIV/INAMI, Mobiele medische toepassingen: uw aanvraag indienen / Applications mobiles medicales: introduire votre demande — conditions and procedure for applications since 1 October 2023, riziv.fgov.be. RIZIV/INAMI, Procedure (bijlage_beschrijving_procedure.docx) and Schematisch overzicht van alle stappen van het proces (schema_procedure.pdf). Belgian law on medical devices of 22 December 2020. All retrieved October 2026.

France opens PECAN — early-access reimbursement for digital medical devices

France's PECAN scheme became operational, offering a digital medical device (DMD) one year of transitional reimbursement while it completes full evaluation for permanent listing via LPPR (therapeutics) or the LATM telemonitoring line. Inspired by Germany's DiGA, it's built to accelerate patient access to useful innovation.

Telemonitoring under PECAN is set at roughly €50 per patient per month; individual-use DTx use a front-loaded first-quarter package plus capped monthly fees.

Based on the launch of the PECAN early-access scheme, April 2023.

South Korea approves its first digital therapeutic

The MFDS granted approval to Somzz, a cognitive-behavioural-therapy-for-insomnia (CBT-I) programme — the country's first authorised DTx, followed weeks later by WELT-I. Revised insurance rules later in 2023 allowed temporary NHI reimbursement for up to three years before full evidence.

Somzz holds a formal HIRA non-covered (“bigeubyeo”) billing code with a reference price inside the NHI claims framework — though in practice hospitals charge patients well above that reference, so it operates largely as self-pay.

Based on the MFDS approval of Somzz, 15 February 2023.

Japan reimburses the world's first hypertension therapeutic app

Japan's Chuikyo (Central Social Insurance Medical Council) approved NHI coverage for CureApp HT, a therapeutic app for hypertension — the first time a country reimbursed a prescription app in that field. Coverage began in September 2022 at an NHI-set price.

It followed CureApp's 2020 smoking-cessation app through the same route: clear PMDA device approval, then have Chuikyo assign an NHI price like any other reimbursed medical technology.

Based on the Chuikyo coverage decision of 3 August 2022.

NICE gives a digital therapeutic its first positive appraisal

NICE published guidance MTG70 recommending Sleepio (Big Health) as a cost-saving option for insomnia in primary care — the first-ever digital therapeutic to receive a positive NICE appraisal. It set the template for NICE's Early Value Assessment route into the NHS.

Rather than a DiGA-style national tariff, UK access flows through NICE recommendations plus NHS commissioning and service contracts — a different mechanism aimed at stretching limited clinical capacity.

Based on NICE guidance MTG70, published 20 May 2022.

Belgium opens its reimbursement tier with a “validation pyramid”

Belgium activated level M3 of the mHealthBELGIUM validation pyramid — the tier at which INAMI-RIZIV can fund apps that prove clinical and socio-economic value. Products climb from M1 (CE-marking + data-security basics) through M2 (interoperability/security) to M3.

The graduated on-ramp has since supported heart-failure and cancer telemonitoring, knee/hip rehab, Holter and sleep-apnoea pathways.

Based on the roll-out of validation-pyramid level M3, 20 January 2021.

Japan reimburses its first digital therapeutic, CureApp SC, for smoking cessation

CureApp's smoking-cessation therapeutic, CureApp SC, went on sale on 1 December 2020 with public health-insurance coverage — the first digital therapeutic in the smoking-cessation field to be reimbursed by a national health-insurance system anywhere in the world, and Japan's first nationally reimbursed digital therapeutic overall. It pairs an app with a connected CO checker.

Regulatory approval from the MHLW had come earlier, in August 2020; the NHI price decision is what unlocked reimbursed, prescribable use.

Based on the start of NHI coverage / launch, 1 December 2020.

The first “apps on prescription” go live in Germany

The DiGA directory opened with its first entries — velibra (anxiety), Kalmeda (tinnitus) and somnio (insomnia) — making them prescribable by physicians and psychotherapists and reimbursed by statutory insurers. Germany's fast-track had turned law into live product in under a year.

Manufacturers set their own price for the first 12 months, after which a negotiated rate with the national association of statutory insurers applies.

Based on the first DiGA listings in the BfArM directory, early October 2020.

Germany writes the world's first national DTx reimbursement law

The Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) entered into force, creating the “app on prescription” — the first legal entitlement for a statutory-insured population to receive prescribed, reimbursed software. It set up the DiGA fast-track that BfArM would operationalise in 2020.

Around 73 million people covered by German statutory insurance became eligible to have a prescribed DiGA reimbursed like any other therapy.

Based on the DVG entering into force, 19 December 2019.

🇨🇦 Canada defines software as a medical device — ten days before Germany starts paying for it

On 18 December 2019 Health Canada published two guidance documents together: Software as a medical device (SaMD): Definition and classification, and Software as a medical device (SaMD): Classification examples. They sit under medical device classification in the agency's guidance listing, alongside its risk-based classification guidance for in vitro and non-in vitro diagnostic devices.

Two things make the date worth a marker in this directory. The first is what else was happening that month: Germany's Digitale-Versorgung-Gesetz entered into force on 19 December 2019, the day after, creating the world's first national reimbursement route for digital health applications. Within forty-eight hours, two countries took the two different steps available — Canada settling what software is, Germany settling who pays for it.

The second is how little has moved on the Canadian side since. Checked in October 2026, both documents still carry their 2019 date in Health Canada's own listing: they have not been reissued or replaced. Canada's 2026 guidance activity is real but sits elsewhere — clinical evidence, machine learning, licensing administration.

Health Canada, Guidance documents on medical devices (canada.ca), both SaMD documents listed with the date 2019-12-18; listing checked October 2026. German DVG date as recorded in this directory's own entry of 28 December 2019.