The cadence of DTx, telemonitoring & device regulation

DTx / DiGA-style reimbursement

The pathway that lets a software therapy get prescribed and paid for like a drug. Germany's DiGA law (2019) is the template three others have explicitly copied; Japan folds DTx into its existing drug-pricing schedule instead. Chips show each country's own DTx-category count today — in France and Belgium this is small, because most of their reimbursed volume is telemonitoring (see below). Not shown: Austria, which has no DTx reimbursement yet — the Digital Austria Act (Jun 2023) laid the groundwork, but a standardised evaluation framework is only targeted to complete by end-2026.

Telemonitoring / RPM

France and Belgium's reimbursement systems are, in practice, telemonitoring systems. Most of their reimbursed volume is remote-monitoring (cardiac/renal/oncology), not DTx. Both grew out of cardiac/heart-failure follow-up before oncology monitoring was added.

Medical product (general device regulation)

The underlying device-safety law everything else sits on top of. Europe is the one region with a genuine shared instrument (the EU MDR); everywhere else, national regulators (FDA, MFDS, NMPA) act independently.

AgeTech / DiPA-style reimbursement

Germany's second digital-reimbursement pathway, and a distinct one from DiGA: DiPA (Digitale Pflegeanwendungen) is funded via long-term-care insurance (SGB XI) rather than statutory health insurance, and targets care/assistance rather than treatment. Currently Germany-only, and currently empty — the pathway is live but nothing has been listed yet.

Prevention app reimbursement (§20 SGB V)

A separate German pathway from DiGA: the GKV-Spitzenverband's Leitfaden Prävention sets the rules for statutory insurers to cover prevention and health-promotion courses under §20 SGB V. Chapter 7 first added certification criteria for digital, self-directed offerings (apps) in 2020 — a decade after several hundred non-digital courses were already covered under the same guideline. Around 15 digital offerings are certified as of this writing, including the detoxi Health App and CyberHealth; certification runs through the guideline itself, not BfArM.

Europe

Americas

Asia

DTx / DiGA — reimbursed count over time

Germany has real month-by-month data (BfArM's own DiGA-Verzeichnis filings) — a genuine growth curve, not just a snapshot. Every other line starts at its enabling legislation or framework (an × marks that point; zero products, by definition) and steps up at each dated listing pulled from this project's own product-level sourcing, dotted while the count is still zero. Where only one dated point exists, the line assumes zero beforehand rather than asserting an earlier date we don't have. Denmark's dashed line is a different metric entirely — apps recommended by its curation council, not reimbursed products.

Telemonitoring — reimbursed count over time

Belgium and France have real per-wave listing dates pulled from this project's own product-level sourcing. UK, USA and the Netherlands only have their enabling-policy date, so their lines are a single step to today's total. Germany's telemonitoring runs on common EBM charge codes billed per-physician, not per-product listings, so there's no dated adoption curve to plot — its line is an illustrative dotted ramp from the EBM codes going live to today's total, not a real month-by-month trajectory.

AgeTech / DiPA — reimbursed count over time

Stays empty for now — the DiPA pathway is live but zero products have been listed yet.