Germany Adds Outcome Reporting and Performance-Linked Pricing to DiGA Rules in 2026

Since the Digital Healthcare Act of 2019, patients covered by German statutory health insurance can be prescribed digital health applications that are listed in a directory maintained by the Federal Institute for Drugs and Medical Devices (BfArM). A manufacturer applies to BfArM, which decides on a complete application within about three months. Where all requirements are met except proof of a positive healthcare effect, BfArM can grant provisional listing. The manufacturer then has 12 months to demonstrate the effect, a period that can be extended once by a further 12 months, which sources describe as available only in exceptional cases.

Most listed applications have been lower-risk products in classes I and IIa. The 2024 Digital Act (Digital-Gesetz) opened the route to certain class IIb medical devices, but with stricter evidence requirements; practitioner guidance indicates that class IIb applications must show medical benefit at the time of application and cannot rely on provisional listing. A 2024 industry report found that about two-thirds of provisionally listed DiGA had subsequently obtained permanent listing.

The Second Ordinance amending the DiGAV came into force on 1 February 2026. Its central addition is application-accompanying outcome measurement (anwendungsbegleitende Erfolgsmessung, AbEM), set out in a new Section 6a of the ordinance. Under section 23a, the specified data must be collected for each calendar quarter and transmitted electronically to BfArM. Section 23b defines the content of the initial and follow-up reports, and new annexes and standard questionnaires accompany sections 23d and 23e.

According to legal commentary, data collection starts in the third quarter of 2026. Data are transmitted in anonymised and aggregated form every six months, and the first report, covering the third and fourth quarters of 2026, is due by 15 April 2027. The data cover the duration and frequency of use, patient satisfaction and self-reported health status, combining technical usage data with patient-reported information; patient participation in the surveys is voluntary.

Commentators also report procedural simplifications and a new requirement for applicants to declare whether their application falls within the EU Artificial Intelligence Act, with manufacturers expected to show compliance with that regulation where it applies. One practitioner source states that the 90-day BfArM review period and the 12-month limit on provisional listing were not changed; this should be checked against the ordinance text.

Separately from the ordinance, section 134(1) SGB V, as amended by the 2024 Digital Act, requires manufacturers and the National Association of Statutory Health Insurance Funds to include performance-dependent price components of at least 20 per cent in DiGA reimbursement amounts from 2026. Where an existing agreement contained no such component, the parties had to agree a compliant reimbursement amount by 1 January 2026 at the latest. The outcome data collected under the amended ordinance are intended to provide the evidence base for these components.

The rule remains contested. Industry associations have called for performance-dependent price components to be removed from the law, citing administrative burden. A 2026 draft bill on stabilising statutory health insurance contribution rates proposed further volume-based mandatory discounts on DiGA reimbursement amounts. One legal database lists a July 2026 amendment to section 134, but the final wording could not be verified at the time of checking, so manufacturers should confirm the current statutory text before negotiating.

Manufacturers of permanently listed DiGA need systems that can capture usage data and administer the standard questionnaires from the third quarter of 2026, and processes to aggregate and transmit the results to BfArM on the six-monthly cycle. New applicants should build outcome measurement into their evidence plans from the start, because the same data will inform both permanent listing and price negotiations.

Sponsors outside Germany considering the DiGA route should note that CE marking alone does not secure listing: BfArM applies its own listing requirements, including evidence of a positive healthcare effect, and the reimbursement price is negotiated separately. Pubrica does not provide legal advice on German social security law; manufacturers should consult BfArM’s current guidance and qualified advisers.