News: DiGA & Medical Software

Der Referentenentwurf zur zweiten Änderung der DiGAV wurde erstmals im Januar dieses Jahres präsentiert und liegt nun in aktualisierter Form erneut vor. Darin sind auch Änderungen, die für Hersteller relevant sind. Dazu zählen unter anderem: Zukünftig müssen...

Mit dem PECAN-Rahmen, der am 31. März 2023 veröffentlicht wurde, besteht in Frankreich ein beschleunigter Pfad für die Erstattung digitaler Gesundheitslösungen – auch für deutsche DiGA-Hersteller potenziell relevant. Bisher hat jedoch keine DiGA eine Zulassung nach...

Beim vdek-Zukunftsforum am 7. Oktober 2025 wurde das fünfjährige Bestehen von DiGA gefeiert. Die Implementierung von DiGA in die Regelversorgung wurde als überwiegend positiv bewertet, wobei die Notwendigkeit betont wurde, die digitale Gesundheitskompetenz der...

As of July 1, 2026, Phase I of the in-use performance measurement (AbEM) applies to all permanently listed digital health applications (DiGA). According to Section 23c(1) of the DiGAV, DiGA manufacturers must submit the following data for the third and fourth quarters...

Nearly three years after the last version, the BfArM has published Version 1.3 of the Guidelines for Digital Nursing Applications (DiPA). This means that the changes from the first DiPAV amendment have now been incorporated into the guidelines. The most important...

The German federal government has approved the draft of the Act on Data and Digital Innovation in Healthcare (GeDIG). It addresses nearly all areas relevant to digitalization, supports the national implementation of the European Health Data Space (EHDS), and is...

The European Commission has updated its list of standard fees charged by Notified Bodies (MDR/IVDR). It consolidates the fee schedules published by the individual Notified Bodies in one place. It’s worth taking a quick look for anyone comparing or budgeting for...

Following the Supreme Court’s ruling in Trump v. Slaughter ( June 29, 2026), the U.S. Federal Trade Commission (FTC) loses its independence: The court ruled, in accordance with the “unitary executive” doctrine, that the President’s authority to issue directives...

On June 23, 2026, France’s CNEDiMTS (part of the French Health Authority, HAS) issued a positive recommendation for Poppins Clinical from BMOTION Technologies. This marks the first time a true digital therapy has been covered through the PECAN reimbursement channel....

Parliament and the Council have given their final approval: For AI in medical devices, the high-risk requirements will be postponed from August 2, 2027, to August 2, 2028. For standalone high-risk AI, the obligations take effect on December 2, 2027; for AI used as a...

A revised version of IEC 62304 is expected to be published in August 2026. It is currently in the final coordination phase. A transition period of 2 to 3 years can be expected before regulators require compliance with the new version. IEC 62304 Edition 2 introduces...