A new version of the DiGA guide (3.6) has been published.
The update to reflect the legislative changes made since 2023, in particular from the Digital Act (DigiG) in March 2024, was long overdue. These are now reflected in the new version.
The update is extensive. The guide has grown from 177 to 215 pages and many relevant topic areas have been added.
The larger changes include, for example:
- DigiG: new rules from the DigiG have now been incorporated into the DiGA guide as well (for DiGA in risk class IIb, for instance)
- DiGAV update: new rules from the draft bill of the 2nd DiGAV amendment ordinance have been incorporated (mainly application-accompanying performance measurement, AbEM)
- BSI TR-03161 as the standard: data security is fully covered by the BSI certificate. Demonstrating data security via the DiGAV checklist is no longer required
- DiGA qualification clarified: a clearer distinction between DiGA and non-DiGA, including a new decision tree on DiGA eligibility (intended purpose, individualisation, control of active medical devices, risk class IIb)
- Evidence requirements specified: clarifications on study design, significance level (5%), randomisation, study reports and analysis
- Interoperability updated: “vesta” replaced by “INA” as the reference for interoperable e-health infrastructure
- Process clarifications: more detailed rules on deadlines, the application portal, the lifecycle, and obligations after listing and delisting
- Scope & structure extended: a substantial expansion of the guide overall (177 → 215 pages) with new chapters, FAQs and examples
We have analysed and summarised all the changes in a structured way and additionally provide a PDF document with the exact changes: To the analysis of the changes