The BfArM has published updated data protection criteria for DiGA and DiPA.
In principle, manufacturers are to demonstrate compliance with the data protection criteria from August 1, 2024 by presenting a certificate. The BfArM points out, however, that there are currently still no accredited bodies for certifying the data protection criteria.
Until concrete timeframes can be given, Annex 1 of the DiGAV continues to apply.
Since the assessment certificate is still under development, further changes to the data protection criteria presented may arise as the assessment criteria and methods are worked out.
The updated assessment criteria have been published at this link: https://www.bfarm.de/DE/Medizinprodukte/Aufgaben/DiGA-und-DiPA/Datenschutzkriterien/_node.html