Surprisingly, on October 11, the BfArM published a new version 3.4 of the DiGA guidelines on the fast-track procedure – after it had only leased a new version on September 4.
Compared to the previous version, only a few chapters in the DiGA guide have been changed:
3.3.3 Data processing outside Germany (with FAQs and clarification on foreign service providers)
3.4.2 Stricter requirements for penetration tests
3.5.4.3 Explanations on “Cascade for implementing a sub-operable interface”
and 3.6.5.1 Editorial changes. LINK