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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

LINK

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