Test health apps for clinical effectiveness and protect patients

Summary

Submission of a draft law on the Digital Care Act: inclusion of a health app in the BfArM's list of digital health applications only if positive effectiveness has been proven through at least one randomized controlled study (RCT), deletion of the probationary period, definition of the term "positive care effects" based on clear and measurable quality criteria and parameters, provision of the Proof of effectiveness exclusively through RCTs, obligation on the part of manufacturers to provide precise information about the target group, how it works and how it works, and its intended purpose

Machine translation from German. The official text remains authoritative.

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• 19/16057

  Drucksache · DE · 18 December 2019

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