The new article highlights the key points related to the studies to be carried out to demonstrate a positive supply effect.
RegDesk Regulatory Roundup
BfArM Guidance on Fast-Track Process for Digital Health Applications: Statement of Positive Care Effect
The document describes in detail the aspects related to the statement of positive care effect to be included in the submission.
The new article addresses the aspects related to the data security measures to be introduced by the parties involved in operations with digital health products.
The new article addresses the matters related to interoperability for medical software products.
The article describes in detail the further quality requirements imposed with respect to digital health applications intended to be marketed and used in Germany.
BfArM Guidance on Fast-Track Process for Digital Health Applications: Evidence – Positive Care Effect
The new article describes the approach to be followed by the applicants when presenting sufficient evidence demonstrating the proper performance of their products when used for the intended purpose.