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 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 addresses the aspects related to data protection in the context of digital health applications.
The Federal Institute for Drugs and Medical Devices (BfArM), a special medical device regulating agency in Germany, issued warning on vulnerabilities detected in one of the most widely used operating systems for medical devices. Medical Device Cybersecurity Issue...