France’s National Agency for the Safety of Medicines and Health Products (ANSM) has developed draft recommendations on the cybersecurity of medical devices.
ANSM developed the draft recommendations to help minimize the risk of a cyberattack in medical devices integrating software (MDIS) in early development and throughout the total product lifecycle (TPLC). Its guideline will implement best practices and appropriate standards to address the inconsistent culture of cybersecurity among device manufacturers, ANSM says.
The draft recommendations recognize the evolving cybersecurity landscape in the increasingly connected world of medical devices. As such, ANSM says they merely “set out the key principles without expanding on the technical details, which would otherwise quickly render this document obsolete given the rate at which both medical devices and attacks can develop.”
ANSM also seeks alignment with the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) as these introduce general safety and performance requirements, including MDIS-specific requirements. MDR and IVDR “pave the way for the introduction of a new approach to risk…
ANSM developed the draft recommendations to help minimize the risk of a cyberattack in medical devices integrating software (MDIS) in early development and throughout the total product lifecycle (TPLC). Its guideline will implement best practices and appropriate standards to address the inconsistent culture of cybersecurity among device manufacturers, ANSM says.
The draft recommendations recognize the evolving cybersecurity landscape in the increasingly connected world of medical devices. As such, ANSM says they merely “set out the key principles without expanding on the technical details, which would otherwise quickly render this document obsolete given the rate at which both medical devices and attacks can develop.”
ANSM also seeks alignment with the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) as these introduce general safety and performance requirements, including MDIS-specific requirements. MDR and IVDR “pave the way for the introduction of a new approach to risk…
