Medical device cyber vulnerabilities represent a risk to their 'safe and effective' operation, and typically require an ongoing maintenance effort to mitigate. This is the FDA's guidance on how existing regulations apply to those cyber maintenance activities.
The MDS2 form and instructions how to complete it. The intent of the MDS2 is to supply healthcare providers with information to assist them in assessing the risks and vulnerabilities of medical devices, as they pertain to disclosure of PII.
"MDISS's deep device expertise & assessment platforms help NH-ISAC advance the security of the health sector overall. That means our shared membership can better prepare for -- and respond to -- cyber threats."