New Regulations. Medical Device Hacking.

What entity promulgated new medical device cybersecurity rule guidance? The FDA

What prompted the new guidance? Claims of heart device hacking

Policy Issues around medical device hacking:

• assess whether the risk of patient harm is sufficiently controlled or uncontrolled
• protection of PHI- protected health information- by devices
• comprehensive risk management programs
• NIST cybersecurity protocols should be the standard