https://twitter.com/scotterven/status/856594905812000768

 […]Cybersecurity of medical devices was identified as one of the top ten regulatory science gaps. […]The scope and nature of this cybersecurity regulatory science research framework is designed to be broad to foster collaboration across all interested stakeholders. The domain is defined by the intersection of safety and security in the design and evolution of medical devices. The objective of the workshop is to facilitate a discussion on the current state of regulatory science in the field of cybersecurity of medical devices, with a focus on patient safety.[…]

https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm549732.htm

 

Postmarket Management of Cybersecurity in Medical Devices
Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCE
Document issued on: January 22, 2016

From Lexology.com:

Is Your Medical Device Cybersecure? FDA Issues Draft Guidance on Postmarket Cybersecurity in Medical Devices

Recently, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining the agency’s recommendations for Postmarket Management of Cybersecurity in Medical Devices.  The guidance is applicable to medical devices that contain software (including firmware) or programmable logic, as well as software that meets the definition of a medical device.  The guidance does not apply to experimental or investigational medical devices.  Comments on the draft guidance are due by April 21, 2016.

Full story:

http://www.lexology.com/library/detail.aspx?g=0d71435c-cfd5-4e49-8a43-198b9be8558e