Monday, May 2, 2016

Archimedes Circular Podcast 0x01: Co-Chairs of the AAMI Medical Device Security Working Group

Not an official logo of the AAMI Medical Device Security Working
Group, but it may become a T-shirt after members catch up.
Welcome to the inaugural Archimedes Circular Podcast. Today, Dr. Kevin Fu interviews the co-chairs of the AAMI Working Group on Medical Device Security ahead of the release of its Technical Information Report 57 to medical device manufacturers on specific security engineering methods designed to help satisfy regulatory expectations of cybersecurity in the 510(k) and PMA processes.

Ken Hoyme and Geoffrey Pascoe are co-chairs of the AAMI Medical Device Security Working group. AAMI is the Association for the Advancement of Medical Instrumentation. Founded in 1967, AAMI is a non-profit organization of 7,000 professionals for the development, management, and use of safe and effective healthcare technology. AAMI consists of over 100 technical committees and working groups that produce Standards, Recommended Practices, and Technical Information Reports for medical devices. The medical device security co-chairs are interviewed by Kevin Fu, a professor at the University of Michigan and the Archimedes Center for Medical Device Security.

For several years, the AAMI Medical Device Security Working group has been toiling away tirelessly on the Technical Information Report #57 (Principles for medical device information security risk management). Its members fondly call it TIR 57.  The document provides advice to front-line medical device engineers on how to begin integrating security engineering into the design and implementation of medical devices. The TIR 57 is based on the input and consensus vote of medical device manufacturers, health delivery organizations, security engineering experts, and faculty.

Kevin:                      Welcome to the Inaugural Archimedes Broadcast. My name is Kevin Fu. I direct the Archimedes Center for Medical Device Security. Today, we’re going to talk about consensus standards and guidance documents for manufacturers to meet FDA expectations on medical device security. Today, I am interviewing Ken Hoyme and Geoff Pascoe, the co-chairs of the Medical Device Security Working Group of AAMI, which is considered the most respected standards body in the medical devices arena. I am also joined by Wil Vargas who is the director of standards at AAMI, so welcome, Ken, Geoff and Wil.
Wil:                         Thank you.
Ken:                          Thank you. Thank you for having us.
Geoff:                      Thanks.