Challenges to sharing of cybersecurity data are being addressed by the new Medical Device ISAO. This session will explain Executive Order 13691, discuss the National Medical Device ISAO Initiative co-led by NHSIAC and MDISS, and explain how the ISAO will contribute to scientifically robust data to inform regulatory policy.
Recognize the unique role of the NHISAC
Discuss the science, technology, epidemiological foundations for the difficulty in identifying and controlling malware
Illustrate and discuss the open collaboration for cybersecurity information
Explain the FDA guidance that medical device manufacturers participate in an ISAO
Identify key aspects of ISAO including the governance model for operations and data sharing