FDA’s Role in Medical Device Cybersecurity

By: Suzanne Schwartz, M.D., M.B.A.

Virtually every aspect of our lives – including our health – has gone digital. Medical devices from insulin pumps to implantable cardiac pacemakers are becoming more interconnected and, like computers and the networks they operate in, can be vulnerable to security breaches.

Suzanne SchwartzA computer virus or hack resulting in the loss of or unauthorized use of data is one thing. A breach that potentially impacts the safety and effectiveness of a medical device can threaten the health and safety of an individual or patients using the device.

Global cyber-attacks in 2017, including WannaCry and Petya/NotPetya, have had a significant impact on our nation’s critical infrastructure, including the health care and public health sector. Hospitals, pharmaceutical companies, and even the Kiev airport were among organizations affected by cybercriminals who unleashed copies of the ransomware earlier this year, with demands of

... read more at: https://blogs.fda.gov/fdavoice/index.php/2017/10/fdas-role-in-medical-device-cybersecurity/