Following a host of computer security issues in medical devices, the U.S. Department of Health and Human Services has released an audit report proposing that the FDA should further integrate its review of cybersecurity into the premarket review process for medical devices. A recent article from Star Tribune
, “A Prescription to Fight Hackers,” takes a deep dive into the extensive proposals laid out in the report, exploring why protecting medical devices from cyberattacks is crucially important.
But how can medical device manufacturers and the wider healthcare sector best protect against these cybersecurity threats? Debevoise partners Luke Dembosky
and Paul D. Rubin
will soon issue an in-depth report aimed at advancing the adoption of comprehensive cybersecurity plans and coordinated vulnerability disclosures. The piece will offer extensive best practices learned from interviews conducted with FDA, device makers, cybersecurity researchers and trade associations, and describe the legal and non-legal issues associated with cybersecurity vulnerability assessments.
A Prescription to Fight Hackers
By Joe Carlson
September 11, 2018