Medical device cybersecurity
Medical device cybersecurity in Healthcare & Life Sciences is now a hard compliance requirement, not a voluntary framework. The U.S. Food and Drug Administration's 2023 final guidance on cybersecurity in premarket submissions and the U.S. Department of Health and Human Services' enforcement posture under HIPAA Security Rule have set a clear expectation: device manufacturers and covered entities must demonstrate active vulnerability management, not just policy documentation. The European Commission's Medical Device Regulation and the parallel work of the European Union Agency for Cybersecurity on sector-specific controls add a second compliance clock for any organization selling into EU markets.
Watch
- FDA's refusal-to-accept policy for premarket submissions lacking a Software Bill of Materials
- HHS Office for Civil Rights settlement patterns tied to networked medical device breaches
- EU Cyber Resilience Act obligations as they intersect with MDR-regulated device categories
- Coordinated vulnerability disclosure expectations under FDA's postmarket cybersecurity guidance
Recent material activity in Healthcare & Life Sciences
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FDA issues Complete Response Letter for novel GLP-1 receptor agonist oral formulation
The FDA issued a CRL for a once-daily oral GLP-1 receptor agonist citing manufacturing consistency concerns at the primary production facility. The agency requested additional CMC data and a pre-approval inspection befor…
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