Lexology December 18, 2025
Surgical and medical devices, plus AI is complex because regulations for this technology exist in different buckets, not one comprehensive rulebook. These buckets include healthcare privacy/security, cybersecurity, device safety, product compliance, etc. The various regulation types to be aware of and the reasons why each is relevant are essential when managing risk.
Healthcare privacy and security regulations: This is the starting point. In the United States, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the HIPAA Security Rule are the regulations that spell out expectations around the management and protection of electronic protected health information (PHI). While not directly a medical device regulation, HIPAA covers medical devices any time PHI is created, stored, transmitted, or integrated with...
Today's Sponsors
Today's Sponsor