
Compliance· Jun 14, 2026
HIPAA and Medical Device Manufacturers
When HIPAA applies to medical device manufacturers, how the 2025 Security Rule NPRM raises the bar, and how HIPAA obligations intersect with the FDA's.
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Looking for a quick answer instead? The FDA medical device cybersecurity FAQ covers Section 524B scope, SBOMs, threat models, CR515 and GMLP, deficiencies, and postmarket duties.
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When HIPAA applies to medical device manufacturers, how the 2025 Security Rule NPRM raises the bar, and how HIPAA obligations intersect with the FDA's.
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