Every article in our archive tagged HIPAA.
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.
Showing 4 of 4 articles tagged HIPAA
Medical device data sovereignty explained: where patient data lives, what HIPAA and GDPR transfer rules require, and how to answer hospital security questionnaires.
Read article
Cybersecurity for CLIA high-complexity labs: HIPAA, 21 CFR Part 11 data integrity, LIMS hardening, vendor patching, AI/cloud analytics, and CMS/CAP inspection readiness.
Read article
De-identification vs anonymization for medical devices: HIPAA Safe Harbor, GDPR Recital 26, and what FDA guidance recommends for AI/ML training data and postmarket telemetry.
Read article
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.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.
