AI regulation in healthcare — what moved, what it means, what to do about it.
Every Monday, you open your inbox wondering what changed. FDA guidance, 45 states legislating AI independently, HIPAA enforcement actions, EU AI Act deadlines — and the federal government actively contesting the state laws you're trying to comply with. Your team can't track it all. Outside counsel charges $500/hr to tell you what you missed.
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On February 3, FDA published the revised final guidance "Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions." Fact This is the third iteration since September 2023, updated specifically to align with the QMSR transition (see Section 02).
Why it matters: This guidance has statutory teeth. Section 524B of the FD&C Act — added by the Consolidated Appropriations Act of 2023 — makes cybersecurity requirements legally enforceable for any "cyber device": a device that includes software, can connect to the internet, and has characteristics making it vulnerable to cyberthreats. Fact
That definition covers every AI-enabled medical device, every SaMD product, and most connected diagnostics on the market. Our Read
The SBOM requirement is the headline. Under Section 524B(b)(3), every cyber device submission must include a machine-readable Software Bill of Materials in SPDX or CycloneDX format. This is not a recommendation — it is a legal requirement. Fact
FDA has signaled that incomplete SBOM submissions will be placed on hold, which in practice means your application won't advance until cybersecurity documentation is complete. Signal
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"The volume and pace of change is crazy these days."
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The Federal Register is one source with no interpretation. We cover 30+ sources across FDA, HIPAA enforcement, state legislatures, the EU AI Act, and 12+ law firm advisories — and we tell you what it means for your product and what to do about it.
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Federal — FDA, HHS, CMS, ONC, FTC, OCR/HIPAA, Federal Register. State — California, Colorado, Texas, Illinois, New York, and any state that introduces AI healthcare legislation. International — EU AI Act, EU MDR, UK MHRA. When a new jurisdiction passes relevant regulation, we add it.
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