Comparison guide
HIPAA vs FDA Cybersecurity
HIPAA protects PHI within its covered relationships; the Security Rule concerns ePHI. The FDA regulates medical devices. Assess applicability separately.
Side-by-side breakdown
| Dimension | HIPAA | FDA cybersecurity |
|---|---|---|
| Regulator | HHS Office for Civil Rights (OCR). | FDA Center for Devices and Radiological Health (CDRH). |
| Scope | Protected Health Information held by covered entities and business associates. | The medical device, its software, and its postmarket lifecycle. |
| Who must comply | Health plans, providers, clearinghouses, and their business associates. | Manufacturers of cyber devices submitted for FDA clearance/approval. |
| Trigger | Covered entity or business-associate status; the Security Rule concerns electronic PHI. | Submission of a cyber device under §524B. |
| Cybersecurity asks | Administrative, physical, and technical safeguards for ePHI within the Security Rule scope. | Section 524B statutory duties plus device-specific guidance recommendations, kept distinct. |
| Manufacturer status | Assess the actual service and relationship; handling health data alone does not establish business-associate status. | Always the regulated party for the device itself. |
When to use which
Assess whether the manufacturer acts as a business associate and whether a business associate agreement is required for the relationship. Do not infer status from device connectivity or health-data handling alone.
Assess whether encryption, access control, logging, and incident-response evidence can support both programs. Keep each applicable duty and evidence purpose distinct rather than assume one assessment replaces the other.
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