Day

May 14, 2003
We hope you find this Regulatory Roadmap on HIPAA Privacy and Security useful.
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On February 20, 2003, a final security rule 45 CFR Part 142 was issued. A copy is at this link: HIPAA Final Security Rule 2003-02. Medical Device manufacturers that produce devices that will maintain patient data should be aware of HIPAA privacy and security requirements to assure appropriate features are incorporated in their devices to...
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IEC 62304 and other Emerging Standards Impacting Medical Device Software

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ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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