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 allow healthcare providers to comply with these aspects of HIPAA.

In addition, medical device, pharmaceutical, and biologics manufacturers that collect individual patient information as part of research or clinical trials need to be aware of these rules as they can affect their internal systems and data handling to assure that the healthcare institutions that provide the patient information are compliant with the regulations.

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