On August 14, 2002, the HIPAA final privacy rule 45 CFR Parts 160 and 164 were modified to respond to comments and to reduce the administrative burden of the rule. A copy of the new rule can be view here: HIPAA Modified Final Privacy Rule 2002-08.
Medical Device manufacturers that produce devices that will maintain patient data in 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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