A final rule being published Feb. 6 and available now gives patients or their designated representatives the right to receive copies of medical test results from laboratories operating under the Clinical Laboratory Improvement Amendments of 1988.
The final rule, from three units of the Department of Health and Human Services, also amends the HIPAA privacy rule by removing exemptions that labs have had to not directly give results to patients or representatives other than an authorized physician.
These changes to the CLIA regulations and the HIPAA privacy rule provide individuals with a greater ability to access their health information, empowering them to take a more active role in managing their health and health care, according to the rule.
CLIA labs not subject to HIPAA will have discretion to give patients access to their reports, subject to applicable state laws. Whether required or done via discretion, labs in general will have up to 30 days to disclose requested reports.
The compliance date for the rule is 240 days after publication in the Federal Register.
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