U.S. patients may soon get direct access to medical test results. The U.S. Department of Health and Human Services (HHS) wants to make sure patients have direct access to the results of their medical laboratory tests.

HHS has proposed regulations that would state that, upon a patient’s request, medical laboratories covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) can give lab results directly to patients or their personal representatives, not just to the patients’ doctors.

The proposed regulations are set to appear in the Federal Register Wednesday.

Three arms of HHS – the Centers for Medicare & Medicaid Services (CMS), the HHS Office for Civil Rights and the Centers for Disease Control and Prevention – worked together to develop the regultions, which would affect some of the regulations that implement the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as well as HIPAA privacy regulations, HHS officials say.

Previously, a CLIA regulations exception let CLIA-certified and CLIA-exempt laboratories get out of complying with a provision that required other labs to give individuals access to protected health information, officials say.

Comments on the proposed regulations will be due 60 days after the official Federal Register publication date.

- Allison Bell

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