HHS PROPOSES BROAD PATIENT RIGHTS TO ACCESS CLINICAL LABORATORY TEST RESULT REPORTS

As part of the Department of Health and Human Services’ (HHS) ongoing efforts to empower patients to be informed partners with their health care providers in making health care decisions, HHS has proposed rules that would give patients (and their authorized representatives) direct access to their own laboratory test result reports. The proposed rule is being jointly issued by three agencies within HHS: CMS, the CDC, and the Office for Civil Rights (OCR). CMS and the CDC are responsible for laboratory regulation under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and the OCR is responsible for administering the Privacy Rule that was issued under the Health Insurance Portability and Accountability Act of 1986 (HIPAA). The proposed rules are also consistent with a proposed regulation under the HITECH Act that would bolster patients’ rights to access their information stored in electronic health records and that would help ease the transition to nationwide adoption of electronic health records.