Yesterday the HHS 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 ‑ the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC), which are responsible for laboratory regulation under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and the Office for Civil Rights (OCR), which 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.
You can see the proposed rule, “CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports,” here.
You can see the HHS fact sheet on this proposed rule here.