Overview: As part of an ongoing effort across the Department of Health and Human Services (HHS) to empower patients to be informed partners with their health care providers in making health care decisions, HHS today 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.
Background: The proposed rules address the interplay between the CLIA rules, state laws governing direct disclosure to patients of their laboratory test results, and the Federal Privacy Rule, which currently defers to CLIA’s disclosure provisions and which preempts contrary State laws on privacy and disclosure of personal health information. Under existing CLIA regulations, a laboratory may release patient test results directly to the patient only if (1) the ordering provider expressly authorizes the laboratory to do so at the time the test is ordered, or (2) state law expressly allows for it.
The current Privacy Rule generally requires certain health care providers such as most clinical laboratories to give individuals access to their health information on request. However, the Privacy Rule’s access requirements, deferring to the CLIA rules, include an exception for direct access by patients to their laboratory test result reports. Thus in 26 states without laws authorizing direct disclosure of test results to patients and 13 states that expressly prohibit it, patients do not have access to their complete medical information.
Provisions of the Proposed Rule: The proposed rule would amend the CLIA regulations to allow laboratories to give a patient his/her individual test result reports on request. At the same time, the proposed rule would eliminate the Privacy Rule’s exception for an individual’s access to laboratory test result reports. The amended Privacy Rule would, in turn, preempt contrary state laws governing a patient’s direct access to lab result reports.
The proposed rule can be downloaded from the Federal Register Inspection Desk at www.ofr.gov/inspection.aspx. Comments will be accepted for 60 days, and a final rule, responding to comments will be published later this year.