As part of an ongoing effort to empower patients to be informed partners with their healthcare providers, the Department of Health and Human Services (HHS) has taken action to give patients a means of direct access to their completed laboratory test reports. The final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow laboratories to give a patient, or a person designated by the patient as his or her “personal representative,” access to the patient’s completed test reports on the patient’s or personal representative’s request. At the same time, the final rule eliminates the exception under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to an individual’s right to access his or her protected health information when it is held by a CLIA-certified or CLIA-exempt laboratory.
The final rule is issued jointly by three agencies within HHS: the Centers for Medicare & Medicaid Services (CMS), which is generally responsible for laboratory regulation under CLIA; the Centers for Disease Control and Prevention (CDC), which provides scientific and technical advice to CMS related to CLIA; and the Office for Civil Rights (OCR), which is responsible for enforcing the HIPAA Privacy Rule.
Under the HIPAA Privacy Rule, patients, patient’s designees, and patient’s personal representatives can see or be given a copy of the patient’s protected health information, including an electronic copy, with limited exceptions. In doing so, the patient or personal representative may have to put the request in writing and pay for the cost of copying, mailing, or electronic media on which the information is provided, such as a CD or flash drive. In most cases, copies must be given to the patient within 30 days of the request. Read a press release from AACC on this HHS action.
