HHS Grants Patients’ Access to Test Reports from Labs
- By BSTQ Staff
As part of an ongoing effort to empower patients to be informed partners with their healthcare providers, the U.S. Department of Health and Human Services (HHS) ruled in February that laboratories are allowed to give patients or their designated representative a means of direct access to the patients’ completed test reports upon their request. This ruling amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The new ruling also eliminates the exception under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to the right of individuals to access their protected health information when it is held by a CLIA-certified or CLIA-exempt laboratory. Under the HIPAA Privacy Rule, patients and their personal representatives can view or be given a copy of the patients’ personal health information, including an electronic copy, with limited exceptions, from the patient’s physician. The new ruling from HHS now gives patients and their designated representatives the option to obtain their reports directly from the laboratory.
The final rule was issued by three agencies within HHS: the Centers for Medicare & Medicaid Services (CMS), which is responsible for laboratory regulation under CLIA; the Centers for Disease Control and Prevention, which provides scientific and technical advice to the CMS related to CLIA; and the Office for Civil Rights, which is responsible for enforcing the HIPAA Privacy Rule.
