The Department of Health and Human Services (HHS) amended the Clinical Laboratory Improvement Amendments of 1988 (CLIA) this week, giving patients or their “personal representative," access to the patient’s completed test reports on the patient’s or patient’s personal representative’s request.
The amendment changes an 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. HHS says this gives patients a new option to obtain their test reports directly from the laboratory, while maintaining the patients’ privacy. The rule requires that the laboratory must give the patient the lab within 30 days of their request.
“Information like lab results can empower patients to track their health progress, make decisions with their health care professionals, and adhere to important treatment plans," Secretary Kathleen Sebelius said in a statement.
The final rule, which was issued by the Centers for Medicare & Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the Office for Civil Rights (OCR), which is responsible for enforcing the HIPAA Privacy Rule, came after more than two years it was initially proposed in 2011. Seven states already require labs to hand over the results to patients, but 13 states actually prohibited it.