Mark Armstrong, a Member of the Firm in the Health Care and Life Sciences practice, in the Houston office, wrote an article titled “New Rules on Direct Patient Access to Laboratory Test Reports.”
Following is an excerpt:
A recent federal rule (the “Rule”) was finalized amending provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to require clinical laboratories covered under CLIA to make available to patients, upon request, completed test reports. The Rule also amends the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to grant individuals the right to access such reports directly from laboratories without the ordering provider’s approval.
Prior to the amendments, a CLIA laboratory could only disclose laboratory test results to three categories of individuals or entities: (1) an ‘‘authorized person,” (2) the person responsible for using the test results in the treatment context, and (3) the laboratory that initially requested the test. In Texas and other states that did not allow individuals to access their own test results, patients were required to receive their test results through their health care providers. The Rule amends the CLIA regulations and gives an individual (or the individual’s personal representative) the right to access, upon request, to the individual’s completed test. HIPAA covered entities have until October 6, 2014 to comply with the Rule.