Rule for Patient Access to Lab Test Results Released
A “final” rule that gives patients (or their representatives) direct access to the patient’s laboratory test reports was published in the Federal Register on February 6, 2014.
The new regulation amends BOTH the CLIA and HIPAA (Health Insurance Portability and Accountability Act of 1996) privacy rules.
The amended CLIA rules now require that patients be given access to laboratory test reports for CLIA-covered services.
In addition, the HIPAA privacy rules will no longer contain a “CLIA exception.” Therefore, ALL laboratories (CLIA and non CLIA) that are covered entities under HIPAA must provide patient access to all of his/her protected health information maintained in the patient’s record, including laboratory test reports, test orders, ordering provider information, billing information, and insurance information.
The access does not have to be provided automatically. Rather, the patient (or his/her representative) must request access to the records. Of course, if a laboratory wishes, it can provide access automatically, such as through an electronic patient “portal.
The new rules also pre-empt state laws that limit an individual’s access to laboratory test reports.
Under HIPAA’s privacy rules, laboratories will be required to provide patients with their completed test reports within 30 days of a request, but laboratories will not be required to explain the results to patients.
The new rule is effective on April 7, 2014. Laboratories must comply with the HIPAA privacy requirements by October 6, 2014.
CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports,
Final Rule, Federal Register, February 6, 2014
Fact Sheet - HHS Finalizes Patients' Right to Access Report of Clinical Laboratory Test Results, February 3, 2014
News Release - HHS Strengthens Patients' Right to Access Lab Test Reports, February 3, 2014
