On February 6, 2014, the Department of Health and Human Services (HHS) published a Final Rule amending regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The Final Rule takes effect on April 7, 2014. HIPAA covered entities must comply by October 6, 2014.
The Final Rule was jointly issued by the Office for Civil Rights (OCR), the Centers for Medicare and Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC), and extends to laboratories a patient's right to access records. The Final Rule removes the HIPAA access exception for CLIA or CLIA-exempt laboratories and requires laboratories that meet the definition of a HIPAA covered entity to provide a patient with direct access to test results.
HHS indicates that the policy behind the extended patient right of access is "part of an ongoing effort to empower patients to be informed partners with their health care providers." The Final Rule does not require laboratories to review test results with patients, but HHS encourages laboratories to refer patients to their health care providers to discuss those results.
Key action items for HIPAA-covered laboratories include:
Update the entity's Notice of Privacy Practices to include the new right of access.
Modify policies and procedures to ensure an authentication process is in place for verifying the identity of the individual requesting PHI directly from the lab.
Ensure that access policies address an individual's right to obtain access and to designate access to a third party, and the obligation to provide the individual (or individual's designee) the PHI in the form requested (including in electronic format if it is readily producible).
Train workforce members on the new access rights and the new policies and procedures for providing an individual access and verifying identity.
Review applicable state law to determine whether there are conflicts with HIPAA (and if so, determine whether HIPAA preempts that state law).
For More Information
The Final Rule is available in its entirety here.