OCR Delays Revisions to Laboratories’ Notices of Privacy Practices

lab_specimensLate last week the Office for Civil Rights (OCR) of the United States Department of Health & Human Services (HHS) announced a delay in its enforcement of the requirement that certain laboratories revise their notices of privacy practices (NPPs). 

As we have previously posted on the HITECH Law Blog, HHS has in the works revisions to the Clinical Laboratory Improvement Act of 1988 (CLIA) regulations concerning whether a lab must release results directly to patients.   Rather than forcing labs to revise their NPPs by September 23, 2013 (today) and then revise them again when the new CLIA regulations are final, HHS chose to delay enforcement until the new CLIA-specific rule is released.

This delay applies to HIPAA-covered,  CLIA-certified or CLIA-exempt laboratories that are not required to provide an individual with access to his or her laboratory test reports under the HIPAA Privacy Rule because the information is subject to the exceptions to the right of access.  The delay does not apply to laboratories that operate as part of a larger legal entity, such as a hospital, and by virtue of that relationship, do not have their own, laboratory-specific, NPPs.

To read more about the HHS Proposed Rule that will enable direct access to laboratory test results by patients, see our September 14, 2011 blog post.  To read the Proposed Rule, click here.

Proposed Federal Regulation Requires HIPAA-Covered Labs to Release Test Results to Patients

On September 12, 2011, the Office of National Coordinator (ONC) for the United States Department of Health & Human Services (HHS) announced a Proposed Rule that will enable direct access to laboratory test results by patients.  Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), laboratories must hold a CLIA certificate in order to perform one of three levels of complex laboratory tests regulated by CLIA.  Even before the passage of the Health Information Technology for Economic and Clinical Health Act (HITECH Act), concerns have been expressed regarding the lack of clarity under state law, and the literal prohibition in some states, regarding whether a CLIA laboratory that is independent (as opposed to hospital based) may release laboratory test results directly to a patient.   Continue reading