Commercial health care laboratories are pushing for new regulations that will allow them to exchange data under the same standards as other entities covered under the HIPAA medical privacy and security rules, Modern Healthcare reports.
Advocates spoke about the proposed changes during this week's Health IT Policy Committee hearing.
Current Barriers
The federal Clinical Laboratory Improvement Act currently covers thousands of hospital labs and commercial reference labs. Under CLIA, labs can release data only to:
- A health care provider responsible for the test; or
- An individual authorized under state law to order or receive tests.
Therefore, state medical privacy regulations often govern the release of lab data.
Advocates say different state regulations often prevent labs from sharing bulk test result data with health information networks. They add that the restrictions also are preventing health plans from accessing the data for case management programs, pay-for-performance initiatives or quality improvement projects.
Proposals
Officials say the American Clinical Laboratory Association has developed proposed amendments to the CLIA statute.
The amendments would expand the CLIA regulations to allow labs to send test results to entities and business associates covered under the HIPAA rules.
Advocates say the amendments also would pre-empt state laws that have hindered labs' data-sharing abilities (Conn, Modern Healthcare, 10/26).