The proposed rule , drafted jointly by CMS, the office of Civil Rights (OCR) and the Centers for Disease Control and Prevention (CDC), would amend a patient privacy provision of two federal laws to grant patients access to test results directly from laboratories through the use of health information technology (health IT). The purposed rule, posted on Sept 14 on the Office of the Federal Register's (OFR) website (www.gpo.gov/fdsys/search/getfrtoc.action), would amend the Clinical Laboratory Improvment Amendments of 1988 (CLIA) so that, at a patient's request, laboratories would be allowed to provide an individual with access to his or her complete test reports using the lab's authentication process to ensure privacy.
The proposed rule would also amend the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, HIPAA generally requires covered entities to give patients access to their records, but one exception to this general mandated is a provision that exempts entities subject to CLIA where a law bars disclosure. If finalized, the proposed HIPAA amendments will remove this exception and CLIA- certified labs and CLIA - exempt labs will be required to provide patients with access test reports.
For details please see the proposed rule (www.gpo.gov/fdsys/pkg/FR-2011-09-14/pdf/2011-23525.pdf).
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