Patients get direct access to lab results under HHS proposal

Patients across the country would be able to obtain their lab results directly from laboratories under new regulations proposed by the Department of Health and Human Services (HHS). The enhanced access to test results is designed to bypass laws in several states that require patients to get the data from their physicians.

The proposed rules would amend the patient privacy provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Under CLIA, labs may release results to the treating provider, the referring lab, and "authorized persons," as defined by state law. The new amendment explicitly states that the patient is an authorized person under federal law.

"We believe that the advent of certain health reform concepts [for example, individualized medicine and an individual's active involvement in his or her own healthcare] would be best served by revisiting the CLIA limitations on the disclosure of laboratory test results," the notice of proposed rulemaking states.

The HIPAA privacy rule also impedes the ability of individuals to obtain their own test results. To avoid conflict with the CLIA rules, the HIPAA law granted CLIA labs an exception to the right that HIPAA confers on patients to access their own medical records. The new proposal would rescind that exemption.

HHS Secretary Kathleen Sebelius announced the proposed lab regulations Monday as part of a patient "empowerment" package that, according to the Secretary, will lead to better health and healthcare.

"When it comes to healthcare, information is power," Sebelius said. "When patients have their lab results, they are more likely to ask the right questions, make better decisions and receive better care."

Left unanswered was the question of how physicians feel about their patients being able to see lab results before they do. Many doctors prefer to view the results first so they can present important ones to their patients in a meaningful way.

Also unveiled at the HHS press conference was a personal health record privacy notice. This creates "an easy-to-read, standardized template allowing consumers to compare and make informed decisions based on their privacy and security policies and data practices about PHR products," according to an HHS press release.

HHS has made consumer empowerment a cornerstone of its health IT policy. The Office of the National Coordinator for Health IT (ONC), an HHS agency, recently launched a new website that educates consumers about the benefits of health IT and provides health education materials.

To learn more:
- read the Notice of Proposed Rulemaking (.pdf)
- see the HHS press release

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