Debating the Proposed CLIA Rule

As part of a large-scale government and industry effort get patients more engaged in their care and to ensure they have better access to their own health data, the government wants to allow labs to release test results directly to patients.

The proposed rule, sponsored by The Centers for Medicare & Medicaid Service and two other federal agencies, would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and require labs to release results directly to patients or their designated representatives upon request.

"What we're hoping this regulation will help achieve is for the healthcare system to become more responsive to patients in general, but at the same time give patients direct access to their information when they want it, Alice Leiter, director of health IT policy at the National Partnership for Women & Families, said in an interview.

"This direct access should strengthen the partnership between patients and clinicians, rather than leaving patients in the dark with respect to their own health information."

The move "empowers patients to become true partners in their healthcare decisions, promotes the transparency our system needs, and ultimately helps us use our healthcare dollars more wisely," Christine Bechtel, vice president of the non-profit women and families partnership and a member of the federal Health IT Policy Committee said in a statement.