New CMS Rules Aim To Boost Consumer Access to Lab Data

On Monday, HHS Secretary Kathleen Sebelius announced that CMS has issued proposed rules designed to improve consumer access to laboratory testing results, Modern Healthcare reports (Conn, Modern Healthcare, 9/12).

The announcement took place during HHS' Consumer Health IT Summit in Washington, D.C. (Kennedy, USA Today, 9/12).

The proposed rules are scheduled to be published in the Federal Register on Wednesday.

Details of Proposed Rules

According to federal officials, some states do not allow patients to have direct access to lab testing data.

The proposed rules aim to facilitate such access by modifying patient privacy provisions under the:

  • Clinical Laboratory Improvement Amendments of 1988; and
  • HIPAA privacy rule.

The amendments to CLIA would require labs "to provide direct patient access to (their) completed test reports" at a patient's request.

In addition, the changes to the HIPAA privacy rule would give patients the right to directly access lab results at CLIA and CLIA-exempt labs (Modern Healthcare, 9/12).

PHR Model Privacy Notice

Also on Monday, federal officials announced a voluntary Personal Health Record Model Privacy Notice.

The notice aims to provide a standardized template to help consumers compare and make decisions about PHR products based on their data practices, as well as privacy and security policies (HHS release, 9/12).

PHRs allow patients to input and track their own health data, such as their:

  • Diet;
  • Weight; and
  • Symptoms for chronic conditions (USA Today, 9/12).

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