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D.C. Report: Federal Health IT Strategic Plan, Proposed Changes to Clinical Lab Improvement Amendments

September 19, 2011
by Sharon Canner, Sr. Director of Advocacy Programs, CHIME
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ONC Issues Final Draft of Federal Health IT Strategic Plan The Office of the National Coordinator released a final version of its 2011-2015 Federal Health IT Strategic Plan this week following a comment period that yielded over 240 public reactions. Most of the public comments focused on ways to provide more health IT education and outreach; privacy implications for health information exchange; timing of Stage 2 and usability issues related to electronic health records. Responding to some of these comments, ONC says that it will plan to establish an HHS Inter-Division Task Force to develop an updated approach to certain health IT privacy and security issues. Specifically, the plan says, One of the major areas being addressed through this process is pursing policy changes that would afford individuals more meaningful choice as to whether their information may be exchanged electronically. ONC is also assessing technical solutions that could support more granular patient choice and data segmentation that could support a patient's choice to share only certain parts of their record during information exchange." Other initiatives will support EHR usability testing and use protocols; improve data portability through EHRs; and conduct consumer outreach and education campaigns to raise awareness of health IT issues.

Proposed Rule Would Allow Patients to Receive Lab Test Results Directly A new notice of proposed rulemaking (NPRM) was issued this week by HHS, suggesting change be made to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and the HIPAA privacy rule. Under the changes, labs would be required "to provide direct patient access to (their) completed test reports" at a patient's request. And the proposed change to the HIPAA Privacy Rule would remove the existing exception to an individual’s right of access to his or her test reports. The NPRM acknowledged that state laws vary in regard to lab test results: some states do not allow patients a right to see their test results; others allow patients to see results only with provider approval and still others have no laws on the subject at all. The NPRM said that the federal regulation would preempt the state laws by providing a universal right to receive direct lab results.

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