This article published with permission from The Burrill Report.
New rules proposed by U.S. Health and Human Services Secretary Kathleen Sebelius would expand patients’ access to data about their own lab tests and make it easier for them to judge how private and secure web-based health records might be.
“When it comes to health care, information is power,” says Sebelius. “When patients have their lab results, they are more likely to ask the right questions, make better decisions and receive better care.”
The proposed changes could play an important part in making it easier for consumers to access and use routine personal medical data in electronic health records, ultimately supporting the government’s goal of digitizing most health records by 2014.
Sebelius wants to see patients gain access to medical test results reports directly from labs by strengthening their rights under the Clinical Laboratory Improvement Amendments of 1988, commonly known as CLIA, and making small changes to privacy provisions in the Health Insurance Portability and Accountability Act.
Stakeholders working with HHS to improve the use and availability of digital health records have told the agency that provisions in CLIA limiting who has access to lab results have become an impediment. The current rules often prevent patients from taking a more active role in their personal health care decisions, say some health care providers, labs, electronic health record system vendors, and health policy experts.
The change proposed by HHS would add language to CLIA specifying that, “upon a patient's request, the laboratory may provide an individual with access to his or her completed test reports.”
Secretary Sebelius also presented a voluntary Personal Health Record Model Privacy Notice, a standardized template intended to help consumers to compare and make informed decisions based on their privacy and security policies and data practices about personal health record products.
“The new template is similar to the Nutrition Facts Labels in that it presents certain complex information in a simple way to improve transparency and consumer understanding about data practices,” the agency says.
The proposals were unveiled at the first-ever HHS Consumer Health IT Summit in Washington, D.C.
“We are at a critical moment in time when we can either choose to innovate, or lag behind in care,” says Farzad Mostashari, national coordinator for health information technology. “A commitment by health care stakeholders to support health IT and provide greater consumer access to their health information is the first step toward a healthier future.”
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