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The inability of the nation's fragmented health IT systems to communicate with one another has made the task of leveraging data extremely difficult, as have concerns about patient privacy and protecting personal health information.
The Health IT (HITECH) portion of the 2009 American Recovery and Reinvestment Act (ARRA) authorized $20 billion to promote EHR adoption, as well as regional interconnectivity and expand the Office of the National Coordinator for Health Information Technology (ONC), headed now by David Blumenthal of Harvard Medical School.
HITECH strengthens privacy and disclosure requirements for e-health systems as a way to bolster public trust in EHR programs, while provisions expect doctors and hospitals to demonstrate that they are making "meaningful use" of certified EHR systems in order to qualify for Medicare bonus payments. That means providing patients access to their health records, implementing computerized order systems, and using IT to submit insurance claims and track patients' medications and lab results.
HITECH supports these efforts by providing $2 billion to help providers adopt qualifying technology; by assisting states and communities in establishing health information exchanges; by developing interoperability standards; and by examining a range of technical and policy issues that impede HIT implementation.
All these efforts support a National Health Information Network that ideally will provide more data on healthcare costs, quality and outcomes. EHRs will accomplish little, says Blumenthal, unless health data "can flow freely, privately and securely to the places where they are needed."
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Increased connectivity among healthcare entities also promises to support more timely monitoring and oversight of medical products by FDA. Congress has instructed FDA to establish a Sentinel System able to detect signals of adverse events for medical products by accessing health records on 100 million people by July 2012.
To meet this goal, FDA is starting with a "mini" Sentinel system that utilizes a distributed data model to tap into medical records held by large health plans and insurers, including CIGNA, Kaiser Permanente and the HMO Research Network. A second phase next year will access additional data from Medicare and other government health programs.
The Harvard Pilgrim Health Care system recently signed a $72 million contract with FDA to coordinate operations for Sentinel and ensure data quality. The distributed data model has the health system data source evaluate its information and transmit summaries to Sentinel, making it unnecessary for FDA to build its own large database, which would raise privacy issues.
While Sentinel's purpose is to serve FDA's regulatory mission, the long-term vision is that it will be part of a larger IT system that also provides data for outcomes studies, comparative effectiveness research and health system quality reporting. And this, in turn, provides additional incentives for providers to participate in e-health activities.
Jill Wechsler, a veteran reporter, has been covering Capitol Hill since 1994.