Sharing Clinical Data Electronically: A Critical Challenge for Fixing the Health Care System

THE UNITED STATES IS UNDERTAKING AN AMBITIOUS EFfort to wire the health care system. The goal is to build a nationwide information infrastructure to serve as the foundation for large and sustained improvements in performance. Widespread adoption of health information technology will support new care delivery models, such as patient-centered medical homes, alongside broader initiatives, such as performance reporting and public health surveillance. To enable the health information technology revolution, Congress allocated nearly $30 billion focused on 2 main goals: transitioning physicians and hospitals from paper-based to electronic systems and enabling these systems to interoperate, allowing clinical data to flow between health care organizations. The vision of complete patient information available across care delivery settings is compelling and central to a highfunctioning health care system. However, the vision is deceptively simple: there are enormous challenges to enabling clinical data to flow across organizations. These challenges are substantially greater than those associated with transitioning physicians and hospitals to electronic health records. Health information exchange (HIE) is the act of sharing clinical data among health care practitioners and practice settings (physicians, hospitals, nursing homes, etc) who are not part of the same organizational entity. Although most electronic health records make clinical data sharing within the same organization relatively easy, sharing across organizations is difficult. Before passage of the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act, policy makers primarily focused on regional health information organizations (RHIOs) to promote HIE. RHIOs brought together physicians, hospitals, and other health care stakeholders in the local community to establish core principles for how they could exchange data with each other. Despite substantial funding from state and federal governments, these organizations have made slow progress in enabling broad exchange and finding sustainable business models. Under HITECH, policy makers are pursuing a more flexible multipronged approach to HIE. First, they included the ability to engage in HIE (ie, share clinical data electronically with others) in the criterion for “meaningful use,” the federal standard for incentives to health care practitioners and hospitals for using an electronic health record. In the future, meaningful use will likely require that clinicians actually engage in HIE, not just demonstrate the ability. Part of the motivation for beginning with less stringent requirements is that even for clinicians and health care organizations with an electronic health record, there are few accessible, affordable options for sending and receiving data electronically across organizations. Therefore, a second part of the federal approach is to engage states in creating such options. In 2010, the US Department of Health and Human Services awarded more than $548 million through the State HIE Cooperative Agreement Program. Over the 4-year program period, states are responsible for ensuring adequate infrastructure to allow for sharing clinical data across care settings. States are in the early stages of implementing their plans and are pursuing a variety of strategies. A third facet of the federal approach is to promote the Direct Project, a set of services that rely on the Internet to securely push data from one authorized user to another. The Direct Project essentially operates like an e-mail inbox, with added security and authorization, and is a relatively simple and inexpensive approach to HIE. The long-term plan is to evolve from clinicians pushing data (ie, sending an e-mail) to searching for individual patients and retrieving their data, with the hope that HIE will be seamless and will require little work by the clinician to search for information outside of the electronic health record. Whether these efforts will successfully result in broadbased HIE is unclear. According to Blumenthal, the Obama Administration’s former point person on health information technology, HIE is one of the “major challenges in delivering on the ambitious agenda of the HITECH Act.” There are at least 5 major barriers, 3 of which seem under federal policy makers’ control. The first is data privacy and security. There remains uncertainty among clinicians about the legal ramifications of a data breach or unauthorized access through HIE. Second, the Direct Project promotes point-