In Depth A doctor consults a patient's electronic health record on a tablet device.

Published on September 3rd, 2014 | by Travis Korte

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Congress Introduces Bill to Improve Clinical Data Registries

Clinical data registries are systems that store and provide access to clinical data, typically from numerous different sources, such as hospitals or individual clinicians. Many different kinds of health care organizations use clinical data registries to bring together clinical information from these diverse sources that they can then analyze for various purposes. Specialized medical societies, such as the American Society of Anesthesiologists , and condition-specific patient groups, such the Lung Cancer Foundation, use these registries to aggregate and study information about their areas of interest, providers use registries to track information on quality and outcomes to inform clinical practice recommendations, and regulators use registries to track adverse events related to specific drugs and devices. For example, the Society of Thoracic Surgeons maintains a registry of quality and patient safety information from a network of surgeons that it uses to evaluate performance and drive clinical research in the field. Although existing registries have demonstrated positive impacts, they are still underused, in part because clinicians find it technically difficult to share data with registries and registries have in some cases failed to make their value clear to clinicians. To address these issues, Congressman Pete Olson (R-TX) introduced H.R. 5214, a bill which would require the Department of Health and Human Services (HHS) to issue recommendations to promote the use of clinical data registries. However, some of the bill’s provisions duplicate existing clinical data registry guidance provided by HHS and are unnecessary.

The bill requires HHS to develop recommendations for clinical registries to achieve five goals: exchange information with electronic health record systems; use registry data to evaluate clinical care; conduct post-market drug and device surveillance; help disseminate best practices for preventing diseases; and help promote preventative screening for certain conditions.

First, the recommendations would include a set of standards to ensure that the registries and electronic health record systems used by clinicians could conduct bidirectional, interoperable exchange of information. Ensuring interoperability would help encourage clinicians to use insights from the registries in their practice and make it easy to submit new data to the registry on a continuous basis.

Second, HHS would be required to investigate how clinical data registries could be used to bolster care evaluation. Such registries could be used to assess the impact of new treatment methods and advances in care coordination by measuring changes in patient health indicators.

Third, HHS would be tasked with considering how the registries could best be designed to allow the Food and Drug Administration to use them for drug and device surveillance purposes. The FDA draws from a range of data sources to inform its post-market surveillance operations, and could use information from regularly updated clinical data registries to rapidly detect problems with approved drugs.

Fourth, the bill directs HHS to recommend ways to use data from clinical registries to help educate health care professionals on the latest clinical practices and tools. Up-to-date data can be an important resource for developing and disseminating new best practices around preventative care.

Finally, the bill would seek recommendations for how health care providers can use registries to promote preventive screenings such as the Medicare annual wellness visits. These sorts of screenings can reduce the risk of chronic diseases, such as heart disease and diabetes.

In a statement to the Center for Data Innovation, Rep. Olson said “H.R. 5214 is a good bill for patient care that requires transparency from the Secretary of Health and Human Services to publish specific ideas for clinical data registries.” He added, “the data collected by these registries helps doctors and hospitals improve their performances which is a win for the patients because it means better care.” However, the bill appears to duplicate some existing efforts, including clinical data registry guidance initiatives at the Agency for Health Research and Quality (AHRQ) and the American Medical Association. For example, the bill’s call for guidance on using clinical data registries to better coordinate care is directly addressed in the AHRQ’s 2010 report “Registries for Evaluating Patient Outcomes: A User’s Guide” (See Chapter 10: “Data Collection and Quality Assurance”). Rep. Henry Waxman (D-CA), the ranking member of the of the House Committee on Energy & Commerce, submitted a memorandum to the committee’s Democratic members echoing this sentiment and arguing that the legislation’s specific instructions could limit registries’ flexibility. Rep. Olson has not yet replied to Rep. Waxman’s concerns. The bill advanced through committee on a 25 – 18 vote on July 30 and awaits full House consideration.

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About the Author

Travis Korte is a research analyst at the Center for Data Innovation specializing in data science applications and open data. He has a background in journalism, computer science and statistics. Prior to joining the Center for Data Innovation, he launched the Science vertical of The Huffington Post and served as its Associate Editor, covering a wide range of science and technology topics. He has worked on data science projects with HuffPost and other organizations. Before this, he graduated with highest honors from the University of California, Berkeley, having studied critical theory and completed coursework in computer science and economics. His research interests are in computational social science and using data to engage with complex social systems. You can follow him on Twitter @traviskorte.



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