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Government Examines Safety Issues in Health Information Technology

by Astrid Fiano, DOTmed News Writer | March 01, 2010
Will FDA regulate health IT?
On Thursday, the Office of the National Coordinator for Health Information Technology (ONC)'s HIT Policy Committee (Adoption/Certification Workgroup) held an important meeting discussing patient risk and safety issues in health information technology (HIT). The topics involved identifying possible risk issues and different approaches in mitigating and addressing risks.

On identifying issues, the witnesses included Ross Koppel, Ph.D. of the University of Pennsylvania Sociology Department faculty, and Principal Investigator at the Center for Clinical Epidemiology and Biostatistics. Dr. Koppel said a major problem in HIT risks is poor usability and a primary focus on administrative needs to the detriment of clinical needs. He suggested more transparency, as vendor contracts often do not allow clinicians to discuss errors with other clinicians, and that the industry should "embrace insight on risks," including a demand for independent and meaningful evaluation of systems on-site and encouragement of constant user feedback.

Gilad J. Kuperman, M.D., Ph.D., Associate Professor, Biomedical Informatics, Columbia University, pointed out HIT risks related to reviewing patient data, such as data not easily retrievable in a complete/accurate manner, confusing screen presentations, or overly complex sets of screens. Dr. Kuperman also found risks related to entering orders (due to poor design of the application or ambiguous options), including uncertainty about an order being committed, entering orders on the wrong patient, picking the wrong kind of order, and errors in creating complex orders with multiple parameters. For risk mitigation, Dr. Kuperman suggested more understanding regarding the human cognitive experience in using clinical software systems.

Alan Morris, M.D. of Intermountain Healthcare and the University of Utah, found the most common risks to be failure to use electronic medical record data to drive clinician decision-support protocols, outdated decision-support protocols, and data inaccurately entered in electronic medical records. He also identified several other risks: inaccurate electronic health records (EHRs), confounding different scales of inquiry, underestimating clinician decision limitations, and inadequate testing and validation of decision-support protocols.

Stakeholders also presented testimony on risks and mitigation of HIT. The stakeholders included Justin Starren of the Marshfield Clinic in Marshfield, WI, and Gay Johannes, Vice President and Chief Quality Officer at Cerner Corporation, in Kansas City, MO. They pointed out the benefits of HIT, such as making information available to facilitate clinical decision making, improving patient care and reducing medical errors. Starren then explained that software-based risks occurred when in development and also after production. Starren discussed how Marshfield mitigated the risks by involving clinic users throughout the design and development of software components, and how the company made a point not to rush through development, but to revise and redesign as many times as needed. "Fitting EHR software to a clinical workflow remains an art. In spite of 40 years of experience, we still have to make significant improvement about one third of the time to our systems, after they go into production," he said. Lastly, Starren suggested developing a culture where IT works for the providers and is responsive to their needs.