October 15, 2019

October 15, 2019

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October 14, 2019

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The FDA Looks Inward as It Tackles Interoperability

Interoperability and patient access to data has been pushed to the forefront as a primary concern for the health industry. This is largely due to proposed rules published this spring by the Office of the National Coordinator for Health Information Technology (ONC) and the Center for Medicare and Medicaid Services (CMS) that seek to advance interoperability and support the access, exchange, and use of electronic health information. In August 2019, the ONC held its third annual National Coordinator for Health IT Interoperability Forum in Washington DC. The event brings together the Health IT technology community, developers, policymakers, and staff to promote the goal of interoperability. One of this year’s keynote speakers was the Food and Drug Administration (FDA)’s Principal Deputy Commissioner, Amy Abernethy, M.D. Ph.D.

Dr. Abernethy’s speech focused on improving the FDA’s competence as it steps into a more substantive role in promoting interoperability in health care. First, Dr. Abernethy highlighted the FDA’s need to improve its overall technical expertise in order to adequately engage with the industry and exchange data among the agency’s Centers. Furthermore, Dr. Abernethy emphasized the need for FDA to change the way it interacts with the technology community at large. Dr. Abernethy explained that, over the years, FDA has learned to work with drug and device industries, patient groups, and trade organizations, but lacks a similar effective line of communication with tech companies.  Dr. Abernethy suggested that this may be due to the historical perception of tech firms as “vendors being told what to do rather than creating solutions with collaboration and guidance.” These efforts by FDA to enhance its capabilities to address increasingly prevalent interoperability concerns is a positive step for the agency, as technology is rapidly advancing and infiltrating the health care space. Such actions are in addition to FDA’s PrecisionFDA movement and the agency’s embrace of artificial intelligence in recent years. In her speech, Dr. Abernethy underscored that the FDA intends to learn from these initiatives in order to improve its capabilities in the future.

Dr. Abernethy ended her keynote by revealing FDA’s upcoming publication of an action plan to modernize the agency’s “approach to the use of technology for its regulatory mission, including the review of medical product applications.” The action plan is also rumored to include information on “uses of artificial intelligence, blockchain, and other technologies,” and promises stakeholder engagement. The action plan is scheduled to be released in the coming months. Stakeholders should monitor developments and evaluate how this update will change its engagement with the FDA. EBG will continue to monitor the progress of the FDA’s interoperability and modernization efforts.

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About this Author

Ebunola Aniyikaiye, Epstein Becker Law Firm, Washington DC, Health Care Law Attorney
Associate

Ebunola Aniyikaiye is an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office of Epstein Becker Green. She will be focusing her practice on such areas as fraud and abuse, health care legislation and policy developments, value-based purchasing and accountable care, and government investigations. 

Ms. Aniyikaiye received her J.D., with a concentration in Health Law, from American University Washington College of Law (AUWCL), where she was an Articles Editor of the...

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