Informatics to play prominent role in next-generation medical devices and pharmaceuticals
(CHICAGO, IL) – The Food & Drug Administration (FDA) has tapped the American Medical Informatics Association (AMIA) to be part of a select group of technical advisors, officials announced at the AMIA 2016 Annual Symposium. Known as the Network of Experts, AMIA will provide rapid access to informatics expertise when needed by FDA officials within the Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER).
“This further validates AMIA as a trusted source of evidence-based informatics expertise,” said AMIA Board Chair and Medical Director of IT Services at the University of Washington’s UW Medicine, Thomas H. Payne, MD, FACP, FACMI. “We are proud to be part of FDA’s Network of Experts, and look forward to helping the FDA understand how informatics can be leveraged to address emerging medical devices and novel pharmaceuticals.”
The Network of Experts is a vetted network of partner organizations and their member scientists, clinicians and engineers who can provide CDRH and CDER staff with access to expertise to supplement existing knowledge within the Centers. In a description of the Network, FDA notes that despite the tremendous internal cadre of scientific expertise within CDRH and CDER, it is unrealistic to expect staff to encompass all of the applicable expertise and experience necessary to fulfill its mission, given the rapidly growing variety and complexity of medical devices and pharmaceuticals. This is particularly true when it comes to new and emerging fields of science and pioneering technologies. In these areas, it is often necessary for staff to gain further scientific understanding from sources outside of the federal government. The Network of Experts facilitates this exchange.
“AMIA stands alone in this distinction among peer associations,” said AMIA President and CEO Douglas B. Fridsma, MD, PhD, FACP, FACMI. “The Network of Experts provides AMIA members a unique opportunity to improve health and healthcare on a national scale.”
2017 will be an important year for the FDA as medical device and prescription drug user fee agreements are debated and authorized by Congress. These agreements outline how FDA will spend billions of dollars in user fees collected from medical device and pharmaceutical companies to review products and drugs. Among the commitments made by FDA to industry are plans to use “real-world evidence,” or RWE, to evaluate the safety and effectiveness of devices and drugs; the use of advanced simulations for clinical trials and “model-informed drug development,” or MIDD; and creation of a Digital Health unit inside CDRH to review Software-as-a-Medical Device and Software-inside-a-Medical Device, known as SaMD and SiMD, respectively.
FDA officials have also discussed their vision for a National Evaluation System for health Technology, or NEST, which will include functional links across a range of systems and federal agencies, developed to capitalize on existing digital information collected in the course of health care delivery, such as electronic health records, insurance claims, and data housed in clinical registries.
“As we look to the horizon, the impact that informatics can have in helping FDA balance the need to facilitate innovation while protecting public health and safety is enormous,” said AMIA Vice President for Public Policy Jeffery Smith, MPP. “During our 2016 AMIA Policy Invitational, FDA Commissioner Califf called informatics ‘a gateway to bring the two together, to facilitate innovation and regulation at the same time.’ We agree, and our members stand ready to assist FDA in this mission.”
AMIA’s Annual Symposium is the premier educational event in the field. The symposium presents leading-edge scientific research on biomedical and health informatics and over 100 scientific sessions. The Symposium presents work from across the spectrum of the informatics field -- translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics and public health informatics.
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AMIA, the leading professional association for informatics professionals, is the center of action for 5,200 informatics professionals from more than 65 countries. As the voice of the nation’s top biomedical and health informatics professionals, AMIA and its members play a leading role in assessing the effect of health innovations on health policy, and advancing the field of informatics. AMIA actively supports five domains in informatics: translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics, and public health.