Hyattsville, MD -Researchers from MedStar Health are partnering with IBM (Global Business Services and Watson Health) to develop a program for post-market safety and effectiveness surveillance for biologic adverse events. At MedStar Health, the work will be led by Aaron (Zach) Hettinger, MD, MS, and Kristen E. Miller, DrPH, CPPS, and will leverage the informatics capabilities of the MedStar Health National Center for Human Factors in Healthcare to support patient outcomes through safety surveillance for the Food and Drug Administration (FDA). The Biologics Effectiveness and Safety initiative is led by the Center for Biologics Evaluation and Research (CBER) as part of the overarching Sentinel initiative across the US FDA.
Leveraging machine learning, artificial intelligence and natural language processing, among other methods, the team will work on developing and automating post-market safety reports for CBER-regulated products which include blood transfusion products and vaccines. The work will integrate an expanding pool of data sources, including 10 million or more electronic health records, in order to define adverse events. The work will also include development to provide a tool for semi-automated patient chart review to conduct validation studies for product safety and effectiveness. The long-term vision of the project is to produce a system capable of robust automated reporting that can scale across provider networks and biologic product areas. MedStar Health’s research efforts leverage real-world prototyping to efficiently identify and assess the challenges and feasibility of constructing such a complex system.
“This collaboration highlights both the feasibility and challenges involved in automating the reporting of biologic adverse events. Our goal is to produce health information technology tools to reduce the reporting burden on healthcare providers and make it more likely that the FDA will receive accurate and timely adverse event reports,” said Dr. Miller “The information collected in this process will support improved analytics and research and help the FDA to protect biologic product safety and improve patient outcomes.”
Aaron (Zach) Hettinger, MD MS, is the medical director and director of cognitive informatics at the MedStar Health National Center for Human Factors in Healthcare. Kristen E. Miller, DrPH, CPPS, is the scientific director of the center, which is the largest human factors engineering program embedded within a healthcare system in the United States.
About the MedStar Health National Center for Human Factors in Healthcare
The MedStar Health National Center for Human Factors in Healthcare occupies a unique position in the United States as the largest human factors program embedded within a healthcare system. It brings together human factors scientists, systems safety engineers, health services researchers, clinicians, and other experts to create a safer and more efficient healthcare environment through four core services in research, usability, safety advisement, and education. The center is part of the MedStar Institute for Innovation and is also affiliated with the MedStar Health Research Institute and MedStar Institute for Quality and Safety. MedStar Health, the parent organization, is the largest not-for-profit healthcare provider in the Maryland and Washington, D.C., region, with 10 hospitals and an extensive ambulatory services network, and is the medical education and clinical partner of Georgetown University.
About MedStar Health Research Institute
The MedStar Health Research Institute is the research arm of MedStar Health, the largest healthcare provider in Maryland and the Washington, D.C., region. MHRI provides scientific, administrative and regulatory support for research programs throughout the MedStar Health system. MHRI’s expertise includes translational research into disease prevention, diagnosis and treatment. These programs complement the key clinical services and teaching programs in the 10 MedStar hospitals and other MedStar entities. For more information, visit www.MedStarResearch.org.
About MedStar Health
At MedStar Health, we use the best of our minds and the best of our hearts to serve our patients, those who care for them, and our communities. Our 30,000 associates and 4,700 affiliated physicians are committed to living this promise through our core SPIRIT values—Service, Patient first, Integrity, Respect, Innovation, and Teamwork—across our more than 300 locations including 10 hospitals, ambulatory, and urgent care centers. As the medical education and clinical partner of Georgetown University, MedStar Health is training future physician leaders to care for the whole person and is advancing care through the MedStar Health Research Institute. From our telemedicine and urgent care services to the region’s largest home health agency, we’re committed to providing high-quality health care that’s also easy and convenient for our patients. At MedStar Health—It’s how we treat people. Learn more at MedStarHealth.org.
Communications & Planning Manager, MHRI