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Collaboration between FDA and private sector analyzes medical device data to drive better healthcare outcomes.
March 4, 2024
By: Michael Barbella
Managing Editor
MITRE, the independent trusted third party for the Medical Device Information Analysis and Sharing (MDIAS) Public Private Partnership (PPP), has announced the addition of Atrium Health. The health system is joining the voluntary MDIAS collaboration between the U.S. Food and Drug Administration (FDA) and stakeholders across the private sector—including patients, hospital providers, and medical device manufacturers—to proactively analyze medical device-related data to improve health care outcomes for consumers. “It’s a pleasure to welcome Atrium Health to MDIAS,” stated Kim Warren, vice president of MITRE’s Center for Transforming Health, operator of the CMS Alliance to Modernize Healthcare, a federally funded research and development center, more commonly known as the Health FFRDC. “As an early adopter—and the very first health system to join MDIAS—Atrium Health’s active participation will benefit patients, regulators, and the medical device ecosystem.” MDIAS convenes multiple stakeholders to discuss medical device quality and safety issues and solve those challenges collaboratively. Recognizing that data from a wide variety of sources can provide greater insights than data from a single source alone, participants agree to share appropriate data with MITRE for analysis and development of recommendations for organizational and industry-wide performance improvement. “Safety is at the heart of our organization,” said Dr. Rasu Shrestha, executive vice president and chief innovation and commercialization officer for Advocate Health, of which Atrium Health is a part. “Delivering the safest care and highest-quality outcomes ensures we’re the most trusted choice for care. We’re also driven to advance the science of medicine in the most innovative ways possible. To that end, our team is dedicated to developing the most comprehensive provider-based research data set in the country. Our organization is excited for this opportunity to join MDIAS to help improve patient safety across the entire health care industry.” The Medical Device Information Analysis and Sharing PPP is a voluntary partnership between the FDA and stakeholders across the private sector—including patients, hospital providers, and medical device manufacturers. It was formed to proactively analyze broad and extensive medical device-related data to improve health care outcomes for patients. The concept stems from the recognition that data from a wide variety of sources can provide greater insights than data from a single source alone. MDIAS enables the medical device community to acquire, integrate, and analyze multiple data sources in a way that provides new insights into systemic quality issues. MITRE’s mission-driven teams are dedicated to solving problems for a safer world. Through public-private partnerships and federally funded R&D centers, MITRE works across government and in partnership with industry to tackle challenges to the nation’s safety, stability, and well-being. Atrium Health is a nationally recognized leader in shaping health outcomes through research, education, and patient care. Based in Charlotte, N.C., Atrium Health is part of Advocate Health. A developer of experiential medical education and groundbreaking research, Wake Forest University School of Medicine is its academic core. Atrium Health is also an innovator in virtual care and mobile medicine, providing care close to home and in the home. Advocate Health is the third-largest U.S. nonprofit integrated health system, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois, Atrium Health in the Carolinas, Georgia and Alabama, and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care, with Wake Forest University School of Medicine serving as the academic core of the enterprise. Advocate Health serves nearly 6 million patients and is engaged in hundreds of clinical trials and research studies. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs nearly 150,000 team members in 68 hospitals and more than 1,000 care locations and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Advocate Health provides nearly $5 billion in annual community benefits.
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