Voluntary Collaboration Between Food and Drug Administration and Private Sector Analyzes Medical Device Data to Drive Better Health Care Outcomes

MITRE, the independent trusted third party for the Medical Device Information Analysis and Sharing (MDIAS) Public Private Partnership (PPP), today announced the addition of Atrium Health. The Charlotte-based health system is joining the voluntary MDIAS collaboration between the 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,” said 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.”

“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.”

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.

Learn more about MDIAS at https://mdias.org.

About MDIAS

The Medical Device Information Analysis and Sharing (MDIAS) 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.

About MITRE

MITRE’s mission-driven teams are dedicated to solving problems for a safer world. Through our public-private partnerships and federally funded R&D centers, we work across government and in partnership with industry to tackle challenges to the safety, stability, and well-being of our nation. Learn more about MITRE’s impact.

About Atrium Health

Atrium Health is a nationally recognized leader in shaping health outcomes through innovative research, education and compassionate patient care. Based in Charlotte, North Carolina, Atrium Health is part of Advocate Health, the third-largest nonprofit health system in the United States, which was created from the combination with Advocate Aurora Health. A recognized leader in experiential medical education and groundbreaking research, Wake Forest University School of Medicine is its academic core. Atrium Health is renowned for its top-ranked pediatric, cancer and heart care, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Atrium Health is also a leading-edge innovator in virtual care and mobile medicine, providing care close to home and in the home. Ranked nationally among U.S. News & World Report’s Best Hospitals in eight pediatric specialties and for rehabilitation, Atrium Health has also received the American Hospital Association’s Quest for Quality Prize and its 2021 Carolyn Boone Lewis Equity of Care Award, as well as the 2020 Centers for Medicare & Medicaid Services Health Equity Award for its efforts to reduce racial and ethnic disparities in care. With a commitment to every community it serves, Atrium Health seeks to improve health, elevate hope and advance healing – for all, providing $2.46 billion last year in free and uncompensated care and other community benefits.

About Advocate Health

Advocate Health is the third-largest nonprofit integrated health system in the United States – 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. Headquartered in Charlotte, North Carolina, 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 across 68 hospitals and over 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. Committed to equitable care for all, Advocate Health provides nearly $5 billion in annual community benefits.

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