Luján, Van Hollen, Beyer, Schrier, Van Drew Introduce Bipartisan, Bicameral Legislation to Reduce Medical Diagnostic Errors

Nearly 800,000 Americans suffer serious harm or death annually due to diagnostic error

Washington, D.C. - Today, U.S. Senators Ben Ray Luján (D-N.M.) and Chris Van Hollen (D-Md.) and U.S. Representatives Don Beyer (D-Va.), Kim Schrier (D-Wash.), and Jeff Van Drew (R-N.J.) announced their reintroduction of the Improving Diagnosis in Medicine Act. This bipartisan, bicameral legislation aims to address the alarming rate of medical diagnostic error in our country to prevent and mitigate the devastating impacts these errors can have, including misdiagnosis, permanent disability, and death. New research published in January 2024 estimates that across health care settings, nearly 800,000 Americans suffer permanent disability or death annually because of diagnostic error. The findings also suggest that diagnostic error is likely the single largest source of deaths across care settings linked to medical error. This research builds on a 2015 report from the National Academies of Sciences, Engineering, and Medicine that concluded most people will experience at least one diagnostic error in their lifetime.

The Improving Diagnosis in Medicine Act would create a new Interagency Council on Improving Diagnosis in Health Care, as well as a new grant program for the establishment and maintenance of Research Centers of Diagnostic Excellence - such as the Armstrong Institute Center for Diagnostic Excellence at Johns Hopkins - that advance research and progress in diagnostic quality, safety, and health care value.

"Diagnostic errors affect millions of Americans and contribute to thousands of patient deaths each year," said Senator Luján. "Improving diagnostic safety and quality in health care is a top priority, and that's why I'm proud to have led the Improving Diagnosis in Medicine Act during my time in the House and to co-lead alongside Senator Van Hollen in the Senate. This bill will advance research and progress in diagnostic quality and safety and I look forward to working with my colleagues to get it passed into law."

"When a patient is ill, a timely and accurate diagnosis can mean the difference between life and death. But far too many Americans face misdiagnoses - ending in tragic consequences. Not only do these errors cost lives - they also cost our healthcare system and patients billions of dollars each year. Getting the diagnosis right the first time is crucial to improving results for patients and saving lives. This legislation tackles that challenge by investing in efforts to prevent and reduce diagnostic error," said Senator Van Hollen.

"Diagnostic delays affect millions of Americans, exacerbate unnecessary costs in our health care system, and result in thousands of preventable deaths each year - but it doesn't have to be this way. By funding better data collection and research sharing, which are two of the major objectives of our bill, we can better increase diagnostic accuracy, improve outcomes for patients, and help close gaps in healthcare equity," said Congressman Beyer. "Our bill would also establish the Research Centers of Diagnostic Excellence to advance research and facilitate better sharing of research on proven methodologies to prevent misdiagnosis. I thank Senators Van Hollen and Luján and Representatives Schrier and Van Drew for their leadership on this legislation, and will continue to work with colleagues to build support for it in the House."

"As a doctor, I know firsthand the importance of accurate, timely diagnosis," said Congresswoman Schrier. "Incorrect or delayed diagnoses, which can happen for a number of reasons, endanger patients and can be costly to our health care system. That's why I'm proud to support this legislation, which puts the proper resources into improving diagnostic accuracy across the medical field and will improve patient care."

"The unfortunate reality is that each year, millions of Americans suffer the consequences of diagnostic errors in healthcare, which are responsible for approximately 10% of patient deaths," said Congressman Van Drew. "This bill would tackle the root causes of these preventable tragedies by prioritizing research and development to enhance diagnostic accuracy and patient safety. By investing in solutions to this critical healthcare challenge, we are investing in a future where patients receive the timely, accurate diagnoses they deserve."

Diagnostic errors stem from a wide variety of causes, including inadequate communication between providers, patients, and their families; the absence of metrics to gauge performance limited feedback to clinicians about diagnostic performance; a lack of information for patients on navigating the diagnostic process; and a culture that discourages transparency and disclosure of diagnostic errors, which impedes attempts to learn from these events and improve diagnosis. The National Academies study concluded that: "Despite the pervasiveness of diagnostic errors and the risk for serious patient harm, diagnostic errors have been largely unappreciated within the quality and patient safety movements in health care."

The Improving Diagnosis in Medicine Act would:

• Authorize a federal grant program for the establishment and maintenance of Research Centers of Diagnostic Excellence that advance research and progress in diagnostic quality, safety, and value in health care.
• Establish an Interagency Council on Improving Diagnosis in Health Care to:
  • Enhance the quality, appropriateness, and effectiveness of diagnosis in health care;
  • Identify and eliminate systemic barriers to supporting research in improving diagnosis in health care;
  • Identify knowledge gaps, research needs, and policy and program deficiencies associated with the diagnostic process and in clinical and health system delivery;
  • Create core diagnostic research services and interdisciplinary teams to facilitate diagnostic research;
  • Build capacity by training and developing a highly-qualified diagnostic research workforce; and
  • Establish valid operational measures of diagnostic error.

The text of the bill is available here.

This legislation is endorsed by Patients for Patient Safety, the Society to Improve Diagnosis in Medicine, Physician-Parent Caregivers, and the Armstrong Institute Center for Diagnostic Excellence.

"As the U.S. branch of the World Health Organization's Patients for Patient Safety network, Patients for Patient Safety US (PFPS US) is very happy to see the Improving Diagnosis in Medicine Act move forward," said Sue Sheridan, President & CEO, Patients for Patient Safety US. "Diagnostic error has contributed to disability and death in my own family, and it looms large among the entire network of PFPS US patients and family members as a cause of devastating loss and heartache. With focus and attention to diagnostic error as preventable harm, PFPS US sees an achievable opportunity to protect patients and reduce the massive cost of diagnostic error now borne by families, the government and taxpayers. On World Patient Safety Day, September 17th, the World Health Organization launched a year of focus on improving Diagnostic Safety. We applaud the sponsors of the Improving Diagnosis in Medicine Act for underscoring the importance of the issue in the United States, and we pledge our support."

As the Founder and President Emeritus of the Society to Improve Diagnosis in Medicine (SIDM), please know that we applaud the leadership of Senators Van Hollen and Lujan and Representatives Beyer, Dr. Schrier, and Van Drew in introducing this bill. Accurate diagnosis is the sin qua non of quality health care. Failure to arrive at a timely and accurate diagnosis or to communicate that effectively to the patient leads to poor outcomes for millions of patients each year, and is a major driver of unnecessary costs. But diagnosis is also one of the most complex tasks in health care; until we have a body of research that supports data-driven reliable improvement strategies, our clinicians and healthcare system will be left struggling. There is much work to be done by all healthcare stakeholders, and this legislation will help to focus and mobilize those efforts," said Mark L. Graber, MD FACP, President and Founder of the Society to Improve Diagnosis in Medicine (SIDM).

"Diagnostic errors in children and young adults have devastating life-altering and life-long consequences that affect the entire family. While fairly common, the full impact is unknown since research focuses on adults," said Santi KM Bhagat, MD MPH, Founder and President, Physician-Parent Caregivers and The Invisible Wave. "This legislation ensures that young people will no longer be overlooked and have the right to an accurate timely diagnosis, the critical first step for the right care and treatment. This will prevent lost days and years during growth and development and allow millions of young people the opportunity to learn, work, grow and participate in society with their peers. We are grateful to Senator Van Hollen for his commitment to protecting the health of young people."

"Addressing diagnostic error is a major public health challenge that every American should care about- no one ever wants face the tragedy of watching a loved one suffer permanent disability or premature death from a missed or delayed medical diagnosis… yet this happens thousands of times a day. The Armstrong Institute Center for Diagnostic Excellence at Johns Hopkins works to prevent these harms through innovative diagnostic research, care transformation, and patient engagement. We are indebted to Senator Van Hollen for championing the landmark Improving Diagnosis in Medicine Act of 2024 that bolsters critical research efforts to prevent these patient harms and achieve health equity in diagnosis," said Dr. David E. Newman-Toker, MD PhD, Director of the Armstrong Institute Center for Diagnostic Excellence, Johns Hopkins University School of Medicine.

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