Short title

This Act may be cited as the

Saving Lives and Reducing Health Care Waste by Improving Diagnosis in Medicine Act

Findings and purpose

Congress finds that diagnostic error is a leading cause of preventable harm and waste in the United States health system, and the modernization of diagnostic safety and quality infrastructure, through applied research, data science, patient engagement, and systems learning, is necessary to improve outcomes and reduce costs.

Research and quality improvement program

Part B of title IX of the Public Health Service Act (42 U.S.C. 299b et seq.) is amended by adding at the end the following:

918.

Research and quality improvement program

(a)

In general

The Director shall establish a comprehensive program of patient-centered research and quality improvement to— (1)assess and understand diagnostic errors, including diagnostic delays, and how to eliminate common failures in the diagnostic process that lead to significant patient harm; and (2) identify, develop, implement, and disseminate evidence-based strategies and best practices for improving diagnostic quality, safety, timeliness, and eliminating health care waste resulting from diagnostic errors and delays. (b)

Activities

The program established under subsection (a) shall include the following: (1)

Continuum of research

A portfolio of conducted and supported activities that is consistent with the research, implementation, and dissemination activities of the Center for Quality Improvement and Patient Safety of the Agency for Healthcare Research and Quality, including— (A)research to assess diagnostic errors and identify improved methods to prevent errors and the harm errors cause; (B)translation and synthesis of research findings and development of tools for implementing prevention strategies into practice; (C)implementation research to refine evidence-based tools for improving diagnostic processes and effectively integrate these solutions into practice; and (D)collaboration with stakeholders across the health care community to disseminate and promote implementation of effective methods, strategies, and tools for wide-scale improvement, including identifying where digital- and artificial intelligence-enabled tools could be beneficial, measure and assess diagnostic safety, accuracy, and timeliness, and assess the impact of improvement on wasteful spending. (2)

Research centers of diagnostic excellence

Consistent with section 911(b), the health care improvement research centers described in such section shall link research directly with clinical practice in geographically diverse locations throughout the United States, and may include— (A)academic medical and institutional research centers that combine demonstrated multidisciplinary expertise in diagnostic outcomes or quality improvement research with linkages directly or through national, State, or local stakeholder partner organizations to relevant sites of care; and (B)provider-based research networks, including plan, facility, or delivery system sites of care (especially primary care), that can evaluate outcomes and evaluate and promote quality improvement approaches. (3)

Financial assistance

The Director may provide financial assistance to assist in meeting the costs of planning and establishing new centers, as well as operating existing and new centers, pursuant to section 902(c). (4)

Advisory committee

(A)

Establishment

The Director shall establish a multi-stakeholder advisory committee, with members that include patients, family members with lived experience, and the patient or consumer advocacy organizations that represent such patients and family members, to support the Director in the planning, implementation, and evaluation of the program under this section. (B)

Purpose

The committee established under subparagraph (A) shall ensure that the program under this section improves patient outcomes by— (i)incorporating advances in data science, artificial intelligence, and health information technology to empower patients and families and strengthen systems-based approaches to improving diagnosis; (ii)integrating the lived experience and the outcomes that matter most to patients and families as well as perspectives of clinicians and health systems, to ensure relevance and uptake in practice; and (iii)maintains a balanced research portfolio that emphasizes scientific rigor, patient-centeredness, and real world applicability. (c)

Authorization of appropriations

(1)

In general

To carry out this section, there are authorized to be appropriated $45,000,000 for each of fiscal years 2027 through 2031. (2)

Availability

Amounts appropriated under this section shall remain available until expended.

Patient safety reporting and learning infrastructure

(a)

In general

Not later than 1 year after the date of enactment of this Act, the Director of the Agency for Healthcare Research and Quality shall develop and submit to Congress a strategic plan to modernize Federal approaches and establish mechanisms that enable patients, families, and caregivers to voluntarily report their experiences of diagnostic error (as defined by the National Academy of Medicine in the consensus study report titled Improving Diagnosis in Health Care 2015) and other patient-safety adverse events and near misses (as defined in the Patient Safety Network primer titled Adverse Events, Near Misses, and Errors, published on December 15, 2024) to a system that meets the requirements established in subsection (c). (b)

Restrictions on the use of reports

(1)

In general

Notwithstanding any other provision of law, reports collected under subsection (a) shall not be admissible in civil or criminal proceedings, and shall be used solely for public health, improvement, and learning purposes. (2)

Clarification

Reporting under subsection (a) shall not preclude or affect the legal rights of patients or family members or caregivers of patients or remedies available to such parties. (c)

Purposes

The strategic plan required under subsection (a) shall— (1)modernize Federal approaches to capturing and using patient-reported safety information, in a manner that— (A)safeguards patient privacy; (B)facilitates integration, as appropriate, with existing data and learning systems within the Department of Health and Human Services, including the Agency for Healthcare Research and Quality, the Centers for Medicare & Medicaid Services, the National Institutes of Health, and the Advanced Research Projects Agency for Health; (C)considers the use of modern data-science methods, including natural-language processing and artificial intelligence, to enable detection of diagnostic and other safety signals from patient-reported data and narrative; and (D)identifies opportunities to align such reporting mechanisms with existing Federal patient-experience (such as Consumer Assessment of Healthcare Providers and Systems), quality-measurement, and safety programs to minimize burden and maximize learning; and (2)recommend a coordinated Federal approach for piloting, evaluating, and scaling such reporting mechanisms to support continuous improvement in diagnostic safety and quality. (d)

Consultation

In developing the strategic plan under subsection (a), the Director of the Agency for Healthcare Research and Quality shall consult with the Administrator of the Centers for Medicare & Medicaid Services, the National Coordinator for Health Information Technology, the Chief Data Officer of the Department of Health and Human Services, and the Chief Artificial Intelligence Officer of the Department of Health and Human Services. (e)

Authorization of appropriations

(1)

In general

To carry out this section, there are authorized to be appropriated $20,000,000 for each of fiscal years 2027 through 2030. (2)

Availability

Amounts appropriated under this section shall remain available until expended.

Fellowships and training grants

(a)

Ruth Kirschstein awards

Section 487(a) of the Public Health Service Act (42 U.S.C. 288(a)) is amended by adding at the end the following:

(5)For purposes of the program under this subsection, biomedical and behavioral research includes diagnostic safety and quality research.

(b)

AHRQ programs

Section 902(b)(1) of the Public Health Service Act (42 U.S.C. 299a(b)(1)) is amended— (1)by inserting and diagnostic safety and quality after subsection (a); and (2)by striking under section 487(d)(3) and inserting for purposes of carrying out section 487.

Quality measure development

Section 931(c)(2) of the Public Health Service Act (42 U.S.C. 299b–31(c)(2)) is amended— (1)by redesignating subparagraphs (B) through (J) as subparagraphs (C) through (K), respectively; and (2)by inserting after subparagraph (A) the following:

(B)diagnostic safety and quality;

Standardized data for diagnosis research and improvement

(a)

In general

The Secretary of Health and Human Services (referred to in this section as the Secretary) shall coordinate with relevant departmental components to promote the standardization, interoperability, and responsible use of key data elements to support diagnostic safety and quality research and improvement. (b)

Consultation with expert panel

In carrying out subsection (a), the Secretary, in coordination with the Director of the Agency for Healthcare Research and Quality, the Administrator of the Centers for Medicare & Medicaid Services, the Director of the National Library of Medicine, the Chief Data Officer of the Department of Health and Human Services, and the Chief Artificial Intelligence Officer of the Department of Health and Human Services, shall convene an expert panel to consider and make recommendations to the National Coordinator for Health Information Technology regarding the specific United States Core Data for Interoperability data elements and classes needed to accelerate diagnostic safety and quality research, training, and quality improvement including— (1)the fidelity, interoperability, auditability, and socio-technical aspects of electronic vocabularies and ontologies related to presenting symptoms as stated by patients, chief complaints of patients, and the status of diagnosis (such as tentative, working, or confirmed); (2)the development and use of symptom-based clinical registries; and (3)enhanced data capabilities that are necessary to support both research and improvement of diagnostic safety and quality. (c)

Report

The Secretary shall make available a summary of the panel’s recommendations and planned actions to advance the integration of such recommended elements into the learning infrastructure for diagnostic safety and quality. (d)

Authorization of appropriations

To carry out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2027 through 2029, to remain available until expended.

Interagency Council on Improving Diagnosis in Health Care

(a)

Establishment

The Secretary of Health and Human Services (referred to in this section as the Secretary) shall establish within the Office of the Secretary an interagency council to be known as the Interagency Council on Improving Diagnosis in Health Care (referred to in this section as the Council). (b)

Objectives

The objectives of the Council shall be the following: (1)Enhance the quality, appropriateness, and effectiveness of diagnosis in health care through— (A)the establishment and support of a broad base of scientific research; (B)the dissemination and implementation of the results of such research; and (C)the promotion of improvements in clinical and health system practices. (2)Identify and eliminate systemic barriers to supporting research in improving diagnosis in health care. (3)Identify knowledge gaps, research and data needs, and opportunities congruent with agency missions to strengthen the clinical and translational research pipeline to improve diagnostic safety and quality, including potential collaborative research initiatives among 2 or more agencies, offices, institutes, or centers within the Department of Health and Human Services or other Federal agencies or offices. (c)

Membership

(1)

Chair

The Director of the Agency for Healthcare Research and Quality (or the Director’s designee) shall be the Chair of the Council. (2)

Members

(A)

In general

In addition to the Chair, the Council shall be comprised of the following: (i)At least 1 designee from each of the following, appointed by the head of the applicable department or agency: (I)The Centers for Disease Control and Prevention. (II)The Centers for Medicare & Medicaid Services. (III)The Department of Veterans Affairs. (IV)The Congressionally Directed Medical Research Program of the Department of Defense. (V)The Office of the National Coordinator for Health Information Technology. (VI)The Office of the Chief Data Officer of the Department of Health and Human Services. (VII)The Office of the Chief Artificial Intelligence Officer of the Department of Health and Human Services. (VIII)The Center for Devices and Radiological Health of the Food and Drug Administration. (ii)Designees from the National Institutes of Health, including a least 1 designee from each of the following: (I)The National Cancer Institute. (II)The National Center for Advancing Translational Sciences. (III)The National Institute of Allergy and Infectious Diseases. (IV)The National Heart, Lung, and Blood Institute. (V)The National Institute of Neurological Disorders and Stroke. (VI)The National Library of Medicine. (VII)The National Institute on Minority Health and Health Disparities. (VIII)The National Institute of Nursing Research. (IX)The Eunice Kennedy Shriver National Institute of Child Health and Human Development. (iii)Designees from such other national research institutes and national centers as may be appropriate, as determined by the Director of the National Institutes of Health. (B)

Additional members

In addition to the designees under subparagraph (A), the Council may include such other designees from Federal departments or agencies as the Chair of the Council determines appropriate. (C)

Designation

A person appointed to the Council as a designee shall be a senior official or employee of the department or agency whose responsibilities and subject matter expertise are relevant to the Council’s objectives listed in subsection (b), as determined by the designating official. (d)

Strategic plan; reports

(1)

Strategic Federal Plan to Improve Diagnosis in Health Care

Not later than 18 months after the date of enactment of this Act, the Council shall develop, submit to the Secretary and Congress, and make publicly available a strategic plan, to be known as the Strategic Federal Plan to Improve Diagnosis, that, consistent with the objectives listed in subsection (b)— (A)identifies coordinated opportunities to enhance scientific research and reduce systemic barriers in order to improve diagnosis in health care; and (B)includes legislative and administrative policy recommendations, including opportunities to remove barriers to, and enhance, inter-agency coordination in the planning, conduct, and funding of, such research. (2)

Reports to Congress

Not later than July 31 of every odd-numbered year beginning with the first such year after the date of submission of the first Strategic Federal Plan to Improve Diagnosis under paragraph (1), the Council shall prepare, submit to the Secretary and Congress, and make publicly available an updated Strategic Federal Plan to Improve Diagnosis that includes— (A)such updates as the Council determines to be appropriate; (B)information on the overall progress of the Federal Government in reducing barriers to research on, and supporting projects to improve, diagnosis in health care; and (C)legislative and administrative policy recommendations, including addressing any needs for greater legislative authority to meet the objectives listed in subsection (b). (e)

Authorization of appropriations

To carry out this section, there are authorized to be appropriated $1,500,000 for each of fiscal years 2027 through 2030.