Saving Lives and Reducing Health Care Waste by Improving Diagnosis in Medicine Act
- Sponsor
- Sen. Van Hollen, Chris [D-MD]
- Committees
- Health, Education, Labor, and Pensions Committee (primary)
- Last action
- Jul 15, 2026
Bottom line
The bill aims to reduce diagnostic errors and associated patient harm and healthcare waste through enhanced federal research, data infrastructure, patient reporting, and interagency coordination.
What it actually does
This bill establishes a comprehensive federal program within the Agency for Healthcare Research and Quality (AHRQ) to research and improve diagnostic safety and quality. It mandates the development of a strategic plan for a patient-reported diagnostic error system, expands research fellowships to include diagnostic safety, promotes standardized health data for diagnosis, and creates an interagency council to coordinate federal efforts in this area. The bill authorizes specific appropriations for these initiatives.
Proponents argue
Proponents argue that diagnostic error is a leading cause of preventable harm and waste in the U.S. health system, and this bill provides a necessary modernization of diagnostic safety and quality infrastructure. They contend that through applied research, data science, patient engagement, and systems learning, the bill will significantly improve patient outcomes and reduce healthcare costs by addressing a critical, often overlooked, aspect of medical care.
Opponents contend
No direct opposition to the core goal of improving diagnostic quality is typically raised. However, potential critics might express concerns about the expansion of federal programs and associated spending, the complexity of interagency coordination, or the potential for increased administrative burden on healthcare providers related to new data standards or reporting requirements, even if voluntary.
The bill is concise and clearly structured, making it accessible for an informed reader to understand its provisions and implications within a reasonable timeframe.
Section 3, Part B of title IX of the Public Health Service Act (42 U.S.C. 299b et seq.), adding Sec. 918
Establishes AHRQ Diagnostic Research and Quality Improvement Program
This provision directs the Director of the Agency for Healthcare Research and Quality (AHRQ) to establish a comprehensive program focused on patient-centered research and quality improvement. The program will assess diagnostic errors, identify how to prevent harm, and develop and disseminate evidence-based strategies for improving diagnostic quality, safety, and timeliness. It also includes the establishment of research centers of diagnostic excellence and collaboration with stakeholders to integrate solutions, including digital and AI-enabled tools.
Supporters argue
Supporters argue that this program is crucial for systematically addressing diagnostic errors, which are a major source of preventable harm and healthcare waste. They contend that by investing in research, developing evidence-based strategies, and leveraging modern technologies like AI, the bill will drive significant improvements in patient safety and healthcare efficiency.
Critics contend
While direct opposition to improving diagnosis is rare, some might argue that such a broad federal program could lead to bureaucratic inefficiencies or that private sector innovation might be more agile in developing solutions. Concerns could also be raised about the allocation of significant federal funds to a new program rather than existing initiatives.
Tradeoffs
The provision balances the need for comprehensive, patient-centered research with the integration of advanced data science and artificial intelligence. There is a tension between ensuring scientific rigor and achieving real-world applicability and widespread dissemination of findings across diverse healthcare settings.
Section 4
Develops Strategic Plan for Patient Safety Reporting and Learning Infrastructure
This section requires the Director of AHRQ to develop a strategic plan within one year for modernizing federal approaches to patient safety reporting. The plan will establish mechanisms for patients, families, and caregivers to voluntarily report diagnostic errors and other adverse events. Crucially, these reports are to be used solely for public health and learning purposes and are not admissible in legal proceedings, while also clarifying that reporting does not affect legal rights.
Section 5, amending 42 U.S.C. 288(a) and 42 U.S.C. 299a(b)(1)
Expands Research Fellowships to Include Diagnostic Safety
This section amends the Public Health Service Act to explicitly include 'diagnostic safety and quality research' within the scope of the Ruth L. Kirschstein National Research Service Awards and AHRQ's general authority for training grants. This ensures that federal funding for biomedical and behavioral research training and career development can be specifically directed towards improving diagnostic processes.
Section 6, amending 42 U.S.C. 299b-31(c)(2)
Adds Diagnostic Safety to AHRQ Quality Measures
This section amends the Public Health Service Act to include 'diagnostic safety and quality' as a specific area for which the Agency for Healthcare Research and Quality (AHRQ) must develop quality measures. This formalizes AHRQ's role in creating metrics to assess and improve the accuracy and timeliness of diagnoses across the healthcare system.
Section 7
Promotes Standardized Data for Diagnostic Safety
This section directs the Secretary of Health and Human Services (HHS) to coordinate with relevant departmental components to promote the standardization, interoperability, and responsible use of key data elements for diagnostic safety and quality research. It mandates convening an expert panel to recommend specific data elements and classes to the National Coordinator for Health Information Technology, focusing on symptoms, chief complaints, diagnosis status, and symptom-based registries, including enhanced data capabilities for AI.
Section 8
Establishes Interagency Council on Improving Diagnosis in Health Care
This section establishes an Interagency Council on Improving Diagnosis in Health Care within the Office of the Secretary of HHS. Chaired by the Director of AHRQ, the Council will include designees from numerous federal agencies (e.g., CDC, CMS, VA, NIH institutes, FDA, ONC, Chief Data/AI Officers). Its objectives are to enhance diagnostic quality through research, disseminate findings, identify systemic barriers and knowledge gaps, and develop strategic plans to coordinate federal efforts and funding in this area.
This subsection explicitly states that reports collected through the patient safety reporting system shall not be admissible in civil or criminal proceedings and shall be used solely for public health, improvement, and learning purposes. It also clarifies that such reporting does not preclude or affect the legal rights or remedies available to patients, family members, or caregivers.
Section 4(b)
Why it matters:This is standard legislative practice to encourage participation in voluntary reporting systems by providing legal protections, while also ensuring that such systems do not inadvertently diminish existing legal rights. It's a necessary legal clarification rather than an attempt to obscure.
Case for: Proponents argue that these protections are essential to build trust and encourage patients and families to voluntarily report diagnostic errors without fear of legal repercussions for themselves or others. This fosters a 'just culture' focused on learning and improvement rather than blame.
Case against: No specific case against these protections is typically made, as they are designed to facilitate the primary purpose of the reporting system. However, some might argue that any system that collects data related to medical errors, even if protected, could theoretically create indirect pressures or be subject to future legislative changes.
Estimated impact: Crucially enables the successful implementation and widespread adoption of the patient safety reporting system by addressing key concerns about legal liability and patient rights.
This provision specifies that the expert panel making recommendations for standardized data elements should consider 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)'.
Section 7(b)(1)
Why it matters:This level of detail is necessary for technical implementation and reflects the complexity of standardizing clinical data, especially subjective patient-reported information. It's a technical specification rather than a hidden policy.
Case for: Proponents argue that this granular focus on the technical aspects of data elements, including patient-stated symptoms and diagnosis status, is critical for developing truly robust and useful data for AI and research. It ensures that the data captures the nuances of the diagnostic process.
Case against: Some might argue that such detailed technical specifications could lead to overly complex or burdensome data collection requirements for healthcare providers, potentially slowing adoption or increasing implementation costs. There could also be debate over the specific ontologies and vocabularies chosen.
Estimated impact: Significantly influences the technical foundation and utility of the standardized data infrastructure for diagnostic safety, impacting the effectiveness of future research and AI applications.