,,ii #aaith ,,congress #b;d ,session ,s4 #dihi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #ae1 #bjbf,mr4 ,van ,hollen 7for himself and ,mr4 ,lujn7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to improve the quality1 appropriateness1 and effectiveness of diagnosis in health care1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,saving ,lives and ,reducing ,health ,care ,waste by ,improving ,diagnosis in ,medicine ,act4 #b4 ,findings and purpose ,congress finds that diagnostic error is a leading cause of preventable harm and waste in the ,united ,states health system1 and the modernization of diagnostic safety and quality infrastructure1 through applied research1 data science1 patient engagement1 and systems learning1 is necessary to improve outcomes and reduce costs4 #c4 ,research and quality improvement program ,part ,b of title ,,ix of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b et seq47 is amended by adding at the end the following3 #iah4 ,research and quality improvement program 7a7 ,in general ,the ,director shall establish a comprehensive program of patient-centered research and quality improvement to-- 7#a7 assess and understand diagnostic errors1 including diagnostic delays1 and how to eliminate common failures in the diagnostic process that lead to significant patient harm2 and 7#b7 identify1 develop1 implement1 and disseminate evidence-based strategies and best practices for improving diagnostic quality1 safety1 timeliness1 and eliminating and health care waste resulting from diagnostic errors and delays4 7b7 ,activities ,the program established under subsection 7a7 shall include the following3 7#a7 ,continuum of research ,a portfolio of conducted and supported activities that is consistent with the research1 implementation1 and dissemination activities of the ,center for ,quality ,improvement and ,patient ,safety of the ,agency for ,healthcare ,research and ,quality1 including-- 7,a7 research to assess diagnostic errors and identify improved methods to prevent errors and the harm errors cause2 7,b7 translation and synthesis of research findings and development of tools for implementing prevention strategies into practice2 7,c7 implementation research to refine evidence-based tools for improving diagnostic processes and effectively integrate these solutions into practice2 and 7,d7 collaboration with stakeholders across the health care community to disseminate and promote implementation of effective methods1 strategies1 and tools for wide-scale improvement1 including identifying where digital- and artificial intelligence-enabled tools could be beneficial1 measure and assess diagnostic safety1 accuracy1 and timeliness1 and assess the impact of improvement on wasteful spending4 7#b7 ,research centers of diagnostic excellence ,consistent with section #iaa7;b71 the health care improvement research centers described in such section shall link research directly with clinical practice in geographically diverse locations throughout the ,united ,states1 and may include-- 7,a7 academic medical and institutional research centers that combine demonstrated multidisciplinary expertise in diagnostic outcomes or quality improvement research with linkages directly or through national1 ,state1 or local stakeholder partner organizations to relevant sites of care2 and 7,b7 provider-based research networks1 including plan1 facility1 or delivery system sites of care 7especially primary care71 that can evaluate outcomes and evaluate and promote quality improvement approaches4 7#c7 ,financial assistance ,the ,director may provide financial assistance to assist in meeting the costs of planning and establishing new centers1 as well as operating existing and new centers1 pursuant to section #ijb7;c74 7#d7 ,advisory committee 7,a7 ,establishment ,the ,director shall establish a multi-stakeholder advisory committee1 with members that include patients1 family members with lived experience1 and the patient or consumer advocacy organizations that represent such patients and family members1 to support the ,director in the planning1 implementation1 and evaluation of the program under this section4 7,b7 ,purpose ,the committee established under subparagraph 7,a7 shall ensure that the program under this section improves patient outcomes by-- 7i7 incorporating advances in data science1 artificial intelligence1 and health information technology to empower patients and families and strengthen systems-based approaches to improving diagnosis2 7ii7 integrating the lived experience and the outcomes that matter most to patients and families as well as perspectives of clinicians and health systems1 to ensure relevance and uptake in practice2 and 7iii7 maintains a balanced research portfolio that emphasizes scientific rigor1 patient-centeredness1 and real world applicability4 7c7 ,authorization of appropriations 7#a7 ,in general ,to carry out this section1 there are authorized to be appropriated #de1jjj1jjj for each of fiscal years #bjbg through #bjca4 7#b7 ,availability ,amounts appropriated under this section shall remain available until expended4 4 #d4 ,patient safety reporting and learning infrastructure 7a7 ,in general ,not later than #a year after the date of enactment of this ,act1 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 patients1 families1 and caregivers to voluntarily report their experiences of diagnostic error 7as defined by the ,national ,academy of ,medicine in the consensus study report titled ,improving ,diagnosis in ,health ,care #bjae7 and other patient-safety adverse events and near misses 7as defined in the ,patient ,safety ,network primer titled ,adverse ,events1 ,near ,misses1 and ,errors1 published on ,december #ae1 #bjbd7 to a system that meets the requirements established in subsection 7c74 7b7 ,restrictions on the use of reports 7#a7 ,in general ,notwithstanding any other provision of law1 reports collected under subsection 7a7 shall not be admissible in civil or criminal proceedings1 and shall be used solely for public health1 improvement1 and learning purposes4 7#b7 ,clarification ,reporting under subsection 7a7 shall not preclude or affect the legal rights of patients or family members or caregivers of patients or remedies available to such parties4 7c7 ,purposes ,the strategic plan required under subsection 7a7 shall-- 7#a7 modernize ,federal approaches to capturing and using patient-reported safety information1 in a manner that-- 7,a7 safeguards patient privacy2 7,b7 facilitates integration1 as appropriate1 with existing data and learning systems within the ,department of ,health and ,human ,services1 including the ,agency for ,healthcare ,research and ,quality1 the ,centers for ,medicare ,medicaid ,services1 the ,national ,institutes of ,health1 and the ,advanced ,research ,projects ,agency for ,health2 7,c7 considers the use of modern data-science methods1 including natural-language processing and artificial intelligence1 to enable detection of diagnostic and other safety signals from patient-reported data and narrative2 and 7,d7 identifies opportunities to align such reporting mechanisms with existing ,federal patient-experience 7such as ,consumer ,assessment of ,healthcare ,providers and ,systems71 quality-measurement1 and safety programs to minimize burden and maximize learning2 and 7#b7 recommend a coordinated ,federal approach for piloting1 evaluating1 and scaling such reporting mechanisms to support continuous improvement in diagnostic safety and quality4 7d7 ,consultation ,in developing the strategic plan under subsection 7a71 the ,director of the ,agency for ,healthcare ,research and ,quality shall consult with the ,administrator of the ,centers for ,medicare ,medicaid ,services1 the ,national ,coordinator for ,health ,information ,technology1 the ,chief ,data ,officer of the ,department of ,health and ,human ,services1 and the ,chief ,artificial ,intelligence ,officer of the ,department of ,health and ,human ,services4 7e7 ,authorization of appropriations 7#a7 ,in general ,to carry out this section1 there are authorized to be appropriated #bj1jjj1jjj for each of fiscal years #bjbg through #bjcj4 7#b7 ,availability ,amounts appropriated under this section shall remain available until expended4 #e4 ,fellowships and training grants 7a7 ,ruth ,kirschstein awards ,section #dhg7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhh7;a77 is amended by adding at the end the following3 7#e7 ,for purposes of the program under this subsection1 biomedical and behavioral research includes diagnostic safety and quality research4 4 7b7 ,,ahrq programs ,section #ijb7;b77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;a7b77#a77 is amended-- 7#a7 by inserting and diagnostic safety and quality after subsection 7a72 and 7#b7 by striking under section #dhg7;d77#c7 and inserting for purposes of carrying out section #dhg4 #f4 ,quality measure development ,section #ica7;c77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#ca7;c77#b77 is amended-- 7#a7 by redesignating subparagraphs 7,b7 through 7,j7 as subparagraphs 7,c7 through 7,k71 respectively2 and 7#b7 by inserting after subparagraph 7,a7 the following3 7,b7 diagnostic safety and quality2 4 #g4 ,standardized data for diagnosis research and improvement 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall coordinate with relevant departmental components to promote the standardization1 interoperability1 and responsible use of key data elements to support diagnostic safety and quality research and improvement4 7b7 ,consultation with expert panel ,in carrying out subsection 7a71 the ,secretary1 in coordination with the ,director of the ,agency for ,healthcare ,research and ,quality1 the ,administrator of the ,centers for ,medicare ,medicaid ,services1 the ,director of the ,national ,library of ,medicine1 the ,chief ,data ,officer of the ,department of ,health and ,human ,services1 and the ,chief ,artificial ,intelligence ,officer of the ,department of ,health and ,human ,services1 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 research1 training1 and quality improvement including-- 7#a7 the fidelity1 interoperability1 auditability1 and socio-technical aspects of electronic vocabularies and ontologies related to presenting symptoms as stated by patients1 chief complaints of patients1 and the status of diagnosis 7such as tentative1 working1 or confirmed72 7#b7 the development and use of symptom-based clinical registries2 and 7#c7 enhanced data capabilities that are necessary to support both research and improvement of diagnostic safety and quality4 7c7 ,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 quality4 7d7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated such sums as may be necessary for each of fiscal years #bjbg through #bjbi1 to remain available until expended4 #h4 ,interagency ,council on ,improving ,diagnosis in ,health ,care 7a7 ,establishment ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall establish within the ,office of the ,secretary an interagency council to be known as the ,interagency ,council on ,improving ,diagnosis in ,health ,care 7referred to in this section as the ,council74 7b7 ,objectives ,the objectives of the ,council shall be the following3 7#a7 ,enhance the quality1 appropriateness1 and effectiveness of diagnosis in health care through-- 7,a7 the establishment and support of a broad base of scientific research2 7,b7 the dissemination and implementation of the results of such research2 and 7,c7 the promotion of improvements in clinical and health system practices4 7#b7 ,identify and eliminate systemic barriers to supporting research in improving diagnosis in health care4 7#c7 ,identify knowledge gaps1 research and data needs1 and opportunities congruent with agency missions to strengthen the clinical and translational research pipeline to improve diagnostic safety and quality1 including potential collaborative research initiatives among #b or more agencies1 offices1 institutes1 or centers within the ,department of ,health and ,human ,services or other ,federal agencies or offices4 7c7 ,membership 7#a7 ,chair ,the ,director of the ,agency for ,healthcare ,research and ,quality 7or the ,director's designee7 shall be the ,chair of the ,council4 7#b7 ,members 7,a7 ,in general ,in addition to the ,chair1 the ,council shall be comprised of the following3 7i7 ,at least #a designee from each of the following1 appointed by the head of the applicable department or agency3 7,i7 ,the ,centers for ,disease ,control and ,prevention4 7,,ii7 ,the ,centers for ,medicare ,medicaid ,services4 7,,iii7 ,the ,department of ,veterans ,affairs4 7,,iv7 ,the ,congressionally ,directed ,medical ,research ,program of the ,department of ,defense4 7,v7 ,the ,office of the ,national ,coordinator for ,health ,information ,technology4 7,,vi7 ,the ,office of the ,chief ,data ,officer of the ,department of ,health and ,human ,services4 7,,vii7 ,the ,office of the ,chief ,artificial ,intelligence ,officer of the ,department of ,health and ,human ,services4 7,,viii7 ,the ,center for ,devices and ,radiological ,health of the ,food and ,drug ,administration4 7ii7 ,designees from the ,national ,institutes of ,health1 including a least #a designee from each of the following3 7,i7 ,the ,national ,cancer ,institute4 7,,ii7 ,the ,national ,center for ,advancing ,translational ,sciences4 7,,iii7 ,the ,national ,institute of ,allergy and ,infectious ,diseases4 7,,iv7 ,the ,national ,heart1 ,lung1 and ,blood ,institute4 7,v7 ,the ,national ,institute of ,neurological ,disorders and ,stroke4 7,,vi7 ,the ,national ,library of ,medicine4 7,,vii7 ,the ,national ,institute on ,minority ,health and ,health ,disparities4 7,,viii7 ,the ,national ,institute of ,nursing ,research4 7,,ix7 ,the ,eunice ,kennedy ,shriver ,national ,institute of ,child ,health and ,human ,development4 7iii7 ,designees from such other national research institutes and national centers as may be appropriate1 as determined by the ,director of the ,national ,institutes of ,health4 7,b7 ,additional members ,in addition to the designees under subparagraph 7,a71 the ,council may include such other designees from ,federal departments or agencies as the ,chair of the ,council determines appropriate4 7,c7 ,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 7b71 as determined by the designating official4 7d7 ,strategic plan2 reports 7#a7 ,strategic ,federal ,plan to ,improve ,diagnosis in ,health ,care ,not later than #ah months after the date of enactment of this ,act1 the ,council shall develop1 submit to the ,secretary and ,congress1 and make publicly available a strategic plan1 to be known as the ,strategic ,federal ,plan to ,improve ,diagnosis1 that1 consistent with the objectives listed in subsection 7b7-- 7,a7 identifies coordinated opportunities to enhance scientific research and reduce systemic barriers in order to improve diagnosis in health care2 and 7,b7 includes legislative and administrative policy recommendations1 including opportunities to remove barriers to1 and enhance1 inter-agency coordination in the planning1 conduct1 and funding of1 such research4 7#b7 ,reports to ,congress ,not later than ,july #ca 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 7#a71 the ,council shall prepare1 submit to the ,secretary and ,congress1 and make publicly available an updated ,strategic ,federal ,plan to ,improve ,diagnosis that includes-- 7,a7 such updates as the ,council determines to be appropriate2 7,b7 information on the overall progress of the ,federal ,government in reducing barriers to research on1 and supporting projects to improve1 diagnosis in health care2 and 7,c7 legislative and administrative policy recommendations1 including addressing any needs for greater legislative authority to meet the objectives listed in subsection 7b74 7e7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #a1ejj1jjj for each of fiscal years #bjbg through #bjcj4