Cardiac implantable electronic devices (CIEDs) generate substantial data, often stored in image or PDF formats. Remote monitoring, now an integral component of patient care, places considerable administrative burdens on clinicians and staff, in large part due to the challenge of integrating these data seamlessly into electronic health records. Since 2006, the Heart Rhythm Society, in collaboration with the CIED industry, has led an initiative to establish a unified standard nomenclature. This effort has harmonized terminology, aligning diverse terms with single terms approved by the Institute of Electrical and Electronics Engineers. With this foundational work complete, attention now turns to developing technical standards for interoperability, which would enable the smooth communication of CIED data between information technology systems used in clinical practice. In this article, by leveraging Health Level 7 Fast Healthcare Interoperability Resources, we present a road map for the technical committee to guide this endeavor. We identify critical data exchange points between remote transceivers, electronic health records, and third-party platforms commonly used for CIED patient data management. Our objective is to establish bidirectional communication among these resources, ensuring the accuracy, timeliness, and accessibility of clinical data for clinicians. We also anticipate substantial benefits for both clinical research and administrative efficiency through the implementation of this interoperability framework.

HomeCirculationVol. 129, No. 24ACC/AHA/SCAI 2014 Health Policy Statement on Structured Reporting for the Cardiac Catheterization Laboratory Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessResearch ArticlePDF/EPUBACC/AHA/SCAI 2014 Health Policy Statement on Structured Reporting for the Cardiac Catheterization LaboratoryA Report of the American College of Cardiology Clinical Quality Committee Timothy A. Sanborn, MD, MS, FACC, FAHA, FSCAI, Chair, James E. Tcheng, MD, FACC, FSCAI, Vice-Chair, H. Vernon Anderson, MD, FACC, FSCAI, Charles E. Chambers, MD, FACC, FSCAI, Sharon L. Cheatham, PhD, APRN, Matthew V. DeCaro, MD, FACC, Jeremy C. Durack, MD, Allen D. Everett, MD, FACC, John B. Gordon, MD, FACC, William E. Hammond, PhD, Ziyad M. Hijazi, MBBS, MPH, FACC, Vikram S. Kashyap, MD, FACS, Merrill Knudtson, MD, FRCP(C), CM, Michael J. Landzberg, MD, FACC, Marco A. Martinez-Rios, MD, FACC, FIACC, FSCAI, Lisa A. Riggs, CNS, Kui Hian Sim, MBBS, FACC, David J. Slotwiner, MD, FACC, Harry Solomon, Wilson Y. Szeto, MD, Bonnie H. Weiner, MD, FACC, FSCAI, William S. Weintraub, MD, FACC, FAHA and John R. Windle, MD, FACC Timothy A. SanbornTimothy A. Sanborn *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , James E. TchengJames E. Tcheng *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , H. Vernon AndersonH. Vernon Anderson *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , Charles E. ChambersCharles E. Chambers *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , Sharon L. CheathamSharon L. Cheatham *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , Matthew V. DeCaroMatthew V. DeCaro Search for more papers by this author , Jeremy C. DurackJeremy C. Durack *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , Allen D. EverettAllen D. Everett *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , John B. GordonJohn B. Gordon *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , William E. HammondWilliam E. Hammond *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , Ziyad M. HijaziZiyad M. Hijazi *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , Vikram S. KashyapVikram S. Kashyap *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , Merrill KnudtsonMerrill Knudtson *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , Michael J. LandzbergMichael J. Landzberg *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , Marco A. Martinez-RiosMarco A. Martinez-Rios *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , Lisa A. RiggsLisa A. Riggs *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , Kui Hian SimKui Hian Sim *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , David J. SlotwinerDavid J. Slotwiner *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , Harry SolomonHarry Solomon *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , Wilson Y. SzetoWilson Y. Szeto *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , Bonnie H. WeinerBonnie H. Weiner *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author , William S. WeintraubWilliam S. Weintraub Search for more papers by this author and John R. WindleJohn R. Windle *American College of Cardiology Representative. †Society for Cardiovascular Angiography and Interventions Foundation Representative. ‡American Heart Association Representative. §Society of Interventional Radiology. ‖Health Level Seven International. ¶Society for Vascular Surgery. #Canadian Cardiovascular Society. **International Society for Adult Congenital Heart Disease. ††Inter-American Society of Cardiology. ‡‡American Association for Critical-Care Nurses. §§Asian Pacific Society of Cardiology. ‖‖Integrating the Healthcare Enterprise. ¶¶Digital Imaging and Communications in Medicine. ##Society of Thoracic Surgeons. ***Clinical Quality Committee representative during this writing effort. Search for more papers by this author Originally published28 Mar 2014https://doi.org/10.1161/CIR.0000000000000043Circulation. 2014;129:2578–2609Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2014: Previous Version 1 IntroductionTable of ContentsPreamble 2579Executive Summary 25801. Introduction 25801.1. Document Development Process 25801.1.1. Writing Committee Organization 25801.1.2. Document Development and Approval 25811.2. Background and Rationale 25812. Principles of Structured Reporting 25822.1. General Principles 25822.2. Integration of Data Acquisition With Workflow 25832.3. Capture of Information as Data Rather Than Prose 25842.4. Role of the Physician in Authoring the Structured Procedure Report 25852.5. The Best Practice Model 25853. Catheterization Procedure Reporting: Anticipating 2 Different Reports 25863.1. The Procedure Log Report 25863.2. The Physician-Authored Structured Procedure Report 25874. The Prototype Formatted, Tabular, Structured Procedure Report 25874.1. Front Page Summary: Highest Value Information 25884.2. Graphics and Images Section 25884.3. Report Body: Details 25884.3.1. Administrative Information 25894.3.2. History and Risk Factors 25904.3.3. Procedure Details 25904.3.4. Diagnostic Results 25914.3.5. Intervention 25914.3.6. Final Diagnoses 25914.3.7. Operators, Titles, Regulatory Attestation 25944.4. Procedure-Specific Content 25944.4.1. Cardiac Catheterization (Right, Left, Coronary Intervention) 25944.4.2. Peripheral Vascular Catheterization 25954.4.3. Cerebrovascular Catheterization 25964.4.4. Valvular Heart Disease: Transcatheter Aortic Valve Replacement 25964.4.5. Congenital and Structural Heart Catheterization 25974.4.6. Combination Procedures 25974.5. Structured Report Style Guide 25974.6. Data Export 25984.7. Paradigm Expansion 25985. Adoption and Implementation 25986. Extending the Structured Reporting Use Case 2600References 2601Appendix 1. Author Relationships With Industry and Other Entities (Relevant) 2603Appendix 2. Peer Reviewer Relationships With Industry and Other Entities (Relevant) 2605Appendix 3. Abbreviations 2609PreambleThis document has been developed as a health policy statement (HPS) by the American College of Cardiology (ACC). HPSs are intended to promote or advocate a position, be informational in nature, and offer guidance to the stakeholder community regarding the stance of the ACC and other contributing organizations on healthcare policies and programs. HPSs are not intended to offer clinical guidance and do not contradict existing ACC clinical policy. They are overseen by the ACC Clinical Quality Committee (CQC), the group responsible for developing and implementing all HPS policies and procedures related to topic selection, commissioning writing committees, and defining document development methodologies. The CQC brings together various areas of the College such as the Advocacy Committee, the National Cardiovascular Data Registry (NCDR), the ACC/American Heart Association (AHA) Task Forces on Guidelines and Performance Measurement, and the ACC Appropriate Use Criteria (AUC) Task Force.The CQC recommended the development of this HPS to document the ACC’s official position on structured reporting of cardiac catheterization procedures. A number of organizations were invited to coauthor this statement with the goal of sharing a unified message on this important topic. Structured reporting is believed to be foundational to the provision of high-quality care for patients undergoing procedures in the cardiac catheterization laboratory. As such, the intended audience for this document includes third-party payers; electronic health record (EHR) and clinical software vendors; accrediting and certifying organizations; and regulators whose areas of responsibility include electronic health data.To avoid actual, potential, or perceived conflicts of interest that may arise as a result of industry relationships or personal interests among the writing committee, all members of the writing committee, as well as peer reviewers of the document, are asked to disclose all current healthcare-related relationships, including those existing 12 months before initiation of the writing effort. The CQC reviews these disclosures to determine what companies make products (on market or in development) that pertain to the document under development. On the basis of this information, a writing committee is formed to include a majority of members with no relevant relationships with industry and other entities (RWI), led by a chair with no relevant RWI. Authors with relevant RWI are not permitted to draft initial text or vote on recommendations pertaining to their RWI. RWI is reviewed on all conference calls and updated as changes occur. Author and peer reviewer RWI pertinent to this document are disclosed in Appendices 1 and 2, respectively. In addition, to ensure complete transparency, authors’ comprehensive disclosure information—including RWI not pertinent to this document—is available as an online supplement. Disclosure information for the ACC CQC is also available online at http://www.cardiosource.org/ACC/About-ACC/Who-We-Are/Leadership/Guidelines-and-Documents-Task-Forces.aspx, as well as the ACC disclosure policy for document development at http://www.cardiosource.org/Science-And-Quality/Practice-Guidelines-and-Quality-Standards/Relationships-With-Industry-Policy.aspx. The work of the writing committee was supported exclusively by the ACC without commercial support. The writing committee members volunteered their time to this effort. Conference calls of the writing committee were confidential and attended only by committee members.Joseph P. Drozda, Jr., MD, FACCChair, ACC Clinical Quality CommitteeExecutive SummaryThe final report is an essential component of every invasive and operative procedure. This vital document records key data used to assess indications and appropriateness of care, details technical aspects of the procedure, describes findings and observations, lists results and calculations, provides the interpretation of the study, and conveys patient care recommendations. In addition to providing essential information to the entire team of care providers, the final report is utilized in billing and inventory management, process and performance improvement, outcomes analysis, teaching and education, and as a data source for registries.1 The final report is a legal medical record document and should be of the highest quality so as to optimize both patient outcomes and institutional operational efficiencies. A structured report generated by a structured reporting process is the most suitable vehicle for these goals, but this approach is only slowly being adopted despite prior recommendations and endorsements. This HPS is intended to provide a general model for structured reporting for invasive and interventional cardiovascular procedures and thus catalyze and accelerate implementation of structured reporting. Through endorsement of this document, the cardiovascular community recognizes the critical importance of structured reporting and calls for its uniform adoption.The general principles of structured reporting in cardiovascular imaging are well established. Information should be captured as data rather than prose; these data should flow bidirectionally to and from the EHR for subsequent presentation and analysis. The final report should be clear, concise, organized, consistent, reproducible, understandable, and in a format that is flexible to accommodate evolutionary procedural changes and documentation requirements.Key considerations for generating a structured report are discussed in detail, with a structured procedure report prototype included for modeling purposes. The prototype final report is segmented into 3 principal sections. The first section (front page) is a single (physical) page that contains the highest value clinical information. Because angiography is inherently visual, the second section is dedicated to the graphical representations of the findings and (optionally) images imported into the report. The body (third section) contains all of the remaining data presented as a series of structured, formatted tables. Procedure-specific content is outlined for diagnostic cardiac catheterization, percutaneous coronary intervention (PCI), peripheral vascular and cerebral vascular procedures, valvular heart disease including transcatheter aortic valve replacement (TAVR), structural and congenital heart disease (CHD), and combination procedures. The concepts enumerated in this HPS are applicable to nonsurgical endovascular procedures performed in a cardiac catheterization laboratory, hybrid catheterization/operating room suite, and interventional/neuroradiology suite.Universal adoption of structured reporting for invasive cardiovascular imaging procedures requires the acknowledgment of its potential benefits and acceptance of the responsibilities entailed. In order to stimulate structured reporting implementation, key groups including physician operators, catheterization laboratory personnel, the software vendor community, and leadership of registries must be on the forefront of advocating the adoption of structured reporting. The ACC/AHA/Society for Cardiovascular Angiography and Interventions Foundation (SCAI) recognize that the development and deployment of structured reporting will be an ongoing process and, therefore, strongly encourage the view that structured reporting be considered one component of the overall quality improvement imperative for cardiovascular care.1. Introduction1.1. Document Development Process1.1.1. Writing Committee OrganizationThe writing committee consists of a broad range of members from the ACC as well as the following societies: American Association of Critical-Care Nurses (AACN), AHA, Asian Pacific Society of Cardiology (APSC), Canadian Cardiovascular Society (CCS), Digital Imaging and Communications in Medicine (DICOM), Health Level Seven International (HL7), Inter-American Society of Cardiology (IASC), Integrating the Healthcare Enterprise (IHE), International Society for Adult Congenital Heart Disease (ISACHD), SCAI, Society of Interventional Radiology (SIR), Society of Thoracic Surgeons (STS), and Society for Vascular Surgery (SVS). Representatives from these societies included those with expertise in cardiothoracic surgery, interventional cardiology, interventional radiology, general cardiology, echocardiography, and cardiac nursing. Along with these specialties, specific knowledge in the areas of TAVR, carotid and cerebrovascular disease, vascular medicine, structural heart disease, patient outcomes, data interoperability, and catheterization laboratory workflows were also reflected in the workgroup to provide an appropriate balance of perspectives. Geographically, the writing committee included both domestic and international members. Relationships with EHR companies and software vendors active in cardiovascular medicine were deemed relevant to this writing effort. This writing committee met the College’s disclosure requirements for RWI as described in the Preamble.1.1.2. Document Development and ApprovalThe writing committee convened by conference call and e-mail to finalize the document outline, develop the initial draft, revise the draft per committee feedback, and ultimately approve the document for external peer review. Each participating organization provided peer reviewers, resulting in 32 reviewers representing 410 comments. To increase its applicability further, the document was posted online for a 3-week public comment period, resulting in 4 people providing 19 additional comments. All comments were reviewed and addressed by the writing committee, resulting in change to the manuscript. A member of the ACC CQC served as lead reviewer to ensure that all comments were addressed adequately. Both the writing committee and CQC approved the version of the final document sent for board review. The ACC Board of Trustees, the AHA Science Advisory and Coordinating Committee, and the Society for Cardiovas

HomeCirculationVol. 119, No. 1ACCF/ACR/AHA/ASE/ASNC/HRS/NASCI/RSNA/SAIP/SCAI/SCCT/SCMR 2008 Health Policy Statement on Structured Reporting in Cardiovascular Imaging Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReview ArticlePDF/EPUBACCF/ACR/AHA/ASE/ASNC/HRS/NASCI/RSNA/SAIP/SCAI/SCCT/SCMR 2008 Health Policy Statement on Structured Reporting in Cardiovascular Imaging , WRITING COMMITTEE MEMBERS Pamela S. Douglas, MD, MACC, FAHA, FASE, Robert C. Hendel, MD, FACC, FAHA, Jennifer E. Cummings, MD, FACC, John M. Dent, MD, FACC, FASE, John McB. Hodgson, MD, FACC, FSCAI, Udo Hoffmann, MD, MPH, Robert J. HornIII, W. Gregory Hundley, MD, FACC, FAHA, Charles E. KahnJr, MD, MS, Gerard R. Martin, MD, FACC, Frederick A. Masoudi, MD, MSPH, FACC, Eric D. Peterson, MD, MPH, FACC, FAHA, Geoffrey L. Rosenthal, MD, PhD, FACC, Harry Solomon, Arthur E. Stillman, MD, PhD, FAHA, Shawn D. Teague, MD, James D. Thomas, MD, FACC, FAHA, Peter L. Tilkemeier, MD, MMM, FACC, FAHA, FASNC and Wm. Guy Weigold, MD, FACC , WRITING COMMITTEE MEMBERS , Pamela S. DouglasPamela S. Douglas , Robert C. HendelRobert C. Hendel , Jennifer E. CummingsJennifer E. Cummings , John M. DentJohn M. Dent , John McB. HodgsonJohn McB. Hodgson , Udo HoffmannUdo Hoffmann , Robert J. HornIIIRobert J. HornIII , W. Gregory HundleyW. Gregory Hundley , Charles E. KahnJrCharles E. KahnJr , Gerard R. MartinGerard R. Martin , Frederick A. MasoudiFrederick A. Masoudi , Eric D. PetersonEric D. Peterson , Geoffrey L. RosenthalGeoffrey L. Rosenthal , Harry SolomonHarry Solomon , Arthur E. StillmanArthur E. Stillman , Shawn D. TeagueShawn D. Teague , James D. ThomasJames D. Thomas , Peter L. TilkemeierPeter L. Tilkemeier and Wm. Guy WeigoldWm. Guy Weigold and Endorsed by the Society of Nuclear Medicine Originally published8 Dec 2008https://doi.org/10.1161/CIRCULATIONAHA.108.191365Circulation. 2009;119:187–200is corrected byCorrectionOther version(s) of this articleYou are viewing the most recent version of this article. Previous versions: December 8, 2008: Previous Version 1 TABLE OF CONTENTS1. Preamble……1882. Introduction and Rationale…1883. Principles of Structured Reporting…189 3.1. General Principles…189 3.1.1. The Need for a Balanced Approach…189 3.2. Technical Characteristics…1904. Components of a Structured Imaging Report191 4.1. Administrative Information…191 4.2. Patient Demographics…191 4.3. Study Referral Data…191 4.4. History and Risk Factors…191 4.5. Study Description…191 4.6. Study Findings…191 4.7. Other Reporting Parameters…1925. Implementation…192 5.1. Professional Societies and Accrediting Bodies…192 5.2. Standards-Setting Organizations…192 5.2.1. DICOM…193 5.2.2. HL7…193 5.2.3. Terminology Standards…193 5.2.4. IHE…193 5.2.5. Government…193 5.3. Industry…193 5.4. Tools and Testing…194 5.5. Workflow and Economic Considerations…194 5.6. Education and Outreach…1946. Future Directions/Potential Applications…194 6.1. Training…194 6.2. Quality Improvement…194 6.3. Registries and Research…195 6.4. Public Reporting/Accountability/Reimbursement…1957. Conclusions…195References…196Appendix 1…197Appendix 2…1981. PreambleThis document is an official American College of Cardiology Foundation (ACCF) Health Policy Statement. This category of documents is intended to promote or advocate a position or is informational in nature and may offer guidance to the stakeholder community regarding the ACCF's stance on health care policies and programs. Health policy statements are not intended to offer clinical guidance and do not contradict existing ACCF clinical policy.These documents fall under the purview of the ACCF Quality Strategic Directions Committee (QSDC). The ACCF QSDC is responsible for developing and implementing all policies and procedures related to topic selection, commissioning writing committees, and defining document methodologies.The QSDC brings together various areas of the College such as the Advocacy Committee, the National Cardiovascular Data Registry, the Performance Measurement Task Force, the Practice Guidelines Task Force, the Appropriateness Criteria Steering Committee, and the Task Force on Performance Assessment, Recognition, Reinforcement, Reporting and Reward (PAR4). The QSDC recommended the development of this Health Policy Statement to document the generally accepted position of the cardiovascular imaging community regarding structured reporting for cardiovascular imaging. Medical specialty societies must provide guidance on the design and implementation of key imaging quality program elements, to influence stakeholder perspectives and also provide meaningful guidance to members in this important area of modern cardiovascular practice. As the growth in imaging has caused payers to reduce costs by limiting access and reducing reimbursement, such attention to quality becomes even more important.The Writing Committee made every effort to avoid any actual, potential, or perceived conflict of interest that might arise as a result of industry relationships or personal interest. Specifically, all members of the Writing Committee, as well as peer reviewers of the document, were asked to provide disclosure statements of all such relationships. Please see Appendix 1 for a listing of the author relationships with industry. Relationships with industry of peer reviewers are listed in Appendix 2.Joseph P. Drozda, Jr, MD, FACC, ChairACCF Quality Strategic Directions Committee2. Introduction and RationaleThe final report is an essential component of any cardiovascular imaging test. It captures critical elements of the study(s) with their interpretation, recording this information for future use. It is often the only communication from the interpreting physician to the caregiver, and is therefore a critical component in the imaging chain of care and imaging quality.1,2 In addition, a report may be used for billing, quality improvement (QI), teaching, and informing patients and their families. By documenting a discrete episode of care, the report may become legal evidence. Accordingly, producing the highest quality report possible is an important goal in cardiovascular (CV) imaging practice for both optimal outcomes and cost efficiency.In a narrow sense, structured reporting refers to the displayed clinical report of a CV imaging procedure, when communicated using standardized content and definitions in a coherent, clinically relevant, and predictable format. However, in a broader sense, structured reporting is the process of organizing data by abstracting and integrating all of the evidence collected during the procedure (procedure logs, physical findings, images, waveforms, measurements, and interpretations) to create an integrated and comprehensive clinical report. It may include procedure data in "structured evidence" formats amenable to automated or semiautomated abstraction for reporting. Other types of standardized formatted reports, such as for quality or performance measures, may be created by a similar process, and may be included in the broad definition of structured reporting. For the purposes of this document, the term "structured reporting" will refer to both the underlying structured data that are collected and stored as part of an imaging procedure when this is done in a coded and structured manner (as opposed to free text, or unstructured data), as well as the displayed version of that data, the clinical report.Structured reporting is important for several reasons.3–6 Imaging quality may be improved and QI activities may be facilitated through imposed consistency of structured data collection and reporting. Key report components and data elements will not be omitted if the report is structured and elements are listed systematically within a standard template. Common lexicons are used to standardize descriptors. Referring physicians may find it easier to understand displayed imaging reports and to extract pertinent results if they are in an expected location and in standard defined terminology. Redundant testing may be reduced, potentially sparing patients from unnecessary exposures to the risks inherent in different imaging tests. Similarly, comparison between studies would be facilitated. Structured reporting and underlying structured data are critical to interoperability between electronic medical record systems, which are dependent on compatible document formats and parallel data structures. Cost savings may be achieved by added efficiency for the imager, the referring physician, hospital systems, and purchasers of health care.The structured reporting principles discussed in this document apply broadly to all forms of cardiovascular imaging. However, their application in certain cases, such as vascular imaging and congenital heart disease, may require additional consideration. Detailed discussion of the implementation of structured reporting in such cases, as well as in each imaging modality, is beyond the scope of this document.Much of the rationale for and underlying principles of structured reporting are similar to those for Health Information Technology in general and specific efforts such as Computerized Physician Order Entry in particular. Thus, structured reporting can be seen not only as a quality improvement vital to "best practices" in imaging laboratories, but also as critical to patient care and safety. This broader significance makes the definition and implementation of structured data and reporting both a health policy and clinical practice imperative.Through the creation and endorsement of this document, the organizations involved not only recognize the critical importance of structured reporting to the achievement of quality in cardiovascular imaging, but also call for its use as essential to quality cardiovascular imaging practice. This would include that imaging laboratories collect data in structured format, that physicians practice structured reporting procedures, that imaging and information systems support structured data archiving and reporting formats, and that reporting software implements structured composition and other required features for interoperability. Both in the narrowest clinical sense, as well as in the broader definition of production, interpretation and exchange of imaging based data, adherence to structured reporting principles is necessary to societal and professional efforts to measure, report, and improve quality.3. Principles of Structured Reporting3.1. General PrinciplesSeveral key principles are essential to optimal structured reporting, the most important of which is clinical relevance (Table 1). If structured reporting fails to meet this standard, it will have failed to provide a useful tool to improve imaging quality. Other principles include completeness, clarity, consistency, and reproducibility. Standards should provide a broad enough framework to be applicable to all CV imaging modalities; for example, descriptions of morphology and function should appear similar regardless of modality. Similarly, standards should be adaptable to apply to all forms of cardiovascular diseases. There must be a consistent minimal data set, with uniformity in data definitions, and a data structure that permits portability while allowing flexibility in presentation. Finally, structured reporting should be pragmatic, striking a balance between consistency and flexibility, conciseness and completeness, and ease of use and rigor. Above all, structured reporting should enhance clarity and facilitate care. Table 1. General Principles of Structured ReportingClinical relevanceCompletenessClarityConsistencyReproducibilityPractical, easy to applyApplicable to all modalitiesAble to evolve over timeAdequate for billingBalanced approachA structured report and its components should contain all of the requisite data for demonstrating medical necessity, appropriateness determination and for billing including documentation of lab characteristics (e.g., accreditation), reasons for study, relevant image acquisition parameters and interpretation. Furthermore, these data should be compatible with billing systems, in addition to clinical information systems.3.1.1. The Need for a Balanced ApproachCritical considerations in implementing these principles are practicality and balance (Table 2). The design and mechanics of any structured report, to be clinically useful, must be well balanced among numerous dichotomies in order to be most practical. First, the reporting mechanism (software) must strike a balance between consistency (achieved by retaining the same data elements in every report) and flexibility (the ability to modify the data elements captured by the reporting mechanism). While much of the benefit of structured reports comes from their consistency and adherence to inclusion of at least a minimal data set, the ability to add "optional" data elements or patient-specific details to this minimal data set would make such reports more practical and useful by providing additional details that are not found among the standard data elements. Such additional detail may be needed when structured reports are used for internal reporting, quality assurance, research, and clinical care of patients with rare disorders. For example, structured reports for imaging studies performed on patients with congenital heart disease may require unique elements to convey needed clinical information. Table 2 Competing Principles of Structured Reporting That Must Be Optimally Balanced to Achieve the Most Practical Result1ConsistencyRequiring same elements and definitions; same organization and structureFlexibilityAllowing addition of elements, details, and free text2CompletenessInclusion of all relevant fields and sufficiently detailed descriptionsConcisenessMinimize time required to read; easily understood3Required elementsAddress key clinical findings expected of the modality; ensure appropriately thorough clinical evaluation of the studyOptional elementsUseful across modalities; facilitate data entry; avoid burdensome user experience4UniversalityCommonality to the process and contentProprietaryAllow opportunities for product developmentSecond, the scope of the report must strike a balance between completeness and conciseness. Reports must be sufficiently inclusive of relevant, detailed data elements to accurately describe the findings, but must not be so lengthy as to be unhelpful to the busy, time-pressured clinician. Similarly, while it may be tempting to collect every piece of data that can possibly be extracted from a study, such a collection process would be burdensome for the reporting laboratory, and therefore unlikely to be widely accepted.Third, the number of elements designated as required must be sufficient to produce robust reports that are consistent in content across different laboratories, but not so numerous as to burden laboratories with the collection of unnecessary elements.Finally, while the whole purpose of structured reporting is to create a widely utilized mechanism that results in a universally recognized clinical document, there must be a balance between requiring conformity across reports and allowing innovation in the development of reporting products and tools, including commercially viable products. As an example, future speech recognition software may use intelligent computer algorithms to populate predefined data elements.3.2. Technical CharacteristicsThe major technical characteristic of structured reporting is interoperability, or the characteristic that ensures that electronic records can be effectively used by a variety of recipients.7 Interoperability includes 5 major aspects that must be addressed in an integrated structured reporting solution (Table 3): Table 3 Technical Characteristics of Structured ReportingPortabilityStandardized context and outputsCompatibilityMultimodality comparabilityPerformance in multiple contexts and environmentsPortability—The use of standardized message formats to exchange data between disparate equipment and systems is essential. This is often called syntactic interoperability, and allows integration of exchanged data into electronic medical record systems. The primary standards include those from Health Level Seven (HL7; http://www.hl7.org/), Digital Imaging and Communications in Medicine (DICOM; http://dicom.nema.org), and Health Information Technology Standards Panel (HITSP; http://www.hitsp.org).Standardized content and outputs—Standard sets of data elements and coded terminology must be used whenever available. This is often called semantic interoperability, and enables receivers to precisely understand the message content. The primary standards include Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT; http://www.ihtsdo.org), Logical Observation Identifiers Names and Codes (LOINC; http://www.loinc.org), and data sets defined by specialty societies. The use of standard data sets is tested in the clinical setting through the Integrating the Healthcare Enterprise initiative (http://www.ihe.net) or similar methodology.Compatibility—This allows data capture in an interoperable format at its origination, or the initial point of collection or production, reducing data re-entry errors and allowing electronic consolidation of all study data with traceability to the source. For example, a sonographer's worksheet of preliminary measurements should be sent in a standard format to the over-reading cardiologist's workstation, where it can be reviewed with the digital images and validated for the clinical report.Multimodality comparability—Uniform and comparable data sets and elements across different imaging modalities must be used. While different modalities may have different capabilities or accuracies, they are measuring the same anatomic structure or physiologic function (e.g., ejection fraction measured by cardiac catheterization or by echocardiography). Comparability allows evaluation of a patient's history across the care continuum. Cross modality comparability is addressed more fully by a standards document defining data elements that has been endorsed by the same societies supporting this health policy statement.8Performance in multiple contexts and environments—The collected structured report data should support clinical and nonclinical activities such as billing, research, and outcomes reporting, without requiring additional data entry. While these purposes may require data at a different level of aggregation, in greater detail, or in an altered format, the structured report data must be sufficiently detailed to allow automated, computerized extraction for nonclinical use. Thus, critical data elements of the structured report should be stored in a "searchable" or "trackable" format within electronic medical records and not in text or string format that is difficult to access.4. Components of a Structured Imaging ReportThe components of a structured report represent categories of information that should be present in every cardiovascular imaging report. Most of the specific statements within each category may be considered data elements, which have been defined in another standards document.8 The examples included are meant to be illustrative, and do not represent mandated content, suggested verbiage, or an exhaustive listing of what might appear in a given report (Table 4). Although it is outside the scope of this document to consider the communication of results beyond structured reporting, it is important to note that there is an American College of Radiology standards document related to this topic.9Table 4. Components of a Structured Cardiovascular Imaging ReportAdministrative information and laboratory identificationPatient demographics and billing informationStudy referral dataHistory and risk factorsStudy descriptionStudy findings, interpretation, and conclusionsOther reporting parameters4.1. Administrative InformationThe administrative section contains pertinent, nonvarying identifying information related to the specific laboratory and site performing the examination, including such information as: laboratory name, site location and type of facility, address and phone, and accreditation entity and status.4.2. Patient DemographicsThe demographics section provides personal information and unique patient identifiers to link the patient to the report. Demographic elements should uniformly include the patient's full name at the time of the test, prior names used for previous tests, medical record number, date of birth, gender, and race. All of these should be included to provide sufficient redundancy to correct errors and to allow comparison of data over time and across providers. Special care must be taken in the identification of fetal, newborn, and pediatric patients as names and other identifiers change following birth and naming. Information required to generate a correct bill, including insurance or other payer information, may be included.4.3. Study Referral DataStudy referral data describe the clinical situation and questions, study indication, and referring provider identification. This portion may also include date and time of the order, study priority (routine, urgent, stat), and special handling instructions such as a call back number for results. Consideration should be given to including the referring physician's National Physician Identifier, a unique identifier of a specific physician. This would allow for linkage of referring physicians, patients, and studies; study of referral practices; and longitudinal tracking of physicians' referrals regardless of geographic location or institutional venue.4.4. History and Risk FactorsThe patient's relevant medical history, risk factors, medications, and allergies play a critical role in image acquisition and interpretation, and should be standardized as are other components of the report. In addition, elements should allow tracking application of relevant Appropriateness Criteria and Practice Guidelines recommendations. Important historical information is best provided by the referring physician who is most familiar with the patient, as well as by the patient. However, some data may only be available by report (rather than verified by the laboratory), or may not be routinely available to the imaging laboratory. Thus the report may document the source of the information as well as any pertinent gaps.4.5. Study DescriptionThe imaging modality, technical specifications of image acquisition, and all components of the test should be described in detail, ideally using generic rather than proprietary verbiage. If there is a unique study identifier or accession number, it should be included. The name, dose, and method of administration of contrast agents or medications, if used, should be documented. If the imaging modality utilizes radiation, dose-reduction strategies employed in the study and the estimated dose or exposure received by the patient during the examination should be included. If the test involves imaging during stress, the method of inducing stress (exercise and/or pharmacological) and the stress protocol used should be indicated. Overall study quality should be noted, with mention made of any limitations due to patient- or equipment-related reasons or other circumstances. Sufficient identifying information should be included to facilitate retrieval of essential components of the examination, regardless of storage medium.4.6. Study FindingsSpecific study findings will vary substantially, depending upon the imaging modality employed, the imaging protocols used, the clinical question asked, the actual results themselves, and other factors. A common practice in structured reporting is to group all quantitative measures, qualitative assessments, and calculated data on a given structure (eg, left ventricular size, shape, and wall thickness, and systolic and diastolic function should appear in adjacent items), with each evaluated structure considered in logical sequence. Measurements should be properly referenced to norms for body size, gender, and age, and they should be reported with corresponding Z-scores when relevant. Physiological and hemodynamic changes observed during a study, whether spontaneous or in response to stress or other interventions, should be included. The report should also include clearly identified fields for interpretation of findings, comparison to prior studies (if available), conclusions and impressions, and any recommendations as a result of the study. The original question for which the study was performed should be explicitly answered.Standard features or sets of investigative tasks for each type of study, as developed and recommended by cardiovascular imaging societies, should be reported using standard data elements and anatomic, morphologic, and functional descriptions. For example, the 17-segment model (Figure) is a consensus standard for left ventricular description by tomographic imaging10 and should be used in both stress and rest reports to document any ischemia, scarring, or wall motion abnormalities. Additional multimodality data elements for adult cardiac imaging are delineated in the companion multisocietal standards document on this topic.8Download figureDownload PowerPointFigure. Seventeen-segment model for assessing left ventricular function. Reprinted from Cerqueira et al10.4.7. Other Reporting ParametersThe report should include the name and identifiers of all individuals involved in the study including names and credentials of the technicians, trainees, nurses, and physician assistants involved in study performance and the interpreting physician. It should include the date and time of the examination as well as the date and time of the finalized report. An attestation clause may be added if any portion of the examination or report was performed by a trainee. Documentation of transfer of care may be included when either routine results or a "critical finding" on the imaging test is reported either in person or via phone conversation to the referring physician and may include the date, time, and name of the receiving individual. Any amendments to a finalized report should include the date, time, and name of the responsible individual.5. ImplementationMany of the preliminary steps needed for the implementation of structured reporting have been completed, including the definition of key data elements for specific imaging modalities11–16 as well as standardized multimodality data elements for adult cardiac imaging8 and congenital heart disease.17 The Society of Thoracic Surgeons and the International Society for Nomenclature of Paediatric and Congenital Heart Disease have been working to further define a standardized system of anatomical descriptors that could be applied to the standardized reporting of cardiovascular imaging studies in pediatric and congenital heart disease. Additional efforts must be made to identify data elements for vascular imaging. The increasing use of commercial software for generating clinical reports has prepared laboratories for the use of standardized reporting. Nevertheless, implementation of structured reporting will require the enthusiastic support of practitioners, professional societies, national standards-setting organizations, and industry. More detail on the roles of each of these types of entities is provided below.An additional important component of the implementation of a policy of mandatory structured reporting is to ensure that any unintended consequences regarding access to care are mitigated. Such concerns may be particularly relevant for solo providers or rural practices that may not have extensive information technology capabilities. Structured reporting solutions need not be complex or expensive; Web-based tools such as those offered by the American Society of Echocardiography's Echo ToolBox (http://www.echotoolbox.com) should place needed resources within the reach of every imaging laboratory.5.1. Professional Societies and Accrediting BodiesCardiovascular professional societies have implicitly promoted structured reporting in guidelines for the performance, interpretation, and application of specific imaging modalities. Examples of explicit support include the multimodality standardization of myocardial segments and nomenclature endorsed several years ago10 as well as single modality efforts.11–16 However, this paper constitutes the first formal recommendation for mandatory structured reporting for all cardiovascular imaging modalities.Current standards for laboratory accreditation do not mandate structured reporting, although many of the elements of complete reports are facilitated by its use. Given that an inadequate report is a frequent cause of accreditation denial, implementation of structured reporting should facilitate accreditation. Societies endorsing this policy document are also sponsors of accreditation efforts, and should play an important role in influencing revision of accreditation standards to include current policy.5.2. Standards-Setting OrganizationsIn the past decade, both the Digital Imaging and Communications in Medicine (DICOM) and Health Level Seven (HL7) consensus standards organizations have adopted formats for structured documents, known as DICOM Structured Reporting and HL7 Clinical Document Architecture (CDA). These general format standards are based on a hierarchical tree of textual, numeric, and coded observations complemented by content templates focused on structures and vocabulary for specific use cases. Continued, active participation and leadership in these standards-setting organizations by the

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