Traditional Remedies for Clinical Trials and Healthcare Information: Patient Care Data in Support of Clinical Research

1. Traditional Remedies for Clinical Trials and Healthcare Information:Patient Care Data in Support of Clinical Research Liora Alschuler, Landen Bain, Rebecca Kush, PhD, Meredith Nahm, Roberto Ruggeri December, 2003

3. The Challenge: Integrate Patient Care and Clinical Research Data

5. Impact on Healthcare and Drug Information Steve Ruberg, Applied Clinical Trials, February, 2002: �The essential kernal of the whole clinical development processs is the data� Thus, without a data-centric approach to developing any e-clinical solution, we are unlikely to be fully successful. The data is the foundation on which we build our entire effort.�

6. Business Drivers Need to shorten cycle time of drug development: Drug company R & D is too high; Government pressure. Drive for personalized, prospective medicine. Patient and investigator convenience. HHS desire to link research data to physician behavior. Rationalize provider document workflow.

7. Project opportunities Starbright � a small clinical trial at Duke�s Clinical Research Institute (DCRI) DCRI�s Data Mgt and IT groups are cooperating with the trial�s investigator. Goal is to capture both patient care and clinical trial data at the front end, and populate both data streams, using CDA and CDISC standards

8. Obstacles Two different world views between patient care and clinical research: Bio-statisticians want perfect data; Clinicians want everything they can grab. Lack of a structured vocabulary. Privacy concerns. CDISC, HL7 divergent data models

9. Starbrite Trial Participants: CDISC Duke Clinic Duke Clinical Research Institute (DCRI) investigatiors Liora Alschuler, Landen Bain, Rebecca Kush, PhD, Meredith Nahm, Steve Woody, Sally Cassells, Richard Low, John Madden, MD technology partners, Microsoft (primary), Arbortext, Topsail, Sentillion

10. Clinical Data Interchange Standards Consortium CDISC is an open, multidisciplinary, non-profit organization committed to the development of worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The CDISC mission is to lead the development of global, vendor-neutral, platform-independent standards to improve data quality and accelerate product development in our industry.

11. CDISC Formed in 1997 as a volunteer group As of 2000, funded as non-profit organization Now supported by >140 corporate members: pharmaceutical companies; biotech companies; CROs; technology providers CDISC Groups now growing in Japan, Europe; initiated in India Standards developed through consensus-based approach by teams of volunteers; public reviews No fee for use of the standards; freely available on CDISC website (www.cdisc.org)

12. ICH and CDISC CDISC developed standards for submission of clinical trial data, which was beyond the scope of ICH since only FDA requires that data be included in regulatory submissions at this time. The current plan is for FDA to reference the HL7-approved CDISC Submission Data Standards (SDS) as a specification in their FDA Guidance on the implementation of the ICH electronic Common Technical Document (eCTD).

13. Health Level Seven ANSI-accredited Standards Development Organization Established 1987 Approx. 2000 members 23 affiliates in Europe, Asia-Pacific, South America, Africa

14. HL7 Working group meetings 3 times each year about 500 attendees

15. a few of the HL7 TCs Modeling & Methodology Patient Care Orders & Observations Structured Documents: Clinical Document Architecture (CDA, SPL) RCRIM: Regulated Clinical Research Information Management CCOW: Context Management

16. a few of the HL7 SIGs XML Genomics Clinical Guidelines Electronic Health Record JAVA Imaging Integration Medication

17. HL7 Standards Version 2.x used worldwide, 90% of US hospitals �pipe & hat�: HL7-proprietary, EDI-like PID||2247^^^Primary|098018500^^^MRN||FIX-INTF^PAT||19650618|Female| Version 2.XML a normative XML encoding for V2 <PatientGroup> - <PID PID07_DateOfBirth="19650618" PID08_Sex="Female"

18. HL7 Standards Version 3 based on Reference Information Model (RIM) technology independent: so far, developing XML schemas, JAVA API RCRIM/CDISC lab reporting is a V3 draft standard, as is SPL First normative V3 spec was CDA

19. eSource & electronic data capture (EDC) redundant with creation of clinic note full burden lies on investigator require that information reside in EMR proprietary data formats CDA & CDISC in �single-source� capture trial data, merge it into clinic note (re-use) works with current technology, workflow (EMR optional destination, not required) open, non-proprietary data formats XML bridging disparate data models Single Source: how is it different?

22. features: contributes to patient chart, not the reverse, optimizes clinical workflow no requirement to create/extract from EMR fewer privacy and regulatory issues can be driven from electronic protocol uses HL7 CDA and CDISC ODM CDA & CDISC in Starbrite Trial

23. System features/requirements: multi-stage, incremental document creation optimal re-use (minimal redundant entry) minimal change to current workflow create both ODM-compliant XML for trials and CDA-compliant XML for clinical records, mapping between ODM.xml and CDA.xml low cost rapid development optimal use of technology partners, off-the-shelf technology CDA & CDISC in Starbrite Trial

24. XML-encoded information With a few simple tags, and controlled vocabulary, XML can describe anything but� the tags need to be defined: <orderNum> : HL7: order placed <orderNum> : CDISC: visit sequence

25. Clinical Document Architecture ANSI/HL7 CDA R1.0-2000 first certified XML spec for healthcare first balloted portion of HL7�s �V3� first RIM-based specification created & maintained by HL7 Structured Documents Technical Committee (SDTC) CDA

26. The scope of the CDA is the standardization of clinical documents for exchange. CDA enables, but does not constrain: authoring document management storage distribution display CDA: scope

27. priority is patient care, other applications facilitated minimize technical barriers to implementation promote longevity of clinical records scoped by exchange, independent of transfer or storage enable policy-makers to control information requirements CDA: Release 1.0

28. What can you dowith a few tags? access/portability/exchange query/locate by patient, provider, practioner, setting, encounter, date integration multiple transcription systems with EHR records re-use/derivative data summaries billing

29. CDA: Major Implementations PICNIC (European Union) SCIPHOX (Germany) HYGEIAnet/WebOnColl (Greece) NHS South Staffordshire (United Kingdom) Aluetietoj�rjestelm� (Finland) MERIT-9 (Japan) e-Claims Supporting Doc Arch (Canada); HIPAA Claims Attachments (US, proposed) Mayo Clinic (US) Buenos Aires project (Argentina) Dalhousie U, QEII Health Sci Ctr (Canada)

31. Requirements for a universal clinical document Span full range of technical sophistication Minimal constraint on content Makes all types of information human readable and, to the greatest extent possible, also machine processible

33. XML-encoded info in CDA <Section> <code code="10123-x" codeSystem="LOINC">Allergies and Adverse Reactions</code> <text> <list> <item><content>Penicillin - Hives</content></item> </list> </text> <component> <Observation> <code code="G-1001" codeSystem="SNOMED" displayName="Prior dx"/> <value xsi:type="CD" code="DF-10074" codeSystem="SNOMED" displayName="Allergy to penicillin"/> <pertinentInformation typeCode="MFST"> <Observation> <code code="G-1001" codeSystem="SNOMED" displayName="Prior dx"/> <value xsi:type="CD" code="D0-00165" codeSystem="SNOMED" displayName="Hives"/> </Observation>

34. Operational Data Model ver. 1.1, April, 2002 www.CDISC.org Defined by set of XML DTDs A database insertion schema CDISC ODM

35. CDISC ODM The technical focus in the development of ODM 1.0 was the definition of structures to represent the three major information components relating to a clinical trial: clinical study metadata (item definitions and protocol) clinical study administrative data (users and access privileges) clinical study data (complete record of patient data and audit trail)

36. CDISC ODM Study allows representation of more than one study in a single file AdminData includes information about the users of the system, the clinical sites involved in the study, and associated security information ReferenceData provides information relevant to the interpretation of data that is not necessarily study specific, such as lab normal ranges ClinicalData contains the actual data item values associated with each study.

37. CDA::ODM XML drives presentation (stylesheet) Model-based Standard vocabulary Distinct Metadata Identifiers Datatypes

38. Use of ODM & CDA in Single-source

41. Five sample data elements BNP Data Endpoint Summary Weight Orthopnea Weight gain

45. eProtocol dictates: Identifiers Vocabulary Extensibility Constraints on source XML Constraints on target XML

46. Status, October, 2003: preliminary technical design and information analysis complete information design, in progress: Liora Alschuler, Sally Cassells (Lincoln Technologies, CDISC) completing data CDA/ODM data mapping technical implementation: kick-off meeting October 14, Durham, NC (attending: Microsoft, Arbortext, Topsail, DCRI) project pilot in place Q1, 2004 CDA & CDISC in Starbrite Trial

47. Single-source: beyond Starbrite Next steps: Design and prototype a general solution Expand scope: integrate with standards-based electronic protocol Implement at one or more additional sites Establish base of industry partnerships to sustain second stage design, testing, implementation

49. 49 About me

50. 50 Healthcare IT 101 Largely a failed endeavor IOM perspective Institute of Medicine, To Err Is Human 98,000 preventable deaths each year MOM perspective Post discharge What meds? Office visit: no value Problems known Why not fixed?

51. 51 Outline HL7 CDA CDA for exchange networks CDA+CCR=CCD Summary, Resources & Questions

52. 52 Health Level Seven (HL7.org) Standards Development Organization Developing standards for interoperability Patient care Public health Clinical trials Reimbursement HIPAA DSMO 20 years, 2000 members 30+ international affiliates �A model community�: building standards to a single information model HIPAA DSMO (designated standard maintenance organgization). 4 DSMOs: HL7, ADA, X12, NCPDP HIPAA DSMO (designated standard maintenance organgization). 4 DSMOs: HL7, ADA, X12, NCPDP

53. 53

54. 54 HL7 for messaging It�s all about the interface: Hospital-centric view of HIT

55. 55

56. 56 HL7 beyond the messaging interface CCOW: multi-application context management, single sign-on Arden Syntax: decision support, guidelines Electronic Health Record: functional, system and interoperability models Reference Information Model (RIM) Clinical Document Architecture

57. 57 Outline HL7 CDA CDA for exchange networks CDA+CCR=CCD Summary, Resources & Questions

58. 58 Clinical Document Architecture ANSI/HL7 CDA R1.0-2000 ANSI/HL7 CDA R2.0-2005 A specification for document exchange using XML, the HL7 Reference Information Model (RIM) Version 3 methodology and vocabulary (SNOMED, ICD, local,�) CDA XML is the wire format, the RIM is �behind the scenes� Differences between R1 and R2 ---------------------------------------------- The R1 header was derived from the RIM, but the body was hand crafted. This was intentional, because they wanted to limit the scope until they really figured out what they wanted to do. R2 has coded entries in the body that derive from the RIM. XML is the wire format, the RIM is �behind the scenes� Differences between R1 and R2 ---------------------------------------------- The R1 header was derived from the RIM, but the body was hand crafted. This was intentional, because they wanted to limit the scope until they really figured out what they wanted to do. R2 has coded entries in the body that derive from the RIM.

59. 59 CDA: A Document Exchange Specification This is a CDA and this and this and this and this and this and this Animation Anything that would go in a patient�s chart. Legally attestable Has a custodian (i.e. the entity holding the record at the time of creation).Animation Anything that would go in a patient�s chart. Legally attestable Has a custodian (i.e. the entity holding the record at the time of creation).

60. 60 CDA: electronic documents eDocuments for Interoperability Many CDA documents comprise an individual electronic medical record Key component for local, regional, national electronic health records Gentle on-ramp to information exchange Everyone uses documents EMR compatible, no EMR required All types of clinical documents Animation Can hold very primitive (scanned docs) or highly structured documents. Does not require physicians to purchase EMR systems or spend a lot of time recoding their records. Lets people start playing today, while providing for much richer data in the future.Animation Can hold very primitive (scanned docs) or highly structured documents. Does not require physicians to purchase EMR systems or spend a lot of time recoding their records. Lets people start playing today, while providing for much richer data in the future.

61. 61 Sample CDA Animation The CDA XML and how it is rendered. Maybe launch the actual CDA sample in a browser (with/without stylesheets). Open one in FireFox and one in IE. Animation The CDA XML and how it is rendered. Maybe launch the actual CDA sample in a browser (with/without stylesheets). Open one in FireFox and one in IE.

62. 62 CDA Header: Metadata Identify Patient Provider Document type... Sufficient for Medical records management Document management Registry/repositoryg Record locator service Store, query, retrieve Animation Note that human readable text is required.Animation Note that human readable text is required.

63. 63 CDA Body: Human-readable report Any type of clinical document H&P Consult Op note Discharge Summary... Format: tif, PDF, HTML, XML: Paragraph List Table Caption Link Content Presentation Animation Note that human readable text is required.Animation Note that human readable text is required.

64. 64 CDA Body: Machine Processible Model-based computable semantics: Observation Procedure Organizer Supply Encounter Substance Administration Observation Media Region Of Interest Act Animation Machine processible data is optional. Animation Machine processible data is optional.

65. 65 CDA: Incremental Computability You have 30 seconds to memorize this, and you be required to recreate this diagram from memory at the end of the class. You have 30 seconds to memorize this, and you be required to recreate this diagram from memory at the end of the class.

66. 66 Incremental Semantic Interoperability Patients transfer between providers with vastly different IT capabilities Need to support information requirements at point of care Full EMR adoption� not predictable based on past adoption curves Assume gradually rising, but still heterogeneous levels of sophistication Data formats (imaging, text, XML) Coded data (metadata, basic structure, simple results reporting, complex clinical statements) Animation Animation

67. 67 Investing in Information CDA can be simple CDA can be complex Simple encoding relatively inexpensive Complex encoding costs more You get what you pay for: like charging a battery, the more detailed the encoding the greater the potential for reuse

68. 68 Outline HL7 CDA CDA for exchange networks CDA+CCR=CCD Summary, Resources & Questions

69. 69 CDA document-based network EHR V-EHR PHR Patient Portal Physician Portal Health Record Bank

70. 70 CDA for Information Exchange International: basis of interoperability in most advanced national networks Finland, Greece, Canada, Germany, Japan, Korea, France, Italy, New Zealand, Australia, and more US: Federal Health Architecture/CHI CMS Notice of Proposed Rule Making Claims attachments using CDA + X12 First pilot concluded, others underway VA/DoD bi-directional exchange US: Document format for NHIN pilots, RHIO design NHIN Pilots: preliminary architecture HITSP: preliminary choice IHE Medical Summary � CDA for NHIN/RHIO exchange Animation CMS= center for medicare/medicaid services. Animation CMS= center for medicare/medicaid services.

71. 71 Major Implementations (outside US) PICNIC (European Union) SCIPHOX (Germany) HYGEIAnet/WebOnColl (Greece) Aluetietoj�rjestelm� (Finland) Health Information Summaries (New Zealand) Referrals (Australia) MERIT-9 (Japan) NHS (Wales) Buenos Aires HMO project (Argentina) Plus projects in France, Italy, Russia, Estonia, Taiwan, Korea� These are all major CDA based applications. The german, greek, finish, and japanese started as regional and are now national. For more info, ask Liora. These are all major CDA based applications. The german, greek, finish, and japanese started as regional and are now national. For more info, ask Liora.

72. 72 CDA: an international standard

73. 73 CDA: Investing in Information CDA at the Mayo Clinic Initiated in 1999 About 50,000 documents each week Clinical documents: Most important capital asset CDA at New York Presbyterian (was Col-Pres) �CDA Philosophy� Clinical notes contain critical information in narrative Best format for information mining and aggregation across applications 1/3 of all discharges summaries Mayo: 50,000/week now. Made a commitment to this in 99 before R1 was final. Their use case was not regional/national exchange, but rather that their investment in clinical records is their most important capital asset (more important their their buildings, hardware, or even their staff). They needed a format with the best chance at longevity. NY Pres: CDA Philosophy � many clinical systems in use. They want to be able to ask questions about care in the institution which are currently stored in many systems. Convert to CDA and store centrally, now they can ask those questions. Also using a medical dictionary and NLP. Ask Liora if you need to know more. Mayo: 50,000/week now. Made a commitment to this in 99 before R1 was final. Their use case was not regional/national exchange, but rather that their investment in clinical records is their most important capital asset (more important their their buildings, hardware, or even their staff). They needed a format with the best chance at longevity. NY Pres: CDA Philosophy � many clinical systems in use. They want to be able to ask questions about care in the institution which are currently stored in many systems. Convert to CDA and store centrally, now they can ask those questions. Also using a medical dictionary and NLP. Ask Liora if you need to know more.

75. IHE Medical Summaries HIMSS 2006: a CDA Gallery - HIMSS 2006 - Apps that implement IHE - GE has imported the touchworks document, and you can see how they are extracting the coded data. - EMR to EMR interoperability is almost unheard of. - MediNotes (not a big player). - Siemens (generates PDF and XML). Supported by EHRVA. - HIMSS 2006 - Apps that implement IHE - GE has imported the touchworks document, and you can see how they are extracting the coded data. - EMR to EMR interoperability is almost unheard of. - MediNotes (not a big player). - Siemens (generates PDF and XML). Supported by EHRVA.

76. 76 Here is a list of vendors that support CDA. At the end we will show some screenshots. Here is a list of vendors that support CDA. At the end we will show some screenshots.

77. 77 Outline HL7 CDA CDA for exchange networks CDA+CCR=CCD Summary, Resources & Questions

78. 78 Agreements/MOUs * Accredited Standards Committee X12 � ASC-X12 * American Dental Association � ADA o ADA Joint Project Statement * American Society for Testing Materials � ASTM * CEN/TC 251 * Clinical Data Interchange Standards Consortium � CDISC * Digital Imaging and Communication In Medicine � DICOM * eHealth Initiative � eHI * Institute for Electrical and Electronic Engineers � IEEE * Integrating the Healthcare Enterprise � IHE * Medbiquitous * National Council for Prescription Drug Program � NCPDP * OASIS * Object Management Group � OMG * University of Nevada Las Vegas � UNLV * College of American Pathologists - SNOMED International Division � SNOMED

79. 79 HL7�s CDA Clinical Document Architecture ANSI/HL7 R1-2000, R2-2005 eDocuments for Interoperability Key component for local, regional, national electronic health records Gentle on-ramp to information exchange Everyone uses documents EMR compatible, no EMR required All types of clinical documents

80. 80 ASTM�s CCR

81. 81 CDA & CCR: differences CCR: simpler XML, but not as expressive. Schemas are normative for CCR. CCR: simpler XML, but not as expressive. Schemas are normative for CCR.

82. 82 ASTM CCR vs. HL7 CDA Conflicting? Overlapping? What if you could have both!#*?I!! What if you could have your data elements And send them in a common exchange framework?

83. 83 ASTM CCR + HL7 CDA = CCD CDA is designed to support professional society recommendations, national clinical practice guidelines, standardized data sets, etc. From the perspective of CDA, the ASTM CCR is a standardized data set that can be used to constrain CDA specifically for summary documents. The resulting specification, known as the Continuity of Care Document (CCD), is being developed as a collaborative effort between ASTM and HL7.

84. 84 ASTM�s CCR

85. 85 Continuity of Care Document CCD maps the CCR elements into a CDA representation.

86. 86 Continuity of Care Document Did this come out of the blue? There is a history of collaboration Many people have participated in both efforts Presentation on CDA for continuity of care at ASTM CCR meeting, August, 2003 Memorandum of Understanding, 2004 Acapulco demo: CDA for CCR, October, 2004 HL7 partnered with Massachusetts Medical Society, Microsoft, Ramsey Systems (UK) Initial HL7 Care Record Summary ballot, April, 2005: Limited to CDA header, no detailed section coding Anticipated: �Development of detailed (CDA Level 3) Implementation Guides for �continuity of care� (CCR) in collaboration with the ASTM E31 under the 2004 Memorandum of Understanding� HL7 ballot on CCR, Spring 2005: incorporated changes required for bi-directional exchange and semantic interoperability

87. 87 Continuity of Care Document �ASTM is dedicated and�privileged to work in collaboration with HL7 on the expression of ASTM's Continuity of Care Record content within HL7's CDA XML syntax and the seamless transformation of clinical and administrative data between the two standards.� Rick Peters, MD, E31.28

88. 88 Continuity of Care Document Benefits Industry concensus on summary document contents and requirements through ASTM ballots (2004, 2005) Industry concensus on document exchange framework through HL7 ballots (1999-2005) Summaries for continuity of care Interoperable with full range of document types Interoperable with HL7 V3 messages, all RIM-based specifications (public health reporting, clinical trials, structured product labels and more)

89. 89 Outline HL7 CDA CDA for exchange networks CDA+CCR=CCD Summary, Resources & Questions

90. 90 CDA for Interoperability HL7/ANSI specification based on Reference Information Model (RIM) Extensible Markup Language (XML) Standard Terminology The spec: Header+Human-readable report+(optional) computable semantics Industry acceptance: Internationally implemented for 6 years US: FHA, CHI, CMS, VA, DoD, NHIN, HITSP... Vendor support: strong & growing Interoperability Full patient record, not just the data that can be coded today Full patient record � summaries and more, implementation guides in the works from multiple professional societies and agencies

91. 91 Current Work HL7 Continuity of Care Document (with ASTM) Pathology reports (with CAP) Imaging reports (with DICOM) Claims attachments, migrate from R1 (with CMS) Medical Summary (with IHE, EHR Vendors Association) Dental reports (with ADA) Anesthesiology Reports (with Anes SIG) Public health reports (with CDC) ... What should we be doing to develop standard documents for LTC?

92. 92 References & More Info www.HL7.org Structured Documents Technical Committee web page All meetings, listservs, open to all JAMIA Dolin RH, Alschuler L, Boyer S, Beebe C, Behlen FM, Biron PV, Shabo A. HL7 Clinical Document Architecture, Release 2. J Am Med Inform Assoc. 2006;13:30�39. http://www.jamia.org/cgi/reprint/13/1/30 Care Record Summary http://www.hl7.org/Library/Committees/structure/CareRecordSummary%5FI2%5F2005SEP%2Ezip CDA Release 2.0 Normative Edition: see HL7.org AlschulerAssociates.com liora@alschulerassociates.com Quick Start Guides CDA/CRS Validator CDA Gallery

93. 93

96. Alschuler Associates, LLC Consultants in standards-based solutions for healthcare information working with vendors, providers, standards developers Clients Military Health System Enterprise-wide documents, files, images (DFIEA) Centers for Disease Control and Prevention Implementation Guide for infectious disease reporting (NHSN) North American Association of Central Cancer Registries Implementation Guide for cancer abstracts Department of Health and Human Services Subcontracts on Health IT Standards Panel (HITSP) and Health Information Standards for Privacy and Confidentiality (HISPC) American Hospital Association Use case development for healthcare IT standards initiative CDA4CDT Co-founder & Project Management Private, commercial clients: Fortune 100 and startups www.alschulerassociates.com

97. HL7 CDA what is it where is it used CCD CDA4CDT & the PEHRC

98. Health Level Seven Non-profit ANSI Standards Development Organization 20 years old 2000+ members individual, corporate 30 affiliates US affiliate in near future �A model community�: building standards to a single information model

99. HL7 Steering Divisions

100. CDA: A Document Exchange Specification This is a CDA and this and this and this and this and this and this

102. CDA Design Principles priority is patient care, other applications facilitated minimize technical barriers to implementation promote longevity of clinical records scoped by exchange, independent of transfer or storage enable policy-makers to control information requirements Animation Animation

103. Sample CDA

104. CDA Header: Metadata Identify Patient Provider Document type... Sufficient for Medical records management Document management Registry/repository Record locator service Store, query, retrieve

105. CDA Body: Human-readable report Any type of clinical document H&P Consult Op note Discharge Summary... Format: tif, PDF, HTML, XML: Paragraph List Table Caption Link Content Presentation

106. CDA Body: Machine Processible Model-based computable semantics: Observation Procedure Organizer Supply Encounter Substance Administration Observation Media Region Of Interest Act Animation Machine processible data is optional. Animation Machine processible data is optional.

107. CDA: Incremental Semantic Interoperability

108. Primary Use Cases access/portability/exchange query/locate by patient, provider, practitioner, setting, encounter, date access distributed information through common metadata document management integration transcription systems EHR records re-use/derivative data summaries, reports decision support

109. CDA for Information Exchange in the US Recommended by Health Information Technology Standards Panel (HITSP) work groups CMS Notice of Proposed Rule Making Claims attachments using CDA + X12 First pilot concluded, others underway Widespread vendor adoption: Integrating the Healthcare Enterprise CDA4CDT Other

110. Current Implementation: US Mayo Clinic Initiated in 1999 About 50,000 documents each week Clinical documents: Most important capital asset New York Presbyterian �CDA Philosophy�: mix of fielded data and narrative Best format for information mining and aggregation across applications Clinical notes contain critical information in narrative 1/3 of all discharges summaries Military Health System Documents, Files, Images Enhanced AHLTA (DFIEA) Enterprise-wide document management Web-services gateway to VA, civilian providers MHS/VHA Bi-direction Health Information Exchange Enterprise Wide Referrals and Authorizations University of Pittsburgh Medical Center Narrative notes using speech recognition, NLP Linking radiology reports with PACS-rendered image Other Kaiser, Trinity, Partners, Ochsner...

111. CDA for Information Exchange IHE choice for Medical Summaries: 2006

112. IHE Medical Summaries HIMSS 2006: a CDA Gallery

113. CDA for Information Exchange

114. CDA & CCD IHE Profiles 2005-2007 based on the Care Record Summary (CRS) first standard implementation guide for CDA restricted to �level 2� to avoid competition w/CCR covered a wider number of use cases IHE 2007-2008 will move to conform with CCD New CDA implementation guides also conform with CCD

119. CDA beyond CCD Not everything we want to exchange is a summary Let�s look at what�s happening with development of other document types...

120. Other CDA content profile development Within HL7: Clinical domains: anatomic pathology, imaging, lab, anesthesiology, pediatrics, long term care, others? ASIG: HIPAA Attachments � adding dental Outside HL7: Public health & MDS NAACCR Cancer abstracts (no HL7 ballot) CDC Infectious Disease Reports (will be HL7 ballot) MDS: soon, from HHS IHE 2006: 1 content type built on HL7 CRS 2007: 7 content types, some constrain CRS, others new Current cycle: updating all to be consistent with CCD adding Discharge Summary CDA4CDT

121. CDA for Common Document Types Project initiated in January, 2007 M*Modal AHDI(was AAMT)/MTIA AHIMA Strong support from dictation / transcription and document management industries Cooperation/coordination with HL7, IHE, EHR vendors and providers

122. CDA4CDT Mission Develop CDA Implementation Guides (IGs) for common types of electronic healthcare documents Bring them through the HL7 ballot process Promote their use and adoption by healthcare organizations and health information exchange networks

123. Rationale Enlarge and enrich the flow of data into the electronic health record Speed the development of interoperable clinical document repositories Bridge the gap between narrative documents produced through dictation and the structured, computable records within an EHR

124. Assumptions: EMR/EHR is the solution Documents are the problem Questions: Are they mutually exclusive or complementary? Can eDocuments bridge the gap? Why would physicians promoting the EHR have an interest in documents?

125. Problems with Documents Can�t compute Can�t automate decision support Can�t validate conformance to content requirements And why are they still prevalent? Nuanced & precise Support human decision making Retain current workflow eDocuments support narrative & codes multiple indices optimized for reimbursement, decision support, quality metrics, research Document management completes the EMR

126. Why encourage continued use of documents? Worst case: no computable clinical data no reuse + information at the point of care Best case: fully computable data to populate EHR Likely case: section-level reuse (i.e. HPI pre-populates Discharge Summary) � we can do this now gradual rise in semantic interoperability

127. Why not keep pushing for fully interoperable records? Semantic interoperability is hard over 250,000 concepts in SNOMED CT we can�t give up, we need safe computability Need information at the point of care Networks need data: self-sustaining networks have Big Data Initial ROI will spur further investment MTIA members process 300M documents/year Complex systems are built from simple systems CDA: no loss of computability

128. CDA4CDT will: Establish consensus on content using CDA eDocument format Propagate support for CDA within the dictation/transcription industry Create consistent electronic documents for importation into EMR, document repositories and health information exchanges Increase EMR adoption Highest potential: Massively increase amount of data in fledgling exchange networks because minimally disruptive to current workflow Defining success: At least 25% of RFPs for transcription, EMRs, integration and information exchange cite compliance as a requirement CDA4CDT: bridging the gap between EHRs and eDocuments

129. CDA4CDT Scope Develop implementation guide for use across the industry Rapid development, leverage framework, precedents Establish section-level content, reuse section templates H&P Timeline Initial draft in 7 weeks Balloted as HL7 Draft Standard for Trial Use March 26 ballot open, April 24 close Ballot reconciliation approximately 5 weeks Revised draft to ballot in August Consult Note Timeline Target August 2007 initial ballot Discharge Summary: Coordinating with IHE on publication Target publication fall 2007

130. Technical working group A focused group of working volunteers prior knowledge of CDA experience implementing CDA familiarity with the current set of CDA implementation guides Participation is open at all stages of the ballot and ballot review process CDA4CDT retains no copyright of balloted material

131. H&P Method Review precedents: ASTM�s Standard Specifications for Healthcare Document Formats (E2184.02) (Headings and subheadings used in the healthcare industry and associated with specific report types) HL7/ASTM Continuity of Care Document (CCD) Clinical LOINC document and section codes HL7 ASIG CDA R2 Attachment for Clinical Notes HL7 Care Record Summary (CRS) IHE profiles, including the content profiles within Patient Care Coordination MHS/DoD-VA-IM-IT Demo Project Discharge Summary and SOAP HL7 CDA R2 Implementation Guides Review samples/templates: Sample CDA documents developed for local provider institutions (Mayo Clinic, University of Pittsburgh Medical Center, New York Presbyterian, and others) Non-CDA sample documents supplied by participating providers and vendors H&P templates from AHIMA, vendors, providers Statistical analysis: over 15,000 dictated H&Ps by M*Modal Test design against samples

132. Draft H&P

133. Ballot results 78 comments received ACP, Trinity Health, Kaiser Permanente, VHA, Regenstreif Epic, GE, Medquist, Northrop All comments addressed All negatives will be withdrawn Draft in revision Will re-ballot in August/September If passed, will be �Draft Standard for Trial Use� (DSTU) stable platform for implementation within 2 years either normative or revised

134. Ballot issues Most difficult balance diversity of current practice against desire for consistency where can you lead the industry, where must you follow? Clarify intended content Past Medical History vs. Surgical History Physical exam: diversity of practice Define full set of sub-headings Allow narrative &/or sub-sections

135. Consult Note Same method as H&P consistent with precedents large scale analysis of dictated notes reuse section-level content review E&M guidelines Examine required metadata Examine report contents Require �reason for referral� Relationship with �reason for visit�, �chief complaint� Seeking pre-ballot review

136. Future work Horizontal: additional document types Op note Specialize the History & Physical Vertical: supporting implementation Quick Start Guides for implementers Training for implementers Promotion: Among providers Education on utility, strategic value End-user training for compliance Whatever it takes to support and promote widespread adoption

137. How can PEHRC, PEHRC members get involved? Participate in design review through CDA4CDT through HL7 Structured Documents TC through HL7 Board of Directors Participate in the ballot as HL7 member or non-member Encourage implementation within professional society within practice group

138. CDA for Common Document Types Founders: Benefactors: Participants: Acusis, Kaiser Permanente, Mayo Clinic, Military Health System, University of Pittsburgh Medical Center, GE Healthcare Management:

139. Short history of CDA Early 1996: Dr. John Mattison runs into Dr. John Spinosa in the parking lot of the Bank of America, La Jolla, CA informal group of physicians with interest in SGML meets monthly build on seminal work of Drs. Lincoln & Essin Jan. 1997: Joined HL7 as SGML SIG July 1997: Kona Architecture developed: principles of coordinated document-based specifications for incremental semantic interoperability Sept. 1997-99: Creation of formal specification; renamed and RIM-based Sept. 2000: Membership ballot passes unanimously; 108 organizations/individuals participate January 2005: CDA Release 2.0 passed membership ballot April 2007: Publication of HL7/ASTM Continuity of Care Document (CCD) Implementation Guide for CDA Recommended by ANSI HITSP for NHIN Many other implementation guides in the works

140. HL7�s Clinical Document Architecture Based on: HL7�s Reference Information Model Extensible Markup Language (XML) Controlled terminology Eight years of implementation experience Mayo Clinic since 1999 PICNIC: EU project across 14 countries Basis of the most extensive and successful exchange networks Finland, Greece, Germany, Japan, France, Italy, England, others

141. How do we move forward and achieve a comprehensive electronic record? What if you could continue to use narrative and dictation and at the same time increase usage of the EHR and make more records available for the health information exchange?

142. HL7: patient-centered health information

143. CDA from Dictation narrative documents can be enhanced through natural language processing and use of templates with no disruption to the existing workflow