HL7 CDA and its broad adoption

1. Joint ITU-WHO Workshop on e-Health Standards and Interoperability(Geneva, Switzerland, 26-27 April 2012) HL7 CDA and its broad adoption Catherine Chronaki Affiliate Director, HL7 International Board of Directors chronaki@ics.forth.gr

2. What is CDA? • CDA is a document markup standard for the structure and semantics of an exchanged "clinical document". • CDA embodies business critical characteristics • Persistence • Stewardship • Potential for authentication • Context • Wholeness • Human readability • A CDA document can • exist outside of a message • include text, images, sounds, multimedia content.

3. Major Components of a CDA Document Header Narrative Block D O C U M E N T E N T R I E S S E C T I O N S B O D Y External References <ClinicalDocument> ... <structuredBody> <section> <text>...</text> <observation>...</observation> <substanceAdministration> <supply>...</supply> </substanceAdministration> <observation> <externalObservation> ... </externalObservation> </observation> </section> <section> <section>...</section> </section> </structuredBody> </ClinicalDocument>

4. What are CDA Characteristics? • Richly expressive and flexible • Encoded in Extensible Markup Language (XML). • Based upon HL7's Reference Information Model (RIM) • Enables data reuse • Patient summaries • Lab and pharmacy messages • Clinical research • Electronic prescriptions • Clinical Decision Support • Public Health • Quality assessment • Constrained by Templates, conformance profiles, implementation guides to be fit for purpose

5. Standard EHR Interface National /xborder Requirements Local EHR Clinical reuse Decision support Secondary use Quality reporting CDA Template Library CDA Implementation Guide

6. What is the Key Value of CDA? Incremental Interoperability means that an implementer can begin with a simple CDA, and then add structured data elements over time. CDA R2 consists of a single CDA XML Schema, and the “architecture” arises from the abilityto apply one or more “templates” which serve to constrain the richness and flexibility of CDA. Professional society recommendations, national clinical practice guidelines, standardized data sets can be expressed as CDA templates. Trifolia workbench library freely available to HL7 members: numerous types of reusable templates that might be created in CDA.

7. Templated CDA Many different kinds of documents A bucket of reusable templates

8. Trifolia Workbench : CDA Template Library greenCDA XML • There are many kinds of templates that might be created. Particularly relevant for documents are: • Document-level templates constrain the CDA header and allowable sections • Section-level templatesconstrain the allowable entries • Entry-level templates, define the atomic clinical statements within document sections CDA Template Library Data Entry Form CDA Instance Validation CDA Implementation Guide Runtime API Support for standards development Support for standards implementation

9. Green CDA The problem The solution Create “authoring schema” to simplify IG creation/ processing: Clinically meaningful XML element and attribute names; 100% transformable into conformant CDA IG; Hiding complexities of HL7 v3 GreenCDAschema modular and easily reproducible We call this strategy: greenCDA greenCDA schemas are modular, corresponding to CDA templates. • An instance conforming to an CDA Implementation Guide may require knowledge multiple specifications • CDA R2 base specification; • HL7 Version 3 data types • CDA templates defined in the IG; • CDA templates referenced by IG; • Terminology code lists defined/referenced by IG; • Validation of an instance conforming to a CDA IG may require additional validation • W3C Schema validation; • Schematron validation;

10. CDA Interoperability Roadmap • Get the data flowing, get the data flowing, get the data flowing. • Incrementally add structure, where valuable to do so. Quality Reporting Decision Support Disease, DF-00000 Metabolic Disease, D6-00000 Clinical Applications Disorder of carbohydrate metabolism, D6-50000 Disorder of glucose metabolism, D6-50100 Meaningful Use! Diabetes Mellitus, DB-61000 SNOMED CT Type 1, DB-61010 Neonatal, DB75110 Carpenter Syndrome, DB-02324 Insulin dependant type IA, DB-61020

11. Why CDA is so widely adopted? • Numerous implementations worldwide • Japan, Korea, France, Europe (epSOS,..), US, Canada, .. • CDA hits the “sweet spot” • CDA expresses clinical documents. A single standard for the entire EHR is too broad. Multiple standards and/or messages for each EHR function may be difficult to implement. CDA is “just right”. • Implementation experience – green CDA • CDA has been a normative standard since 2000, and has been balloted through HL7's consensus process. CDA is widely implemented. • Gentle on-ramp to information exchange • CDA is straight-forward to implement, and provides a mechanism for incremental semantic interoperability. • Improved patient care • CDA provides a mechanism for inserting evidence-based medicine into the process of care (via templates) • CDA crosses institutional borders/Lower costs • CDA’s top down strategy let’s you implement once, and reuse many times for new scenarios.

12. Extra slides

13. Conclusions and Recommendations Templated CDA Future of CDA CDA Version 3 Rapid adoption of template libraries Template/ schema tooling Vocabulary binding International resources ISO Standardization Lessons from CDA adoption Intuitive/ low entry Free Trifolia library Collaboration Mobile health comes next with Green CDA • Provides reusable building blocks • Streamlines efforts: Implement once, deploy often. • Promotes modularity and reusability across Igs • Offers “incremental interoperability” is core to CDA’s strategy : Begin with simple CDA, and add templates as they are prioritized.

14. Continuity of Care Document • Medications • Medical Equipment • Immunizations • Vital Signs • Results • Procedures • Encounters • Plan of Care • Clinical history • Advance Directives • Support • Functional Status • Problems • Family History • Social History • Allergies

15. CDA Guiding Principles Prioritizes documents generated by clinicians involved in direct patient care. Minimizes the technical barriers needed for implementation Promotes longevity of all information Enables exchange that is independent of the underlying transfer or storage mechanism. Assures that policy-makers can control their own information requirements without relying upon extensions

16. HIT Standards, Terminologies, and Profiles: a Strong Collaboration Drive www.jointinitiativecouncil.org • Standards Development Organizations • HL7 International, ISO/TC 215 Health Informatics, IHTSDO CEN/TC 251 Health Informatics, CDISC, GS1, others • Terminologies • Regenstrief (LOINC) • EDQM • WHO (ICD) • Integration Profiles • Integrating the Healthcare Enterprise (Content profiles) • Continua Health Alliance (personal health devices

17. CDA Template Development* TODAY Active Harmonization A thousand flowers bloom Gradual increase in templates demanded by new use cases * After the Gartner Curve

18. Templated CDA • Many different kinds of documents • A library of reusable templates A CDA document using CCD templates plus others A CDA document using CCD templates CCD New Section… DischargeDiagnosis Mode ofTransport Surgical Finding Chief Complaint Discharge Diet Family History Medications Problems Payer Vital Signs Allergies Social History Demographics . . . . CDA

19. The Business Case for CDA CDA is highly flexible and configurable – CDA support every type of clinical document. A single standard for the entire EHRmay be too broad. Multiple standards and/or messagesfor each EHR function may be difficult to implement. CDA satisfies all such needs. CDA Implementation experience is vast - CDA has been a Normative Standard since 2000, and has been balloted through HL7's consensus process. CDA is widely implemented. CDA provides a gentle on-ramp to information exchange - CDA is straight-forward to implement, and provides a mechanism for incremental semantic interoperability. CDA improves patient care - CDA provides a mechanism for inserting evidence-based medicine directly into the process of care (via templates) CDA lowers costs – Leveraging CDA provides “top down” strategy allowing initial implementation to be reused many times for highly varying scenarios.

20. Requirements for Achieving Quality • Policy Alignment • Relevant Standards • Economic Incentives • Industry Collaboration • Public Health Support • Research Validation • Trust

21. Collaboration If you want to go fast, go alone. If you want to go far, go together. - African Proverb

22. Quality Reporting Framework

23. Leveraging Open Source Quality Measures eMeasure QRDA Category II/III Reports PQRI XML Registry Specification QRDA Category I Instances popHealth: An open-source quality measure

24. Quality Assessment using CDA Templates

25. Translating a Use Case to CDA

26. Understanding Templated CDA

27. Highly Configurable CDA Templates

28. 01.01.2020

29. Content for Patient Summary ‘Minimum dataset’ Information/dataset Contains Patient Identification Unique identification for the patient in that country. Patient Personal information Full name. Date of birth Gender Allergies Allergy description and agent Medical Alerts Other alerts not included in allergies List of current problems Problems/diagnosis that need treatment and/or follow up by a Health Professional Medication Summary Current medications Name of Country of origin of the patient (country A) Country Date of Creation Data on which PS was generated Date of last update Data on which PS was updated Author organization At least an author organization (HCPO) shall be listed. In case there is not HCPO identified at least a HCP shall be listed. J. Thorp 2011

30. Example: Need for information in France Maria Schmidt, a 25 year old Austrian student shows up at the Emergency department at CHU Dijon (Hospital in Dijon). The chief complaint is abdominal pain occurring 3 to 4 hours after a meal An abdominal x-rays show signs of intestinal occlusion. The overall clinical presentation is inconclusive, with a diffuse abdominal pain and not needing surgical intervention The physician considers keeping the patient under observation only, or performing an exploratory laparotomy Hospital in Dijon (CHU Dijon) ? J. Thorp 2011

31. Request to the French NCP As the physican knows that epSOS can provide more information, she searches for the patient. The search is directed towards the French National Contact Point (NCP), which in turn will provide the location of the student’s Patient Summary French NCP CHU de Dijon Request for information J. Thorp 2011

32. Request from NCP France to NCP Austria The French NCP issues a request for information to the Austrian NCP. French NCP Austrian NCP Request for information J. Thorp 2011

33. Austrian Patient Summary – 1 • The Austrian Patient Summary of the patient is located • The document is syntactically transformed into the epSOS format, according to the specifications xml - epSOS CDA original Transformation National Connector and National Transformer J. Thorp 2011

34. Austrian Patient Summary – 2 • The original document is transformed into an epSOS document • The original document is also transformed into a pdf file • The pdf has the same header as the epSOS document (in order to provide the link and the traceability between the two documents) original pdfwith the same CDA header epSOS CDA CDA+ pdf National Connector and National Transformer J. Thorp 2011

35. Information from Austrian NCP to French NCP The Austrian NCP sendstwo documents to the French NCP: the transformed document (in epSOS format) the original document in a document (pdf) format Austrian NCP French NCP Information returned J. Thorp 2011

36. Results available for the French physician The French physician receives the original document as pdf in German as well as the transformed document in the epSOS format. French NCP Information returned original pdfwith the same CDA header epSOS CDA CHU de Dijon J. Thorp 2011

37. Austrian Patient summary is understandable by the French physician J. Thorp 2011

38. CDA: Towards Standard EHR Interface Quality Measure EHR system Decision Support CDA Template Library Comparative Effectiveness Clinical Research Public Health