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 Geneva, Switzerland, 26-27 April 2012 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. Major Components of a CDA Document <ClinicalDocument> ... <structuredBody> <section> <text>...</text> <observation>...</observation> <substanceAdministration> <supply>...</supply> </substanceAdministration> <observation> <externalObservation> ... </externalObservation> </observation> </section> <section> <section>...</section> </section> </structuredBody> </ClinicalDocument> Header Narrative Block External References E N T R I E S S E C T I O N S B O D Y D O C U M E N T 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 Standard EHR Interface National /xborder Requirements Local EHR Clinical reuse Decision support Secondary use CDA Template Library Quality reporting CDA Implementation Guide 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 ability to 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. Templated CDA Many different kinds of documents A bucket of reusable templates Trifolia Workbench : CDA Template Library 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 templates constrain the allowable entries Entry-level templates, define the atomic clinical statements within document sections greenCDA XML CDA Template Library Data Entry Form CDA Instance Validation CDA Implementation Guide Support for standards development Runtime API Support for standards implementation Green CDA The problem 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; Geneva, Switzerland, 26-27 April 2012 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 GreenCDA schema modular and easily reproducible We call this strategy: greenCDA greenCDA schemas are modular, corresponding to CDA templates. 9 CDA Interoperability Roadmap 1. 2. Get the data flowing, get the data flowing, get the data flowing. Incrementally add structure, where valuable to do so. Quality Reporting Decision Support Clinical Applications Meaningful Use! Coded Discrete Data Elements HL7 CDA Structured Documents Narrative Text SNOMED CT Disease, DF-00000 Metabolic Disease, D6Disorder of carbohydrate 00000 metabolism, D6-50000 Disorder of glucose metabolism, D6-50100 Diabetes Mellitus, DB-61000 Type 1, DBNeonatal, 61010 DB75110 Carpenter Syndrome, DB02324 Insulin dependant type IA, DB-61020 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. Extra slides Geneva, Switzerland, 26-27 April 2012 12 Conclusions and Recommendations Templated 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. Geneva, Switzerland, 26-27 April 2012 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 13 Continuity of Care Document • • • • • • • • Clinical history Advance Directives Support Functional Status Problems Family History Social History Allergies • • • • • • • • Medications Medical Equipment Immunizations Vital Signs Results Procedures Encounters Plan of Care 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 HIT Standards, Terminologies, and Profiles: a Strong Collaboration Drive 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 www.jointinitiativecouncil.org Integrating the Healthcare Enterprise (Content profiles) Continua Health Alliance (personal health devices CDA Template Development* TODAY A thousand flowers bloom * After the Gartner Curve Active Harmonization Gradual increase in templates demanded by new use cases 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 New Section… Discharge Diet Surgical Finding Mode of Transport Discharge Diagnosis Chief Complaint Payer Problems Medications Vital Signs Social History Family History Allergies CDA .... Demographics CCD The Business Case for CDA CDA is highly flexible and configurable – CDA support every type of clinical document. A single standard for the entire EHR may be too broad. Multiple standards and/or messages for 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. Requirements for Achieving Quality Policy Alignment Relevant Standards Economic Incentives Industry Collaboration Public Health Support Research Validation Trust Collaboration If you want to go fast, go alone. If you want to go far, go together. - African Proverb Quality Reporting Framework Leveraging Open Source Quality Measures popHealth: An open-source quality measure eMeasure QRDA Category II/III Reports PQRI XML Registry Specification QRDA Category I Instances Quality Assessment using CDA Templates Translating a Use Case to CDA Understanding Templated CDA Highly Configurable CDA Templates 30.05.2016 Content for Patient Summary ‘Minimum dataset’ Information/dataset Contains Patient Identification Unique identification for the patient in that country. Patient Personal information Allergies Full name. Date of birth Gender 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 Country Name of Country of origin of the patient (country A) 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 Example: Need for information in France Hospital in Dijon (CHU Dijon) ? • 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 J. Thorp 2011 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 Request for information CHU de Dijon J. Thorp 2011 Request from NCP France to NCP Austria • The French NCP issues a request for information to the Austrian NCP. French NCP Request for information Austrian NCP J. Thorp 2011 Austrian Patient Summary – 1 1. The Austrian Patient Summary of the patient is located 2. 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 Austrian Patient Summary – 2 1. The original document is transformed into an epSOS document 2. The original document is also transformed into a pdf file 3. The pdf has the same header as the epSOS document (in order to provide the link and the traceability between the two documents) epSOS CDA original pdf with the same CDA header CDA+ pdf National Connector and National Transformer J. Thorp 2011 Information from Austrian NCP to French NCP • The Austrian NCP sends two documents to the French NCP: • the transformed document (in epSOS format) • the original document in a document (pdf) format French NCP Information returned Austrian NCP J. Thorp 2011 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. Information returned original pdf with the same CDA header French NCP epSOS CDA CHU de Dijon J. Thorp 2011 Austrian Patient summary is understandable by the French physician J. Thorp 2011 CDA: Towards Standard EHR Interface Quality Measure EHR system Decision Support Comparative Effectiveness Clinical Research Public Health CDA Template Library