TDT4210 Lecture Sept. 14th 2005: Part 2: Electronic Patient Records – archives and history

1. TDT4210 Lecture Sept. 14th 2005:Part 2: Electronic Patient Records – archives and history Ø. Nytrø/I. D. Sørby, IDI, NTNU

2. The Patient Record: (Norw.: Pasientjournalen) • Eng.: • EPR: Electronic patient record • EHR: Electronic health record • CPR: Computerized patient record • CMR: Computerized medical record • EMR: Electronic medical record • The record is: • An account of a patient’s health and disease after he or she has sought medical help • A legal report of medical actions • A (historic) source of information that is shared among care providers • A working tool supporting patient care • A tool for classification T. Nystadnes, KITH. Translated/adjusted for TDT4210 by Ø. Nytrø and I. D. Sørby

3. The patient record (cont.): • Physician’s record, nursing record, dentists record... • Every care provider is obliged to keep a record • The Norwegian Record (”Norgesjournalen”, R. Piene) • Hierarchic, structured in folders • Electronic: • First for GPs • Not paper based • Scanned paper (!) • Functionality: Cronological, not contents based T. Nystadnes, KITH. Translated/adjusted for TDT4210 by Ø. Nytrø and I. D. Sørby

4. Patient record contents: • Observations • Statements • Test- and laboratory answers • Pictures • Diagnoses • Family information • Assessment • Information about medications • Documents: Reports, sick leaves, prescriptions • Free text notes • Codes: Diagnoses (ICPC, ICD10, SNOMED etc.) T. Nystadnes, KITH. Translated/adjusted for TDT4210 by Ø. Nytrø and I. D. Sørby

5. Important aspects of the EPR: • Important to distinguish between patient record contents, system, and user interface (Contents ≠ System ≠ Interface) • Record contents is used differently by health care personnel in various roles and situations • Possible to utilize an electronic medium such that: • It is possible to navigate and search in the information • The information can be filtered • The information can be adapted to each individual user (physician, nurse, patient) and situation • ”Decision support” used to be ”hot”, but is now merely seen as part of the solutions • Access control vs. patients’ rights and confidentiality • Patient record contents also used in research activities • Sharing of information between different health care services • Record and record system architecture T. Nystadnes, KITH. Translated/adjusted for TDT4210 by Ø. Nytrø and I. D. Sørby

6. EPR standardizationFrom structured components to archetypes Torbjørn Nystadnes, KITH, Adjusted/translated 2005 by I. D. Sørby

7. Contents • What is an electronic patient record? • Short ”historic” overview • The main principles in a generic EPR architecture • Two level modeling, use of templates/archetypes

8. Dagbladet 2. Juni 1998:

9. What is an electronic patient record: • Administrative and medical patient data electronically stored in a consistent way. A computer-based patient record may contain characters, signals, images, and sounds • Normally, only one record for each patient within one health care service should exist, even if the patient receives help from several categories of care providers • Different health care services cannot use shared patient records • The patient’s consent or other legal justification is needed to give access to or to hand out record or record information

10. EPR standardization work CEN/TC251 - WG1 (European Committee for Standardization, Technical Committee for health informatics, work group 1, www.centc251.org) • 1995: ENV-12265 EHCRA - Electronic healthcare record architecture • Basic mechanisms to describe data contents and structure • EPR consists of components in a structure • 1999: ENV13606:Electronic Healthcare Record Communication: • Extended Architecture - generic record architecture • Domain Term List – terms used for headlines for groups of record information • Distribution Rules – access control • Messages for Exchange of Record Information • 2002: Task Force EHRcom – revision of ENV13606 ISO/TC215 - WG1 http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=infostand_ihisd_isowg1_e • International standards for health informatics • Technical specification: "Requirements for an Electronic Health Record Reference Architecture” • Co-operation with CEN/TC251

11. CEN/TC251 – WG1

12. Health Level 7 (www.hl7.org) • An American National Standards Institute (ANSI) approved Standards Developing Organization (SDO). • A not-for-profit volunteer organization • Its members-- providers, vendors, payers, consultants, government groups and others who have an interest in the development and advancement of clinical and administrative standards for healthcare—develop the standards • Health Level Seven’s domain is clinical and administrative data • HL7 v3 RIM (Reference Information Model) • RIM is a large pictorial representation of the clinical data (domains) and identifies the life cycle of events that a message or groups of related messages will carry • Co-operation between CEN/TC251, ISO/TC215, and HL7 in order to harmonize the standardization work

13. openEHR foundationhttp://www.openEHR.org openEHR aims • promote and publish the formal specification of requirements for representing and communicating electronic health record information, based on implementation experience, and evolving over time as health care and medical knowledge develop; • promote and publish EHR information architectures, models and data dictionaries, tested in implementations, which meet these requirements; • manage the sequential validation of the EHR architectures through comprehensive implementation and clinical evaluation; • maintain open source "reference" implementations, available under licence, to enhance the pool of available tools to support clinical systems; and • collaborate with other groups working towards high quality, requirements-based and interoperable health information systems, in related fields of health informatics.

14. CEN Task Force: EHRCom • Revision of ENV 13606 to a adequate European standard (EN) for communication of EPR • Is among others based on the following: • ENV13606 – This shall be the basis • Other CEN standards and prestandards • Similar work performed by ISO • The ongoing harmonization process with HL7 • The vendors’ experiences with ENV13606 • openEHR • Architecture and domain specific needs are to be separated • "Archetypes" should be used to describe domain specific needs • It should be possible to use various communications methods

15. EHRCom • The work is divided into the following tasks: • Reference Model • Archetype Model • Archetype Generation • Terminology Support • Security Features • Exchange Messages • Liaison with Industry • Documentation and Dissemination

16. Norwegian EPR standard: Architecture, archives and access control • Initiated by The Ministry of Health and Care Services • Developed by a project task force chaired by KITH: • The Norwegian Medical Association (Legeforeningen), Norwegian Nurses Association (Sykepleierforbundet), The Norwegian Board of Health, and The National Archival Services of Norway (Riksarkivet) was represented in the working group • A broad reference group • Is based on laws and regulations and Norwegian and international standards: • Noark-4 • ENV13606 Electronic Healthcare Record Communication • Has been on a broad hearing and was finished in June 2001

17. About the standard • The standard should be used for • Every kind of patient records • In every health care service • The patient records must be able to contain all types of information • It describes requirements concerning: • Access control • Handling of patients’ rights • One basic, generic record architecture • But concrete document types etc. is not described • Mechanisms for handling of code systems etc. • Format for delivery of EPR to depot archive • Forms a basis for record information exchange between different health care services

18. EPR architecture • EPR consists of components in a structure • Several structures in one record possible, e.g. primarily organized by: • Process (episode of care etc.) • Problem • Traditional topic related document groups • The structures are primarily hierarchical • Powerful reference mechanisms leads to other opportunities as well • One component may be located several places… • …but any component has one primary connection to one superior component (original context)

19. Generic EPR architecture  "Dokument"  "Sak" "Fragment"   "Dataelement"

20. The case concept (Norw.: sak) • The EPR may include the following main case types: • Subject related cases • E.g.: Document groups according to the recommendations of the Norwegian Board of Health (Helsetilsynet) • Such cases should normally always stay open • Problem related cases • Some cases may be related to concrete diagnoses… • Others may be more diffuse • Process related cases • E.g.: Episode of care, contacts • Shall be able to contain subprocesses • Every case consists of: • one case head which describes the case, a number of documents and/or other cases and/or imported documents

21. Cases  Problem: Diabetes Episode of care 12.-21.06.01 Test answers - tissue and fluid  Documents Cases and documents

22. Documents and fragments • One document represents one independent registration in the record • Approval as one whole • E.g.: Record note, referral, discharge report, requisition • Every document consists of a number fragments • The fragments are approved as part of the document • Every fragment consists of • one or more data elements • and/or other fragments • and possibly one or more headings

23. Type of document:Referral Fragment type:Issued by Name of health personnel, role etc Health care service name, address etc. Fragment type:Problem description Problem code Problem description Fragment type: Desired process Code for treatment or investigation Process code Process description Fragment type:Document head Recipient name, address etc. Patient name, ID number, address Documents and fragments

24. Other structure elements • Possibility of links between components in EPR • Links are associated with a link type, e.g. • <...> is caused by <...> • (the hepatic injury is caused by drug) • <...> indicates <...> (Norw.: <…> er holdepunktet for <…>) • (the test result indicates an infectious disease) • Links to components of other patients’ EPR can be created • Connections to components of the EPR about the same patient at a different health care service can be made

25. Templates for cases, documents, etc. • This is a basic standard which mainly describes how record contents is to be handled, not the information itself • Document templates are needed in order to be able to use the standard in particular health care services • A complete (?) set of such templates are developed for the maternal, child and school health services (Norw.: helsestasjons- og skolehelsetjenesten) • Templates for medical treatment and some other minor areas are developed • Templates for other parts of the health care service is under development

26. Two-level modeling: Use of archetypes

27. XML -document with clinical information "EHCR template" XML document that includes "mapping" to the HL7 rim EHCR system XML-Schema Template "editor" Envelope EHCR message  Documentation Information model Original "document" XML document Template development

28. Medication templates

29. Access control • Principle: • A decision to carry out a concrete procedure with a legal objective has to be made before access to a patient record can be given • Decided action/process is used to state the aim of the access and to delimit what health information that can be accessed • Roles describe the health care personnel’s rights according to treatments etc. • Roles are connected to organizational units • Some types of actions/procedures may only be effectuated if a former action which opens for this has been effectuated

30. Access consent (Norw: Samtykke til innsyn) • The patient has the right to deny health care personnel access to his/her record (but there are exceptions) • It should be possible to registrer the patient’s consent claim in the record • The claims might be connected to parts of the record, e.g. one case • The claims mighht be directed towards specific persons • Some selected actions/treatments can be excepted from the consent claim • It should be possible to state in the record if others than the patient can give access consent • The patient’s access consent can be limited to a specific action or a specific service provision

31. Consent claim Service provision:1 year follow-up Information Decided procedure:1 year follow-up Per Spellmann,patient Principles for access control Might bring forward Ola Normann Has Appear as Has Service provider:Ola Normann. physician, Dept. of surgery Role:Physician, Dept. of surgery EPR: Per Spellman’s record Based upon at Performs Registered in Contains Leads to need of Role template:Physician Org. unit: Dept. of surgery Give access to Performs Based upon Procedure template:1 year follow-up Appear as Has connected Service provider:Kari Ås, surgeonDept. of surgery Procedure deskr. etc.Follow-up programme Has decided Document templates1 year follow-up Kari Ås

32. Prinsipper for tilgangsstyring Per Spellmann,pasient Kan komme med Ola Normann Har Opptrer som Har Tjenesteyter:Ola Normann. lege, Kirurgisk avdeling Rolle:lege, Kirurgisk avdeling EPJ: Per Spellmans journal Samtykkekrav Basert på ved Utfører Registrert i Inneholder Medfører behovfor Rollemal:Lege Org. enhet: Kirurgisk avd. Tjenesteytelse:1 år oppfølging Informasjon Gir tilgang til Besluttet tiltak:1 år oppfølging Utfører Basert på Tiltaksmal:1 år oppfølging Opptrer som Har tilknyttet Tjenesteyter:Kari Ås, kirurgKirurgisk avdeling Prosedyrebeskr. etc.Oppfølgingsprogram Har besluttet Dokumentmaler1 år oppfølging Kari Ås

33. National strategy for electronic patient records, pre-project (S@mspill 2007) • One of the efforts in the S@mspill report and in “Superior ICT strategy for the regional health care services“ • The pre-project shall propose visions and directions for the development of EPRs in Norway, and suggest a plan for further actions • The project is co-ordinated with other EPR related actions under National ICT • Report: http://www.shdir.no/vp/multimedia/archive/00001/10-_EPJ-strategi_pros_1529a.doc • National architecture strategy: //www.hemit.no/upload/2221/Forprosjektrapport_v1_1.pdf • Nasjonal IKT: http://www.shdir.no/index.db2?id=5258

34. DocuLive demonstration • DocuLive EPR system is used in several Norwegian Hospitals; e.g. St. Olavs hospital in Trondheim • www.hemit.no/elaring