HL7 EHR System Functional Model and Standard (ISO/HL ), Release 2

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1 HL7 EHR System Functional Model and Standard (ISO/HL ), Release 2 Health Information Management Systems Society (HIMSS) Las Vegas, NV 20 Feb 2012 Presented by: Mark G. Janczewski, MD, MPH Deloitte Consulting, LLP

2 Agenda 1. Introduction 2. Release 2 Background 3. Conformance Clause / Functional Profiles 4. Glossary / Verb Hierarchy 5. Function List

3 Brief History of HL7 Functional Model (FM) In the Spring of 2003 HL7 began efforts to develop a standardized functional specification for Electronic Health Records Systems (EHR-S) Approved July 2004 as a Draft Standard for Trial Use Approved February 2007 as a fully accredited standard by the American National Standards Institute (ANSI) Approved mid-2009 as an International (ISO) Standard CCHIT referenced the EHR-S FM (Release 1) and domainspecific Functional Profiles in developing its product certification criteria 5

4 Electronic Health Record (EHR) vs. EHR-System EHR: Underlying single, logical patient record Record is structured Serves as Provider legal record EHR System: Software that provides functionality to: Manage and maintain the record Accomplish various clinical, research, and business requirements May be: Monolithic system; or System of systems

5 Functional Model (FM) Scope Summary Is Not A messaging specification An EHR design specification An implementation specification (not the how ) Does not prescribe technology Does not dictate how functions must be implemented (e.g., via the user interface, database design) Is A system specification An EHR system specification A reference list of functions that may be present in an EHR-S (the what and why ) Enables consistent expression of functionality Provides flexibility for innovation and product differentiation Gold standard, sensitive to what can practically be done by a system yet guides future system development

6 A Way to Specify the Complete EHR Meets applicable certification criteria Capabilities beyond certification criteria are specified by the EHR-S FM and more domainspecific Functional Profiles (e.g. Emergency Dept., Behav. Health) Certification is a necessary, but not sufficient, description of what functions a system can perform. The Functional Model provides a more comprehensive set of EHR-S functional requirements

7 Continued Development 2007: FM passes HL7 Full Normative Ballot, Release : FM published as HL7/ANSI Standard 2009: FM passes Joint Ballot with HL7, ISO and CEN, Release 1.1 November 2009: FM published as ISO/HL : FM Release 2 Development 2012: FM Release 2 joint balloting HL7, ISO, CEN, IHTSDO and CDISC

8 Inputs to EHR-S FM Release 2. Vital Rptg. RM & ES Beh. Health LTC UC Alignment EHR Lifecycle EHR Interoperability Model. Provider Based PHR-S FM & Profiles SOA R1 Adjustments, Enhancements EHR-S Profiles EHR-S FM Release 2 Privacy, Security, Confidentiality Other Industry Initiatives Certification (CCHIT, Q-Rec) Health Info Exchange Data Use Fraud Mgt Quality Rev Cycle International Standards (ISO TC215, ISO 20514, ISO DIS CEN 18308, 13606) Others?

9 Release 2 Timeline When/Target May July September EHR-S FM Release 2 Activity Draft for Comment Comment Reconciliation and Continued Chapter Updates 2011 September September November EHR Working Group (WG) Meeting San Diego, California Continued content development and quality assurance December 6th January April 2 nd Ballot Draft Ready Submission to ISO, CEN, CDISC and IHTSDO for Ballot preparation EHR WG Meeting San Antonio, Texas HL7 Ballot Opens 2012 May 7 th May May November Joint (HL7, ISO, CEN, CDISC and IHTSDO) Ballot Closes EHR WG Meeting Vancouver, BC, Canada Ballot reconciliation and material updates December 1 2 nd Ballot Draft Ready for Submission to ISO, CEN, CDISC and IHTSDO for Ballot preparation 2013 January April HL7 WG Meeting Ballot

10 Significant R2 Changes from R1/R1.1 Introduction of Overarching Criteria Chapter Enhancement and enforcement of Glossary specifically the Action-Verb Hierarchy Reorganization of Chapters Substantial increase in number and granularity of conformance criteria Substantial increase in number of functions Implicit functions are now made more explicit. Incorporation of EHR Interoperability Model and EHR Lifecycle Model (previous independent Draft Standard for Trial Use [DSTU] documents) Substantial improvements to Conformance Clause chapter

11 Conformance Clause and Statement The Conformance Clause defines the minimum requirements for functional profiles claiming conformance to the EHR-S FM. The value of the Conformance Clause A vendor can provide a Conformance Statement that shows how well it conforms to relevant Functional Profiles

12 Conformance to Profiles EHR-S EHR-S Conforms to Canadian Children s Hospital Derived Domain Profile Conforms to Domain Profile Hospital Domain Profile Conforms to Functions Conformance Criteria EHR-S Clinic Domain Profile Rules for functional Profiles Pharmacy EHR-S Companion Profile Implementations Functional Profiles Cancer Research EHR-S Functional Model

13 Glossary - Introduction Glossary clearly defines terms in the Functional Model and Profiles Includes a specific Action Verb hierarchy Goal is to promote clarity and consistency when interpreting and applying the text of the HL7 Electronic Health Record System Functional Model (EHR-S FM). Release 2 Glossary has undergone a complete review and is more comprehensive including all terms used in the Model. Glossary includes 238 active terms.

14 Release 2 Action-Verb Hierarchy Data Management Category Action-Verbs for the full range of data handling actions by a system. Release 1.1 Create Add, input Define, Tailor, Specify, Set Generate Cite, Include Export Find, Identify Specify Prompt Manage (Data) Capture Maintain Render Exchange Determine Manage- Data- Visibility Auto- Populate Enter Import Receive Store Update Remove Extract Present Transmit Export Archive Backup Decrypt Encrypt Recover Restore Save Annotate Edit Harmonize Integrate Link Tag Delete Purge Import Receive Transmit Analyze Decide De-Identify Hide Mask Re-Identify Unhide Unmask

15 Secure (System) Category Action Verbs Action-Verbs for controlling access (authenticating and authorizing users), tracking activities (logging and auditing), and sustaining operations. Secure (System) Control Access Track Sustain (Operations) Authenticate Authorize Log Audit

16 Extension of Function List The number of conformance criteria increased from 972 in R1.0, 983 in R1.1 and 2,310 in R2.0 Summary Breakdown of Functions and Conformance Criteria HL7 EHR-S Functional Model, Release 2 Release 1.1 Release 1 Chapter Functions Conformance Criteria OV Overarching Criteria 2 33 CP Care Provision CPS Care Provision Support POP Population Health Support AS Administration Support RI Records Infrastructure TI Trust Infrastructure Conformance Criteria Conformance Criteria TOTALS: 322 2,

17 Chapter Reorganization Direct Care (DC) Supportive (S) Information Infrastructure (IN) Care Provision Support (CP) Overarching (O) Care Provision (CP) Population Health Support (POP) Record Infrastructure (RI) Trust Infrastructure (TI) Administrative Support (AS)

18 EHR-S Functional Model Components Function ID Function Name Function Statement Function Description Examples See Also Conformance Criteria

19 Overarching Criteria Chapter Criteria that apply to all EHR Systems and consequently must be included in all EHR-S FM compliant profiles Examples: OV.1 The system SHALL conform to function TI.1.1 (Entity Authentication). The system SHALL conform to function TI.1.2 (Entity Authorization). Overarching The system SHALL conform to function TI.1.3 (Entity Access Control). IF the system receives or transmits data for which jurisdictionally established interchange standards exist, THEN the system SHALL conform to function IN.5.1 (Interchange Standards) to support interoperability. The system SHOULD conform to function IN.6 (Business Rules Management). The system SHOULD conform to function IN.7 (Workflow Management). OV.2 Manage User Help

20 Care Provision Focus on functions required to provide care to a specific patient and enable hands-on delivery of healthcare Organized in general order of an encounter Care Provision CP.1 CP.2 CP.3 CP.4 CP.5 CP.6 CP.7 CP.8 CP.9 Manage Clinical History Render Externally-sourced Information Manage Clinical Documentation Manage Orders Manage Results CP.1 Manage Treatment Administration CP.1.1 Manage Future Care CP.1.2 Manage Patient Education & Communication CP.1.3 Manage Care Coordination & Reporting CP.1.4 CP.1.5 CP.1.6 CP.1.7 CP.1.8 Example child functions: Manage Clinical History Manage Patient History Manage Allergy, Intolerance and Adverse Reaction List Manage Medication List Manage Problem List Manage Strengths List Manage Immunization List Manage Medical Equipment, Prosthetic/Orthotic, Device List Manage Patient and Family Preferences

21 Care Provision Support Focus on functions required to support the provision of care to a specific patient to enable hands-on delivery of healthcare Organized in alignment with Care Provision chapter Care Provision Support CPS.1 CPS.2 CPS.3 CPS.4 CPS.5 CPS.6 CPS.7 CPS.8 CPS.9 Record Management Support Externally-sourced Information Support Clinical Documentation Support Orders CPS.4 Support Orders Support Results CPS.4.1 Manage Order Set Templates Support Treatment Administration CPS.4.2 Support Medication & Immunization Orders Support Future Care CPS Support for Medication Interaction & Allergy Checking Support Patient Education & CPS Communication Support for Patient Specific Dosing and Warnings Support Care Coordination CPS & Reporting Support for Medication Ordering Efficiencies Example child functions: CPS Support for Medication Recommendations CPS.4.3 Support for Non-Medication Ordering CPS.4.4 Support Orders for Diagnostic Tests CPS.4.5 Support Orders for Blood Products and Other Biologics

22 Population Health Support Focus on input to systems that perform medical research, promote public health, & improve the quality of care at a multi-patient level Population Health Support POP.1 POP.2 POP.3 POP.4 POP.5 POP.6 POP.7 POP.8 POP.9 POP.10 Support for Health Maintenance, Preventive Care and Wellness Support for Epidemiological Investigations of Clinical Health Within a Population Support for Notification and Response Support for Monitoring Response Notifications Regarding a Specific Patient s Health Donor Management Support Measurement, Analysis, Research and Reports Public Health Related Updates De-Identified Data Request Management Support Consistent Healthcare Management of Patient Groups or Populations Manage Population Health Study-Related Identifiers Example child functions: POP.6 Measurement, Analysis, Research and Reports POP.6.1 Outcome Measures and Analysis POP.6.2 Performance and Accountability Measures POP.6.3 Support for Process Improvement POP.6.4 Support for Care System Performance Indicators (Dashboards)

23 Administration Support Focus on functions to assist with the administrative and financial requirements Administration support AS.1 Manage Provider Information AS.2 Manage Patient Demographics, Location and Synchronization AS.3 Manage Personal Health Record Interaction AS.4 Manage Communication AS.5 Manage Clinical Workflow Tasking AS.6 Manage Resource Availability AS.7 AS.8 AS.9 Manage Encounter/Episode of Care Management Manage Information Access for Supplemental Use Manage Administrative Transaction Processing AS.1 AS.1.1 Example child functions: AS.1.2 AS.1.3 AS.1.4 AS.1.5 AS.1.6 AS.1.7 Manage Provider Information Manage Provider Registry or Directory Manage Provider's Location Within Facility Provider's On Call Location Manage Provider's Location(s) or Office(s) Team/Group of Providers Registry or Directory Provider Caseload/Panel Manage Practitioner/Patient Relationships

24 Record Infrastructure Focus on records, record entries and record management, including R1.1 functions/criteria and key provisions of the RM-ES Functional Profile, EHR Interoperability and Lifecycle Model DSTUs. Consists of Release1.1 s : IN.2 (Record Management, except Audit), IN.8 (Record Archive/Restore) and IN.10 (Record Lifecycle - Record Infrastructure previously EHR Lifecycle Model DSTU). RI.1 RI.2 RI.3 Record Lifecycle and Lifespan Record Synchronization Record Archive and Restore Example child functions: RI.1.1 RI RI RI RI RI RI RI RI RI RI RI Record Lifecycle Originate and Retain Record Entry Amend Record Entry Content Translate Record Entry Content Attest Record Entry Content View/Access Record Entry Content Transmit and/or Disclose Record Entries Receive and Retain Record Entries De-identify Record Entries Pseudomynize Record Entries Re-identify Record Entries Extract Record Entry Content

25 Trust Infrastructure Contains the remaining Release 1.1 Infrastructure functions, including Audit. Trust Infrastructure TI.1 Security TI.2 Audit TI.3 Registry and Directory Services TI.4 Standard Terminology and Terminology Services TI.5 Standards-Based Interoperability TI.6 Business Rules Management TI.7 Workflow Management TI.1 Security TI.1.1 Entity Authentication TI.8 Database Backup and Recovery TI.1.2 Entity Authorization TI.9 System Management Operations and Performance TI.1.3 Entity Access Control Example child functions: TI.1.4 Patient Access Management TI.1.5 Non-Repudiation TI.1.6 Secure Data Exchange TI.1.7 Secure Data Routing TI.1.8 Information Attestation TI.1.9 Patient Privacy and Confidentiality

26 Want to Know More? Join HL7, review the HL7 web site ; Work Groups; Electronic Health Records Subscribe to HL7 EHR WG list serve Download and review Functional Profiles Attend open public sessions No HL7 membership required Request an HL7 Ambassador Briefing

27 Disclaimer This presentation contains general information only and Deloitte is not, by means of this presentation, rendering accounting, business, financial, investment, legal, tax, or other professional advice or services. This presentation is not a substitute for such professional advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified professional advisor. Deloitte shall not be responsible for any loss sustained by any person who relies on this presentation. About Deloitte: Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee, and its network of member firms, each of which is a legally separate and independent entity. Please see for a detailed description of the legal structure of Deloitte Touche Tohmatsu Limited and its member firms. Please see for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting.

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