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4/12/2015 7:44 AM The Role of Standards in Health IT A Focus on Health Level Seven Kenneth S. Rubin Enterprise Architect, EDS Kenneth S. Rubin Enterprise Architect, EDS
Page 2 ©2005, Ken Rubin Presentation Overview About Healthcare Standards HL7 Overview Standards and the Electronic Health Record Standards on the Edge The Impacts of Standards
Page 3 ©2005, Ken Rubin A little personal background… Approximately 15 years of IT experience Approximately 8 years health informatics experience Roles: –Veterans Health Administration Health Information “Application” Architect EDS-VA Segment Chief Technologist –Standards Chair, OMG Healthcare Domain Task Force Chair, HL7 Services Specification Project Past Chair, HL7 Process Improvement Committee
Page 4 ©2005, Ken Rubin About Healthcare Standards…
Page 5 ©2005, Ken Rubin Why do we care? Business View –Business demand to interoperate –Required for regulatory/statutory compliance; beneficial reimbursement –Patients receive care at many places –Consumers demand interoperability. “Why am I giving you this information again?!” Technical View –Collaboration with business partners forces the need for IT interoperability among them –Facilitate the integration of new technologies and products –Minimize risk of vendor lock-in –Reduce cost of design, development, maintenance
Page 6 ©2005, Ken Rubin Lets examine the impact of standards… How would you … –Integrate a new laboratory system into an enterprise? –Share patient demographic information with insurers? –Collect information on your patient for an inpatient visit from their primary care provider? –Send disease registry information to the NCI? –Support drug-order checking? –Validate that a new EHR system performs to industry expectations of functionality? –Purchase systems that will work within your business?
Page 7 ©2005, Ken Rubin Significant Healthcare Standards Development Organizations (SDOs) HL7 X.12 NCPDP ASTM OMG DICOM SNOMED ICD LOINC IHE CEN TC 251 ISO TC 215 “Functional” Standards Structured Doc Standards Terminology Standards Messaging Standards Services Standards Standards Profiling
Page 8 ©2005, Ken Rubin Key Drivers Influencing the Standards Community Governments and Regulation –CMSCMS –ONCHIT [US]ONCHIT [US] –EU Large Provider/Health Organizations –Veterans Health AdministrationVeterans Health Administration –Dept of Health and Human ServicesDept of Health and Human Services –National Health Service [UK]National Health Service [UK] –Kaiser-PermanenteKaiser-Permanente –Mayo ClinicMayo Clinic Vendor Community –Cerner –Epic –GE Healthcare –IBM –McKesson –Microsoft –Oracle Healthcare –Siemens
Page 9 ©2005, Ken Rubin HL7 Overview
Page 10 ©2005, Ken Rubin HL7… …is a not-for-profit, ANSI accredited Standards Development Organization (SDO) …has affiliates in 30+ countries …uses an open consensus standards process …comprises ~450 organizational members including providers, vendors, consultants …has total members …routinely has 500+ attend Working Group Meetings Slide content provided by Helen Stevens and Gordon Point Informatics, used with permission.
Page 11 ©2005, Ken Rubin Why is it significant? Collection of many of the healthcare industry thought-leaders and top talent Strong international presence and perspective Broad participation and consensus process “Networking” Viewed as the lead in healthcare IT Regulatory agencies are increasingly using HL7 for mandated healthcare standards
Page 12 ©2005, Ken Rubin Scope of HL7 Activities and Standards Messaging RIM CDA CCOW CTS Vocab Arden Decision Support Services EHR Modeling and Methodology Vocabulary Architecture Review Board CCOW Clinical Decision Support Conformance Control Query Financial Management Medical Records Orders and Observations Patient Administration Patient Care Personnel Mgmt Regulated Clinical Research and Information Management Scheduling and Logistics Structured Documents Arden Syntax Attachments Clinical Guidelines Community-based Health Pediatrics Electronic Health Records Government Projects Image Management Java Lab Automation and Testing Medication Security and Accountability Templates XML Services Public Health and Emergency Response
Page 13 ©2005, Ken Rubin Key Events in HL7’s History 1987Consortium of health providers, vendors, consultants produce Version 1.0 prototype 1994Accredited by ANSI Versions “production” standards 2000Version Version 3 begins phased release 2002Version Version 3.0 starts ANSI Accreditation Slide content provided by Helen Stevens and Gordon Point Informatics, used with permission.
Page 14 ©2005, Ken Rubin How does HL7 work? ANSI Rules: –Open Membership –Consensus Driven –All votes must be reconciled during meetings –Negative votes must be withdrawn or found ‘non- persuasive’ –2 Levels of balloting – Committee and Membership –90% of votes in Membership level ballots must be affirmative to pass –Single persuasive vote may halt the standard Slide content provided by Helen Stevens and Gordon Point Informatics, used with permission.
Page 15 ©2005, Ken Rubin Version 2 Messaging standard in pervasive use throughout the industry Uses its own message Encoding Rules –(Uses|delimiters|to|separate|fields, components, and sub- components) –Field location indicates the semantics of a field (e.g., PID.3 – Patient Identifier) –“Z”-elements for extending the standard for custom segments, fields, events Practical and useful as a standard, but not without issues –“Optionality” – great for uptake of the standard but bad for interoperability –Not “plug-and-play” –Refinement required: conformance using Message Profiles Scope covers Patient Administration, Orders and Observations, Scheduling, Financial Management
Page 16 ©2005, Ken Rubin Version 2 Example: Patient Registration MSH|^~\&|REGADT|MCM|IFENG|| ||ADT^A04|000001|P|2.4||| EVN|A04| | |01|| PID|||191919^^^GENHOS^MR~ ^^^USSSA^SS|253763|MASSIE^JAMES^A|| |M|||171 ZOBERLEIN^^ISHPEMING^MI^49849^""^||(900) |(900) ||S|C| ^^^GENHOS^AN| || NK1|1|MASSIE^ELLEN|SPOUSE|171 ZOBERLEIN^^ISHPEMING^MI^49849^""^|(900) |(900) ~(900) |EC1^FIRST EMERGENCY CONTACT NK1|2|MASSIE^MARYLOU|MOTHER|300 ZOBERLEIN^^ISHPEMING^MI^49849^""^|(900) |(900) ~(900) |EC2^SECOND EMERGENCY CONTACT PV1||O|O/R||||0148^ADDISON,JAMES|0148^ADDISON,JAMES|0148^ADDISON,JAM ES|AMB|||||||0148^ADDISON,JAMES|S|1400|A|||||||||||||||||||GENHOS ||||| | PV2|||||||| |||||||||||||||||||||||||| OBX||ST|1010.1^BODY WEIGHT||62|kg|||||F OBX||ST|1010.1^HEIGHT||190|cm|||||F DG1|1|19||BIOPSY||00| GT1|1||MASSIE^JAMES^""^""^""^""^||171 ZOBERLEIN^^ISHPEMING^MI^49849^""^|(900) |(900) ||||SE^SELF| ||||MOOSES AUTOCLINIC|171 ZOBERLEIN^^ISHPEMING^MI^49849^""|(900) | IN1|0|0|BC1|BLUE CROSS|171 ZOBERLEIN^^ISHPEMING^M149849^""^||(900) |90||||||50 OK|
Page 17 ©2005, Ken Rubin Version 2 Example: Patient Registration Message Header and Event MSH|^~\&|REGADT|MCM|IFENG|| ||ADT^A04|000001|P|2.4||| EVN|A04| | |01|| Patient Identity PID|||191919^^^GENHOS^MR~ ^^^USSSA^SS|253763|MASSIE^JAMES^A|| |M|||171 ZOBERLEIN^^ISHPEMING^MI^49849^""^||(900) |(900) ||S|C| ^^^GENHOS^AN| || Next of kin NK1|1|MASSIE^ELLEN|SPOUSE|171 ZOBERLEIN^^ISHPEMING^MI^49849^""^|(900) |(900) ~(900) |EC1^FIRST EMERGENCY CONTACT NK1|2|MASSIE^MARYLOU|MOTHER|300 ZOBERLEIN^^ISHPEMING^MI^49849^""^|(900) |(900) ~(900) |EC2^SECOND EMERGENCY CONTACT Patient Visit Information PV1||O|O/R||||0148^ADDISON,JAMES|0148^ADDISON,JAMES|0148^ADDISON,JAMES|AMB|||||||014 8^ADDISON,JAMES|S|1400|A|||||||||||||||||||GENHOS||||| | PV2|||||||| |||||||||||||||||||||||||| Patient Height and Weight OBX||ST|1010.1^BODY WEIGHT||62|kg|||||F OBX||ST|1010.1^HEIGHT||190|cm|||||F Diagnosis DG1|1|19||BIOPSY||00| Guarantor and Insurance GT1|1||MASSIE^JAMES^""^""^""^""^||171 ZOBERLEIN^^ISHPEMING^MI^49849^""^|(900) |(900) ||||SE^SELF| ||||MOOSES AUTOCLINIC|171 ZOBERLEIN^^ISHPEMING^MI^49849^""|(900) | IN1|0|0|BC1|BLUE CROSS|171 ZOBERLEIN^^ISHPEMING^M149849^""^||(900) |90||||||50 OK|
Page 18 ©2005, Ken Rubin Version 3: A New Methodology Semantic consistency resulting from use of a harmonized information model Subsets of information specialized for use cases Binding to multiple technologies via “Implementation Technology Specifications” Methodology and tooling to transform model into protocols Broadening of scope to include non-messaging standards Models available at
Page 19 ©2005, Ken Rubin 11 returns_to 1..* *specifies_ability_in0..* can_accompany 1 1..* * is_managed_by 0..* Messagecontrol ParticipationAct HL7 RIM RoleEntityStructuredDocuments
Page 20 ©2005, Ken Rubin HL7 Reference Information Model: Normative Backbone Classes Terminology “Cloning” Domain Information Models Constraints Serialization HL7 RIM Version 2.04 Core, used with permission courtesy of HL7
Page 21 ©2005, Ken Rubin Clinical Document Architecture A “container” representation for representing electronic documents for intra- and inter- organization information sharing Different than messaging due to “holistic” representation Ability to support security, maintain integrity, and capturing signing information Three levels of increasing specificity
Page 22 ©2005, Ken Rubin CCOW Context Management Specification A specification to manage user experience context at the workstation Coordinates multiple applications to ensure that they are all presenting the same patient Supports complexities in state management between applications Demonstrated to have been a factor influencing patient safety
Page 23 ©2005, Ken Rubin HL7 Web Site Tour
Page 24 ©2005, Ken Rubin HL7 Web Site Tour
Page 25 ©2005, Ken Rubin Standards and the Electronic Health Record
Page 26 ©2005, Ken Rubin Why Standards are Crucial for EHR An EHR is the culmination of lifetimes of medical information in support of clinical care Rarely does anyone receive all their care from one provider [organization] The “longitudinal” record is of high value, but it must be assembled from multiple sources Assembly itself is VERY difficult Assembly of quality, semantically meaningful, and consistent data has been near impossible to date
Page 27 ©2005, Ken Rubin Many Standards Play in the EHR EHR Definitional Standards [ISO] EHR Functional Standards [HL7, ASTM] EHR Access Standards [HL7, OMG] EHR Structural Standards [HL7, ASTM, CEN]
Page 28 ©2005, Ken Rubin HL7 Electronic Health Record Functional Model Does not contain a definition of the EHR Enumerates functionality that the community has attributed as useful for EHR Provides a mechanism for “profiling” Electronic Health Records by attributing functions to care settings Standard Care Setting Profiles are being balloted by “realm” (e.g., countries, regions, and municipalities) Available at
Page 29 ©2005, Ken Rubin HL7 Electronic Health Record Functional Model
Page 30 ©2005, Ken Rubin HL7 Electronic Health Record Functional Model HL7 Electronic Health Record Functional Model, used with permission
Page 31 ©2005, Ken Rubin Standards on the Edge
Page 32 ©2005, Ken Rubin What is the Healthcare Service Specification Project? An effort to create common “service interface specifications” tractable within Health IT A joint standards development project involving Health Level 7 (HL7) and the Object Management Group (OMG) Its objectives are: –To create useful, usable healthcare standards that address functions, semantics and technologies –To complement existing work and leverage existing standards –To focus on practical needs and not perfection –To capitalize on industry talent through open community participation
Page 33 ©2005, Ken Rubin Where would these specifications be used Inter-Enterprise (such as RHIOs) –By functionally specifying behavior, roles between applications and products are clarified, and the technologies supporting them can be profiled and sharpened Intra-Enterprise –Standardization on functionality allows for better integration of off-the-shelf and custom development environments, and promotes more of a “plug and play” environment Intra-Product –Facilitates vendors ability to integrate third-party value-add components and speed design phase with higher confidence Custom-Implementation –Affords organizations wishing to custom-develop the opportunity to later integrate off-the-shelf
Page 34 ©2005, Ken Rubin Context of HSSP Specifications Ability to Interoperate High Low
Page 35 ©2005, Ken Rubin The Impacts of Standards…
Page 36 ©2005, Ken Rubin The Impacts of Standards Business –As a vendor? As a provider? As a payer? As a supplier? –Ability to grow market, penetrate organizations, establish market share –IT solutions for mergers/acquisitions –Implications on procurement? Architectural –Product design impacts –Technology insertion –Cost reduction/avoidance –Time-to-market Innovation –Collaboration resulting in creative solutions –Disruptive agent –Market pressure “Keep up with the Joneses”
Page 37 ©2005, Ken Rubin A Few Key Takeaways… Standards play a vital role in piecing together Health IT “The best way to predict the future is to invent it.” – Alan Kay You can participate if you want. Sign up for a list and jump in! Healthcare Service Architecture Workshop in DC has been announced and will occur this October
Page 38 ©2005, Ken Rubin Special Thanks to… Health Level Seven Helen Stevens, Gordon Point Informatics Ioana Singureanu, Eversolve Object Management Group, OMG HDTF
Page 39 ©2005, Ken Rubin Questions?Questions?
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18 Copyright © 2005, Oracle. All rights reserved. Distributing Modular Applications: Introduction to Web Services.
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