TICSalud. Healthcare Transformation: EHR Systems A New Challenge for Health Information Technology. Bogotá,, Colombia 16 August 2007

Transcription

1 Healthcare Transformation: EHR Systems A New Challenge for Health Information Technology TICSalud Bogotá,, Colombia 16 August 2007 John Ritter HL7 EHR TC co-chair Healthcare Standards Architect John.Ritter@intel.com 1

2 Agenda The Electronic Health Record ecosystem Example HL7 standard: EHR-System Functional Model EHR-S FM: Uses and Benefits Intel s goal and commitment to HIT standards Call to Action Questions? 2

3 Ingredients necessary for HIT transformation Total commitment from stakeholder representative Phased, comprehensive, measurable Long term vision Resilience, Continuity Political drive Increase quality of care, Reduce Costs Clear roadmap Transformation Financing Stakeholders participation, Educational campaigns Collective engagement Multidisciplinary teams Mobilise the adequate resources Meet the expectations of patients and clinicians 3

4 Laws and Regulations: Which building blocks can be influenced by standards? Patient Patient Privacy Privacy EU EU Directives Directives 95/46/EC, 95/46/EC, 2002/58/EC 2002/58/EC Processing Processing of of personal personal data data Transparency Transparency Legitimacy Legitimacy Proportionality Proportionality Caregiver s Caregiver s behaviour behaviour Medical Code of Ethics Medical Code of Ethics Quality Quality Patient consent Patient consent Responsibility Responsibility Confidentiality Confidentiality Traceability Traceability US HIPAA US HIPAA Gives Gives the the citizen citizen rights rights over his/her health over his/her health information information Sets rules and limits on Sets rules and limits on who can look at and receive who can look at and receive a a citizen's citizen's health health information information Provider s Provider s / / Vendor s Vendor s Responsibility Responsibility / / Liability Liability EHR-S Functional Model EHR-S Functional Model Reduce Reduce uncertainty uncertainty Define contractual terms Define contractual terms Identify responsibilities Identify responsibilities Health Health insurance insurance law law Health Health Care Care Insurance Insurance Act Act 2004 in France 2004 in France Telemedicine Telemedicine acknowledged acknowledged in in the the law law Medical Medical devices devices EU MDD and US FDA EU MDD and US FDA Certification Certification Compliance Compliance with with standards standards Safety Safety Test-history Test-history Documented Documented 4

5 Standards: Why they matter Data is complex Standards-based data representation reduce complexities Vocabularies and glossaries are inconsistent Standards provide common dictionary Platforms and systems are incompatible Standards-based platforms promote interoperable system communication Work-flow is highly variable between care settings and among care givers Standards close the gaps; data can be seamlessly exchanged Vendors have business reasons to sustain proprietary solutions Standards-based solutions promote interoperability among vendors 5

6 Why standards development takes a long time Standards development is typically a very slow process because it takes time to: Generate a market for a product Generate a consensus that a standard is required (usually after entrepreneurs have already invested time and money in proprietary solutions) Develop (and test) draft standards Gather feedback from all stakeholders Harmonize competing (or overlapping) standards Educate the stakeholders on the existence of the standards Move the industry from non-standards based solutions to standards-based solutions. We need to work on shortening the time to market 6

7 Personal health: Continua Health Alliance We believe that through the efforts of a collaborative industry organization, we can enable a personal health eco-system where many diverse vendors can combine their products into new value propositions with significant health benefits for people worldwide. 7

8 The Continuum of Care 100% Healthy, Independent Living Community Clinic Chronic Disease Management Doctor s Office QUALITY of LIFE Assisted Living Skilled Nursing Facility Specialty Clinic Community Hospital ICU 0% HOME CARE RESIDENTIAL CARE $1 $10 $100 $1,000 $10,000 COST of CARE/DAY 8 ACUTE CARE

9 Shift Left and standards Vision: Patient related information can be exchanged freely between the various systems in the continuum of care. Personal health records and platforms are a foundational enabler to extend the healthcare system into the home. Healthcare-IT standards (esp. Electronic Health Records) provide the foundation for institutional data-sharing and integration of this data with home care and residential care. Security and privacy related challenges as well regulatory issues which may be impediments which need to be addressed. 9

10 Crossing healthcare domain boundaries requires standards Implant Pedometer Digital Home Weight Cell Phone Pulse Ox Clinical and Hospital Information Systems Chronic disease Independent living Post trauma Pre-op Healthy lifestyle Bloodpressure Cuff Personal Health System PC Fitness equipment Medication Tracking Trans-National Health Information Networks 10 National Health Information Networks

11 The continuum of care requires standards Vision: Patient-related information can be exchanged freely between the various systems in the continuum of care. Standards-based Personal Health Records and platforms are a foundational enabler to extend the healthcare system into the home. Healthcare-IT standards (especially Electronic Health Records) provide the foundation for institutional datasharing and integration of this data with home care and residential care. Security- and privacy-related challenges, as well regulatory issues, may be impediments that need to be addressed. 11

12 Why aren t we interoperable yet? in order to realize this objective, everybody must adhere to same standards in order to achieve systems interoperability unlike other vertical industries (such as the financial industry), healthcare is still lagging behind when it comes to the use of interoperability standards Partially because standards don t exist, partially because too many exist, and partially because they are not used or not in a consistent fashion 12

13 Availability of Standards Automatic Interoperability Standards only create the opportunity for interoperability and are an ingredient Two types: de jure & de facto Frequently defined in the form of a specification Frequently developed in a standards organization (ANSI, ISO, IEEE ) Restrictions range from open to proprietary Standards-based Interoperability requires Market viable use-cases A Standard or collection of Standards to enable the use-cases Interoperability Guidelines (i.e., Profiles ) that describe how to use the Standards to promote interoperability Promotion (marketing, education, conferences, evangelists) Interoperability compliance testing (formal and/or informal) 13

14 A standards-based framework for interoperability Service Interop Can I get info, please? Service Service Oriented Architecture (SOA) (SOA) SW dev paradigm Service- level Integration Model Component Component- - based systems OMG, PDF- - H Document services (e.g. summary patient info) Special Purpose ehealth Standards Content Interop Document Exchange Clinical Pathways and decision support Sending and receiving Summary Patient Info Protocols, guidelines Rules Order sets, Orders Observations Workflow models eprescriptions Discharge Summaries Operative Reports Visit Notes Arden Syntax, Asbru, CPG-RA, EON, GASTON, GEM, GLARE, GLIF, GUIDE, HELEN, HGML, Prestige, PRODIGY, PROforma (AREZZO, Tallis), SAGE, Stepper Medical adaptation of BPEL, WSCL IHE Implementation frameworks: UK- NHS SPINE, Denmark MedCom,, France DMP DMP Semantic Interop OK what does it mean? Semantic normalization (w/descriptive logic) Lexical interoperability SNOMED-CT, ICD, CPT, NANDA, General Purpose I.T. Standards Data Exchange Generic I.T. Infrastructure Sending you Data Element/s Transmit data date elements and data sets sets from one one system to to HL- 7, DICOM, CDISC.. GEO Specific: CEN CENELEC, ETSI, ISO, ASTM 14

15 Managing the complexity of the standards-based systems integration task Messaging standards HL7 Clinical data X12 Financial data, HIPAA mandated transactions DICOM Images IEEE Bedside instruments Electronic Healthcare Records (EHRs) HL7/CDA, CEN EHRcom (TC 251), openehr Terminology standards LOINC Logical observation identifier names and codes Drugs RxNorm, NDF-RT Billing CPT, ICD-9 CM, ICD-10 CM Clinical UMLS, SNOMED and others 15

16 Key Global HIT enablers HL7 (Health Level Seven) standards Key SDO with significant global reach into 27+ countries (esp. known for messaging and document standards) V2.x well established, but older technology V3 XML Based, lots of activity for industry using SOA IHE (Integrating the Healthcare Enterprise) profiles Covers 6 healthcare Domains IT Infrastructure, Patient Care Coordination, Patient Devices, Cardiology, Radiology and Lab Develops interoperability profiles Compose standards from several SDO s to deliver guidelines for Interoperable message exchange Used for creating and moving secured patient information Annual Connect-a-thons allow vendors to demonstrate interoperability Successful score achieves stamp of approval and ability to claim conformance. 16

17 Background and Context of the HL7 EHR-System Functional Model and Standard Health Level Seven (HL7) is an ANSI-accredited standards development organization The term HL7 is often used synonymously for the HL7 organization and the HL7 messaging standard HL7 standards are divided into two camps: 1.Healthcare-related data/information/routing Standards Messaging Standards (V2.x and V3) Other Standards (CDA, CCOW, Vocabulary, Devices, etc.) 2.Healthcare-related Functional Standards 17

18 Background and Context (con t) Healthcare Messages and Documents proper context is within a healthcare system Analogy: Cars and Trucks proper context is within a highway system A highway system lists all of the functions that cars SHALL, SHOULD, and MAY perform The EHR-System Functional Model (FM) lists all of the functions that healthcare products SHALL, SHOULD, and MAY perform 18

19 Background and Context (con t) Thus, the EHR-S FM serves as the cornerstone for describing: EHR Systems Enabling Modularity Defining Functionality Scoping subsystems EHR System interoperability Clarifying Interfaces Enabling well-defined Services 19

20 Overview of the EHR-S FM Standard Origin: HL7 EHR Special Interest Group (SIG) established, Spring 2002; became EHR Technical Committee (TC), May 2004 Goal: Create a consensus-based, well-defined list of all healthcare-related functions that may serve as a Universe Of Discourse for all stakeholders First question: What is an EHR-S? Multi-month debate followed 20

21 Overview of the EHR-S FM Standard What is an EHR-S? o One possibility: Define an EHR-S as just a medicine-only, clinical, hospital-based system. For example, no labs, no pharmacies, no financials, no nursing homes, no patientinput. o Another possibility: Define an EHR-S to include behavioral health, community health, public health, healthcare-related workflow, and patient-entered / patient-accessed data. 21

22 Overview of the EHR-S FM Standard Existing EHR-S Definition 1: The set of components that form the mechanism by which patient records are created, used, stored, and retrieved. A patient record system is usually located within a health care provider setting. It includes people, data, rules and procedures, processing and storage devices (e.g., paper and pen, hardware and software), and communication and support facilities. Source: The IOM's 1991 report, The Computer-Based Patient Record: An Essential Technology, and updated in 1997 (Dick, R.S, Steen, E.B., and Detmer, D.E. (Editors), National Academy Press: Washington, DC 22

23 Overview of the EHR-S FM Standard Existing EHR-S Definition 2: Longitudinal collection of electronic health information for and about persons, where health information is defined as information pertaining to the health of an individual or health care provided to an individual; Immediate electronic access to person- and population-level information by authorized, and only authorized, users; Provision of knowledge and decision-support that enhance the quality, safety, and efficiency of patient care; and Support of efficient processes for health care delivery. Source: 2003 IOM Letter Report, Key Capabilities of an Electronic Health Record System 23

24 Overview of the EHR-S FM Standard Existing EHR-S Definition 3: A system for recording, retrieving and manipulating information in electronic health records. Source: The 2003 ISO/TS references the IOM 1991 definition above as well as CEN 13606,

25 Overview of the EHR-S FM Standard The resulting EHR-S FM standard is: Consensus-based Internationally-oriented Harmonized with predecessor healthcare-related efforts such as: Committee é Européen de Normalisation (CEN 13606) Institute Of Medicine openehr ISO/TC 215 International Standards Organization Technical Specification ASTM E31 25

26 Overview of the EHR-S FM Standard EHR-System Functions describe the behavior of a system in useroriented language so as to be recognizable to the key stakeholders of an EHR System. Source: HL7 EHR-S S FM Overview Chapter 26

27 Overview of the EHR-S FM Standard The EHR-S FM consists of three parts: Direct Care Doctor places a healing hand on the patient Supportive Helps the doctor place a healing hand on the patient Information Infrastructure Provides infrastructure for Direct Care and Supportive 27

28 Overview of the EHR-S FM Standard Direct Care Functions: Enable hands-on delivery of healthcare and offer clinical-decision support Example: Child presents with cold symptoms, Enable the doctor to record that event Alert the provider that a vaccination is due and offer contraindication alerts regarding children who have symptoms of a cold Source: HL7 EHR-S S FM Overview Chapter 28

29 Overview of the EHR-S FM Standard Supportive Functions: Assist with the administrative and financial requirements Provide input to systems that perform medical research, promote public health, and improve the quality of care Example: Child is being scheduled for an appointment Electronically verify insurance eligibility Electronically query local immunization registries (to insure that the child is currently registered) Determine the child s immunization status Report any immunization to an immunization registry Provide any encounter data required by financial and administrative systems Source: HL7 EHR-S S FM Overview Chapter 29

30 Overview of the EHR-S FM Standard Information Infrastructure Functions: Provide a framework for the proper operation of the Directcare and Supportive functions Offer EHR-S technical capabilities that are essential, yet transparent, to the user Example: Secure transmission, backup, archive Provide a secure electronic environment for the immunization registration query Report the child s immunization event in a secure fashion Transparently archive and backup the child s record and provide an audit trail of all accesses to the child s record Source: HL7 EHR-S S FM Overview Chapter 30

31 Overview of the EHR-S FM Standard Layout of the 178 functions of the FM: Functional Identification Number Functional Name Functional Statement Functional Description See also column Conformance Criteria ID Type Name Statement Description See Also Conformance Criteria (Normative) (Normative) 31

32 Overview of the EHR-S FM Standard ID Type Name Statement Description DC.1.5 F Manage problem list Create and maintain patient-specific problem list A problem list may include, but is not limited to: Chronic conditions, diagnoses, or symptoms, functional limitations, visit or stay-specific conditions, diagnoses, or symptoms. Problem lists are managed over time, whether over the course of a visit or stay See Also Conformance Criteria IN IN The system SHALL display all active problems associated with a patient. 2. The system SHALL create a history of all problems associated with a patient. 3. The system SHALL retrieve a history of all problems associated with a patient. 4. The system SHALL provide a user interface to deactivate a problem. 5. The system MAY provide the ability to re-activate a previously deactivated problem. 6. Source: HL7 EHR-S S FM Direct Care Chapter 32

33 Overview of the EHR-S FM Standard Source: HL7 EHR-S S FM Supportive Chapter 33

34 Overview of the EHR-S FM Standard Digital Source: Health HL7 Group EHR-S S FM Information Infrastructure Chapter 34

35 Current Status of the Standard Became ANSI standard in February 2007 Accepted as an ISO Work Item in March

36 Application of the Standard Create a profile of a healthcare-related solution, module, or system Communicate with developers, stakeholders, vendors, or partners via explicit (functional) language Define the roles that vendors/partners/stakeholders will play Perform gap analyses Prepare for (possible) certification 36

37 Application of the Standard (con t) Create Intellectual Property documents using welldefined (functional) language Manage/Coordinate stakeholders expectations Etc. 37

38 Who benefits? Vendors: System definition / scope / profiles; RFP s; best-ofbreed collaboration; certification Healthcare Providers (primary and ancillary): modularization; apples-to-apples comparisons; simplify interfaces; purchasing incentives; access to best practices; access patient data; streamline workflow Quality-Oversight / Accreditation organizations: collect raw data for analysis and reporting; identify troublesome providers 38

39 Who else benefits? Governments: Public Health data; Identify fraud and abuse; Quality Assurance; Compliance; Reduce costs Payers: Reduce paperwork; pay for performance; value-add services (e.g., PHR) Standards Development organizations: reduce overlap and duplication; identify gaps Patients: interface with provider, payer, pharmacy, PBM; reduce office waiting time; reduce paperwork; populate PHR s; self-manage healthcare 39

40 Intel s EHR Standards goal Support/promote the adoption of harmonized standards world-wide Support EHR market horizontalization Remove adoption barrier for EHR technology Simply stated: Intel wins when the healthcare industry moves away from paper records, towards electronic records. 40

41 Intel s commitment to HL7 HL7 Leadership roles: Service Oriented Architecture (SOA) leadership EHR TC co-chair International Mentoring Committee co-chair HL7 CEO HL7 Standards involvement: Functional standards: EHR-System Functional Model, PHR FM, Interoperability Model SOA/HSSP (Healthcare Services Specification Project) Messaging and Document standards: CDA, V3, CCD 41

42 Intel s involvement in HIT American Health Information Community Federally chartered commission appointed by HHS Sec. Leavitt to advise HHS on Health IT strategies Craig Barrett, Intel Chairman ISO TC/215 U.S. Technical Advisory Group Certification Commission for Health I.T. Interoperability Expert Panel 42

43 Call to Action Begin now - Get Involved! Join HL7, IHE, ISO, CEN, Consider starting/joining local/regional chapters of HL7 Consider attending HL7 Working Group Meetings or Educational Summits to receive education Demand ONLY standards based solutions HL7 V2.x or V3 (preferred) w/cda/ccd IHE Domain Profiles IT Infrastructure Domain for Enterprise Solutions Patient Care Coordination for EMR/EHR/PHR Insist on Interoperable platforms and solutions Intel is here to help! 43

44 Summary Standards-related issues are major impediments to the adoption of IT in the healthcare industry Intel believes that standards-based interoperability benefits all players in the eco-system and helps to lower costs, reduce errors, and improve quality of care Intel is a globally active participant in driving standards and policy-related initiatives in diverse domains including: Personal Health Records, Personal Health Platforms, Electronic Health Records and Security, Privacy and Trust 44

45 Links to More Information Visit the HL7 web site: Subscribe to HL7 list serves Contact worldwide Affiliates (see HL7 website) Attend open public sessions (no HL7 membership required) Review EHR Profiles at the NIST website: 45

46 Questions/Answers/Discussion 46

47 Thank you very much for your attention Contacts Roberto Martinez: Government Affairs Brad Lund: Global Healthcare Standards Architect John Ritter: Healthcare Standards Architect 47

48 (Backup slides) 48