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1 ASTM International C. Peter Waegemann Immediate Past Chair Committee E31 on Health Informatics CEO, Medical Records Institute Chair, Mobile Healthcare.

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Presentation on theme: "1 ASTM International C. Peter Waegemann Immediate Past Chair Committee E31 on Health Informatics CEO, Medical Records Institute Chair, Mobile Healthcare."— Presentation transcript:

1 1 ASTM International C. Peter Waegemann Immediate Past Chair Committee E31 on Health Informatics CEO, Medical Records Institute Chair, Mobile Healthcare Alliance

2 2 My Background in Health Informatics Standards 2006Immediate past Chair of ASTM E Chair, ANSI Healthcare Informatics Standards Board Chair of ASTM E Chair of US TAG to ISO TC Member of ASTM, AMIA, AHIMA, HL7, IEEE, ABA (HEALTHCARE), MCC, NCPDP, WEDI, ASC X12, etc. 1998Founding Father of ISO TC Chair and Founding Father of CorbaMed OMG 1994Chair: New ASTM Subcommittee on Authenticity of Computer-based Patient Records Chair : Committee for Improving International Relations at the ANSI HISPP International and Regional Subcommittee Appointment by CEN TC 251 as Expert for Project Team 13 Member of the ASTM Executive Committee 1993Chair: Task Force on Ownership of Health Information at ASTM Subcommittee Privacy, Confidentiality and Access And others such as Board Member of SNOMED International, etc.

3 3 About ASTM International ASTM Organized in 1898 Independent, private sector, not-for-profit organization Provides a management system and administrative framework for development of voluntary, consensus standards and promotion of related knowledge, which demonstrate a high degree of technical quality and global market relevance.

4 4 ASTM Serves Multiple Sectors Health Informatics Metals Petroleum and Lubricants Environment – Air – Soil – Water Construction Materials Consumer Products Mechanical Testing Plastics Road and Paving Medical and Surgical Materials and Devices Textiles Corrosion of Metals Pharmaceutical Process Analytical Technology

5 5 ASTM Standards are Voluntary They are: – Developed voluntarily – Used voluntarily Mandatory only when: – Cited in a contractual agreement – Referenced by a government body

6 6 The ASTM Structure 30,000 Members – 104 countries represented – 90 industry sectors represented 132 Technical committees 2,200 Subcommittees Thousands of task groups

7 7 ASTMs Balloting Process TG SOCIETY MAIN Subcommittee Main Committee 60% return; 90% affirmative Subcommittee 60% return; 2/3 affirmative TG – draft development; no formal balloting COS Ensures due process is afforded to all participants Final level of approval

8 8 Modeling ImagingMessaging Communication Confidentiality Security Financial / Management Health Records and Care Functions Identification Systems Medical Concept Representation Decision Support Systems 9 7 Very Simplified: Standards Areas for Health Informatics HL7 CEN TC 251 OpenEHR DICOM Others DICOM HL7 X12 NCPDP IP/XML ASTM E31 ISO TC 215 CEN TC 251 Others Many By Country/ System ASTM HL7 Many Others Govern- ments ASTM Others SNOMED LOINC Many Others Various Incl. HL7


10 10 International Health Care Standards US Standards CENT TC 251 British Standards Dutch Standards French Standards Swedish Standards Australian Standards German Standards Japanese Standards Finland Belgium Switzerland Danish Standards Austrian Standards Italian Standards Rep. of Korea Ecuador Norwegian Standards South Africa Spain Singapore Thailand ISO TC 215 Brazil Denmark New Zealand Czech Republic Israel Vietnam Yugoslavia Poland Russia

11 11 Why Has There Been So Little Success?

12 12 1. Information Content Inconsistencies Different Cultural Aspects CCR EHR Standards Needs Content Agreed Upon by Medical Specialties Taught by Medical Schools Implemented by Software Vendors

13 13 Everything or Just Relevant Information? Summary Referral Data Set Management-Specific Information

14 14 2. Information Capture How to get information into the computer? How to get physicians to use computers in the exam room? Complex issues EHR

15 15 Is Documentation Like This Acceptable Anywhere Else Than in Health Care? Legibility Structure Meaning Method of Documentation

16 16 ASTM E31 Standards (cont.) E31.22 Health Information Transcription and Documentation – Scope: To develop standards for the systems, processes, and management of medical transcription and its integration with other modalities of report generation. E31.22 Standards E1902 Standard Guide for Management of the Confidentiality and Security of Dictation, Transcription, and Transcribed Health Records E1959 Standard Guide for Requests for Proposals Regarding Medical Transcription Services for Healthcare Institutions E2185 Standard Specification for Transferring Digital Voice Data Between Independent Digital Dictation Systems and Workstations E2117 Standard Guide for the Identification and Establishment of a Quality Assurance Program for Medical Transcription E2364 Standard Guide to Speech Recognition Technology Products in Health Care E2344 Standard Guide for Data Capture Through the Dictation Process

17 17 3. Information Representation Inconsistent Meaning of Text Different Code Sets Lack of standards Reimbursement Code Sets – CPT – ICD9CM Clinical Code sets – SNOMED – LOINC – Many Others EHR

18 18 Unless a Coherent Framework of Terminology is Used, Interoperability Cannot be Achieved Framework of Terminology That Allows Mapping to Each Vocabulary or Code Set Ontology-based Web Language (OWL)

19 19 Toward Greater Clinical Specificity HL7 begins to specify code sets for certain message fields HL7 Vocabulary SIG Recommending Code Sets for OBX Segment : LOINC for observation identifier fields SNOMED for use in the value field Should the National Library of Medicine (NLM) include HL7 codes in the UMLS? Coordinating the development of a common drug code model with several drug code developers

20 20 Code Sets Code Sets becoming more structured and stable – SNOMEDs Reference Terminology Developed Concept-based hierarchies created Stable foundation provided – Code Sets converging with SNOMED ADA Micro-glossary DICOM Micro-glossary LOINC Micro-glossary NANDA Micro-glossary Others – The NLMs UMLS becomes a meta-thesaurus

21 21 Codes and Code Sets (including issues of maintenance) ¶ World Health Organization (WHO) –International Classification of Diseases, Ninth Revision (ICD-9) –International Classification of Diseases, Tenth Revision (ICD-10 ) · CMS and the National Center for Health Statistics (NCHS) –International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) –International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) –International Classification of Diseases (ICD) –Disease Classification (code set) ¸ American Medical Association (AMA) –Physicians Current Procedural Terminology (CPT)

22 22 Codes and Code Sets (continued..) ¹ College of American Pathologists –Systematized Nomenclature of Human and Veterinary Medicine (SNOMED) International º American Dental Association (ADA) –Current Dental Terminology (CDT) » Advisory Committee on Dental Electronic Nomenclature Indexing and Classification (ACODENIC) –Microglossary of SNOMED for Dentistry ¼ Center for Nursing Classification, University of Iowa College of Nursing Nursing Interventions Classification (NIC) ½ International Conference on Harmonization –International Medical Terminology (IMT)

23 23 Codes and Code Sets (continued..) ¾ Health Care Claim Adjustment Reason Code/Health Care Claim Status Code Committee –Health Care Claim Adjustment Reason Codes –Health Care Claim Status Codes ¿ Logical Observation Identifier Names and Codes (LOINC) Consortium –Logical Observation Identifier Names and Codes (LOINC) è Georgetown University Home Care Project –Home Health Care Classification (HHCC) System è Perspective on Code Sets Within Transaction Standards

24 24 ASTM Standards E31.01 Controlled Vocabularies for Healthcare Informatics Chair: Peter Elkin Scope: 1, Standardize existing High Level principles for the contents and structure of Controlled Health Vocabularies. 2. Develop a description and comparison of existing formalisms for health concept representation. 3. Develop a standard formalism for Controlled Health Vocabularies. a. This implies a natural ordering of the terminology from its formal definitions. b. The standard formalism must abide by the rules established in Task #1. 4. Work toward a standard model for vocabulary evolution, maintenance, and distribution. 5. Work to develop mechanisms to facilitate international use of common underlying formal structures for Controlled Health Vocabularies E31.01 Standards E 1284 Standard Guideline for Construction of a Clinical Nomenclature for the Support of Electronic Health Records

25 25 4. Data Models and Operational Conformity In order to achieve interoperability, a standardized model must be applied to as well as a standardized data model Current competing models are RIM, FAM, GEHR (OpenEHR), etc. CDA EHR

26 26 ASTMs View Messaging From Messages to Documents 2005-From Documents to Authenticated Data

27 27 5. Clinical Practice Integrating Guidelines and Protocols Disease Management Pathways Software and Patient Management EHR

28 28 6. Decision Support Standardized Decision Support – Admission Systems – Eligibility – Diagnostic Support – Order Entry and Test Results – Etc. EHR

29 29 7. Confidentiality/Security General Security Authentication Data Integrity Accessibility Auditability EHR

30 30 Security Standards US HIPAA ASTM E31 Standards ISO TC 215 PKI Standard CEN TC 251 Security Standards

31 31 Signature Standards Different in each Country: – US – UK – Germany – Australia – Sweden

32 32 Security, Safeguards and Electronic Signatures ASTM E31 Standards Committee on Healthcare Informatics ACR NEMA / DICOM Accredited Standards Committee (ASC) X12 CEN TC251 Working Group 6 on Security, Privacy, Quality and Safety Health Level Seven (HL-7) IEEE National Council for Prescription Drug Programs (NCPDP)

33 33 ASTM E31 Standards (cont.) E31.17 Privacy, Confidentiality and Access Scope: To develop standards that address access, privacy, confidentiality and data security of health information in its many forms and locations. E31.17 Standards E 1869 Guide for Confidentiality, Privacy, Access and Data Security Principles for Health Information Including Computer Based Patient Records E 1986 Standard Guide for Information Access Privileges to Health Information E 1987 Standard Guide for Individual Rights Regarding Health Information E 1988 Standard Guide for the Training Persons Who Have Access to Health Information PS 115 Provisional Standard Specification for Security Audit and Disclosure Logs for Use in Health Information Systems PS 105 Provisional Standard Guide for Amendments to Health Information Standards Under Development Draft Standard for Utilization and Retention of Encrypted Signature Certificates

34 34 ASTM E31 Standards (cont.) E31.20 Data and System Security for Health Information Scope: To develop standards addressing security of health information data and systems and the process for authentication in computer-based patient records systems. E31.20 Standards E 1714 Standard Guide for the Properties of a Universal Healthcare Identifier (UHID) E 1762 Standard Guide for Electronic Authentication of Health Care Information E 1985 Standard Guide for User Authentication and Authorization PS 100 Provisional Standard Specification for Authentication of Healthcare Information Using Digital Signatures PS 101 Provisional Standard Guideline on a Security Framework for Healthcare Information PS 102 Provisional Standard Guide for Internet and Intranet Security Standards Under Development Draft Standard Specification for Transmission of Healthcare Information Using Secure Messaging Protocols Draft Standard for Data, System, Network and Device Integrity, Security, Availability, Reliability and Permanence

35 35 8. Performance The most-overlooked criterion – Affects Selection of Systems EHR No Standards exist.

36 36 Reliability No Standards

37 37 9. Technical Interoperability Which interoperability system will succeed in health care? – OSI – Microsoft – CORBAmed – GEHR/OpenEHR – HL7 – Generic Internet: XML with Ontology EHR

38 38 Continuity of Care Record Standard A core data set of the most relevant current and past information about a patients health status and healthcare treatment Organized and transportable Prepared by a practitioner at the conclusion of a healthcare encounter Enables the next practitioner to readily access such information

39 39 Unique Standards Development Effort Consortium of sponsoring organizations ASTM International E31 Health Informatics Committee Massachusetts Medical Society HIMSS American Academy of Family Physicians American Academy of Pediatrics American Medical Association Patient Safety Institute American Health Care Association National Association for the Support of LTC Mobile Healthcare Alliance (MoHCA) Medical Group Management Association American Academy of Osteopathic Family Physicians

40 40 Sponsors represent… ANSI-recognized standards development organization Over 500,000 practitioners Over 13,000 IT professionals Over 19,000 managers of over 11,000 organizations in which 240,000 physicians practice Over 12,000 institutions in the long-term care community providing care to over 1.5 million elderly and disabled Major stakeholders in m-Health Patients, patient advocates, data sources, corporations, provider institutions….

41 41 CCR Body – Payers – Advance Directives – Support – Functional Status – Problems – Family History – Social History – Alerts – Medications – Medical Equipment – Immunizations – Vital Signs – Results – Procedures – Encounters – Plan of Care – Healthcare Providers Patient administrative and clinical data sections

42 42 ASTM E31 Evolution Physician-driven Sponsor opportunities Practical interoperability – vendor involvement Involved in Re-organization Involved in Harmonization International opportunities

43 43 On The Side... Practical Use of CCR for Consumer Empowerment by MoHCA – Consumer Health Manager

44 44 Structure of the PHR in the CHM Comprehensive Physician-authenticated Health Information Cannot be changed or added to by consumer Consumer/Patient- managed Observations, Collection of Data, Even Corrections Personal/Private Health Information Consumers Area of Recordings Role-based Privacy Requirements

45 45 Thank You Copies of these slides may be obtained from

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