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ASTM International Committee E31 on Health Informatics

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Presentation on theme: "ASTM International Committee E31 on Health Informatics"— Presentation transcript:

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

2 My Background in Health Informatics Standards
2006 Immediate past Chair of ASTM E31 Chair, ANSI Healthcare Informatics Standards Board Chair of ASTM E31 Chair of US TAG to ISO TC 215 Member of ASTM, AMIA, AHIMA, HL7, IEEE, ABA (HEALTHCARE), MCC, NCPDP, WEDI, ASC X12, etc. 1998 Founding Father of ISO TC 215 1997 Chair and Founding Father of CorbaMed OMG 1994 Chair: 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 1993 Chair: 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 About ASTM International
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 ASTM Serves Multiple Sectors
Mechanical Testing Plastics Road and Paving Medical and Surgical Materials and Devices Textiles Corrosion of Metals Pharmaceutical Process Analytical Technology Health Informatics Metals Petroleum and Lubricants Environment Air Soil Water Construction Materials Consumer Products

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

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

8 Standards Areas for Health Informatics
Very Simplified: Standards Areas for Health Informatics 1 2 3 4 5 6 7 Health Records and Care Functions Confidentiality Security Financial / Management Imaging Messaging Communication Identification Systems Modeling HL7 CEN TC 251 OpenEHR DICOM Others HL7 X12 NCPDP IP/XML ASTM E31 ISO TC 215 CEN TC 251 Others Many By Country/ System Govern-ments ASTM Others DICOM ASTM HL7 Many Others 8 9 Medical Concept Representation Decision Support Systems SNOMED LOINC Many Others Various Incl. HL7

9 Healthcare Informatics Standards Developers

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

11 Why Has There Been So Little Success?

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

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

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 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 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 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 Code Sets Code Sets becoming more structured and stable
SNOMED’s 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 NLM’s UMLS becomes a meta-thesaurus

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

23 Codes and Code Sets (continued..)
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) Georgetown University Home Care Project Home Health Care Classification (HHCC) System Perspective on Code Sets Within Transaction Standards

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 Standard Guideline for Construction of a Clinical Nomenclature for the Support of Electronic Health Records

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 ASTM’s View 1990-1998 Messaging 1998-2005 From Messages to Documents
2005- From Documents to Authenticated Data

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

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

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

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

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

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

36 Reliability No Standards

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 Continuity of Care Record Standard
A core data set of the most relevant current and past information about a patient’s 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 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 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 CCR Body Patient administrative and clinical data sections 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

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

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

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

45 Thank You Copies of these slides may be obtained from

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