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ASTM International

ASTM International. C. Peter Waegemann Immediate Past Chair Committee E31 on Health Informatics. CEO, Medical Records Institute Chair, Mobile Healthcare Alliance. My Background in Health Informatics Standards. 2006 Immediate past Chair of ASTM E31

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ASTM International

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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 Alliance

  2. My Background in Health Informatics Standards 2006 Immediate past Chair of ASTM E31 1996-2001 Chair, ANSI Healthcare Informatics Standards Board 2002-2006 Chair of ASTM E31 2000-2004 Chair of US TAG to ISO TC 215 1992-1999 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 31.17 Privacy, Confidentiality and Access And others such as Board Member of SNOMED International, etc.

  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. 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 ASTM Serves Multiple Sectors

  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 • 104 countries represented • 90 industry sectors represented • 132 Technical committees • 2,200 Subcommittees • Thousands of task groups

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

  8. Very Simplified: Standards Areas for Health Informatics 1 2 3 4 5 6 7 Health Records and Care Functions Confidentiality Security Financial / Management Imaging MessagingCommunication 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 ANSI DICOM SNOMED ADA CEN TC 251 NCPDP HL7 • JCAHO • NCQA • NCCLS • OMG • IHE • CDISC • MoHCA • OTHERS • (100+) ISO TC 215 ? WHO AHIMA HIMSS NLS NIST NAHIT LOINC PHIN Others ASTM E31 ASC X12N/EDIFACT IEEE

  10. International Health Care Standards Vietnam Yugoslavia ISO TC 215 Rep. of Korea Ecuador AustralianStandards Czech Republic US Standards Israel Singapore Russia BritishStandards Switzerland AustrianStandards ItalianStandards Thailand DutchStandards DanishStandards NorwegianStandards FrenchStandards SwedishStandards Brazil NewZealand Belgium GermanStandards Finland Poland CENTTC251 JapaneseStandards SouthAfrica Denmark Spain

  11. Why Has There Been So Little Success?

  12. EHR 1. Information Content • Inconsistencies • Different Cultural Aspects • CCR 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. EHR 2. Information Capture • How to get information into the computer? • How to get physicians to use computers in the exam room? • Complex issues

  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. EHR 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

  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 (elkin.peter@mayo.edu) • 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. EHR 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

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

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

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

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

  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 • Sweden

  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 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 115Provisional Standard Specification for Security Audit and Disclosure Logs for Use in Health Information Systems • PS 105Provisional 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 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. EHR 8. Performance • The most-overlooked criterion • Affects Selection of Systems No Standards exist.

  36. Reliability No Standards

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

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

  45. Thank You Copies of these slides may be obtained from peter@medrecinst.com

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