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
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
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
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 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
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