ASTM International
C. Peter Waegemann
Immediate Past Chair
Committee E31 on
Health Informatics
CEO, Medical Records Institute
Chair, Mobile Healthcare Alliance
1
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.
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About ASTM International
ASTM
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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.
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ASTM Serves Multiple Sectors
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Health Informatics
Metals
Petroleum and
Lubricants
Environment
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– Air

– Soil

– Water
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Construction Materials
Consumer Products
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Mechanical Testing
Plastics
Road and Paving
Medical and Surgical
Materials and Devices
Textiles
Corrosion of Metals
Pharmaceutical Process
Analytical Technology
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ASTM Standards are
Voluntary

They are:
– Developed voluntarily
– Used voluntarily

Mandatory only when:
– Cited in a contractual agreement
– Referenced by a government body
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The ASTM Structure
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30,000 Members
– 104 countries represented
– 90 industry sectors represented
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132 Technical committees
 2,200 Subcommittees
 Thousands of task groups
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ASTM’s Balloting Process
COS
SOCIETY
Ensures due process is afforded to
all participants
Final level of approval
Main Committee
60% return; 90% affirmative
MAIN
Subcommittee
TG
Subcommittee
60% return; 2/3 affirmative
TG – draft development;
no formal balloting
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Very Simplified:
Standards Areas for Health Informatics
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2
Modeling
HL7
CEN TC 251
OpenEHR
DICOM
Others
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4
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Confidentiality Financial /
Imaging Messaging
Communication Security
Management
DICOM
8
Medical
Concept
Representation
SNOMED
LOINC
Many Others
HL7
X12
NCPDP
IP/XML
ASTM E31
ISO TC 215
CEN TC 251
Others
Many
By
Country/
System
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Health
Records
and Care
Functions
ASTM
HL7
Many
Others
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Identification
Systems
Governments
ASTM
Others
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Decision
Support
Systems
Various
Incl. HL7
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ANSI
DICOM
Healthcare
Informatics
Standards
Developers
SNOMED
ADA
CEN
TC 251
NCPDP
HL7
•JCAHO
•NCQA
•NCCLS
•OMG
•IHE
•CDISC
•MoHCA
•OTHERS
•(100+)
?
WHO
AHIMA
HIMSS
NLS NIST
NAHIT
LOINC
PHIN
Others
ISO TC 215
ASTM E31
ASC X12N/EDIFACT
IEEE
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International Health Care
Standards
Vietnam
Yugoslavia
ISO
Australian Standards
Rep. of Korea
Ecuador
TC 215
Czech Republic
Israel
US Standards
British Standards
Austrian
Standards
Dutch Standards
French Standards
Swedish Standards
German Standards
South Africa
Singapore
Russia
Switzerland
Italian Standards
Danish Standards
Norwegian Standards
New Zealand
Finland
Poland
Japanese Standards
Thailand
Brazil
Denmark
Belgium
CENT TC 251
Spain
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10Why
Standards
Areas
ofSo
theLittle
EHR
Has There
Been
Content : Scope of health
Information Capture
Voice, handwriting, direct input, document imaging, etc.
Compliance with Principles of Documentation.
Success?
Information
Representation:
Terminology, Code
sets, Languages, etc.
information (limited to
department or to one
provider?), Scope of
completeness of information.
QA and Testing:
Systems’ testing and
operational quality assurance
Interoperability:
Common (inside systems)
convergence EHR domain,
(outside) disparate domain, data
and functional mapping, translation
rules, versioning, audit;
Operational Dimension and Data
Model: Actors, actions, process states/state
EHR
transitions, work flows, allocation,
deployment, staging, routing, conditionals,
version control, audit levels, etc. Classes,
relationships, attributes, states, identifiers,
data types, version control, and audit control.
Clinical Practice:
Standards of care/practice,
protocols (e.g., care plans, critical
paths), problem management and
resolutions.
Performance
Performance standards,
measures of performance.
Security/Confidentiality
Decision Support:
Standards for clinical decision making,
algorithms, triggers, responses, logical
support, etc.
Privacy and security protections: information flow (chain of trust): end-to-end (point of origination to point of access security, stewardship, accountability,
authentication, audit; trust, authentication, audit, access control, encryption, trusted data stores, trusted communications, data/function classifications,
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user/role clearances. Accountability, encompassing organizations, business units and individuals, user identification, encryption, data integrity, nonrepudiation, signature architecture. Backup/recovery, emergency mode operations, audit, etc.
1. Information Content

Inconsistencies
 Different Cultural Aspects
 CCR
Standards Needs
Content Agreed Upon by
Medical Specialties
EHR
Taught by Medical Schools
Implemented by Software
Vendors
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Everything or Just
Relevant Information?
Summary
 Referral Data Set
 Management-Specific Information

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2. Information Capture
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How to get information into the computer?
 How to get physicians to use
computers in the exam room?
 Complex issues
EHR
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Is Documentation
Like This Acceptable
Anywhere Else Than
in Health Care?
• Legibility
• Structure
• Meaning
Method of
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Documentation
ASTM E31 Standards (cont.)
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E31.22 Health Information Transcription and Documentation
–
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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
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3. Information
Representation
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Inconsistent Meaning of Text
Different Code Sets
Lack of standards
Reimbursement Code Sets
– CPT
– ICD9CM
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Clinical Code sets
– SNOMED
– LOINC
– Many Others
EHR
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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)
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Toward Greater Clinical
Specificity
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HL7 begins to specify code sets for certain message fields
HL7 Vocabulary SIG Recommending Code Sets for OBX
Segment:
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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
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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
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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)
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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)
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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
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ASTM Standards
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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
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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
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ASTM’s View
1990-1998 Messaging
1998-2005 From Messages to Documents
2005From Documents to Authenticated
Data
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5. Clinical Practice
Integrating Guidelines
and Protocols
 Disease Management
 Pathways
 Software and Patient
Management

EHR
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6. Decision Support
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Standardized Decision
Support
– Admission Systems
– Eligibility
– Diagnostic Support
EHR
– Order Entry and Test
Results
– Etc.
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7.
Confidentiality/Security

General Security
 Authentication
 Data Integrity
 Accessibility
 Auditability
EHR
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Security Standards
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US HIPAA
 ASTM E31 Standards
 ISO TC 215 PKI Standard
 CEN TC 251 Security Standards
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Signature Standards
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Different in each Country:
– US
– UK
– Germany
– Australia
– Sweden
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Security, Safeguards and Electronic
Signatures
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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)
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ASTM E31 Standards (cont.)
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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
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Standards Under Development
 Draft Standard for Utilization and Retention of Encrypted Signature Certificates
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ASTM E31 Standards (cont.)
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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.
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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
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8. Performance

The most-overlooked criterion
– Affects Selection of Systems
No Standards exist.
EHR
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Reliability
No Standards
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9. Technical
Interoperability

Which interoperability system will
succeed in health care?
– OSI
– Microsoft
EHR
– CORBAmed
– GEHR/OpenEHR
– HL7
– Generic Internet: XML with Ontology
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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
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Unique Standards Development Effort
Consortium of sponsoring organizations
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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
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Sponsors represent…
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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,
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corporations, provider institutions….
CCR Body

Patient administrative and clinical data
sections
– Payers
– Medical Equipment
– Advance Directives
– Immunizations
– Support
– Vital Signs
– Functional Status
– Results
– Problems
– Procedures
– Family History
– Encounters
– Social History
– Plan of Care
– Alerts
– Healthcare Providers
– Medications
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ASTM E31 Evolution
 Physician-driven
 Sponsor
opportunities
 Practical interoperability – vendor
involvement
 Involved in Re-organization
 Involved in Harmonization
 International opportunities
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On The Side...

Practical Use of CCR for Consumer
Empowerment by MoHCA
– Consumer Health Manager
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Structure of the PHR in the CHM
Cannot be
changed or added
to by consumer
Role-based
Privacy
Requirements
Comprehensive
Physician-authenticated
Health Information
Consumer/Patientmanaged Observations,
Collection of Data,
Even Corrections
Consumer’s Area of
Recordings
Personal/Private Health
Information
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Thank You
Copies of these slides may be obtained from peter@medrecinst.com
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