ASTM International

1
ASTM International

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

• 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

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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

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

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ASTMs 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
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Very Simplified Standards Areas for Health
Informatics
1
3
2
4
5
6
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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
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9
Medical Concept Representation
Decision Support Systems
SNOMED LOINC Many Others
Various Incl. HL7
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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
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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
Spain
Denmark
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Why Has There Been So Little Success?
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1. Information Content

• Inconsistencies
• Different Cultural Aspects
• CCR

Standards Needs Content Agreed Upon by Medical
Specialties 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

• How to get information into the computer?
• How to get physicians to use
• computers in the exam room?
• Complex issues

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

Method of Documentation
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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

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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

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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

• 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

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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

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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

• E31.01 Controlled Vocabularies for Healthcare
  Informatics
• Chair Peter Elkin (elkin.peter_at_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

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ASTMs View

• 1990-1998 Messaging
• 1998-2005 From Messages to Documents
• 2005- From Documents to Authenticated Data

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5. Clinical Practice

• Integrating Guidelines and Protocols
• Disease Management
• Pathways
• Software and Patient Management

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6. Decision Support

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

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7. Confidentiality/Security

• General Security
• Authentication
• Data Integrity
• Accessibility
• Auditability

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Security Standards

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

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Signature Standards

• Different in each Country
• US
• UK
• Germany
• Australia
• Sweden

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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)

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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

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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

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8. Performance

• The most-overlooked criterion
• Affects Selection of Systems

No Standards exist.
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Reliability

• No Standards

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9. Technical Interoperability

• Which interoperability system will
• succeed in health care?
• OSI
• Microsoft
• 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 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

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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

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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.

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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

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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
Comprehensive Physician-authenticated Health
Information
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Thank You

• Copies of these slides may be obtained from
  peter_at_medrecinst.com