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ASTM InternationalASTM 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 My Background in Health Informatics StandardsInformatics Standards

2006 Immediate past Chair of ASTM E31 1996-2001 Chair, ANSI Healthcare Informatics Standards Board 2002-2006 Chair of ASTM E312000-2004 Chair of US TAG to ISO TC 2151992-1999 Member of ASTM, AMIA, AHIMA, HL7, IEEE, ABA

(HEALTHCARE), MCC, NCPDP, WEDI, ASC X12, etc.1998 Founding Father of ISO TC 2151997 Chair and Founding Father of CorbaMed OMG1994 Chair: New ASTM Subcommittee on Authenticity of Computer-based

Patient RecordsChair : Committee for Improving International Relations at the ANSI HISPP International and Regional SubcommitteeAppointment by CEN TC 251 as Expert for Project Team 13Member 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 InternationalAbout 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 ASTM Serves Multiple SectorsSectors

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

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ASTM Standards are ASTM Standards are VoluntaryVoluntary

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 StructureThe ASTM Structure30,000 Members

– 104 countries represented– 90 industry sectors represented

132 Technical committees2,200 SubcommitteesThousands of task groups

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ASTM’s Balloting Process ASTM’s Balloting Process

TGTG

SOCIETYSOCIETY

MAINMAIN

SubcommitteeSubcommittee

Main CommitteeMain Committee60% return; 90% affirmative60% return; 90% affirmative

SubcommitteeSubcommittee60% return; 2/3 affirmative60% return; 2/3 affirmative

TG – draft development;TG – draft development;no formal ballotingno formal balloting

COSCOS Ensures due process is afforded to Ensures due process is afforded to all participantsall participants

Final level of approvalFinal level of approval

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Modeling Imaging Messaging Communication

Confidentiality

Security

Financial /

Management

Health Records and Care Functions

Identification Systems

1 32 4 5 6

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Medical Concept Representation

Decision Support Systems

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Very Simplified:

Standards Areas for Health Informatics

HL7CEN TC 251OpenEHRDICOMOthers

DICOM HL7X12NCPDPIP/XML

ASTM E31ISO TC 215CEN TC 251Others

ManyBy Country/System

ASTMHL7Many Others

Govern-mentsASTMOthers

SNOMEDLOINCMany Others

VariousIncl. HL7

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HL7

ASTM E31ASTM E31

ISO TC 215

ASC X12N/EDIFACT

IEEE

NCPDPCEN

TC 251

ADA

Healthcare Informatics Standards Developers

DICOMSNOMED

•JCAHO•NCQA•NCCLS•OMG•IHE•CDISC•MoHCA•OTHERS•(100+)

ANSI

?WHO AHIMAHIMSSNLS NISTNAHITLOINCPHINOthers

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International Health Care International Health Care StandardsStandards

US Standards

CENT TC 251

British Standards

Dutch Standards

French Standards

Swedish Standards

Australian Standards

German Standards

Japanese Standards

FinlandBelgium

Switzerland

Danish Standards

Austrian Standards

Italian Standards

Rep. of Korea

Ecuador

Norwegian Standards

South Africa Spain

Singapore

Thailand

ISO

TC 215

Brazil

Denmark

New Zealand

Czech RepublicIsrael

Vietnam

Yugoslavia

Poland

Russia

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Why Has There Been So Little Why Has There Been So Little Success?Success?

10 Standards Areas of the EHR

EHR

Information CaptureVoice, handwriting, direct input, document imaging, etc.

Compliance with Principles of Documentation.

Information Representation: Terminology, Code sets, Languages, etc.

Operational Dimension and Data Model: Actors, actions, process states/state 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.

Decision Support:Standards for clinical decision making, algorithms, triggers, responses, logical support, etc.

Security/Confidentiality

PerformancePerformance standards,

measures of performance.

Interoperability:Common (inside systems)

convergence EHR domain, (outside) disparate domain, data

and functional mapping, translation rules, versioning, audit;

QA and Testing:Systems’ testing and

operational quality assurance

Content : Scope of health information (limited to department or to one provider?), Scope of

completeness of information.

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, user/role clearances. Accountability, encompassing organizations, business units and individuals, user identification, encryption, data integrity, non-repudiation, signature architecture. Backup/recovery, emergency mode operations, audit, etc.

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1. Information Content1. Information Content

InconsistenciesDifferent Cultural AspectsCCR

EHR

Standards Needs

Content Agreed Upon by Medical Specialties

Taught by Medical Schools

Implemented by Software Vendors

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Everything or Just Relevant Everything or Just Relevant Information?Information?

SummaryReferral Data SetManagement-Specific Information

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2. Information Capture2. Information Capture

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 Documentation

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ASTM E31 Standards (cont.)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 3. Information RepresentationRepresentation

Inconsistent Meaning of Text Different Code Sets Lack of standards Reimbursement Code Sets

– CPT– ICD9CM

Clinical Code sets– SNOMED– LOINC– Many Others

EHR

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Unless a Coherent Unless a Coherent Framework of Terminology is Framework of Terminology is Used, Interoperability Cannot Used, Interoperability Cannot

be Achievedbe 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 Toward Greater Clinical SpecificitySpecificity

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 SetsCode 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 Codes and Code Sets (including issues of maintenance)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..)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..)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 StandardsASTM 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

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4. Data Models and 4. Data Models and Operational ConformityOperational 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 ViewASTM’s View

1990-1998 Messaging

1998-2005 From Messages to Documents

2005- From Documents to Authenticated Data

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5. Clinical Practice5. Clinical Practice

Integrating Guidelines and Protocols

Disease ManagementPathwaysSoftware and Patient

Management

EHR

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6. Decision Support6. Decision Support

Standardized Decision Support– Admission Systems– Eligibility– Diagnostic Support– Order Entry and Test

Results– Etc.

EHR

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7. Confidentiality/Security7. Confidentiality/Security

General SecurityAuthenticationData IntegrityAccessibilityAuditability EHR

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Security StandardsSecurity Standards

US HIPAA ASTM E31 StandardsISO TC 215 PKI StandardCEN TC 251 Security Standards

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Signature StandardsSignature Standards

Different in each Country:– US– UK– Germany– Australia– Sweden

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Security, Safeguards and Electronic Security, Safeguards and Electronic SignaturesSignatures

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.)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.)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. Performance8. Performance

The most-overlooked criterion– Affects Selection of Systems

EHR

No Standards exist.

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ReliabilityReliability

No Standards

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9. Technical Interoperability9. Technical Interoperability

Which interoperability system will

succeed in health care?– OSI– Microsoft– CORBAmed– GEHR/OpenEHR– HL7– Generic Internet: XML with Ontology

EHR

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Continuity of Care Record Continuity of Care Record StandardStandard

A core data set of the most relevant current and past information about a patient’s health status and healthcare treatment

Organized and transportablePrepared by a practitioner at the conclusion

of a healthcare encounterEnables the next practitioner to readily

access such information

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Unique Standards Development EffortUnique Standards Development EffortConsortium 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…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 BodyCCR 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

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ASTM E31 EvolutionASTM E31 Evolution

Physician-drivenSponsor opportunitiesPractical interoperability – vendor

involvementInvolved in Re-organizationInvolved in HarmonizationInternational opportunities

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On The Side...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 CHMStructure of the PHR in the CHM

Comprehensive Physician-authenticated

Health Information

Cannot be changed or added

to by consumer

Consumer/Patient-managed Observations,

Collection of Data, Even Corrections

Personal/Private Health Information

Consumer’s Area of RecordingsRole-based

Privacy Requirements

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Thank YouThank You

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