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© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 EHR System Functional Model and Standard (ISO/HL7 10781), Release 2 Health Information Management Systems Society (HIMSS) Las Vegas, NV 20 Feb 2012 Presented by: Mark G. Janczewski, MD, MPH Deloitte Consulting, LLP
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HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

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Page 1: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

HL7 EHR System Functional Model and

Standard (ISO/HL7 10781), Release 2

Health Information Management Systems Society (HIMSS) Las Vegas, NV 20 Feb 2012

Presented by:

Mark G. Janczewski, MD, MPH Deloitte Consulting, LLP

Page 2: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Agenda

1. Introduction 2. Release 2 Background 3. Conformance Clause / Functional Profiles 4. Glossary / Verb Hierarchy 5. Function List

Presenter
Presentation Notes
Explain that tutorial is organized generally around the chapters of the specification; but they have been reorganized to allow for a better flow during the tutorial.
Page 3: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

5

Brief History of HL7 Functional Model (FM)

In the Spring of 2003 HL7 began efforts to develop a standardized functional specification for Electronic Health Records Systems (EHR-S) Approved July 2004 as a Draft Standard for Trial Use Approved February 2007 as a fully accredited standard by the

American National Standards Institute (ANSI) Approved mid-2009 as an International (ISO) Standard

CCHIT referenced the EHR-S FM (Release 1) and domain-specific Functional Profiles in developing its product certification criteria

Page 4: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Electronic Health Record (EHR) vs. EHR-System EHR:

Underlying single, logical patient record Record is structured Serves as Provider legal record

EHR System: Software that provides functionality to:

Manage and maintain the record Accomplish various clinical, research, and business

requirements May be:

Monolithic system; or System of systems

Page 5: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Functional Model (FM) Scope Summary

Is Not… A messaging specification An EHR design specification An implementation

specification (not the “how”) Does not prescribe

technology Does not dictate how

functions must be implemented (e.g., via the user interface, database design)

Is… A system specification An EHR system specification A reference list of functions that

may be present in an EHR-S (the “what” and “why”) Enables consistent expression of

functionality Provides flexibility for innovation

and product differentiation Gold standard, sensitive to what

can practically be done by a system yet guides future system development

Presenter
Presentation Notes
Example: A car MUST have the ability to stop. (But it is not our role to specify HOW to stop the car: with an old wooden lever, drum brakes, disc brakes, pneumatics, magnetism; using wires, hydraulics, electro-mechanical devices, or mechanisms yet-to-be-invented.)
Page 6: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

A Way to Specify the Complete EHR

Meets applicable

certification criteria

Capabilities beyond certification criteria are specified by the EHR-S FM and more “domain-

specific” Functional Profiles (e.g. Emergency

Dept., Behav. Health)

Certification is a necessary, but not sufficient, description of what functions a system can perform. The Functional Model provides a more comprehensive set of EHR-S functional requirements

Page 7: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Continued Development

2007: FM passes HL7 Full Normative Ballot, Release 1 2007: FM published as HL7/ANSI Standard 2009: FM passes Joint Ballot with HL7, ISO and CEN,

Release 1.1 November 2009: FM published as ISO/HL7 10781 2010-2011: FM Release 2 Development 2012: FM Release 2 joint balloting

HL7, ISO, CEN, IHTSDO and CDISC

Presenter
Presentation Notes
CEN Technical Committee 251 (CEN/TC 251) is a workgroup within the European Union working on standardization in the field of Health Information and Communications Technology (ICT) in the European Union. The goal is to achieve compatibility and interoperability between independent systems and to enable modularity in Electronic Health Record systems. International Health Terminology Standards Development Organisation (IHTSDO) is a not-for-profit association that develops and promotes use of SNOMED CT to support safe and effective health information exchange. SNOMED CT is a clinical terminology and is considered to be the most comprehensive, multilingual healthcare terminology in the world. Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization, whose mission is "to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of health-care". Their main project, the described data standard, bears the same name. The data standards are defined as a series of Models, which can be expressed using an underlying electronic format. The preferred electronic format is XML, using the Operational Data Model (ODM) as a base XML Schema.
Page 8: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

….

Inputs to EHR-S FM Release 2

Vital Rptg.

RM & ES

Beh. Health

LTC

EHR-S Profiles

Other Industry Initiatives

Privacy, Security,

Confi- dentiality

Health Info

Exchange

….

Data Use • Fraud Mgt • Quality • Rev Cycle

Certifi- cation (CCHIT, Q-Rec)

EHR-S FM Release 2

Others?

UC Alignment

EHR Lifecycle SOA R1

Adjustments, Enhancements EHR

Interoperability Model

Inter- national

Standards (ISO TC215, ISO 20514,

ISO DIS CEN 18308,

13606)

Provider Based

PHR-S FM &

Profiles

Page 9: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Release 2 Timeline When/Target EHR-S FM Release 2 Activity

2011

May Draft for Comment

July – September Comment Reconciliation and Continued Chapter Updates

September 12-15 EHR Working Group (WG) Meeting – San Diego, California

September – November Continued content development and quality assurance

December 6th Ballot Draft Ready Submission to ISO, CEN, CDISC and IHTSDO for Ballot preparation

2012

January 16-19 EHR WG Meeting – San Antonio, Texas

April 2nd HL7 Ballot Opens

May 7th Joint (HL7, ISO, CEN, CDISC and IHTSDO) Ballot Closes

May 14-17 EHR WG Meeting – Vancouver, BC, Canada May – November Ballot reconciliation and material updates

December 1 2nd Ballot Draft Ready for Submission to ISO, CEN, CDISC and IHTSDO for Ballot preparation

2013

January 13 - 18 HL7 WG Meeting

April Ballot

Page 10: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Significant R2 Changes from R1/R1.1 Introduction of Overarching Criteria Chapter Enhancement and enforcement of Glossary – specifically the

“Action-Verb Hierarchy” Reorganization of Chapters Substantial increase in number and granularity of

conformance criteria Substantial increase in number of functions

Implicit functions are now made more explicit. Incorporation of EHR Interoperability Model and EHR

Lifecycle Model (previous independent Draft Standard for Trial Use [DSTU] documents)

Substantial improvements to Conformance Clause chapter

Page 11: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Conformance Clause and Statement

The Conformance Clause defines the minimum requirements for functional profiles claiming conformance to the EHR-S FM.

The value of the Conformance Clause – A vendor can provide a Conformance Statement that shows how well it conforms to relevant Functional Profiles

Page 12: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Conformance to Profiles

EHR-S

EHR-S

EHR-S

EHR-S

Domain Profile

Hospital

Domain Profile

Clinic

Domain Profile

Pharmacy

Derived Domain Profile

Canadian Children’s Hospital

Companion Profile

Cancer Research

Functions Conformance

Criteria

Rules for functional Profiles

Conforms to

EHR-S Functional Model Functional Profiles Implementations

Conforms to Conforms to

Presenter
Presentation Notes
An EHR system does not conform directly to the Functional Model; rather, it conforms to a functional domain profile, or to a domain profile in combination with a selected companion profile . Thus, it is possible for a vendor to claim that his system conforms to a single profile, or to multiple profiles.
Page 13: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Glossary - Introduction Glossary clearly defines terms in the Functional Model

and Profiles Includes a specific Action Verb hierarchy Goal is to promote clarity and consistency when

interpreting and applying the text of the HL7 Electronic Health Record System Functional Model (EHR-S FM).

Release 2 Glossary has undergone a complete review and is more comprehensive including all terms used in the Model.

Glossary includes 238 active terms.

Page 14: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Release 2 Action-Verb Hierarchy

Data Management Category Action-Verbs for the full range of data

handling actions by a system.

Manage (Data)

Capture Maintain Render Exchange Determine Manage-

Data-Visibility

Auto-Populate Enter Import Receive

Store Update Remove Extract Present Transmit Export Import Receive Transmit

Analyze Decide De-Identify Hide Mask Re-Identify Unhide Unmask

Archive Backup Decrypt Encrypt Recover Restore Save

Annotate Edit Harmonize Integrate Link Tag

Delete Purge

Release 1.1 Create Add, input Define, Tailor, Specify, Set Generate Cite, Include Export Find, Identify Specify Prompt

Presenter
Presentation Notes
The first three subsets cover the capture, maintenance and rendering of data as follows: Capture: Auto populate fields of data based on partially filled information, Enter data manually, Import data from an external source (which may be a device), and Receive data from another system (which may be in a device). Maintain: Store, Update and Remove data: Store: Save data on local media, Backup data on backup storage media, and Encrypt data for security and privacy purposes; Update: Edit data by modifying it, Annotate data with notes, Tag data with labels, Harmonize data with other sources, Integrate data together, and Link data to other data; Remove: Delete data from the index or directory, and Purge data from the storage media. Render: Extract data based on certain criteria, Present data on an attached device, and Transmit data to external systems or devices. The next subset provides verbs for the determination of actions in processing data: Determine: Analyze data using rules and analytical steps and then Decide appropriate actions as a result of that analysis. The final subset allows the construct of statements restricting the visibility of data and reversing those actions: Manage-Data-Visibility: De-Identify data as to prevent associating the data to a specific person, Hide data so that only authorized users can see that the data exist, and Mask data so that users can see that the data exist but only authorized users can actually view the actual data. To reverse these actions: Re-Identify, Unhide, and Unmask.
Page 15: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Secure (System) Category Action Verbs

Action-Verbs for controlling access (authenticating and authorizing users), tracking activities (logging and auditing), and sustaining operations. Secure (System)

Control Access Track Sustain (Operations)

Authenticate Authorize Log Audit

Presenter
Presentation Notes
One parent, Secure (System), and three (3) intermediate children: Control Access, Track, and Sustain (Operations).
Page 16: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Extension of Function List The number of conformance criteria increased

from 972 in R1.0, 983 in R1.1 and 2,310 in R2.0 Summary Breakdown of Functions and Conformance Criteria

HL7 EHR-S Functional Model, Release 2 Release 1.1 Release 1 Chapter Functions Conformance

Criteria Conformance

Criteria Conformance

Criteria

OV Overarching Criteria 2 33

CP Care Provision 41 494

CPS Care Provision Support 76 559

POP Population Health Support 18 108

AS Administration Support 55 249

RI Records Infrastructure 37 186

TI Trust Infrastructure 93 681

TOTALS: 322 2,310 983 972

Page 17: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Chapter Reorganization

Overarching (O) Care Provision (CP)

Care Provision Support (CP)

Population Health Support (POP)

Administrative Support (AS)

Record Infrastructure (RI) Trust Infrastructure (TI)

Direct Care (DC) Supportive (S)

Information Infrastructure (IN)

Page 18: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

EHR-S Functional Model – Components

Function ID Function Name Function Statement Function Description Examples See Also Conformance Criteria

Presenter
Presentation Notes
THIS IS JUMP SLIDE TO GO TO THE EXCERPT PAGES OF THE Direct Care and Decision Support pages of the model – with samples of the Supportive and Information Infrastructure chapters. Note: the Statements and Descriptions “suggest” Conformance Criteria. Note: the “Example” portion of the Description serve to offer specific instances of functionality covered by certain Conformance Criteria. Examples are not exhaustive, but are meant for clarification.
Page 19: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Overarching Criteria Chapter Criteria that apply to all EHR Systems and

consequently must be included in all EHR-S FM compliant profiles

Examples:

Ove

rarc

hing

OV.1 The system SHALL conform to function TI.1.1 (Entity Authentication).

The system SHALL conform to function TI.1.2 (Entity Authorization).

The system SHALL conform to function TI.1.3 (Entity Access Control).

IF the system receives or transmits data for which jurisdictionally established interchange standards exist, THEN the system SHALL conform to function IN.5.1 (Interchange Standards) to support interoperability.

The system SHOULD conform to function IN.6 (Business Rules Management).

The system SHOULD conform to function IN.7 (Workflow Management). OV.2 Manage User Help

Page 20: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Care Provision Focus on functions required to provide care to a specific patient

and enable hands-on delivery of healthcare Organized in general order of an encounter

Care

Pro

visi

on

CP.1 Manage Clinical History CP.2 Render Externally-sourced Information CP.3 Manage Clinical Documentation CP.4 Manage Orders CP.5 Manage Results CP.6 Manage Treatment Administration CP.7 Manage Future Care CP.8 Manage Patient Education & Communication CP.9 Manage Care Coordination & Reporting

CP.1 Manage Clinical History CP.1.1 Manage Patient History

CP.1.2 Manage Allergy, Intolerance and Adverse Reaction List

CP.1.3 Manage Medication List CP.1.4 Manage Problem List CP.1.5 Manage Strengths List CP.1.6 Manage Immunization List

CP.1.7 Manage Medical Equipment, Prosthetic/Orthotic, Device List

CP.1.8 Manage Patient and Family Preferences

Example child functions:

Page 21: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Care Provision Support Focus on functions required to support the provision of care to a

specific patient to enable hands-on delivery of healthcare Organized in alignment with Care Provision chapter

Example child functions:

Care

Pro

visi

on S

uppo

rt CPS.1 Record Management

CPS.2 Support Externally-sourced Information CPS.3 Support Clinical Documentation CPS.4 Support Orders CPS.5 Support Results CPS.6 Support Treatment Administration CPS.7 Support Future Care CPS.8 Support Patient Education & Communication CPS.9 Support Care Coordination & Reporting

CPS.4 Support Orders

CPS.4.1 Manage Order Set Templates

CPS.4.2 Support Medication & Immunization Orders

CPS.4.2.1 Support for Medication Interaction & Allergy Checking

CPS.4.2.2 Support for Patient Specific Dosing and Warnings

CPS.4.2.3 Support for Medication Ordering Efficiencies

CPS.4.2.4 Support for Medication Recommendations

CPS.4.3 Support for Non-Medication Ordering

CPS.4.4 Support Orders for Diagnostic Tests

CPS.4.5 Support Orders for Blood Products and Other Biologics

Page 22: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Population Health Support Focus on input to systems that perform medical research, promote

public health, & improve the quality of care at a multi-patient level

POP.6 Measurement, Analysis, Research and Reports POP.6.1 Outcome Measures and Analysis POP.6.2 Performance and Accountability Measures POP.6.3 Support for Process Improvement POP.6.4 Support for Care System Performance Indicators (Dashboards)

Example child functions:

Popu

latio

n He

alth

Sup

port

POP.1 Support for Health Maintenance, Preventive Care and Wellness POP.2 Support for Epidemiological Investigations of Clinical Health Within a Population POP.3 Support for Notification and Response

POP.4 Support for Monitoring Response Notifications Regarding a Specific Patient’s Health POP.5 Donor Management Support POP.6 Measurement, Analysis, Research and Reports POP.7 Public Health Related Updates POP.8 De-Identified Data Request Management POP.9 Support Consistent Healthcare Management of Patient Groups or Populations POP.10 Manage Population Health Study-Related Identifiers

Page 23: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Administration Support Focus on functions to assist with the administrative and financial

requirements

Adm

inis

trat

ion

supp

ort

AS.1 Manage Provider Information

AS.2 Manage Patient Demographics, Location and Synchronization AS.3 Manage Personal Health Record Interaction AS.4 Manage Communication AS.5 Manage Clinical Workflow Tasking AS.6 Manage Resource Availability

AS.7 Manage Encounter/Episode of Care Management AS.8 Manage Information Access for Supplemental Use AS.9 Manage Administrative Transaction Processing AS.1 Manage Provider Information

AS.1.1 Manage Provider Registry or Directory

AS.1.2 Manage Provider's Location Within Facility

AS.1.3 Provider's On Call Location

AS.1.4 Manage Provider's Location(s) or Office(s)

AS.1.5 Team/Group of Providers Registry or Directory

AS.1.6 Provider Caseload/Panel

AS.1.7 Manage Practitioner/Patient Relationships

Example child functions:

Page 24: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Reco

rd

Infr

astr

uctu

re

RI.1 Record Lifecycle and Lifespan

RI.2 Record Synchronization

RI.3 Record Archive and Restore

Record Infrastructure Focus on records, record entries and record management,

including R1.1 functions/criteria and key provisions of the RM-ES Functional Profile, EHR Interoperability and Lifecycle Model DSTUs.

Consists of Release1.1’s : IN.2 (Record Management, except Audit), IN.8 (Record Archive/Restore) and IN.10 (Record Lifecycle -

previously EHR Lifecycle Model DSTU). RI.1.1 Record Lifecycle

RI.1.1.1 Originate and Retain Record Entry RI.1.1.2 Amend Record Entry Content RI.1.1.3 Translate Record Entry Content RI.1.1.4 Attest Record Entry Content RI.1.1.5 View/Access Record Entry Content RI.1.1.6 Transmit and/or Disclose Record Entries RI.1.1.7 Receive and Retain Record Entries RI.1.1.8 De-identify Record Entries RI.1.1.9 Pseudomynize Record Entries RI.1.1.10 Re-identify Record Entries RI.1.1.11 Extract Record Entry Content

Example child functions:

Page 25: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Trust Infrastructure Contains the remaining Release 1.1 Infrastructure functions,

including Audit.

Trus

t Inf

rast

ruct

ure

TI.1 Security TI.2 Audit TI.3 Registry and Directory Services TI.4 Standard Terminology and Terminology Services TI.5 Standards-Based Interoperability TI.6 Business Rules Management TI.7 Workflow Management TI.8 Database Backup and Recovery TI.9 System Management Operations and Performance

TI.1 Security TI.1.1 Entity Authentication TI.1.2 Entity Authorization TI.1.3 Entity Access Control TI.1.4 Patient Access Management TI.1.5 Non-Repudiation TI.1.6 Secure Data Exchange TI.1.7 Secure Data Routing TI.1.8 Information Attestation TI.1.9 Patient Privacy and Confidentiality

Example child functions:

Page 26: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

Want to Know More?

Join HL7, review the HL7 web site www.HL7.org ; Work Groups; Electronic Health Records http://www.HL7.org/Special/committees/ehr/index.cfm

Subscribe to HL7 EHR WG list serve http://www.HL7.org/special/committees/list_sub.cfm?list=ehr

Download and review Functional Profiles Attend open public sessions

No HL7 membership required

Request an “HL7 Ambassador Briefing”

Page 27: HL7 EHR System Functional Model and Standard (ISO/HL7 10781)

© 2011 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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