1. Networking and Health Information Exchange
Welcome to Networking and Health Information Exchange, Standards Developing Organizations. This is Lecture b.
In this lecture we will provide some detail about the organizations that develop standards for Health Information Technology (HIT) for the global community. We will discuss specific organizations and the kind of standards each organization develops.
Standards Developing Organizations
Lecture b
This material (Comp 9 Unit 3) was developed by Duke University, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number IU24OC This material was updated by Normandale Community College, funded under Award Number 90WT0003.
This work is licensed under the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. To view a copy of this license, visit

2. Standards Developing Organizations Learning Objectives
Understand different kinds of standards being developed and for what purpose
Learn about Standards Developing Organizations and the standards they create
Demonstrate how to find, obtain, and use standards that are needed to facilitate networking and health information exchange
The Objectives for this lecture are to:
Understand different kinds of standards being developed and for what purpose
Learn about Standards Developing Organizations and the standards they create
Demonstrate how to find, obtain, and use standards that are needed to facilitate networking and health information exchange

3. ISO TC 215 Healthcare Informatics
Standards have national priority
Members are nations
Established in 1998
Products include Technical Reports, Technical Specifications, and International Standards
The International Standards Organizations Technical Committee (ISO TC 215) was established in 1998 under strong initiative and leadership from the U.S. and the United Kingdom. Most countries require use of an ISO standard, if one exists. Standards are available from ISO, but at a cost.
Membership is by nations, represented by delegates representing the countries. Currently TC 215 has 32 participating countries and 21 observing countries ( these numbers are in constant fluctuation) and represents most regions of the world. ISO TC 215 has published almost 100 standards under their direct responsibilities. Balloting is by country.
Products are:
Technical Reports – Which describe and discuss a topic. TRs are for information only.
Technical Specifications – Similar to a standard but does not require compliance. A TS is a strong suggestion.
International Standards – Known as a normative document, must be followed explicitly to be compliant. Any departure from the standard is non-compliant.
ISO has many Technical Committees, and several are of interest to health care. Other TCs are represented in TC 215 through liaison (30 in number). Other organizations can also establish liaison relationships with ISO (10). Liaison members of TC 215 include CDISC, COCIR, DICOM, GS1, HON, ICN, IHE, IHTSDO, IMIA, and WHO.

4. Work Groups of TC 215 WG1 – Data Structure WG2 – Data Interchange
WG3 – Semantic Content
WG4 – Security
WG6 – Pharmacy and Medicines – Business
WG7 – Medical Devices
WG8 – Business requirements for Electronic Health Records
WG9 – SDO Harmonization
TC 215 has eight active work groups. One other group, WG5 on data cards, completed its work and was inactivated.
WG1 deals with data structure and is the WG that defines standards for the EHR and related material.
WG2 deals with data interchange and includes messaging standards, data types, data models, and such.
WG3 deals with terminology.
WG4 deals with security.
WG6 deals with pharmacy, regulatory and adverse event reporting standards.
WG7 deals with connectivity to medical devices. This group works closely with IEEE and CEN on standards that connect medical devices to systems.
WG8 is similar to WG1 – sometimes the distinction is difficult to define. This WG deals more with what an EHR is rather than its structure and architecture.
WG9 is a different type of WG in that its purpose is harmonization of standards activities among multiple SDOs. It is closely affiliated with the Joint Initiative Council – a collaborative organization of many international SDOs.

5. Significant Relationships
Vienna Agreement
HL7 Pilot Agreement
IEEE Partnership Agreement
The European Committee on Standardization (CEN) has a bilateral agreement with ISO, called the Vienna Agreement, whereby CEN standards can become ISO standards, and ISO standards can become CEN standards.
HL7 International has a pilot agreement through which HL7 standards can be submitted to TC 215 to become ISO standards.
IEEE has a partnership agreement through which IEEE standards can become ISO standards.

6. Harmonization of International Standards
Creation of Joint Initiative Council in 2007
Founding members
ISO TC 215
CEN TC 251
HL7 International
Later members include
CDISC
IHTSDO
GS1
Operates as a council of equals and was formed to create a single standard for a single business use
The Joint Initiative Council was formed in 2007 by ISO, CEN, and HL7 International. SDOs subsequently joining JIC include CDISC, IHTSDO, and GS1.
The purpose of the JIC is to create one standard for one purpose. One of the first successes of the JIC was the creation of a single standard for data types. Other activities include a standard for reporting adverse events (Individual Case Safety Report), a glossary, the Biomedical Research Integrated Domain Group (BRIDG) , EHR Functional Model and others. A standard moves to JIC when multiple SDOS have an interest in creating the same standard and the SDOs agree to work together.

7. CEN TC 251 Workgroup within European Union
Goal is to achieve compatibility and interoperability between independent systems and to enable modularity in EHR systems
Although CEN has been in existence for a long time, the health focus was created in the early 1990s. The acronym CEN comes from the French name of the organization – Comité  Européen de Normalisation.
The 27 member countries of the European Union are members of CEN.
CEN has published over 160 technical reports, technical specifications, pre-standards and European standards since the early 1990s.
18 of these standards are jointly published as ISO standards.
Much of the standards work in CEN is done by paid consultants.
Balloting is by country.

8. CEN TC 251 Work Groups WG I – Information Models
WG II – Terminology and knowledge representation
WG III – Safety and Quality
WG IV – Technology for Interoperability
CEN functions with four work groups.
WG I is similar to ISO WG1, WG6 and WG8.
WG II is similar to ISO WG 3.
WG III is similar to ISO WG4.
WG IV is similar to ISO WG 2 and ISO WG 8.

9. CEN Standard EN 13606
An important CEN standard is EN – Health Informatics – Electronic Health Record communication, published in 5 parts
Reference Model
Archetypes interchange specification
Archetypes and term lists
Security
Interface specification
These standards are being used in the European Union and are becoming ISO standards
EN means European National Standard. The reference model defined in Part 1 is different than the HL7 Reference Information Model and has created some harmonization problems. Reference information models are important because they are the basis from which the data parts of standards are created and are key to interoperability. Part 1 also defines the architecture for the EHR. The EHR is defined as a hierarchical structure of components or folders – similar to a paper chart in which a single encounter would be a folder. The collection of folders would create the EHR.
Archetypes are data structures such as the components that are part of a blood pressure measurement. The UK uses these archetypes as a key part of data definition and data interchange. Europe is now moving toward the use of archetypes. Again, there is competition between HL7’s Detailed Clinical Models and templates. However, efforts are being made to harmonize these activities. Part 5 competes with HL7 messaging standards, and is in little use at this time.
The other parts of are not in significant use at this time.

10. Health Level 7 International
Formed in 1987 as a U.S. SDO; invited international affiliates in the early 1990s
Now HL7 International with over 40 international country members
Is an ANSI accredited SDO
The name Health Level 7 comes from two terms - Health which represents the domain of focus and includes clinical and administrative data. Level 7 refers to the highest level of the ISO communications model for Open Systems Interconnection (OSI) – the application level. HL7 is in use in most hospitals in the US and an increasing number of clinics and doctor’s offices. HL7 is governed by a board of 15 members including 4 officers – chair, vice-chair, secretary and treasurer. The organization is led also by a Chief Executive Officer (Dr. Charles Jaffe) and an Executive Director (Mark MacDougall).
An external Advisory Council provides advice to the organization.
HL7 International is ANSI accredited and is an ISO partner. Many HL7 standards are required for use by ONC as part of the Meaningful Use requirement.

11. HL7 Steering Divisions Domain Experts Foundation and Technology
Structure and Semantic Design
Technical and Support Services
In the technical organizational structure of HL7, there are four Steering Divisions.
These Divisions are:
Domain Experts
Foundation and Technology
Structure and Semantic Design
Technical and Support Services
Each has a number of Work Groups that make up the division. The next four slides will detail the content of these steering divisions. They are grouped by similarity in the kind of work done by the group. The Steering Divisions provide the composition and leadership in the Technical Steering Committee (TSC) which provides the technical leadership of HL7. The TSC is led by the TSC Chair (member volunteer), and the HL7 Chief Technical Officer, who is a member of the HL7 Staff (John Quinn).

12. Domain Experts Anatomic Pathology Anesthesiology Attachments
Child Health
Clinical Interoperability Council
Community Based Health Services
Emergency Care
Government Projects
Health Care Devices
Imaging Integration
Laboratory
Patient Care
Patient Safety
Public Health Emergency Response (PHER)
Pharmacy
Regulated Clinical Research Information Management (RCRIM)
The Domain Experts Steering Group includes all of the domain specific activities. The members of this group, shown on the screen, is the most clinical group in HL7 and brings the clinical community into the standards-making process.

13. Foundation and Technology
Conformance & Implementation
Infrastructure & Messaging
Implementable Technology Specifications (ITS)
Java
Understand different kinds of standards being developed and for what purpose
Learn about Standards Developing Organizations and the standards they create
Demonstrate how to find, obtain, and use standards that are needed to facilitate networking and health information exchange
Shown here is the Foundation and Technology division. These members build the basic pieces that others, like Domain Experts & Structure and Semantic Design Work Groups, use to actually construct the messages.

14. Structure and Semantic Design
Arden Syntax
Clinical Context Object Workgroup (CCOW)
Clinical Decision Support
Clinical Statement
Electronic Health Record (EHR)
Financial Management
Genomics
Orders & Observations
Patient Administration
Personnel Management
Scheduling & Logistics
Structured Documents
The Structure and Semantic Design Group addresses structural standards. They include administrative and service-related standards. Orders and Observation deals with laboratory ordering and results reporting, for example. Clinical Decision support standards are required for meaningful use. Details of the products from these work groups will be discussed in following slides.

15. Technical and Support Services
Education
Electronic Services
Implementation
Marketing Committee
Technical and Support Services division has Work Groups who focus on tools and products that make HL7 successful at doing its work. For instance, publishing makes sure there are tools and processes for publishing the work. The work groups in this division do not develop HL7 products, they provide the tools so that others can do so.

16. HL7 Products Messaging Standards Infrastructure
Version 2.x (current is 2.7 published 12/07)
XML Encoding Rules for v2 Messages
Version 3.0 (2008 Normative Edition in publication)
Infrastructure
Master file structure infrastructure
Role-Based Access Control
Version 2.x messaging standards are the first standards HL7 produced. It is, in fact, its purpose for coming into existence. Over 90% of the hospitals in the US use v2.x standards.
Version 2.7 is the latest current published version, and version 2.8 is in ballot. These messaging standards will be discussed in detail in another unit. Connectivity and sharing data use messaging standards. The master file structure infrastructure standards permit the exchange of files, such as data dictionaries, vocabularies, and other resources among participants.
Role-based access control is very important for privacy and security. These standards define who can have access to data based on what role they play in that patient’s care.

17. HL7 Products Models Reference Information Model Data Types
Common Message Element Type
XML Implementation Technology Specification - Structures
As noted, the Reference Information Model (RIM) is the base for HL7 model-based standards, including HL7 v3 messaging and the Clinical Document Architecture (CDA) standard. The RIM is the model to which components of all HL7 data-related standards are linked. The prime components are Entity, Role (of the Entity), Act, and Participation (of the Entity with the Act).
Data types are essential to interoperability. They can be as simple as a date – is it DDMMYY or MMDDYY? Is it a 12 hour clock with am or pm, or is it a 24 hour clock? What is the time zone, and how is it expressed? The basic data types are ones that you might use in a computer program – binary, numeric, integer, floating point, character, text, string, date-time, etc.
The Common Message Element Type, or CMET, defines commonly used constructs such as a telephone number, a person, name, or an address. CMETS are reusable data structures and have great value in the international setting.
The XML Implementation Technology Specification (ITS) for structures defines the constructs for XML syntax in HL7 messages.

18. HL7 Products Application Electronic Health Record
Functional EHR-S Standard
Interactions for EHR-S and Functional PHR-S
Profiles
EHR Behavioral Health Functional Model
EHR Child Health Functional Model
Scheduling
Notifiable Condition Report
Personnel Management
Genomics - Pedigree
These standards move into the application area. The EHR Functional Model defines the functionality required for an EHR System. Different applications are addressed by creating profiles or implementation guides for various domains and care settings. This standard is the basis for certification of EHRs in the U.S., and is now being used in other countries as well. This topic will be discussed in detail in later units. The Behavioral Health Functional Model and the Child Health Functional Model are examples of profiling the basic standard for a specific domain. Profiling is expanding into a number of sites, settings, and uses.
Scheduling permits the exchange of appointment and diagnostic test scheduling among units.
Notifiable Conditions reporting defines required reporting for example for communicable diseases, infectious diseases, sexually-transmitted diseases (STDs) and such.
Personnel Management includes standards that support reporting and the exchange of data relating to personnel management.
The Genomics standard is rapidly being used for sharing family histories – constructing family trees.

19. HL7 Products Documents Decision Support
Clinical Document Architecture (CDA)
Continuity of Care Document (CCD)
Decision Support
Arden Syntax
Virtual Medical Record
GELLO: Common Expression Language
Infobutton
The Clinical Document Architecture (CDA) is a standard for creating documents. Its use is becoming world-wide and permits a measure of conformance and integrity in the exchange of data. The CDA will be discussed in detail in a later unit. The Continuity of Care Document (CCD) is a specialization of the CDA – in a sense an implementation guide for the exchange of summary patient data. HL7 has now produced a number of purpose-specific implementation guides.
The decision support products will also be addressed in detail in later units. Clinical Decision Support Systems (CDSS) are important, not only for meaningful use, but for applying knowledge to data to provide information. The Arden Syntax and the virtual Medical Record permit an SOA-based approach to decision support through a mapable interface to any EHR.
GELLO is the language for creating clinical guidelines. InfoButton is a standard for attaching knowledge and the presentation of knowledge for any data element. This standard has been quickly used by vendors to add value to their product.

20. HL7 Products Regulated Studies Structured Product Labeling (SPL)
Annotated ECG
Individual Case Safety Report (ICSR)
Drug Stability Study
Regulated Product Submission
Common Product Model (CPM)
Periodic Reporting of Clinical Trials Laboratory Results
These regulated product standards have been influenced by regulatory bodies such as the FDA and European Medicines Agency (EMEA).
Structured Product Labeling (SPL) is a standard for defining what you get on the small print piece of paper that is included with your drug package. It addresses such things as potential side effects, ingredients, dosing instructions, precautions, etc. SPL provides this data in a structured way to be used in a computable manner.
The annotated ECG includes the tracing, measurements, and comments in a structured way.
The Individual Case Safety Report (ICSR) serves to report drug-caused adverse events. This standard is being used internationally by both FDA and ICH/EMEA.
The other standards relate to drug trials and for the submission of regulated products detail to the FDA. The Common Product Model (CPM) addresses expanding types of products including devices and substances.

21. HL7 Products Clinical Context Object Workgroup (CCOW)
Clinical Context Management
Application Protection Package
Manager Protection Package
User Authenticator Package
The Clinical Context Object Workgroup (CCOW) has created a set of standards that takes a patient ID and passes it to related systems, retrieves that patient record, and links it to the current system. In essence, this standard permits single sign on. The user is authenticated across the different systems. If a site is supported by multiple different systems, CCOW will provide access to the same patient’s data across the different applications without logging on to that system and independently bringing up that patient’s record. CCOW is a tremendous time-saver. The other parts of CCOW provide additional functionality across multiple systems or applications.

22. Implementation Guides
HL7 Claims Attachments
Secure HL7 Transactions Using Internet Mail
HL7 Security Service Framework
CDA R2
Common Audit Message
Standard Guide for Implementing HL7 EDI Communication Security
HL7 Version 2.x Messaging Profiling Specification
Continuity of Care Document (CCD)
And growing…
An Implementation Guide (IG) defines specifically what is required in the use of a standard for a specific purpose. The IG removes optionality. For example, it states what data elements are required, and when. It defines specifically what vocabularies are to be used. It defines when data is exchanged. With a well-written IG, interoperability can be achieved across the group using the IG.
Some IGs define the rules for providing security using the internet. Other IGs define security requirements for a variety of settings. For example, CCD is an implementation guide for exchanging patient summary data. Another example is, the rules for claims attachments are defined by CMS. It specifies what clinical or administrative data are to be sent supporting the claim.
Displayed here is a list of Implementation Guides being developed by HL7, and this list continues to grow.

23. HL7 Standards Named in HHS Final Rule
HL7 v2.5.1 Implementation Guide: Electronic Laboratory Results Reporting to Public Health
Clinical Document Architecture (CDA)
Continuity of Care Document (CCD)
Messaging Standard v2.5.1
Messaging Standard v2.3.1
Several HL7 standards will be required by HHS as a part of the Meaningful Use.
Named standards include:
HL7 v2.5.1 Implementation Guide: Electronic Laboratory Results Reporting to Public Health
Clinical Document Architecture (CDA)
Continuity of Care Document (CCD)
Messaging Standard v2.5.1 and
Messaging Standard v2.3.1
You are likely to encounter these standards in your job as an IT person. We will discuss all of these standards in detail in other parts of this component.

24. CDISC Standards Study Data Tabulation Model (SDTM)
Recommended for FDA regulatory submissions
Analysis Data Model (ADaM)
Complements SDTM submission by detailing statistical analysis performed on clinical trials results
Operational Data Model (ODM)
Clinical Data Acquisition Standards Harmonization (CDASH)
Laboratory Data Model (LAB)
CDISC Terminology
The Clinical Data Interchange Standards Consortium (CDISC) is an organization started mainly by pharmaceutical companies. It is a research-based organization created to support clinical trials. It is now international, and holds meetings around the world. Most of the standards define data elements used in research and clinical trials. Study Data Tabulation Model (SDTM) defines data elements used in clinical trials. The CDISC Analysis Data Model (ADaM) defines statistical analyses performed on clinical trials data. Other standards include an operational data model (ODM), clinical data acquisition standards harmonization (CDASH), a lab data model, and terminology for clinical trials.

25. GS1 Key Standards Barcodes
eCom – electronic business messaging standards for automatic transmission of data
GDSN – Global Data Synchronization – allow business partners to have consistent item data in their systems at the same time
EPCglobal – use RFID technology to track items in real time
Key GS1 standards include:
Barcodes
eCom – Electronic business messaging standards for automatic transmission of data
GDSN – Global Data Synchronization – allow business partners to have consistent item data in their system at the same time
EPCglobal – Use RFID technology to track items in real time.
If you work in a setting that uses barcodes, you are likely to use a GS1 standard. GS1 creates a unit identifier that can exist throughout the supply chain. Ideally, this standard will be used from product creation to product use. The GS1 ID system enhances traceability – the ability to trace a product throughout its life cycle.
RFID is for Radio Frequency Identifiers. It is a badge that contains an RF transmitter that transmits the identity indicated on the card. It is used to track people, including physicians and patients, equipment, and supplies.

26. Standards Developing Organizations Summary- Lecture b
Multiple SDOs = competing and overlapping standards
Redundancy in work
Redundancy in people
Limited resources
This concludes Lecture b of Standards Developing Organizations.
In this lecture you learned that there are many SDOs, both national and international, that create standards necessary for interoperability. The challenge exists that there are both overlapping and competing standards and there are gaps in the required standards. Each SDO has its own focus, but in time most SDOs have creeping scope. It is interesting that we have so many SDOs, because producing standards is an expensive task. Most SDOs have budgets in the million dollar range, and many companies spend hundreds of thousands of dollars annually to participate in making standards.
Consequently there are limited resources for creating standards, so why not work together? The making of standards has created other businesses, including consultants who teach you how to use standards; and educators who teach you about standards.
You won’t remember the details of every one of the SDOs we discussed in this unit, but you will have some familiarity with the names, and some idea of what kinds of standards are produced.

27. Standards Developing Organizations References – Lecture b
American Dental Association. (n.d.). Retrieved from American Dental Association website:
ANSI - American National Standards Institute. (n.d.). Retrieved from
ANSI Accredited U.S. Technical Advisory Groups (TAGs) to ISO. (n.d.). Retrieved from
ASCX12 - About ASC X12. (n.d.). Retrieved from ASC X12 website:
ASTM International - Welcome to ASTM.org. (n.d.). Retrieved from ASTM International website:
CDISC Strength Through Collaboration. (n.d.). Retrieved from Clinical Data Interchange Standards Consortium website:
DICOM (Digital Imaging and Communications in Medicine). (n.d.). Retrieved from Medical Imaging & Technology Alliance - a division of NEMA website:
GS1 The global language of business. (n.d.). Retrieved from
Health Level Seven International. (n.d.). Retrieved from HL7 website:
IEEE Advancing Technology for Humanity. (n.d.). Retrieved from IEEE website:
IHE - Welcome to Integrating the Healthcare Enterprise. (n.d.). Retrieved from IHE International website:
Joint Initiative on SDO Global Health Informatics Standardization. (n.d.). Retrieved from Health Level Seven International website:
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28. Standards Developing Organizations References – Lecture b
MedBiquitous Advancing Healthcare Education Through Collaboration. (n.d.). Retrieved from MedBiquitous Consortium website:
National Council for Prescription Drug Programs . (n.d.). Retrieved from
National Institute of Standards and Technology. (n.d.). Retrieved from U.S. Department of Commerce website:
National Quality Forum. (n.d.). Retrieved from The National Quality Forum website:
OASIS - Advancing open standards for the information society. (n.d.). Retrieved from OASIS website:
OMG. (n.d.). Retrieved from Object Management Group, Inc. website:
openEHR - Welcome to openEHR. (n.d.). Retrieved from openEHR website:
TC 215 Health Informatics. (n.d.). Retrieved from ISO (International Organization for Standardization) website:
Technical Committees, Workshops and other bodies. (n.d.). Retrieved from CEN (Comité Européen de Normalisation) website:
The Internet Engineering Task Force (IETF). (n.d.). Retrieved from Internet Society website:
U.S. National Library of Medicine - National Institutes of Health. (n.d.). Retrieved from U.S. National Library of Medicine website:
W3C. (n.d.). Retrieved from W3C website:
Welcome to IHTSDO. (n.d.). Retrieved from International Health Terminology Standards Development Organisation website:
World Health Organization. (n.d.). Retrieved from WHO website:
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29. Standards Developing Organizations Lecture b
This material was developed by Duke University, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number IU24OC This material was updated by Normandale Community College, funded under Award Number 90WT0003.
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Health IT Workforce Curriculum Version 4.0