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Health Level Seven® International 

Unlocking the Power of Health Information 

An A SI accredited standards developer 

February 7, 2011 

Patrick Gallagher 

National Institute of Standards and Technology 

100 Bureau Drive, Stop 1070 

Gaithersburg, MD 20899-1070 

RE: Standardization Feedback for Sub-Committee on Standards 

On behalf of the Board of Directors of Health Level Seven International (HL7), we are pleased to offer our 

comments on the effectiveness of federal agency participation in the development and implementation of

standards. Our responses are organized according to the RFI’s four broad headings: 

• Perspectives on government’s approach to standards activities 

• Issues considered during the standards setting process 

• Adequacy of resources 

• Process review and improvement metrics 

Perspectives on government’s approach to standards activities

HL7 has worked with multiple government agencies over the course of the last two decades. During 

2010, a number of these agencies participated as organizational members of HL7, including Agency for 

Healthcare Research and Quality, (AHRQ), Centers for Disease Control and Prevention (CDC), Centers 

for Medicare & Medicaid Services (CMS), Department of Defense (DoD), Food and Drug Administration 

(FDA), the National Cancer Institute (NCI), the National Library of Medicine (NLM), the National Institute 

of Standards and Technology (NIST), and the US Department of Veterans Affairs (VA). A number of 

state public health agencies also maintain membership within HL7. 

HL7 has forged strong and successful partnerships with many federal agencies to develop and bring 

needed standards to the marketplace. One of HL7’s earliest collaborations was with the CDC in the early 

1990s to develop messages permitting the transmission of immunization records from care providers to 

local and state public health agencies and on to CDC immunization registries, queries of these registries 

for immunization public health records, and the return of these immunization records to care providers. 

These messages are still in widespread use today and CDC continues to maintain and distribute the 

current code sets for these messages 

The National Committee for Vital and Health Statistics (NCVHS) and CMS worked closely with HL7 and 

X12 through the HL7 Attachments Work Group to develop the supplemental information needed to 

support healthcare insurance and other e-commerce transactions. Started in 1997, the work group has 

created and balloted implementation guides and attachment specifications that use HL7 Version 2.x 

messaging and the HL7 Version 3 Clinical Document Architecture (CDATM) standards. These were 

incorporated into a notice of proposed rulemaking (NPRM) under HIPAA in 2005, and work continues 

today for an update and expected future publication of final rule on transactions to support attachments 

for both claims and referral authorization. 

In the mid 1990s, HL7 worked with the NLM on a three-year project to develop and apply methods to 

ensure that the UMLS Meta-Thesaurus was aligned with the HL7 vocabulary standards. This work was 

undertaken to ensure Consolidated Health Informatics (CHI) vocabularies as distributed through NLM’s 

UMLS Metathesaurus are usable with HL7 and to develop implementation guide(s) for the use of HL7 to 

transmit electronic health record (EHR) data and documents between two systems, independent of 

source and destination architectures. 
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Office: +1 (734) 677-7777 • Fax: +1 (734) 677-6622 • E-mail: hq@HL7.org • Website: www.HL7.org

Health Level Seven and HL7 are registered trademarks of Health Level Seven International. Registered in the U.S. Trademark Office. 

The FDA has been an active participant in, and founding member of, the HL7 Regulated Clinical 

Research Information Management Work Group, a joint collaboration between HL7, the FDA and the 

Clinical Data Interchange Standards Consortium (CDISC). This group develops standards to improve or 

enhance information management during clinical research and regulatory evaluation of the safety, 

efficacy and quality of therapeutic products and procedures worldwide. Among other work products, this

group has developed two very successful standards: the Structured Product Labeling (SPL), a document 

markup standard approved by HL7 and adopted by FDA as a mechanism for exchanging product 

information; and the Biomedical Research Integrated Domain Group (BRIDG) Model, a domain analysis 

model representing protocol-driven biomedical/clinical research. The FDA has also worked with HL7 to 

develop the Individual Case Safety Report (ICSR) standards for reporting adverse events and product 

problems to regulatory agencies, and the Common Product Model for periodic reporting of safety updates

in relation to medicinal products in pre- and post-marketing. 

In 2001, at the request of the then DHHS National Health Information Infrastructure (NHII) and now ONC, 

the VA partnered with HL7 to fund the creation of an internationally-focused Electronic Health Record 

System Functional Model (EHR-S FM). Subsequently, HL7’s EHR Work Group has created an 

internationally-focused Personal Health Record System Functional Model (PHR-S FM) and conformance 

requirements that provide guidance in the development of functional profiles (which are realm-, 

application- or care setting-specific constraints of the EHR-S FM and PHR-S FM). 

AHRQ funded and supported HL7’s recent efforts to create a forum for clinicians to bring their needs and 

knowledge to HL7 without being burdened by the technical requirements of standards developments. This 

effort ultimately resulted in the formation of the Clinical Interoperability Council, an active work group 

within HL7 that provides a nexus of communication and bridge to the standards development framework, 

organizational processes and forums for the clinical community to define content, flow, and other domain 

requirements necessary to the development of robust health data standards. More recently, substantial

HL7 cooperation and collaboration with ONC contractors produced a balloted implementation guide that 

met ONC’s requirements for clinical laboratory messaging. 

In recent years, the National Cancer Institute (NCI) has collaborated with HL7 to develop the Services

Aware Interoperability Framework (SAIF). SAIF is an architecture framework for achieving interoperability 

via HL7’s artifacts including support services, messages, and clinical documents created with HL7’s V3

Clinical Document Architecture (CDA). This architecture framework is in use at the NCI and is being 

implemented across HL7. 

NIST is also a long-time HL7 member and has made a number of contributions to our standards 

development process. While HL7 fully supports accredited processes, we also recognize that there are 

other equally good and effective processes. NIST has studied and published a number of findings relative 

to the characteristics of good process that result in successful standards adoption and has brought some 

of those findings and processes into HL7 without conflicting with our own ANSI-accredited processes. 

NIST is well qualified to provide guidance and advice to federal agencies relative to good processes and 

characteristics of processes that should be implemented nationally to meet the goals of the American 

Recovery and Reinvestment Act of 2009 (ARRA) Title XIII Health Information Technology for Economic 

and Clinical Health Act (HITECH Act). 

Finally, a number of federal agency employees have also participated in the governance of HL7 by 

serving on its Board of Directors. Other federal agency employees serve on HL7’s Advisory Council 

and/or Technical Steering Committee (TSC). Both HL7 and the federal agencies have benefitted from 

these activities and collaborations and we anticipate continuing to work with these groups in the future. 

Issues Considered During the Standards Setting Process

HL7’s intellectual property takes the form of copyrights on its balloted standards and implementation 

guides, and various trademarks on its name and key products. Our standards are registered with the US

Copyright Office and are covered under the protections of that agency. As a not-for-profit organization, 

HL7 derives its revenues from licensing fees, which are then re-invested to provide services to HL7 
3300 Washtenaw Ave., Suite 227 • Ann Arbor, MI 48104-4261 • USA 

Office: +1 (734) 677-7777 • Fax: +1 (734) 677-6622 • E-mail: hq@HL7.org • Website: www.HL7.org

Health Level Seven and HL7 are registered trademarks of Health Level Seven International. Registered in the U.S. Trademark Office. 

members and participants in the form of meetings and meeting support, balloting services, and Internetaccessible products and services. HL7 therefore asserts control of its intellectual property and assumes 

that all users, including the US government, will pay appropriate license fees to access and use HL7 

intellectual property. 

There are a number of apparent discrepancies around federal agency funding of standards, particularly 

those that federal agencies have helped develop. HL7 recommends timely resolution and publication of 

guidance with respect to these discrepancies. For example, the National Technology Transfer and 

Advancement (NTTA) Act of 1995 directs federal agencies to use standards developed by voluntary 

consensus bodies. However, HIT guidance from Federal CIO Sept 17, 2010 directs certain federal 

agencies to “Incorporate shared Federal standards and terminologies where available, and contribute to

their ongoing development where needed.” Other legislation indicates that a standards development 

organization cannot enforce its own copyright against a free distribution of its standard, and USC § 105 

indicates that the US government owns the copyright to work completed by contractors hired by a federal 

agency. Likewise, there is currently no shared understanding as to how much of American National 

Standards Institute (ANSI)-accredited standard the government can use without compensating the SDO 

for fair and reasonable IP rights. Such discrepancies create confusion and will continue to hinder 

collaboration and successful adoption of needed standards. HL7 requests clarification on the apparent 

discrepancy in the law and letters above. 

HL7 recognizes that an individual’s health does not respect jurisdictional borders and therefore is 

committed to the development and use of international standards. We recommend that the US 

government include this criterion in its standards selection process. The FDA already respects this 

criterion, with the proposed use of the GS1 standard for unique device identifier being a recent example. 

Finally, HL7 agrees wholeheartedly that innovation is crucial to the successful launch of our national

healthcare reform initiative. However, such innovation cannot be so inwardly focused as to overlook the 

work and accomplishments of our colleagues in other countries. 

Adequacy of Resources

There is ongoing federal support for maintenance and free access to the Systematized Nomenclature of 

Medicine – Clinical Terms (SNOMED CT) and Logical Observation Identifiers Names and Codes 

(LOINC), two federally mandated vocabulary standards. These represent successful case studies, and 

federal support of these standards should continue. Expansion of this approach to encompass other 

standards required for national healthcare reform, including Digital Imaging and Communications in 

Medicine (DICOM), the National Council of Prescription Drug Programs (NCPDP), HL7, etc., or the 

creation of a subscription service to ensure easy access to and understanding of the licensing 

requirements, will enable standards organizations to develop the tools and implementation guides crucial 

to successful standards adoption. NIST is well qualified to guide and advise the federal agencies in the 

development of licensing and/or subscriptions arrangement suitable for this purpose. 

While HL7 has enjoyed and benefitted from the participation of federal agency employees, there is an 

increasing and continuing need for federal involvement in the accredited standards development process. 

Ensuring that federal agencies are involved early in the standards development and that most, if not all, 

of the relevant federal agencies are actively engaged would be helpful. As a beneficiary of successful 

standards adoption, the federal government should feel compelled to support the infrastructure needed to 

develop and maintain standards, particularly those that are mandated. Canada Health Infoway and 

Standards Australia are just two of the many examples of standards activities that enjoy country-wide 

support as a result of government sponsorship. 

A number of changes within HL7 are making our standards more enticing to the communities but 

adoption will be hindered without faster development of tools to assist with the implementation of robust 

interoperability standards across international environments. The federal government can assist this 

effort by assuming some of the licensing or tools development costs. 
3300 Washtenaw Ave., Suite 227 • Ann Arbor, MI 48104-4261 • USA 

Office: +1 (734) 677-7777 • Fax: +1 (734) 677-6622 • E-mail: hq@HL7.org • Website: www.HL7.org

Health Level Seven and HL7 are registered trademarks of Health Level Seven International. Registered in the U.S. Trademark Office. 

Process Review and Improvement Metrics

Substantial process improvement can be realized by upfront harmonization rather than retrospective 

review. The industry is aware of the good and critical work of IHE, the Standards and Interoperability

Framework initiatives, HL7 and other standards groups, and it is incumbent on the federal government to 

help fund the standards lifecycle and the corresponding infrastructure of all of those groups to enable 

improvement. Only then can we ensure development and adoption of the interoperability standards that 

will be required for the greatest endeavor of all time. 

Sincerely, 

 

Charles Jaffe, MD, PhD, FACP, FACMI Robert Dolin, MD, FACP, FACMI, FHL7 

Chief Executive Officer Chairman of the Board