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March 7, 2011 

National Institute of Standards and Technology 

USA Department of Commerce 

SOS_RF@NIST.gov

Subject: GE Healthcare Comments 

Standardization Feedback for Sub-Committee on Standards 

Federal Register notice – Request for information [75 FR 76397 (Dec. 8, 2010)] 

GE Healthcare provides these comments in response to the Request for Information published in the Federal 

Register on December 8, 2010 (75 FR 76397). 

GE Healthcare appreciates the opportunity to provide input on important issue of federal agency participation in 

aligning Health Information Technology to be consistent with national priorities, the National Technology Transfer 

and Advancement Act, the OMB Circular A-119 and the American Recovery and Reinvestment Act. GE Healthcare 

encourages NIST and other involved regulatory federal agencies to more strongly coordinate their activities while 

continuing to endorse the use of consensus-based standards. In this regard, we urge NIST to consider the 

observations regarding federal coordination of and involvement with standards development contained in the 

comments for this Request for Information submitted by the HIMSS Electronic Health Record Association.

The participation of NIST scientists and experts in the application of connectivity standards for medical device data 

has benefited that process and the use of standards. For example, the NIST ITL SSD has worked closely with the 

members of the IEEE 11073 and IHE Patient Care Devices communities. By providing test tooling in a transparent 

and consensus-based approach, NIST’s participation enhances the value of existing standards such as ISO/IEEE 

11073 and promotes vendor adoption of that standard. This activity also promotes international standards that can 

be used in multiple markets. 

The last section of our comments focuses on the exemplary collaboration between the NIST ITL Software and 

Systems Division (SSD) Interoperability Group and the Integrating the Healthcare Enterprise (IHE) Patient Care 

Devices (PCD) domain. 

NIST ITL SSD and IHE Patient Care Devices Domain 

Our comments refer to the following group within NIST: 

National Institute of Standards and Technology (NIST) 

Information Technology Laboratory (ITL) 

Software and Systems Division (SSD) 

Interoperability Group 

and specifically to the NIST IHE-PCD HL7 V2 Test Effort, led by John Garguilo and Lisa Carnahan:

John Garguilo (john.garguilo@nist.gov) 

Sandra Martinez (sandra.martinez@nist.gov) 

Julien DeShayes (julien.deshayes@nist.gov) 

Kevin Brady (kevin.brady@nist.gov, Acting Manager, Interoperability Group) 

Isabelle Barclay (Guest Researcher) 

Maria Cherkaoui (Guest Researcher, term ended Nov 2010) 

Lisa Carnahan (lisa.carnahan@nist.gov, former Group Leader, moving to another section of NIST) 

Ram D. Sriram, Ph.D. (sriram@nist.gov, Division Chief, Software and Systems Division) 

The NIST ITL SSD Interoperability Group has worked closely with the Integrating the Healthcare Enterprise (IHE) 

Patient Care Devices (PCD) domain to develop test tools and databases that support rigorous conformance testing of 

HL7 V2.6 messages that convey near real-time medical device data to and from a hospital EMR using the IHE PCD 

Device Enterprise Communication (DEC) Technical Framework. 
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The NIST tooling has played an essential role in the IHE PCD effort, since it has been used for Pre-Connectathon, 

Virtual-Connectathon and Connectathon testing for the past several years. The NIST tooling integrates the widely 

used HL7 Messaging Workbench with the ISO/IEEE 11073 Medical Device Communications nomenclature and 

domain information model to provide a rigorous yet easy-to-use testing framework that is now a foundational part of 

our testing. 

NIST has also developed the Rosetta Terminology Mapping Management System (RTMMS) that provides a 

repository of harmonized medical device terms plus associated co-constraints (e.g. units-of-measure, enumerated 

values, measurement sites, etc.) and is currently used by all vendors participating in the IHE PCD domain. 

The NIST test tools and the RTMMS provide an HL7 V2.6 message testing framework facilitate comprehensive and 

rigorous message validation. Participation of NIST further legitimizes the use of open standards for sending 

medical device date to the EMR in a ‘plug-and-play’ manner that will benefit our industry, our customers and 

ultimately the patients we serve. 

NIST IHE-PCD HL7 V2 Test Effort Specific Recommendation 

The NIST IHE PCD HL7 V2 test effort is a major project that requires a long-term commitment by NIST as well as 

the vendors and standards organizations. Developing and updating the underlying IEEE and HL7 standards can take 

several years, followed by a multi-year deployment by vendors. Thus, funding period for NIST work in this area 

should be extended to at least ten years to ensure the availability of state-of-the-art test tools and supporting 

databases. The longer funding period will encourage vendors and other standards organizations to participate in 

making the NIST tooling the cornerstone of their testing methodology, to the benefit of all. 

Respectfully submitted, 

Paul Schluter, Ph.D. Richard Gardner 

Principal Engineer, Patient Care Solutions Regulatory Affairs Leader - Standards 

GE Healthcare Systems GE Healthcare 

8200 West Tower Avenue 540 W. Northwest Hwy 

Milwaukee, WI 53223 Barrington, IL 60010 

office: (414) 362-3610 office: (847) 277-6013 

cell: (414) 702-2026 cell: (847) 848-0679