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March 1, 2011 

U.S. Department of Commerce 

National Institute of Standards and Technology 

National Science and Technology’s Subcommittee on Technology 

RE: Standardization feedback for Subcommittee on Standards 

Dear Sir/Madam: 

This letter represents the comments of the Medical Imaging & Technology Alliance (MITA), and 

comes in response to the Request for Information by the National Institute of Standards and 

Technology (NIST), on behalf of the National Science and Technology Council’s Subcommittee 

on Standards, which was issued on December 8, 2010 in the Federal Register, 75 Federal 

Register 76397, Docket No. 0909100442-0563-02. The Request for Information is seeking 

comments on the effectiveness of Federal agencies’ participation in the development and 

implementation of standards, and the adequacy and availability of Federal resources for 

standards-setting activities. 

The purpose of the Request for Information is to help the Subcommittee on Standards develop 

case studies that Federal agencies can consider in their future engagement in standards 

development and conformity assessment, in key technology areas. MITA’s comments will focus 

on the key area of health information technology, with regard to implementation of a Nationwide 

Health Information Network (NHIN). 

MITA is the Medical Division of the National Electrical Manufacturers Association (NEMA) 

and is the collective voice of medical imaging equipment and radiopharmaceutical 

manufacturers, innovators and product developers. These technologies include: 

• Medical X-ray equipment 

• Computed tomography (CT) scanners 

• Ultrasound 

• Nuclear medicine imaging equipment (including radiopharmaceuticals) 

• Radiation therapy equipment 

• Magnetic resonance imaging (MRI) 

• Imaging Informatics Systems 

MITA appreciates the opportunity to share its views with you, and commends NIST for its 

interest in improving Federal agency participation in standards activities. MITA believes that the 

Office of the National Coordinator (ONC) has not fully recognized that imaging is central to 

clinical practice, and that the Digital Imaging and Communications in Medicine (DICOM) 

Standard, which is essential to communication of imaging information, already exists, and is 

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readily available for implementation. Adoption and use of this standard is key to achievement of 

the NHIN and work must begin now to ensure its implementation. 

Specific Comments

MITA agrees with the findings of the President’s Council of Advisors on Science and 

Technology (PCAST) Report, which found that the Federal government had not optimized its 

activities for achievement of the NHIN. MITA supports the Report’s recommendation that ONC 

redirect its focus toward achieving a robust health information exchange and an effective 

functioning infrastructure in which clinical information can be communicated and shared among 

providers regardless of their location. 

One of the key components of the NHIN is the capability to exchange images and imaging 

reports among providers. This can only be accomplished by adoption and use of universally 

recognized standards. The DICOM Standard is currently the nearly universally accepted tool 

which enables communication of images and imaging reports. DICOM is in widespread use by 

providers worldwide and is available now for implementation. 

MITA offered to help ONC implement these capabilities. At meetings with ONC on April 9, 

2009 and August 13, 2009, MITA described its experience and expertise on development, 

deployment and testing of the DICOM Standard, and offered its assistance to facilitate the 

implementation of NHIN. 

 In addition, in response to a solicitation for input from the White House Office of Science and 

Technology Policy, MITA’s letter of November 12, 2009 cited those areas where MITA’s 

expertise and experience can provide valuable advice to the Health Information Technology 

(HIT) Policy Committee. These areas include, for example: 

1. Providing actual field examples of clinical facilities which have successfully 

implemented the DICOM Standard; 

2. Conducting a feasibility analysis to demonstrate the benefits of DICOM implementation; 

3. Analyzing how providers are likely to receive various proposed solutions based on their 

individual health information technology capabilities 

In our letter of March 15, 2010, in response to the Interim Final Rule issued on January 13, 2010, 

in 75 Federal Register 2014, MITA recommended that the DICOM Standard be adopted in the 

initial set of standards as an essential step to achieve the goal of systems’ interoperability and 

Meaningful Use of EHR technology. MITA requested that ONC promptly provide the 

opportunity for imaging equipment manufacturers to describe and explain the value of the 

DICOM Standard to achieve this goal. MITA emphasized that it was important that discussions 

begin promptly to ensure an orderly transition from Stage 1 to Stage 2. 

Medical imaging device manufacturers have extensive expertise and experience with respect to 

the DICOM Standard, and with other standards-based tools, to coordinate radiology report 

sharing among providers. However, ONC has not yet effectively utilized this expertise, or 

collaborated with medical imaging device manufacturers to implement these capabilities. As a 

result, this has created confusion, and in effect has hampered, rather than facilitated, progress 

toward achievement of the NHIN. 
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MITA Recommendations

MITA believes that ONC’s, and CMS’ leadership and participation in the development of the 

NHIN need to be significantly improved and increased in order to successfully implement this 

capability. To achieve this goal, we make the following recommendations: 

1. ONC and CMS should immediately and publicly acknowledge the criticality of the 

adoption and use of the DICOM Standard for communication of images and imaging 

information, and the importance of the use of Integrating the Healthcare Enterprise (IHE) 

Profiles, such as XDS-I.b, for addressing clinical workflow and interoperability issues. 

2. ONC should make the adoption and use of the DICOM Standard and IHE Profiles key 

goals for the implementation of Meaningful Use of EHR technology in 2013 and 2015, 

and industry should be a full participant in this process. 

3. ONC should revise its strategic planning process to include as full participants not only 

provider representatives, but also representatives of medical imaging device 

manufacturers, information technology companies and those organizations with expertise 

in creation, implementation and testing of health data infrastructure. Based on their 

participation, and fully utilizing their expertise and experience, the ONC Strategic Plan 

should be thoroughly evaluated and revised in order to achieve the NHIN. 

4. ONC should recognize that by following the DICOM Standard and IHE models, much of 

the cost of adoption and government overhead can be removed by allowing selfcertification of conformance to both DICOM and IHE by manufacturers. This selfcertification system has worked well for industry and has been in place for over 20 years. 

Conclusion

The foundation of the NHIN rests on achievement of systems interoperability, adoption of a 

robust health information exchange capability, and an effectively functioning infrastructure. The 

adoption and use of the DICOM Standard, as well as other standards-based tools, must be given 

top priority to ensure the Meaningful Use of electronic health record technology. This work 

must begin now to ensure that the necessary steps will be taken in a careful, coordinated fashion. 

The active participation and leadership of ONC in the process of development of the NHIN is 

vital to saving lives, reducing healthcare costs and improving the quality of healthcare delivery 

for all Americans. MITA stands ready to assist NIST in this important effort. 

If you have any questions, please contact me directly at (703) 841 – 3279 or by e-mail at 

dfisher@medicalimaging.org. 

Sincerely, 

 

David Fisher 

Executive Director 

Medical Imaging & Technology Alliance (MITA)