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Epic 1979 Milky Way Verona WI 53593 (608) 271‐9000 FAX (608) 271‐7237 www.epic.com

March 7, 2011

Patrick Gallagher

Director

National Institute of Standards and Technology

Co‐Chair, National Science and Technology Council’s Sub‐Committee on Technology

Attention: Ajit Jillavenkatesa

100 Bureau Drive

Gaithersburg, MD 20899

Mr. Gallagher:  

Epic appreciates the opportunity to comment on the December 8, 2010 Request for Information

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

of standards and conformity assessment activities and programs. Epic is an electronic health

record (EHR) developer based in Verona, Wisconsin.  Our suggestions in this letter are based on

two decades of experience programming electronic health records and participating in the EHR

industry in standards and interoperability initiatives.

Standards‐Setting Processes and Benefits

Standard‐setting activities are the most successful when they gather the participation of the

groups that will eventually be held to those standards. These groups have the domain

knowledge to balance practical need with technical feasibility. In the healthcare interoperability

sector, there is a rich history of clinicians, healthcare professionals, and experts from every level

of the technical infrastructure convening to define both needs and solutions to create a base of

standards from which interoperability can be made practical.  

For example, Integrating the Healthcare Enterprise (IHE), a multi‐stakeholder group made up

of both users and industry experts, continually and consistently works together through

voluntary workgroups to define the use of base standards. In addition to these definitions, IHE

also coordinates their yearly testing and demonstration, is responsible for certifying systems as

compliant, and advertises and advocates for the use of these profiles across the industry

throughout the United States and the world. Through this functional approach, systems that are

certified in a role defined by IHE can continue to distinguish themselves competitively while

still working from a base set of functionality that allows them to communicate with other

systems.

The benefit of having data exchanging standards is a faster and less costly implementation of

the exchange for its participants. As long as standards set a base requirement and allow for
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Epic 1979 Milky Way Verona WI 53593 (608) 271‐9000 FAX (608) 271‐7237 www.epic.com

extendibility, innovation and competitiveness are not harmed. Organizations that want to

contribute more can do so; with time, if such contributions are really beneficial to all, they

should become standards.  

The organizations that introduced them benefit again as they already have done what is now

required, thus allowing them to use their resources to innovate again. Standardization has

spurred innovation by allowing more time to spend on new ideas and development that

otherwise would have been taken to implement and code one off exchanges.

Perspectives on Government’s Approach to Standards Activities

Where possible, the role of the Federal government should be that of convener, organizing

stakeholders, providing support, and setting and meeting reasonable deadlines with the help of

domain experts. The role of the Federal government should be to encourage and coordinate

standard‐setting activities.  The history of the industry’s voluntary participation in standards‐

setting activities, however, speaks to vendor commitment with little to no Federal intervention

and to our recognition of the need for meaningful standards, and so we urge the government to

examine progress to date when considering how their participation can advance the process.

Beyond their potential role as convener where no effective convener exists, Federal/Government

agencies should participate in the standard setting activities like other stakeholders with the

understanding that they can bring valuable input to the table. Sometimes the needs of these

agencies are different from current trends. We should approach such needs as additional use

cases and strive to meet them as priorities permit. Rare needs should be treated as extensions to

the standards that others can implement if they wish to do business with the respective federal

agency. See, for example, the Social Security Administration; the SSA CDA implements

extensions of the C32 document, which is appropriate as SSA data needs can be different.

However, the transactions used for the exchange are typical IHE implementations. This is a

great example of use of existing standards with additions of needed extensions.

Additional Comments

Where possible, industry‐led standard‐setting activities already involve stakeholders from

foreign interests. Such an approach best accommodates any overlap of standards because the

standards are written a priori from an international perspective and for an international user

base.  

Finally, like many voluntary organizations, standard‐setting groups are most limited by the

time of their volunteers. Most volunteers can address small tasks about which they are

passionate, but may not have the time to coordinate large‐scale efforts that require joint

participation by many people. Federal agencies can play a valuable role in recognizing the
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Epic 1979 Milky Way Verona WI 53593 (608) 271‐9000 FAX (608) 271‐7237 www.epic.com

contribution capacity of the many players and organizing these contributions into a

comprehensive whole.

Thank you for your consideration. We hope our perspective is useful as you consider your role

in this process.

Epic

1979 Milky Way

Verona, WI 53593

(608) 271‐9000

www.epic.com