[Federal Register Volume 69, Number 219 (Monday, November 15, 2004)]
[Notices]
[Pages 65599-65601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25382]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Coordinator for Health Information Technology; 
Development and Adoption of a National Health Information Network

AGENCY: Department of Health and Human Services.

ACTION: Request for information.

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SUMMARY: Public comment is sought regarding considerations in 
implementing the President's call for widespread adoption of 
interoperable electronic health records (EHRs) within 10 years. On 
April 27, 2004, President Bush established the position of the National 
Health Information Technology Coordinator. On May 6, 2004, Secretary 
Tommy G. Thompson appointed David J. Brailer, MD, PhD to serve as 
National Coordinator for Health Information Technology. The Executive 
Order signed by the President required the National Coordinator to 
report within 90 days of operation on the development and 
implementation of a strategic plan. This Framework for Strategic Action 
entitled: ``The Decade of Health Information Technology: Delivering 
Consumer-centric and Information-rich Health Care'' (the Framework), 
was presented at the Health Information Technology Secretarial Summit 
II on July 21, 2004. The Framework is posted for reference at: [http://www.hhs.gov/onchit/framework/]. The Framework outlines an approach 
toward the nationwide implementation of interoperable health 
information technology in both the public and the private sectors.
    In order to realize a new vision for health care through the use of 
information technology, the report called for a sustained set of 
strategic actions, embraced by the public and the private health 
sectors, which will be taken over many years. The Framework outlined 
four major goals: inform clinical practice with use of EHRs, 
interconnect clinicians so that they can exchange health information 
using advanced and secure electronic communication, personalize care 
with consumer-based health records and better information for 
consumers, and improve public health through advanced biosurveillance 
methods and streamlined collection of data for quality measurement and 
research.
    This Request for Information (RFI) addresses the goal of 
interconnecting clinicians by seeking public comment and input 
regarding how widespread interoperability of health information 
technologies and health information exchange can be achieved. This RFI 
is intended to inform policy discussions about possible methods by 
which widespread interoperability and health information exchange could 
be deployed and operated on a sustainable basis.

DATES: Responses should be submitted to the Department of Health and 
Human Services (HHS), Office of the National Coordinator for Health 
Information Technology (ONCHIT), on or before 5 p.m. e.s.t. on January 
18, 2005.

ADDRESSES: Electronic responses are preferred and should be addressed 
to: <a href="/cdn-cgi/l/email-protection#5c121415120e1a151c34342f723b332a"><span class="__cf_email__" data-cfemail="5d131514130f1b141d35352e733a322b">[email protected]</span></a> in the Office of the National Coordinator for 
Health Information Technology, Department of Health and Human Services. 
Include NHIN RFI Responses in the subject line. Non-electronic 
responses will also be accepted. Please send to: Office of the National 
Coordinator Health Information Technology, Department of Health and 
Human Services, Attention: NHIN RFI Responses, Hubert H. Humphrey 
Building, Room 517D, 200 Independence Avenue, SW., Washington, DC 
20201.

FOR FURTHER INFORMATION CONTACT: On December 6, 2004, there will be a 
technical assistance conference call to answer questions from potential 
responders. More details will be provided on how to participate in this 
call on the ONCHIT Web site [http://www.hhs.gov/onchit/]. Additionally, 
a public, online Frequently Asked Question (FAQ) page will be provided 
to answer questions throughout the response period on ONCHIT's Web 
site.
    Please direct e-mail inquiries and responses to <a href="/cdn-cgi/l/email-protection#28666061667a6e616840405b064f475e"><span class="__cf_email__" data-cfemail="f5bbbdbcbba7b3bcb59d9d86db929a83">[email protected]</span></a>. 
For additional information, contact Lee Jones or Lori Evans, in the 
Office of the National Coordinator for Health Information Technology at 
toll free (877) 474-3918.
    Background: As the nation embarks on the widespread deployment of 
EHRs, a variety of concomitant challenges and barriers must be 
addressed. One of these is interoperability, or the ability to exchange 
patient health information among disparate clinicians and other 
authorized entities in real time and under stringent security, privacy 
and other protections. Interoperability is an essential factor in using 
health information technology to improve the

[[Page 65600]]

quality and efficiency of care in the United States. Interoperability 
is necessary for compiling the complete experience of a patient's care, 
for maintaining a patient's personal health records and for ensuring 
that complete health information is accessible to clinicians as the 
patient moves through various healthcare settings. Interoperability is 
needed for clinicians to make fact-based decisions so medical errors 
and redundant tests can be reduced. Interoperability is also critical 
to cost-effective and timely data collection for biosurveillance, 
quality measurement and clinical research. In short, interoperability 
is essential for realizing the key goals that are desired from health 
information technology.
    With the exception of a few isolated regional projects, the United 
States does not currently have meaningful health information 
interoperability capabilities. Moreover, the broad set of actions and 
tasks that are needed to achieve interoperability are not well-defined. 
It is known that interoperability requires a set of common standards 
that specify how information can be communicated and in what format. On 
this, there has been considerable effort and progress achieved by 
private sector organizations such as Health Level 7 (HL7), and by the 
American National Standards Institute (ANSI), both of which are 
voluntary consensus standards setting organizations. Also, HHS and 
other Federal agencies have advanced the adoption of standards through 
the Consolidated Health Informatics (CHI) initiative, as well as the 
Public Health Information Network (PHIN) and National Electronic 
Disease Surveillance System (NEDSS) under the leadership of the Centers 
for Disease Control and Prevention (CDC). With HHS participation, HL7 
has also created a functional model and standards for electronic health 
records.
    However more remains to be done to achieve interoperability and to 
determine the process by which these tasks should be pursued in the 
public and private sectors. Clearly needed are interconnection tools 
such as mobile authentication, identification management, common web 
services architecture and security technologies. Also needed are 
precisely defined implementation regimens that are specified at the 
level of software code. There is also a need for common networking and 
communication tools to unify access and security. Aside from this, 
mechanisms for ensuring the sustainable operation of these components 
on a widespread and publicly available basis must be defined. There are 
potentially other components that may not be known at this time. The 
collective array of components that underlie nationwide 
interoperability is referred to as a National Health Information 
Network (NHIN) in the Framework.
    The NHIN could be developed and operated in many ways. It could 
include state-of-the-art web technologies or more traditional 
clearinghouse architectures. It could be highly decentralized or 
somewhat centrally brokered. It could be a nationwide service, a 
collection of regional services or a set of tools that share common 
components. It could be overseen by public organizations, by private 
organizations, or by public-private consortia. Regardless of how it is 
developed, overseen or operated, there is a compelling public interest 
for a NHIN to exist.
    Therefore, the National Coordinator for Health Information 
Technology is seeking comments on and ideas for how a NHIN can be 
deployed for widespread use. To begin this process, the National 
Coordinator is inviting responses about the questions in this RFI. We 
intend to explore the role of the federal government in facilitating 
deployment of a NHIN, how it could be coordinated with the Federal 
Health Architecture (FHA), and how it could be supported and 
coordinated by Regional Health Information Organizations (RHIOs). (For 
additional information on the FHA and the RHIOs, please refer to the 
report: ``The Decade of Health Information Technology: Delivering 
Consumer-centric and Information-rich Health Care,'' at: [http://www.hhs.gov/onchit/framework/]).
    There are many perspectives that can be brought to bear on this 
important topic. Health information technology organizations, 
healthcare providers, industry associations and other stakeholders all 
have important insights that will inform future deliberation. In the 
interest of having the most compelling, complete and thorough responses 
possible, we encourage interested parties to collaborate and submit 
unified responses to this RFI wherever possible. Comments from the 
public at large are also invited.

Request for Information

    General 1. The primary impetus for considering a NHIN is to achieve 
interoperability of health information technologies used in the 
mainstream delivery of health care in America. Please provide your 
working definition of a NHIN as completely as possible, particularly as 
it pertains to the information contained in or used by electronic 
health records. Please include key barriers to this interoperability 
that exist or are envisioned, and key enablers that exist or are 
envisioned. This description will allow reviewers of your submission to 
better interpret your responses to subsequent questions in this RFI 
regarding interoperability.
    2. What type of model could be needed to have a NHIN that: Allows 
widely available access to information as it is produced and used 
across the health care continuum; enables interoperability and clinical 
health information exchange broadly across most/all HIT solutions; 
protects patients' individually identifiable health information; and 
allows vendors and other technology partners to be able to use the NHIN 
in the pursuit of their business objectives? Please include 
considerations such as roles of various private- and public-sector 
entities in your response.
    3. What aspects of a NHIN could be national in scope (i.e., 
centralized commonality or controlled at the national level), versus 
those that are local or regional in scope (i.e., decentralized 
commonality or controlled at the regional level)? Please describe the 
roles of entities at those levels. (Note: ``national'' and ``regional'' 
are not meant to imply Federal or local governments in this context.)

Organizational and Business Framework

    4. What type of framework could be needed to develop, set policies 
and standards for, operate, and adopt a NHIN? Please describe the kinds 
of entities and stakeholders that could compose the framework and 
address the following components:
    a. How could a NHIN be developed? What could be key considerations 
in constructing a NHIN? What could be a feasible model for 
accomplishing its construction?
    b. How could policies and standards be set for the development, use 
and operation of a NHIN?
    c. How could the adoption and use of the NHIN be accelerated for 
the mainstream delivery of care?
    d. How could the NHIN be operated? What are key considerations in 
operating a NHIN?
    5. What kind of financial model could be required to build a NHIN? 
Please describe potential sources of initial funding, relative levels 
of contribution among sources and the implications of various funding 
models.
    6. What kind of financial model could be required to operate and 
sustain a functioning NHIN? Please describe the

[[Page 65601]]

implications of various financing models.
    7. What privacy and security considerations, including compliance 
with relevant rules of the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA), are implicated by the NHIN, and how 
could they be addressed?
    8. How could the framework for a NHIN address public policy 
objectives for broad participation, responsiveness, open and non-
proprietary interoperable infrastructure?

Management and Operational Considerations

    9. How could private sector competition be appropriately addressed 
and/or encouraged in the construction and implementation of a NHIN?
    10. How could the NHIN be established to maintain a health 
information infrastructure that:
    a. Evolves appropriately from private investment;
    b. Is non-proprietary and available in the public domain;
    c. Achieves country-wide interoperability; and
    d. Fosters market innovation.
    11. How could a NHIN be established so that it will be utilized in 
the delivery of care by healthcare providers, regardless of their size 
and location, and also achieve enough national coverage to ensure that 
lower income rural and urban areas could be sufficiently served?
    12. How could community and regional health information exchange 
projects be affected by the development and implementation of a NHIN? 
What issues might arise and how could they be addressed?
    13. What effect could the implementation and broad adoption of a 
NHIN have on the health information technology market at large? Could 
the ensuing market opportunities be significant enough to merit the 
investment in a NHIN by the industry? To what entities could the 
benefits of these market opportunities accrue, and what implication (if 
any) does that have for the level of investment and/or role required 
from those beneficiaries in the establishment and perpetuation of a 
NHIN?

Standards and Policies To Achieve Interoperability

    (Question 4b above asks how standards and policy setting for a NHIN 
could be considered and achieved. The questions below focus more 
specifically on standards and policy requirements.)
    14. What kinds of entity or entities could be needed to develop and 
diffuse interoperability standards and policies? What could be the 
characteristics of these entities? Do they exist today?
    15. How should the development and diffusion of technically sound, 
fully informed interoperability standards and policies be established 
and managed for a NHIN, initially and on an ongoing basis, that 
effectively address privacy and security issues and fully comply with 
HIPAA? How can these standards be protected from proprietary bias so 
that no vendors or organizations have undue influence or advantage? 
Examples of such standards and policies include: secure connectivity, 
mobile authentication, patient identification management and 
information exchange.
    16. How could the efforts to develop and diffuse interoperability 
standards and policy relate to existing Standards Development 
Organizations (SDOs) to ensure maximum coordination and participation?
    17. What type of management and business rules could be required to 
promote and produce widespread adoption of interoperability standards 
and the diffusion of such standards into practice?
    18. What roles and relationships should the federal government take 
in relation to how interoperability standards and policies are 
developed, and what roles and relationships should it refrain from 
taking?

Financial and/or Regulatory Incentives and Legal Considerations

    19. Are financial incentives required to drive the development of a 
marketplace for interoperable health information, so that relevant 
private industry companies will participate in the development of a 
broadly available, open and interoperable NHIN? If so, what types of 
incentives could gain the maximum benefit for the least investment? 
What restrictions or limitation should these incentives carry to ensure 
that the public interest is advanced?
    20.What kind of incentives should be available to regional 
stakeholders (e.g., health care providers, physicians, employers that 
purchase health insurance, payers) to use a health information exchange 
architecture based on a NHIN?
    21. Are there statutory or regulatory requirements or prohibitions 
that might be perceived as barriers to the formation and operation of a 
NHIN, or to support it with critical functions?
    22. How could proposed organizational mechanisms or approaches 
address statutory and regulatory requirements (e.g., data privacy and 
security, antitrust constraints and tax issues)?

Other

    23. Describe the major design principles/elements of a potential 
technical architecture for a NHIN. This description should be suitable 
for public discussion.
    24. How could success be measured in achieving an interoperable 
health information infrastructure for the public sector, private sector 
and health care community or region?

    Dated: November 9, 2004.
David J. Brailer,
National Coordinator, Office of the National Coordinator for Health 
Information Technology.
[FR Doc. 04-25382 Filed 11-10-04; 11:30 am]
BILLING CODE 4150-24-P


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