[Federal Register: November 15, 2004 (Volume 69, Number 219)]
[Notices]
[Page 65599-65601]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no04-78]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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: NHINRFI@hhs.gov 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 NHINRFI@hhs.gov.
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
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
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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]
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