
January 18, 2005
Office of the National Coordinator for Health
Information Technology
Department of Health and Human
Services
Attention: NHIN RFI Responses
Hubert H. Humphrey Building,
Room 517D
200 Independence Avenue, S.W.
Washington, DC
20201
Submitter: Gregory C. Simon
Organization:
FasterCures/The Center for Accelerating Medical Solutions
Re:
Request for Information on the Development and Adoption of a National
Health Information Network
Dear Dr. Brailer:
FasterCures is a nonpartisan, nonprofit organization whose goal
is to save lives by saving time in the discovery, development, and
deployment of treatments and cures for deadly diseases. Our mission is to
evaluate the current system of medical research; identify inefficiencies,
misplaced priorities, and conflicting incentives inhibiting the pace of
discovery and development; and propose and pursue improvements to the
existing system. We seek to enhance and accelerate the efforts of those
directly involved in developing and overseeing the introduction of safe
and effective treatments and cures. We appreciate this opportunity to
comment on how the widespread interoperability of health information
technologies and the electronic exchange of health information can be
achieved through the development and adoption of a National Health
Information Network (NHIN).
Despite the remarkable advances medical research has produced in recent
years, cancer, heart disease, diabetes, and other illnesses continue to
take a staggering toll in treatment costs, lost productivity, suffering,
and death. As our population ages, the number of those afflicted by
disease and the costs to treat these individuals will rise exponentially
in the decades ahead. By 2001, healthcare spending accounted for more than
14 percent of the gross domestic product. With 76 million baby-boomers
turning 50 at the rate of one every seven seconds, it is imperative that
we move research advances forward more quickly. The biomedical revolution
– combined with rapid technological innovation – is presenting the promise
of longer life spans and greater relief from suffering. Unfortunately,
there are numerous indications that the massive United States’ investment
in biomedical research and discovery is not being translated as rapidly as
possible into new medicines and treatments.
With the mandate of protecting and promoting the health of all
Americans, the U.S. Department of Health and Human Services must lead the
transformation of our current research and healthcare system from the
outdated model of the last century to an integrated, information-based,
high-quality, health-sustaining model that will extend life expectancy and
improve the quality of life in the 21st century. We share HHS’ goal of
improving the quality and efficiency of healthcare in the United States
through the widespread adoption of interoperable health information
technology.
The NHIN is an important step toward building the system that will
deliver the promise of longer lives and better health in this century. In
recent years, there has been broad recognition that many of the current
problems with the healthcare system originate from healthcare
professionals not having the right information at the right time. This
information deficit affects every participant in the system, from the
patient and the healthcare practitioner to the public health monitor and
the biomedical researcher. To achieve the promise of better health and a
better healthcare system, the NHIN must address the needs of the entire
system and enhance the exchange of information among the domains of
personal health management, healthcare delivery, public health, and health
research.
For the most part, the development and adoption of a national health
information network is being promoted as a necessary step to reduce
healthcare costs, avoid medical errors, and improve care. Consequently,
the focus of the NHIN to date has been primarily on healthcare delivery,
specifically, on connecting those communities that are dedicated to
treating patients. But the real savings, both in healthcare costs and,
more importantly, in eliminating human suffering, will come from curing
disease and from limiting its damage.
The development of the NHIN presents a unique opportunity to support
and further the nation’s health research enterprise, thereby improving the
nation’s health. By enabling research use of information collected in the
patient care process, the NHIN will significantly accelerate the search
for cures. In order for that to happen, the vital, yet narrow, focus of
the NHIN to support healthcare delivery must be expanded to support the
entire healthcare continuum, including health research.
The ability of researchers to access and analyze the clinical
information contained in millions of medical and personal health records,
with appropriate privacy and human subject protection safeguards, could
speed the discovery of new therapies beyond anything imaginable today.
Similarly, a system that supports data sharing from the care process to
the researcher also can support dissemination of results from the
researcher to the practitioner and the patient, thereby speeding the
translation of research results into clinical practice.
In summary, the NHIN should have the capability to serve as a broadly
enabling research infrastructure that facilitates and promotes sharing and
reuse of data from the patient care process and channels the results of
clinical research back into the hands of patients and practitioners where
it can do the most good.
Sincerely,
Gregory C.
Simon, JD
President, FasterCures / The Center for Accelerating
Medical Solutions
Response to the Request for Information on the
Development and Adoption of a National Health Information Network
(NHIN)
Question 1. The primary impetus for considering a NHIN is to
achieve interoperability of health information technologies used in the
mainstream delivery of healthcare 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.
Response 1:
The NHIN is an information and communications
network infrastructure designed to allow users from the patient, health
research, public health, and healthcare communities, to exchange
information, knowledge, and tools whenever and wherever it is required to
improve healthcare and avoid problems stemming from inaccurate, incomplete
or inaccessible data and information. To be successful, the NHIN must
connect and integrate four major health system domains: personal health
management; healthcare delivery; public health management; and
health research.
Existing NHIN efforts have focused principally on questions related to
only three of the four components of the health system: personal health
management, healthcare delivery, and to a lesser extent public health
management. Very little attention and no sustained effort have been
devoted to ensuring that the vast amount of health information and data
accumulated through the clinical care process will be accessible to the
biomedical research community. Given that both near and long term
healthcare savings depend on advances in research and on the rapid
translation of research results into practice, it is essential to
incorporate into the NHIN the standards, architecture, and technologies
necessary to inform the research endeavor with data from the patient care
process.
A NHIN research capability – with strict adherence to patient privacy
and human subjects protections – will support improvements throughout the
healthcare continuum. For example, patient data will inform the search for
the most effective treatments and cures and the results of research in
turn will inform patient and practitioner treatment decisions, creating a
continuous, reinforcing exchange of information that ultimately results in
improved health and healthcare. The outcome should be a broadly enabling
healthcare and research infrastructure that promotes appropriate sharing
and reusing of data and results to inform care and facilitate
collaborative research.
The integration of research needs into the development of the NHIN
needs to begin with a framework defining the characteristics and
development priorities of the research-enabling network.
FasterCures recommends the following Guiding Principles as a
starting point for such a framework.
Guiding Principle #1
Enable Bi-Directional
Data Exchange
The NHIN should support access to health
information and healthcare data collected in the course of routine
medical care and from other sources to improve research capabilities.
Similarly, it should support widespread access to research data to
improve health and healthcare.
Guiding Principle #2
Encourage Optimum Use
of Patient Data
The NHIN should provide incentives to promote
and facilitate the broadest and most effective use of patient care data
in clinical research and ensure that clinical research results be widely
available and integrated into decision-support tools to benefit patient
care and improve personal health decisions.
Guiding Principle #3
Facilitate
Collaborative Research
The NHIN should have the capability to
serve as a broadly enabling research infrastructure that promotes the
sharing and reusing of clinical research results to facilitate
collaborative research.
Guiding Principle #4
Require Common Data
Standards
The NHIN should require that a single set of
standards be developed and adopted for the collection and exchange of
data across all health communities, including the research community.
Guiding Principle #5
Create a Network of
Networks
The NHIN should support a federated and
interoperable system that links to pre-existing and future networks,
creating a “network of networks.”
Guiding Principle #6
Be Technology and
Content Independent
The NHIN should be designed with the
flexibility to respond to the evolution of technology, which creates
potential new sources and uses of data.
Guiding Principle #7
Safeguard Privacy and
Assuring Informed Consent
The NHIN must be capable of
ensuring compliance with appropriate requirements for patient privacy,
informed consent, and confidentiality.
Key Barriers. Many potential barriers exist that could hinder
the full adoption and implementation of the NHIN. Other organizations,
such as Connecting for Health, are addressing these issues in greater
detail. Those barriers that particularly impact the integration of
research into the NHIN include:
- Standards for data, clinical taxonomies – because
nomenclatures, clinical taxonomies, and data capture differ across the
medical field, standards need to be put in place that allow for
consistent, reliable information within the electronic health record.
- Privacy and consent – there are a variety of often
inconsistent federal and state laws and regulations governing medical
record privacy and human subjects protection, making it difficult for
researchers to decipher how this complex web of laws and regulations
applies to specific research endeavors.
- Cultural and social obstacles – historically, healthcare
delivery and health research have occupied almost entirely separate
domains within the health system, and even within the individual domains
activity is fragmented and compartmentalized.
- Technology/networking standards – without interoperable
systems resulting from a comprehensive standards initiative, the NHIN
will not successfully accomplish its goals for connectivity and
information exchange.
Key Enablers. As a general matter, the leadership and resources
of the federal government are critical enablers of the development and
implementation of the NHIN. This is particularly true with respect to
standards development and adoption, and the creation of public-private
partnerships to stimulate the development of local infrastructure, build
the business case for adoption of electronic medical records and data
exchange, and ensure that the NHIN improves access to healthcare in rural
and underserved areas.
Specifically with respect to research, obtaining the involvement of the
research community from both the public and private sectors will also
serve as a key enabler. In this regard, consideration should be given to
leveraging some of the work being done to improve the clinical research
process through the creation of research networks and consortia. For
example, the work that has been done by the National Institutes of Health
(NIH) to develop a common lexicon of standard vocabularies used to define
medical and scientific events could enrich similar efforts related to the
development Electronic Health Records (EHRs).
Finally, the NHIN will not happen, and certainly will not facilitate
research, without the support and participation of patients and the public
at large. Building and gaining their trust in a national health
information network may well be the most important factor to the success
of this endeavor. Efforts must be made to more broadly engage the patient
community and the public in decision-making related to the NHIN and to
increase their understanding of its potential benefits.
Question 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 healthcare 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.
Response 2:
FasterCures agrees that the best model for
the NHIN is a public-private partnership, which engages all health system
stakeholders and leverages the strengths of all participants. Much like
the partnership that existed at the early stages of the Internet’s
development, both the public and private sectors have critical roles to
play in the development and adoption of the NHIN. A public-private
partnership model would allow the NHIN to:
- Support rapid, accurate, and secure exchange of information between
authorized users across the entire health continuum,
- Ensure connectivity among all data management and information
exchange tools, providing that these tools conform to a set of common
principles and agreed upon standards, and
- Enable individuals and organizations to construct systems that they
need at the local level to best meet their patient care and/or research
goals and requirements.
With these elements in mind, the role of
the federal government emerges clearly: to establish a national vision and
a coordination structure that will provide leadership; support standards
setting, research and evaluation; and develop appropriate incentives to
stimulate widespread adoption and implementation.
Similarly, the role of the private sector emerges as the technology and
solutions innovator, by providing the standards and technical “know-how”
to enable interoperability and protect patient health information.
Furthermore, the private sector will be the key innovator in constructing
the data management and information exchange tools needed to power the
system.
Question 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.)
Response 3:
FasterCures believes that the NHIN should
support a decentralized, federated, network of networks. Decentralization
would allow the core data within the network to remain under the control
of healthcare providers and patients, with the network facilitating its
exchange. It also would allow organizations to join the network as they
became ready – either technologically or philosophically. Decentralization
would also provide a mechanism for research, public health and other data
rich health organizations to independently participate in the NHIN and
share their information with practitioners while still controlling access
as they see fit.
By allowing for a decentralized structure, a common set of policies and
standards must be put in place that will facilitate the reliable and
efficient sharing of data among authorized users within the health care
community. This federated approach will require participants to adhere /
comply with these agreed upon policies and standards. This system will
dictate who can have access to patient information and for what use. For
the research community, it will set the parameters for access and
use.
Question 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?
Response 7:
The conduct of research that uses information
from the NHIN should adhere to appropriate requirements for patient
privacy and informed consent, confidentiality, and security. At the same
time, policies and regulations created to protect patient privacy must
also accommodate the strong public interest in furthering medical research
and the compelling interest of individual patients to participate in and
contribute to such research. The integration of research into the
development of the NHIN will require addressing mechanisms for
authentication and authorization, such as IRB approval, for
research-specific data use.
The NHIN must ensure the security and integrity of patient data. The
two issues cannot be decoupled. In order to gain public confidence in and
enthusiasm for the use of health information technology, a secure system
must be established, including access control, authentication, an audit
trail and enforcement features.
Whether personal health information is exchanged for research or other
purposes, FasterCures agrees with the principles articulated by
Connecting for Health:
- Individuals have a right to know if their information has been
accessed and by whom, and whenever any clinical records have been shared
between organizations.
- Individuals also have a right to exercise control over the uses and
disclosures of their data, have access to data about themselves, and be
able to ensure that data is accurate, timely and complete.
Question 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?
Response 14:
Any entity developing NHIN standards should be
willing to include participants with the knowledge and expertise to
articulate and address system characteristics and capabilities that are
needed for each component of the NHIN. In addition, any standards
development process must be transparent to the broader public, allowing
for input and innovation from multiple sectors.
When identifying the key players/entities to engage from the standards
community, HHS should:
- Rely on proven and existing Standards Development Organizations
(SDOs). There are many organizations that have successfully
developed and implemented standards on a large scale. Some of these
include: HL7, the World Wide Web Consortia, ANSI, and X12. These
organizations have worked in the technical and the healthcare fields and
sometimes both. Successful standards development for the NHIN will
require expertise that understands how to integrate information
technology with the needs and requirements of each of the four domains
of the healthcare system.
- Include all stakeholders. Standards development is critical
to linking all of the users and beneficiaries of the NHIN. Successful
standards development must be based on an initial understanding of the
broad scope of the NHIN and the needs of the communities the system is
being designed to serve. In order to ensure that progress in meeting one
need does not adversely impact the ability to meet another, it is
important to have the range of stakeholders involved in the process from
the earliest stages. Therefore, FasterCures believes that it is
essential to involve experts from the research community in this
process, including clinical researchers and bioinformatics
professionals.
Standards development for the NHIN needs to be focused principally in
two areas. First, standards are needed that will enable the NHIN to
interconnect with all of its many parts, creating an interoperable network
of networks. These standards will ensure consistency and facilitate
communications and information exchange. They include data standards as
well as networking protocols. A second set of standards is needed to
address security issues such as confidentiality, authentication,
accessibility, authorization, and reliability.
Both “families” of standards will be prerequisites to creating the
NHIN. Currently, there are several credible healthcare and standards
organizations working these standards. However, their efforts, while
impressive, only touch on a small portion of what still needs to be done
in order to enable the NHIN. Further, these efforts tend to focus on
narrow topics and platforms rather than addressing the needs of an
overarching system.
Standards development has traditionally been a private sector endeavor,
with the federal government participating as needed. In this case, the
federal government must take a leadership role in standards development,
helping to articulate the framework for the NHIN, applying resources to
standards development and diffusion (possibly through demonstration
projects), and being an early adopter of these standards. The federal
government needs to accelerate the deployment of the NHIN by clearly
highlighting NHIN standards as a national priority and partnering with the
private sector, including established standards organizations.
Validation and a structure for certification of compliant technologies
and applications also are essential for the widespread adoption of NHIN
standards. The federal government has had extensive experience and success
in funding technology and standards demonstration projects.
FasterCures believes that the government should fund NHIN
demonstration projects aimed at verifying these interface, data exchange,
and security-based standards. It should simply be reiterated that, as is
the case for standards development, standards diffusion activities also
will need to include the major stakeholders.
Question 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?
Response 18:
FasterCures agrees with the framework
articulated by the National Coordinator, which emphasizes that the
development of the NHIN must be a joint effort between federal, state, and
local governments and the private sector. The federal government has a
critical leadership role to play in the development of interoperability
standards, as discussed in response to Question 14. Specifically, the
federal government should clearly articulate the vision and framework for
the NHIN. Articulating a clear vision will establish the parameters within
which the technology and standards developers can address the specific
scope and scale of the endeavor. The federal government needs to clearly
include the research capability within the NHIN, as a mandatory system
parameter, thus ensuring that research needs and requirements are added to
the mix of issues to be resolved.
HHS needs to engage the substantial federal information technology and
health research establishment to participate in the development of the
NHIN. Given the significant leadership position of the federal research
establishment, including NIH, the Department of Defense, the National
Science Foundation, and the Department of Veteran Affairs, this
participation can be expected to catalyze the involvement of other
research stakeholders. In addition, the federal government should convene
the key stakeholders to engage in the standards development process.
Further, as a potential funding and purchasing source, the standards
priorities of the federal government will be addressed.
FasterCures also believes that the government should fund NHIN
demonstration projects aimed at verifying these interface, data exchange,
and security-based standards. These demonstration projects will serve two
purposes: to validate the standards and speed the diffusion process of the
NHIN. Neither patient communities nor healthcare providers should be
expected to accept technologies and connectivity without proof that an
NHIN improves healthcare while maintaining privacy and security. Putting
these standards to the test verifies that the concept works and adds
value. In addition, greater familiarity and exposure to the healthcare
community of the NHIN and its interconnected systems through demonstration
projects will speed its adoption and acceptance.
This being said, the federal government should rely heavily on those
organizations that have already devoted significant time and resources to
developing healthcare standards and connectivity protocols. These
organizations have a proven track record in standards development and are
the experts in structuring the process, gaining buy-in, and propagating
the standards. In addition, the federal government should avoid dictating
the types of systems developed and/or deployed at local and regional
levels. It should support the role of the private sector as the technology
and solutions innovator. This will allow the private sector and its
vendors to actively engage in the innovation and technology development
process, leading to robust competition and quality products.
Question 24. How could success be measured in achieving an
interoperable health information infrastructure for the public sector,
private sector and healthcare community or region?
Response 24:
There are a number of reasonably well-documented
characteristics of our existing medical system that need improvement. For
the research enterprise, these characteristics include things like the
time it takes for innovations in medical treatment to reach widespread
adoption in clinical practice; the delays encountered in the clinical
research process because of problems recruiting patients for those
studies; and the failure rate for treatments which enter into clinical
trials, etc. Metrics can be developed around many of these types of
characteristics, which will capture whether the NHIN is returning the
anticipated results. Here again, in defining success metrics the
government should ensure that the key stakeholders are involved.
FasterCures believes that the integration of research needs into
the NHIN has the potential to benefit the research endeavor in a number of
ways. Observers have noted, for example, that it could make it easier to
assemble data on both small, highly-defined populations as well as on
broad-based populations, to share data across studies, and to look at
questions where the variability of disease progression is important. No
doubt there are a variety of important questions that are not getting
asked due to current infrastructure and connectivity limitations, and that
new uses and questions will emerge. The integration of health research
into the NHIN will be judged a success to the extent that some or all of
the following outcomes are realized:
- Empowerment of patients. Arming patients with the ability to
access their health information will empower them to approach personal
healthcare in a more proactive manner. In addition, an NHIN that
connects patients to the research community will allow for their more
active participation in the research endeavor through clinical trials or
other means.
- Faster and less costly studies. A comprehensive network would
facilitate data sharing and collaboration between the clinical care and
research communities, as well as within the research community,
eliminating and/or minimizing the need to recreate separate data sets in
their entirety for every new investigation. Particularly in the area of
medical genomics, the information being collected through the routine
patient care process can be a significant source of phenotypic
information necessary to unravel the complex relationships between
genetics disease and environment, thus accelerating discovery.
- Rapid diffusion of research into practice. The NHIN would
provide the essential mechanism for speeding useful knowledge to
clinicians from the research community. This might come in the form of
adverse drug interactions or promising treatment protocols.
- Access to more complete information. A more complete picture
of patient histories and current treatment courses will allow
researchers to increase the robustness and scope of their work.
Near and long-term healthcare savings depend on research.
FasterCures believes that including research in the NHIN will pay
enormous dividends in accelerating the discovery of new medical
innovations.