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Comments on NHIN

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,

Greg's Signature

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.

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