With the Health Insurance Portability and Accountability Act (HIPAA) of 1996, Congress essentially transformed the nearly fifty-year-old National Committee on Vital and Health Statistics (NCVHS) into the nation's primary external advisory group for health information policy. While in the past, NCVHS was responsible for making recommendations only to the government, the HIPAA legislation mandated a number of national health data standards to encompass both government and the private sector. The Committee has worked for two years on specific HIPAA policy mandates. It is now evident that the Department of Health and Human Services (HHS) needs to craft a comprehensive approach to health information policy to guide development of the nation's information capacities for optimal use in improving the health status of all Americans. NCVHS is committed to helping the Department address this important policy matter. This paper is intended for HHS, through the HHS Data Council, as a preliminary description of opportunities and challenges in this area.
The national information infrastructure (NII) can be an essential tool and resource in promoting the nation's health. However, it is a largely untapped resource. The health sector has not applied information and communication technologies as effectively as have other sectors, and health is under represented in the NII relative to the scale of the national health enterprise and its importance to the American public. Making the health component congruent with the NII and an integral part of its development requires two concurrent processes: building the health information infrastructure (HII), and integrating it into the broader national information infrastructure.
It is important to emphasize that neither "NII" nor "HII" refers to a database but to a set of technologies, standards and applications that support communication and information. It encompasses all aspects relating to health, computers, and telecommunications. ("Telehealth" is now the accepted umbrella term for the full spectrum of applications using computers and telecommunications for health. The Secretary of DHHS officially endorsed it over 18 months ago, and the FCC has also adopted it.) Many, possibly most, of these technologies are common across sectors or share common elements. As the linkages between the NII and the HII are strengthened, solutions developed in other sectors, such as security measures, will emerge that can be adapted to solving problems in the health arena. The information content of an eventual HII will be diverse, reflecting an array of purposes such as improving clinical care, monitoring public health, and educating consumers and patients. While clinical encounter data will be a core component of the HII, data from population surveys and other information about the determinants of health will also be important. Multiple stakeholders will have a role to play in its development and maintenance, including public agencies, health care and research institutions, professional and standards organizations, consumer organizations, and the telecommunications and computer industries.
A great deal of work is already underway on the health dimension of the NII. However, these activities are fragmented and in some cases serve limited interests. Because of its diverse responsibilities as policy maker, payor, regulator, and generator of information to all audiences, HHS is the most appropriate body in the federal government to mobilize efforts to consolidate and augment these advances and move the health information infrastructure to the next stage. The National Committee on Vital and Health Statistics therefore proposes that the Department, working through the Data Council, assume a leadership role in developing 1) a detailed vision for the health dimension of the NII, and 2) a strategy for realizing that vision in partnership with other stakeholders in government and the private sector. We offer our support and assistance in this effort. We note, moreover, that comprehensive approaches to national health information infrastructures have been developed in other countries, including Canada, the European Union, and the United Kingdom. They reflect similar visions of an information strategy to enable professionals and the public to make informed decisions about health and health services.
This document provides an overview of the areas that must be part of such a strategy, with comments on specific developments the Committee believes to be necessary. The process should begin with a complete inventory of the issues, progress to date, and major players in each of these areas. Additional areas may emerge during the inventory process.
Clearly, the use of information and communication technologies for health purposes has potential risks as well as benefits, and opinions vary about the relative balance between the two. NCVHS believes that while this balance must be carefully watched, the technologies have decidedly positive applications for health. We envision that increased use of information and communication technology can favorably and dramatically impact upon access, quality and the cost of care by informing treatment decisions, extending service delivery, monitoring health, empowering consumers, facilitating communication between patients and providers, and generating knowledge for clinical care and public health. Finally, such systems can identify and track disparities between groups so that they can be eliminated through action where possible and appropriate. Computerization is already beginning to streamline administrative processes and reduce costs. Each of these developments (which are discussed in more detail below) has the potential to contribute to improved health outcomes, greater cost-effectiveness, and increased satisfaction.
The sensible application of information technology to the health of Americans will only occur if the public is assured that peoples health records or other personal health information will not be used to harm them, and that individual privacy will not be abused. The Committee has identified this as a real concern in its hearings and reports relating to privacy and confidentiality as well as the unique personal identifier. NCVHS is on record as supporting a policy of not moving forward to implement any form of unique personal health identifier until federal protections of personal health information are enacted into law. The Committee is pleased that the Administration has announced its decision not to implement a unique personal health identifier until appropriate privacy protections are in place.
Another serious risk is associated with the development of information and communication technologies: greater dependence on technology could widen the gap between haves and have-nots in this country. There are already significant differences in access to quality health care among various segments of the population. Some Americans could be put at an even greater disadvantage unless there is a concerted effort to reduce barriers to communication and information technology such as costs of equipment and service and limited health/technology literacy. For this reason, NCVHS recommends that the administration assign high priority to developing and implementing policies to facilitate access to communication and information technologies for all Americans.
While the benefits of the health care information infrastructure generally outweigh the costs and risks, there may be a few situations where the cost burden to invest in automation deserves special consideration. These circumstances might occur in some solo practices or health care settings in rural or isolated areas. It may be in the governments interest to use such actions as tax incentives and enhanced payments to ensure that savings will actually accrue to all health care providers. For those special cases that need help, government assistance should be considered to enable the transition to the health information infrastructure.
An important role for the federal government, therefore, is to support research and strategic planning to determine how to minimize the risks for privacy and address other issues, and to ensure that all Americans will benefit from the NII. The promise of the HII will only be met if there is equitable access for both health care providers and the public. One of the roles NCVHS will assume is monitoring the health component of the NII in the light of these concerns.
There is work to be done in each of the following systems, technologies and applications, which together comprise the health information infrastructure (HII).
Population-based data. The health information infrastructure must include population- based data so that public health can be supported at the community, State, and national level. Among other things, this necessitates major improvements in data on populations at special risk, such as people with disabilities and certain racial and ethnic minorities, and groups that may be too small to register on the radar of existing surveys such as the National Health Interview Survey. Strengthening the population dimension of the infrastructure will make it possible to identify and analyze disparities in health status and care and to track progress on eliminating the gaps. It is at this level that population-based health information can be integrated with data from the other sectors essential to the well-being of the population, including education, business, welfare, housing, justice, and environmental health.
Within the context of rigorous protections for privacy and the confidentiality of personal health information, HIPAA has the potential for introducing major and exciting innovations to population-based data on the health of the American population. The health data reforms enabled by HIPAA could result in the following future benefits: population-based data could be constructed for a wide range of encounters with the health care system in the United States; population-based encounter data on small and difficult to sample populations could become available and offer relevant information regarding interventions in a sufficiently timely manner to evaluate effectiveness; some population-based encounter data could be integrated with population-based survey and public health surveillance data on health status and health outcomes. In time it might be possible to construct population-based health and encounter histories. With a well reasoned HII strategy, the nation should be able to transform its knowledge of the health of the American people and move to optimize the health of individuals and communities through more effective interventions such as targeted educational programs, community services, and evidence-based health care services. Greater knowledge of the populations health and health care services will facilitate both population-based public health and clinical approaches to improve health.
Computer-based health records. Computer-based information on health care and health status can facilitate coordination, research and assessment for both clinical care and public health and permit individuals to participate more closely in their own health care. The nation needs to significantly improve the development and diffusion of computer-based health records (CHRs) of three types: patient, personal, and population. Patient CHRs record clinical care and are used by delivery systems in which doctors, nurses and other health professionals provide an array of hospital, primary care, and other ambulatory and institutional health services. Institutionally focused systems are under rapid development and approaching maturity, but are not widely available. Those focused on the ambulatory setting are much less well developed and in use. Personal CHRs are personal health records for individual use, including assessment of health status and linkage with physicians' records. Some refer to these as consumer-oriented health records. Systems of both types also will facilitate the coordinated management of personal health by the variety of professionals involved in personal health care. The integration of clinical CHRs and personal CHRs could further contribute to continuity of care and informed self-management. The data in population CHRs derive from the health care system and have been made as non-identifiable as possible for public health and research applications. They may also incorporate survey data. Population CHRs are used for monitoring public health and the outcomes of care and also for health services research, including quality assessment.
Integration of data from these three types of CHRs, and especially integration of data from patient CHRs and population CHRs, has the potential to greatly improve our understanding of health needs, health barriers, and health services utilization of the American people. To strengthen these systems, however, they should be driven by patient care and health status, not reimbursement.
COMPUTER-BASED HEALTH RECORDS
Knowledge management and decision support. The rapid growth of the health knowledge base poses great challenges for both health professionals and the public. Its huge and varied content includes findings from biomedical and health services research, public health data, technology innovations, and policy/legal developments. This knowledge, along with less technical information, is increasingly distributed on the World-Wide Web with potentially universal access and open distribution. These developments warrant action to better serve both professionals and the public.
First, research and development on knowledge management and decision support systems are vital to support the movement toward evidence-based care, cost effectiveness, and quality enhancement. Such systems, especially those available at the point of care, can help clinicians choose evidence-based interventions that are associated with the best health outcomes. While closed systems have been under development for a long time, further attention should be focused on the potential of Internet-based delivery of evidence relating to best health outcomes and also on barriers to acceptance and implementation of that evidence.
Second, the virtual explosion of consumer/patient oriented Web sites and applications, many commercially sponsored, calls for a careful assessment of the roles of the public and private sector in promoting quality and accuracy. Concerns about misinformation have prompted both the public and private sector to explore information quality standards, and a consensus on core elements seems to be emerging. The Department is already engaged in these discussions and providing leadership through its own Web sites. Public policy must weigh the risks of inaccurate or fraudulent information against the benefits of public education and the strong demand for such resources, and also consider First Amendment issues. Clearly there is an opportunity for enhanced levels of professional review and assessment of consumer/patient oriented Web sites and applications, particularly for information quality and decision logic. Professionals and ordinary citizens will benefit from access to a continually updated repository of current knowledge that meets "best evidence" criteria for accuracy and reliability. Some repositories should be linked with consumer input about preferences and satisfaction.
Telemedicine. Telemedicine (care at a distance) can extend the reach of health professionals to remote sites. With proper review and management, integrated clinical and consumer applications can link prevention, health promotion, patient education, and beneficiary/patient services as well as distance care itself. Telemedicine can support the movement toward outpatient and home-based care, foster economically feasible service delivery, and promote the goal of universally accessible health care. The extension of telemedicine services in rural or underserved urban areas has the potential to improve the health of homebound chronically ill and frail elderly persons whose mobility is limited by illness, transportation costs, or other factors. In this area, as in others, it will be important to monitor access to ensure that technology is being used to narrow rather than widen the gap between the haves and have-nots in our nation.
In addition to protection from unwarranted invasions of privacy and from discrimination, which are discussed above, several other cross-cutting processes are essential to progress in the above domains:
Standards and measures. The standards development process needs to be guided by criteria for prospective standards. Sometimes referred to as standards for standards, these criteria would facilitate interoperability so that systems can serve multiple functions or at least talk to each other, as in cross-cutting public health and clinical uses. The criteria would be useful when approaching such policy decisions as unique patient identification and the use of "smart cards" for access to services and would help in resolving confidentiality issues and developing appropriate security procedures and technology.
A high priority is the development of standards and nomenclature for capturing the state of knowledge in medicine and health care. Standards of terminology must be developed, maintained, and made accessible at minimal cost to users. These forms of standardization are critical to the linkages and comparisons needed to assess both the quality of care and the health status of the population. The Unified Medical Language System of the National Library of Medicine is a good start for this process, but it is not sufficiently encompassing. In addition to a robust "server" to allow those needing the terms to have access to them on a low-cost basis, a clearer system is needed to constantly review definitions, reach consensus, and then integrate the new terms to older closest synonyms. Clinical records need to reflect primarily clinical realities and not focus on financial and billing procedures and terms. Care will be most easily delivered in a cost-effective and high quality manner if the language used for care delivery and a variety of management purposes most accurately reflects medical conditions and treatments.
Research, education and development. For health information technology to realize its potential, more research, education and development are needed, both within and beyond academic health centers and in other private sector entities, including commercial settings. Agreement on a comprehensive research agenda, with roles for various sectors, would help maximize efforts. Information technology should be an integral part of clinical research and professional expertise, a goal that necessitates substantial support for robust information systems and attention to the culture in which the technology is introduced. To address all health care needs, research also must move further to involve patients and practitioners beyond academia as both informed contributors to and consumers of research efforts. Research and education will have key roles in assuring that all Americans have the opportunity to benefit from the HII. Support for basic research is needed as well as for applied research. It should be remembered that most of what we now refer to as the information age had its origins more than two decades ago. The pace of basic research has not kept up, particularly in areas where cross-cutting breakthroughs are needed, including non-technical topics such as cultural and behavioral issues relating to acceptance and optimum use of technology by individuals and institutions.
Universal access to health information resources. Recent telecommunications reforms promise to make Internet access more affordable for rural health care providers, rural public health agencies, schools, and libraries. But they fall short in ensuring universal access because they only support certain costs for these institutions and do nothing to promote Internet connections to homes and the workplace. To make possible two-way communication and realize the full potential of telehealth, every American should have access to the Internet and intranets at home, at work, and/or in public places such as libraries and community centers. As noted above, telecommunications contact with health care providers permits patients to receive from these providers some forms of care and health status monitoring, as well as education, in their homes. In addition, access to health information resources helps consumers fulfill their responsibilities for self-education and self-care and understand how they can exercise their right to choose their health plans, providers, and care.
International collaboration. The United States is a member of a global society, and we must play an integrative and collaborative role with other countries. Moreover, the United States can learn much from other nations that have taken the lead in some aspects of communications technology. Threats to health, such as emerging diseases and environmental hazards, do not stop at national borders; international collaboration is critical in order to integrate surveillance and warning systems. For all of these reasons, we must ensure that national activities and policies make good sense within the context of a global society. We must promote advancements in the international information infrastructure through both government and private development initiatives and carry our fair share of the effort to create it.
Building the health information infrastructure and integrating it in the NII will require an aggressive review of federal policies and procedures as well as a major commitment of resources from federal and state governments and the private sector. The private sector has been responsible for much of the progress to date in the health information area and in the NII as a whole, and certainly future progress depends on strong private-public partnerships.
As the first step in the process, we suggest that the Data Council determine where multiple agencies can and should coordinate their efforts and where new structures would be more efficient. Achieving sufficient visibility and assuring progress on this crucial national objective may require the appointment of an individual to assure action and monitor progress from within the Secretary's office or at the White House.
Diverse political leadership has supported the development of the NII and the concomitant HII. Vice President Gore has shown important leadership in promoting the development of the NII and in stressing that everyone must have a chance to benefit from it. He has cited the need to bring the economic, health, and educational benefits of the information revolution to all and challenged the country to connect every classroom, library, hospital and clinic to the NII by the year 2000. We welcome the Vice President's strong statements in May and July 1998 about the need for attendant health information privacy protections, and Secretary Shalala's 1997 testimony to Congress on this subject. House Speaker Gingrich has expressed similar goals in a number of pronouncements.
The Committee is ready to respond to requests from the Department to support the leadership of the Data Council in furthering the objectives outlined above. Fortunately, there is already a strong base on which to build. Department staff and members of NCVHS subcommittees and workgroups are already engaged in areas such as standards and security, computer-based patient records, privacy and confidentiality, populations, quality, and health statistics for the 21st Century. These efforts, together with work elsewhere in the Department on the public health information infrastructure, knowledge management, decision-support, consumer health information, and telemedicine can provide core components for an integrated and comprehensive strategy.
Generally, we see our role in terms of four types of activity:
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Don E. Detmer, M.D., Chair
Jeffrey S. Blair, M.B.A.
Daniel Friedman, Ph.D.
Richard K. Harding, M.D.
Clement J. McDonald, M.D.
Mary Jo Deering, Ph.D., OPHS, Lead Staff
Sandra Haydock, HCFA
Meade Morgan, CDC
Dena S. Puskin, Sc.D., HRSA
Steven J. Steindel, Ph.D., CDC
Susan B. Kanaan, consultant/writer