Improving Patient Records: Conclusions and Recommendations
Computer-based patient records and the systems in which they function are becoming an essential technology for health care in part because the information management challenges faced by health care professionals are increasing daily. Technological progress makes it possible for CPRs and CPR systems to provide total, cost-effective access to more complete, accurate patient care data and to offer improved performance and enhanced functions that can be used to meet those information management challenges. CPRs can play an important role in improving the quality of patient care and strengthening the scientific basis of clinical practice; they can also contribute to the management and moderation of health care costs.
The Institute of Medicine (IOM) study committee believes that the time is right for a major initiative to make CPRs a standard technology in health care within a decade. Achieving this goal within 10 years will require a nationwide effort and a great deal of work. More research and development are needed in several critical areas to ensure that systems meet the needs of patients, practitioners, administrators, third-party payers, researchers, and policymakers. For example, the need to protect patient privacy must be balanced by the need for timely access to data at multiple sites. Systems must offer both considerable flexibility for users and standards required for data transfer and exchange.
CPR implementation will necessitate both organizational and behavioral changes. Organizationally, it will require substantial coordination across the many elements of the pluralistic U.S. health care system. Behaviorally, it will demand that users develop new skills to use CPR systems and to change their documentation behaviors.
The committee recommends the following:
This chapter summarizes the committee's principal conclusions and presents recommendations for improving patient records (see Box 5-1). These recommendations, to which committee members gave unanimous approval, outline a course to facilitate the transition of health care away from the current paper patient record and toward routine use of the CPR and its
supporting CPR system. Specifically, the committee's recommendations recognize the CPR as the standard patient record of the future, provide an organizational framework for overcoming barriers to CPR development and implementation, and identify steps that will advance the use of CPRs and CPR systems.
Patient records are the primary repository of data in the information-intensive health care industry. Although clinical information is increasingly likely to be computerized, the current, predominant mode for recording patient care data remains the paper record. Paper records have the advantages of being familiar to users and portable; when they are not too large, users can readily browse through them. Paper records, however, have serious, overriding limitations that frequently frustrate users and perpetuate inefficiencies in the health care system. Further, the impact of these limitations is growing as the health care system becomes more complex. Modern patient care requirements have outgrown the paper record.
Quality improvement and cost containment continue to be major concerns for the health care industry. Quality assurance; utilization management; appropriateness, effectiveness, and outcomes assessment; clinical practice guidelines; and value purchasing are all prominent responses to the quality or cost challenges faced by present-day health care. Each of these initiatives increases the legitimate demand for complete, accurate, readily accessible patient data.
Health care professionals today face an unprecedented information explosion as the quantity and complexity of patient data and medical knowledge increase practically daily. Current patient records cannot adequately manage all the information needed for patient care. Paper patient records have not kept and cannot keep pace with the rapidly changing health care system. As a result, they increasingly impede effective decision-making throughout the health care sector—from the bedside to the formulation of national health care policy.
Some health care institutions are already applying computer technologies to this information management challenge. In general, however, the diffusion of information management technologies has been slower in health care than in other information-intensive industries. Moreover, the majority of information management applications in the health care sector have focused on financial and administrative rather than clinical data.
In its study, the committee reviewed the needs of patient record users, as well as existing and emerging computer technologies. It concluded that better CPR systems—systems that meet user needs more fully—can be achieved within 10 years. Nevertheless, the committee cautions that merely automating
current patient records will perpetuate their deficiencies and will not be sufficient to satisfy emerging user demands. If future patient records are to be an asset in patient care, they must offer broader functions than those provided by the record systems of today.
The future patient record will be a computer-based, multimedia record capable of including free text, high-resolution images, sound (e.g., auscultations), full-motion video, and elaborate coding schemes. CPR systems will offer access (availability, convenience, speed, reliability, and ease of use), quality, security, flexibility, connectivity, and efficiency. In addition, future patient records will provide new functions through links to other databases and decision support tools.
No contemporary clinical information systems are sufficiently comprehensive to be considered full CPR systems. Several existing systems, however, offer prototypes of components of CPR systems.
The committee considers nine technological capabilities to be essential to CPR systems: (1) databases and database management systems, (2) work-stations, (3) data acquisition and retrieval, (4) text processing, (5) image processing and storage, (6) data-exchange and vocabulary standards, (7) system communications and network infrastructure, (8) system reliability and security, and (9) linkages to secondary databases.
No new technological breakthroughs are needed to develop robust CPR systems, but some emerging technologies are crucial. Low-cost yet powerful clinical workstations and improved human interface technologies are needed. Voice-recognition systems, high-capacity networks (e.g., fiberoptic), and open-architecture systems will be required to achieve broad adoption of CPR systems. Emerging clipboard-sized computers that accept input through a hand-held stylus may also prove to be a critical development. In addition, CPR diffusion requires development of standards for health care data and greater emphasis on protecting the integrity and confidentiality of CPR data.
Technology is not the only potentially limiting factor in advancing CPR systems; informational, organizational, and behavioral barriers must also be addressed. Barriers to CPR development include development costs and lack of consensus on CPR content. CPR diffusion is adversely affected by the disaggregated health care environment, the complex characteristics of CPR technology, unpredictable user behavior, the high costs of acquiring CPR systems, a lack of adequate networks for transmitting data, a lack of leadership for resolving CPR issues, a lack of training for CPR developers and users, and a variety of legal and social issues.
The committee developed a plan for advancing the development and implementation of CPRs and CPR systems that identifies a broad group of stakeholders who would be affected (both positively and negatively) by CPR system implementation. It also identifies a group of organizations
that, in the committee's view, could contribute significantly to such development and implementation. Finally, the plan identifies a series of activities that would advance CPR efforts.
Carrying out these activities will require adequate funding and effective organization. The committee reviewed organizational structures that could be used to provide the necessary framework for coordinating CPR activities. It concluded that no existing organization has the mandate and resources necessary to lead this effort. Thus, the committee believes that a new organization is needed to support CPR development and implementation. The committee proposes a framework for the establishment of such an organization, but it also emphasizes that securing adequate resources for and engaging the appropriate parties in CPR development efforts are more important than the precise structure of the recommended organization.
RECOMMENDATION 1. The committee recommends that health care professionals and organizations adopt the computer-based patient record (CPR) as the standard for medical and all other records related to patient care.
The committee believes that future patient records must be more than a way to store patient data—they must also support the clinical decision process and help improve the quality of patient care. Achieving widespread use of CPRs is a major component of building a national health care information system that can support the provision of integrated health care services across settings and providers of care. Further, widespread use of CPRs would contribute to the collection of patient care data as a national health care resource. Achieving these objectives requires that CPRs be more than automated paper records.
The committee defined the CPR as an electronic patient record (i.e., a repository of health care information about a single patient) that resides in a system specifically designed to support users through availability of complete and accurate data, alerts, reminders, clinical decision support systems, links to medical knowledge, and other aids. Further, the committee identified 12 attributes that comprehensive CPRs and CPR systems possess.
- The CPR contains a problem list that clearly delineates the patient's clinical problems and the current status of each (e.g., the primary illness is worsening, stable, or improving).
- The CPR encourages and supports the systematic measurement and recording of the patient's health status and functional level to promote more precise and routine assessment of the outcomes of patient care.
- The CPR states the logical basis for all diagnoses or conclusions as a means of documenting the clinical rationale for decisions about the management of the patient's care. (This documentation should enhance use of a scientific approach in clinical practice and assist the evolution of a firmer foundation for clinical knowledge.)
- The CPR can be linked with other clinical records of a patient—from various settings and time periods—to provide a longitudinal (i.e., lifelong) record of events that may have influenced a person's health.
- The CPR system addresses patient data confidentiality comprehensively—in particular, ensuring that the CPR is accessible only to authorized individuals. (Although absolute confidentiality cannot be guaranteed in any system, every possible practical and cost-effective measure should be taken to secure CPRs and CPR systems from unauthorized access or abuse.)
- The CPR is accessible for use in a timely way at any and all times by authorized individuals involved in direct patient care. Simultaneous and remote access to the CPR is possible.
- The CPR system allows selective retrieval and formatting of information by users. It can present custom-tailored "views" of the same information.
- The CPR system can be linked to both local and remote knowledge, literature, bibliographic, or administrative databases and systems (including those containing clinical practice guidelines or clinical decision support capabilities) so that such information is readily available to assist practitioners in decision making.
- The CPR can assist and, in some instances, guide the process of clinical problem solving by providing clinicians with decision analysis tools, clinical reminders, prognostic risk assessment, and other clinical aids.
- The CPR supports structured data collection and stores information using a defined vocabulary. It adequately supports direct data entry by practitioners.
- The CPR can help individual practitioners and health care provider institutions manage and evaluate the quality and costs of care.
- The CPR is sufficiently flexible and expandable to support not only today's basic information needs but also the evolving needs of each clinical specialty and subspecialty.
The committee believes that the CPR can be well established within a decade in the majority of offices of physicians, dentists, and other health care professionals and in clinics, hospitals, and multifacility provider institutions. Achieving such widespread use in only 10 years is an ambitious goal, but it can be accomplished if two conditions are met. First, a concentrated effort—with appropriate leadership, resources, coordination, and incentives—must be mounted. Second, CPR systems must be affordable and at least minimally acceptable to users.
The committee considers it essential to maintain and exploit the interest in CPRs that has been building over the past several years. A less aggressive target (e.g., 20 years) for implementation of CPRs as standard patient records could result in a loss of momentum. In contrast, a well-coordinated effort could help to accelerate progress and secure CPR implementation within the 10-year target set by the committee. The committee's remaining recommendations outline how such a concentrated effort might be organized and identify specific strategies for addressing CPR system affordability and acceptability to users.
RECOMMENDATION 2. To accomplish Recommendation 1, the committee recommends that the public and private sectors join in establishing a Computer-based Patient Record Institute (CPRI) to promote and facilitate development, implementation, and dissemination of the CPR.
The committee identified a series of activities to facilitate CPR development and implementation: (1) identification and understanding of CPR design requirements; (2) standards development; (3) research and development of CPRs and CPR systems (including networking infrastructure); (4) demonstrations of effectiveness, costs, and benefits of CPR systems; (5) review of legal constraints and needed legal protection; (6) coordination of information and resources for CPR development and diffusion; (7) coordination of information and resources for databases of secondary records; and (8) education and training of developers and users.
Some of these activities are already under way, but they are fragmented and hampered by inadequate resources and coordination. The committee believes that securing adequate resources and managing them effectively are essential to development and widespread implementation of CPR systems. To facilitate these tasks, some portion of the research devoted to CPRs should focus on the value of CPR systems. These efforts could provide potential funders of future research and development and purchasers of systems with credible evidence on which to base CPR investment decisions. Both funding and evaluation expertise from the public and private sectors should be channeled into a coordinated effort to amass this evidence. In addition, priorities should be established so that resources can be directed toward activities that promise the greatest contribution to development of CPRs and CPR systems.
Many organizations and individuals could play a role in advancing CPRs and CPR systems, but these actors are dispersed throughout the health care field and have different kinds and levels of interest in CPR development. There is no one focal point for CPR efforts and no spokesperson or organization to speak for CPR interests. Further, the nation at present has no means of developing consensus on CPR-related issues or of setting priorities among alternative uses of CPR development resources.
No existing organization has the mandate or resources for ongoing coordination of CPR resources and activities. Consequently, the committee recommends either the creation of a new organization or the extension of an existing organization's charter to achieve such coordination. For the purposes of this report, the committee has called this new or expanded component of an existing organization the Computer-based Patient Record Institute (CPRI).1
The CPRI has a four-part mission:
- Support the effective, efficient use of computer-based patient information in patient care, health care policymaking, clinical research, health care financing, and continuous quality improvement.
- Educate change agents and stakeholders (including the general public and health care professionals) about the value of computer-based patient records in improving patient care.
- Foster the CPR as the primary vehicle for collecting patient data.
- Promote the development and use of standards for CPR security and data content, structures, and vocabulary.
The CPRI should take several specific steps to achieve this mission:
- Establish a forum for CPR users and developers to address such issues as definition of CPR functions and content.
- Facilitate data and security standards setting and endorse such standards.
- Promote CPR data transmission through national high-speed networks by representing the biomedical community in planning for such networks.
- Address legal issues related to CPRs and CPR systems.
- Develop mechanisms for sharing the costs of acquiring and operating CPR systems among all users of CPR data.
- Define priorities and criteria for CPR demonstration projects that could be used by federal agencies, private foundations, and health care provider institutions.
- Conduct workshops and conferences to educate health care professionals and policymakers.
- Explore the need for a clearinghouse for secondary CPR information.
One of the first tasks of the CPRI should be to develop a detailed plan for achieving CPRs in terms of incremental steps that can be completed by the many individuals and organizations interested in CPR development. Such
a plan would establish priorities for CPR development within and among activities (e.g., define where data standards are most needed or where they could be applied most quickly). By defining and coordinating the roles of key change agents, the CPR can help focus attention on the most important tasks and avoid redundancy of effort. Moreover, by tracking and reporting concrete progress toward CPR development, the CPRI can help maintain and perhaps continue to increase interest in and resources for CPR development. It is essential that the CPRI and all organizations and individuals associated with CPR development build on existing efforts. For example, CPRI can work with the Agency for Health Care Policy and Research (AHCPR) to identify needed progress for existing databases so that secondary user needs can be better met during the transition to CPRs.
The committee, for several reasons, concluded that in the long run an independent public-private organization would be the optimal structure for the CPRI. No one federal agency would have the prestige, funding, or personnel to pursue a complete CPR agenda successfully; in addition, suspicion or skepticism on the part of the private sector (both the business and the health care communities) regarding a purely governmental effort would be difficult to overcome. The committee emphasizes that if the CPRI is to be successful, it must represent all patient record users, particularly practitioners.
A purely private sector effort also has little likelihood of success: past history shows that private sector CPR development has been fragmented, unique to particular institutions, and generally underfunded. Indeed, the base of funding in the private sector is not sufficiently solid to support a new organization at this time. In addition, it is unlikely that private sector activities can overcome intentional and unintentional governmental barriers, such as the myriad state laws and regulations that hamper progress in this area. Furthermore, certain government agencies (notably the Departments of Defense and Veterans Affairs) have made more progress in this area than the private sector, and that work should be incorporated into any national effort.
Ultimately, the committee concluded that a federally initiated and funded approach would be most appropriate for inaugurating the necessary activities. The goal of such an interim effort would be to turn over, within five years, CPR coordination efforts to a public-private organization supported by its members. The committee thus recommends a two-phase strategy for the establishment of the CPRI. In the first phase, the secretary of the Department of Health and Human Services should establish an office or program to organize specific activities aimed at reducing the barriers to computer-based patient record development. In the second phase, the CPRI should be established as a public-private organization dedicated to coordinating the many activities needed to facilitate widespread use of the CPR.
The main goals of the initial federal program should be to respond to immediate needs to advance CPR efforts and to lay the groundwork for the
CPRI. In particular, because many of the barriers to implementation relate to lack of information, the interim effort should emphasize education and evaluation of the value of CPR systems. This effort should also focus on coordinating standards development and representing the health care field's interests in the emerging national high-speed computer network.
Ideally, the interim office should be run by a small professional staff headed by a recognized expert in CPR development. An advisory board with representation from both the private and public sectors should also be established. Program staff would support standards activities, conduct educational programs, serve as liaisons to professional organizations and commissions, represent the health care community in National Science Foundation network discussions, advise AHCPR and other extramural funders of research and demonstration projects, and plan for the second phase of CPR development and implementation.
This program should be funded initially by the DHHS agencies that have a fundamental interest in patient data; these include AHCPR and other Public Health Service agencies such as the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), the Health Resources and Services Administration (HRSA), and the Health Care Financing Administration (HCFA). Approximately $2 million to $5 million per year would be required for the first two years; more substantial funding would be needed for the next three years. The program should be closely aligned with AHCPR, but consideration should be given to contracting with a private sector organization to run the program. (Private sector management would allow greater flexibility and facilitate the eventual anticipated transition to a public-private entity.)
The committee urges that the private sector actively support immediate CPR activities through participation and funding (e.g., of demonstration projects) and that it be prepared to support the CPRI financially within five years. Failure of the private sector to support CPR efforts adequately could result in federal government control or dominance of CPR development and implementation efforts.
RECOMMENDATION 3. Both the public and private sectors should expand support for the CPR and CPR system implementation through research, development, and demonstration projects. Specifically, the committee recommends that Congress authorize and appropriate funds to implement the research and development agenda outlined below. The committee further recommends that private foundations and vendors fund programs to support and facilitate this research and development agenda.
Over the past several decades, impressive technological innovations in computer-based information storage, retrieval, and communication have allowed U.S. industry and research organizations to revolutionize the management
of information throughout society. Yet in terms of the rapidly expanding information needs of health care, the public and private sectors have mounted only relatively limited, fragmented efforts to take advantage of these technological innovations. Most computer systems in the health care sector have evolved either from automated systems in single departments (such as the laboratory or pharmacy) or from administrative systems that support patient registration, scheduling, or financial needs. Although such systems must share data with a CPR, they cannot be used as the beginning point for its development. Major tasks in system design, computer programming, and technical integration must be completed before current technology can be exploited to speed development of the CPR. In addition, much must be learned about how the CPR can be integrated and effectively used by different health care professionals and organizations to meet their needs.
The committee strongly urges that a major research and development (R&D) effort be supported and that several demonstration prototypes of the CPR be developed, implemented, and evaluated in a variety of health care environments. Specifically, major long-term financial and organizational support for R&D and for prototype demonstration projects in implementing the CPR is greatly needed in at least six major areas: (1) data acquisition, (2) data and security standards, (3) networking support, (4) cost-benefit analysis of CPR systems, (5) CPR and quality assurance, and (6) structure and format of the patient record.
The single greatest challenge in implementing the CPR is to develop a technology that is sufficiently powerful and appropriate to the needs and preferences of health care professionals so that they can—and will—enter medical and other health care data directly into the computer. Significant new technologies (e.g., graphical user interface, voice-recognition technology, high-resolution computer displays, high-speed communication networks, and hand-held data entry devices) can now support data entry by practitioners. These technologies hold great promise for CPR systems that will be acceptable for direct professional use. Much work, however, remains to be done to translate the potential benefits of these technologies into functioning CPR systems.
Data and Security Standards
Three kinds of standards apply to health data: content, data-exchange, and vocabulary. Nationally accepted standards for CPR data are of prime
importance to the CPR: they are necessary for transmitting complete or partial patient records, and they are essential to the aggregation of information from many sources, either for longitudinal records of individual patients or for databases of secondary records to be used for research or epidemiological purposes. Significant efforts are under way to support standards development for CPR data dictionaries, uniform coding, vocabulary, and data formatting. More needs to be accomplished, however, before the CPR can be shared across institutions or even by different clinical information systems within institutions.
CONTENT STANDARDS Two main kinds of standards must be developed for the content of CPRs. The first requirement is a minimum data set that applies to all CPRs; the second is content standards for specific kinds of CPR records (e.g., hospital, dentist office). The lack of either of these kinds of standards will impede effective use of CPR data by clinical and nonclinical users because record content will continue to vary among practitioners and provider institutions. A further requirement is to establish a specific meaning for data elements; that is, data elements should be used to collect the same piece of information in all record systems. Efforts by various federal agencies (e.g., HCFA, DoD, VA) and health data standards groups to develop clinical data dictionaries should be coordinated to ensure a reasonable level of consistency and compatibility. The committee suggests that the CPRI foster efforts to establish a composite clinical data dictionary that would enable users to translate data from different systems to equivalent meanings.
DATA-EXCHANGE STANDARDS It is likely that patient record data will continue to be diverse because they are produced using a variety of technologies from different vendors and by a complex mix of institutions, service bureaus, reimbursement agencies, and government agencies. A major priority should be to develop and promote standards for data representation and data exchange. Without such standards, it will be impossible to support the necessary exchange of patient medical, financial, and administrative information among the different interested organizations and institutions.
In 1991, no nationally or internationally recognized format standard exists for transferring a complete patient record between disparate clinical information systems. At present, only one health data format standard (Medix, from the Institute of Electronic and Electrical Engineers) even has the objective of transferring the entire patient record, and it is not yet operational. Therefore, the CPRI should coordinate efforts to develop, test, and demonstrate a health data format standard capable of transmitting all or any portion of the CPR between different clinical systems. The committee urges that special care be taken to include input from and coordination with international
standards efforts (especially those in Europe) to ensure that the format standard complies with the International Standards Organization's Open Systems Interconnect.
CLINICAL VOCABULARY STANDARDS Effective retrieval and use of health care information in the CPR depend in large part on the consistency with which a CPR content names and describes clinical findings, clinical problems, procedures, and treatments. The development and widespread dissemination of the content and techniques of effective vocabulary control of high-priority data elements are major intellectual, technical, and organizational challenges.
Standardized vocabulary efforts such as the Unified Medical Language Systems (UMLS) of the National Library of Medicine (NLM) are needed to establish a common vocabulary base for clinical systems. The committee believes that funding for development of standards for clinical vocabulary systems should be expanded and, because of the technical difficulties involved, sustained for at least a decade. The committee urges that the NLM be granted increased funding over the same period to refine the UMLS further, particularly the vocabulary involved in patient care and access to clinical knowledge bases. The NLM is the appropriate organization to educate the health care community concerning UMLS and other clinical vocabulary activities, and it is well positioned to do so effectively. The CPRI could work closely with the NLM to ensure efficient, nonredundant efforts in this area.
PATIENT DATA CONFIDENTIALITY Among the highest priorities in the coming decade will be the enhancement and application of methods to ensure the privacy and confidentiality of patient data in the CPR. Much of the technology to make the CPR more secure already exists, but for greatest effectiveness these technologies must be better deployed or embedded in CPR systems.
Today, no standards define the limits and scope of privacy and confidentiality for sensitive data in clinical information or CPR systems. Thus, the committee suggests that the CPRI coordinate development of such standards for health care, which will include minimal procedures with which systems must comply to ensure privacy and confidentiality in CPR systems. The institute should also address similar issues for computer systems containing secondary records (derived from data in the CPR) and establish standards for these systems as well. In particular, standards are needed to address the limits and procedures for removing (or scrambling) patient and provider identifiers in secondary records.
DATA AND SYSTEM SECURITY Standards are needed to ensure the integrity of the data in CPR systems. The committee suggests that the CPRI actively participate in developing such standards and that it coordinate and cooperate with the FDA and the Information Security Foundation proposed in the National Research Council's 1991 report, Computers at Risk: Safe Computing in the Information Age (published by the National Academy Press). Considerable attention was focused in the late 1980s on broad security measures for computer systems; now, the special requirements of the CPR need to be articulated and infused into the deliberations about these evolving industry standards. The committee therefore recommends that the CPRI coordinate efforts with organizations that are already active in establishing standards for secure systems and for the transmission of sensitive data over standard communications networks.
The information-intensive nature of health care mandates a strong emphasis on communication and transmission of information to many different organizations in diverse places. Electronic mail, file transfer, and image communication will become increasingly important support services, not only within a given hospital or health care institution but also across cities and states, and nationwide. Strong federal support will be critical for providing networking opportunities for health care information transfer at all organizational levels.
Current federal initiatives to develop high-performance national computer networks largely address the key relevant issues (enhanced transmission speeds, logistics of routing, standards for connectivity, and transmission protocols). The overall focus to date, however, has been on communications support for the research community; recognition of the role of such networks in supporting the clinical enterprise in general and the CPR in particular has been limited. To remedy this inadequacy, the CPRI should become an active participant in discussions by the Federal Networking Council regarding the National Research and Education Network.
In view of the substantial direct costs of CPR development and implementation, issues of cost-effectiveness are important from both institutional and societal perspectives. It is not reasonable to imagine wholesale investment in and development of CPRs and CPR systems without some reliable sense of what will be gained, and at what cost. Given study time and staffing constraints, the committee did not systematically inquire into evidence regarding the cost-effectiveness of CPRs or conduct a cost-benefit
analysis. Nevertheless, it recognizes the significance of economic considerations and, as is appropriate for any new medical technology, calls expressly for an examination of the cost-effectiveness of various features of the CPR before any widespread deployment occurs.
Major questions remain regarding the costs and benefits of the as yet incomplete and untried technology of a comprehensive CPR and CPR system. Accurate estimates have been extremely difficult to obtain because only incremental parts of the CPR system have been operational at any one time. To obtain a more accurate picture of costs and benefits will require major R&D efforts—for instance, extensive modeling and simulation projects or community-based demonstrations that could later be generalized beyond the community sites. An especially important step will be for investigators to develop sound models of total costs and benefits because it is likely that the CPR will range into areas of function and value far beyond those of current patient records.
These R&D projects should address at least three issues related to the benefits of CPRs and CPR systems. First, the nature and magnitude of benefits to individual patients, practitioners, provider institutions, and society generally should be evaluated. Second, short-term versus long-term benefits must be examined. Third, monetary and nonmonetary benefits should be estimated and compared. In addition, a methodological issue must be addressed because researchers are unlikely to be able to determine benefits in dollar terms with any precision. Thus, sophisticated approaches for characterizing benefits must be employed, such as is done for complex technology assessments.
R&D efforts must also address at least two issues concerning the costs of CPRs and CPR systems. First are the costs of acquisition, implementation, and operation; included in these should be the costs of the R&D itself. Second, short- and long-term costs must be appropriately identified. Cost determinations will depend on calculation of direct costs, indirect costs, and amortization of capitalized equipment.
The CPR can and should become a resource (with a capability far beyond that of paper patient records) for the systematic evaluation of health care practices and policies. The committee was unanimous in its view that, at least on a trial basis, linking CPR information with health status assessment provides an unprecedented opportunity to study the effectiveness and outcomes of health care procedures. Similarly, the CPR offers a vehicle for dissemination of clinical practice guidelines.
Both individual practitioners and health care provider institutions can use the CPR for their own purposes in evaluating and comparing patterns and
outcomes of care, and they can do so more efficiently than with a paper-based patient record system. In addition, those organizations whose responsibilities include the accreditation, regulation, and improvement of health care can, with appropriate safeguards, accumulate and analyze the data they need using the CPR rather than the paper record.
Quality of care has taken on greater salience in recent years, and public and private programs of quality assurance and continuous quality improvement have multiplied. Many of these rely (or intend to rely) on information residing in computer databases, including administrative or insurance claims files. At present, these kinds of databases are rather primitive foundations for reliable quality assurance efforts, and they have at best sparse information on important aspects of the processes and outcomes of care. Moreover, emerging efforts to develop uniform clinical data sets based on information in paper records are hampered by various drawbacks in using those records (e.g., long manual abstraction times).
Thus, CPRs and CPR systems offer great promise for furthering the nation's movement toward improving the quality of health care. Many questions, however, remain to be investigated. These include definition of minimum clinical data sets for different types and settings of care, development of appropriate real-time clinical reminders and alerts, and mechanisms for applying the statistical tools and methods of modern continuous quality improvement approaches. Although other public and private sector agencies and organizations will undoubtedly take primary responsibility for R&D in this area, the CPRI should be empowered to work directly with those groups to support these activities.
Structure and Format of the Patient Record
The technological capabilities of CPR systems offer new possibilities for improved design of patient record structure and format. To use these capabilities most effectively, the committee believes the relationship between the structure of patient records and the quality of patient care should be explored further. For example, specific elements of patient records that contribute to patient care outcomes need to be identified for incorporation into CPR systems.
The committee declined to endorse a particular patient record format at this time; rather, it strongly urges rigorous evaluation of the value of various attributes of different patient record structures.
RECOMMENDATION 4. The CPRI should promulgate uniform national standards for data and security to facilitate implementation of the CPR and its secondary databases.
As discussed earlier, major financial and organizational support is needed
to promote the development of uniform national standards for data and security. Once agreed upon, these standards must be incorporated into the design and use of CPR systems; they must also be continually reviewed and revised to keep up with technological advances.
Mechanisms must be developed to communicate standards to the parties affected by them. For example, system developers and vendors should be notified when uniform national standards have been established so they can design systems with up-to-date features. System purchasers, for their part, must be educated about the value of these voluntary standards to ensure that they will buy systems that offer features that meet the standards. System users (e.g., clinicians) who may be one step removed from purchase decisions also need to be educated about standards so they can demand such features in the systems that are acquired by their institutions. Furthermore, institutions should adopt and enforce organizational policies and procedures that support standard security practices. The CPRI is an appropriate body to develop mechanisms for endorsing and communicating health care standards to affected parties.
RECOMMENDATION 5. The CPRI should review federal and state laws and regulations for the purpose of proposing and promulgating model legislation and regulations to facilitate implementation and dissemination of the CPR and its secondary databases and to streamline the CPR and CPR systems.
The committee identified at least four ways in which legal issues affect CPR development and use. First, the inconsistency of licensure laws—for instance, for hospitals across the states—can impede development and diffusion of new systems. Second, regulations can force inefficiencies on record keeping (e.g., redundant collection of data). Third, laws concerning ownership, responsibility, and control of patient records and data may be ambiguous or inconsistent, or both, and thus hinder the electronic transfer of CPR data. Fourth, laws protecting confidentiality of computer-based patient data need to be strengthened to address concerns about patient privacy.
The committee concluded that a comprehensive review of pertinent laws and regulations, especially state laws and regulations, is needed to remove potential legal barriers and to ensure adequate protection of patient privacy. Following this review, guidelines should be developed and disseminated to appropriate audiences. The committee noted that the Uniform Health-Care Information Act should be included in this review and that efforts should focus on why it has not been widely adopted. The committee also determined that the review process should include an assessment of and recommendations regarding penalties for violation of the privacy of patients or providers through unauthorized access or misuse of patient data in the CPR or other patient records.
The committee assigns high priority to these legal and regulatory issues because they pose major obstacles for steady progress toward the CPR and may take a long time to resolve. For this reason, the committee suggests that the CPRI convene a panel of experts to conduct such a review and prepare a report, including guidelines for state and congressional consideration. The committee also suggests that the CPRI disseminate the findings of the report through educational conferences and other means.
RECOMMENDATION 6. The costs of CPR systems should be shared by those who benefit from them. Specifically, the full costs of implementing and operating CPRs and CPR systems should be factored into reimbursement levels or payment schedules of both public and private sector third-party payers. In addition, users of secondary databases should support the costs of creating such databases.
The committee believes that capturing complete and accurate clinical data is an essential element of the patient care process; it sees the CPR as an essential tool for improving and evaluating the quality of patient care and for decreasing its costs. Short-run benefits of CPRs and CPR systems should include (1) improved patient care resulting from increased availability of patient data, medical knowledge, and clinical aids (e.g., decision support); (2) increased productivity of health care professionals from improved access to patient data and reduction of redundant data recording; and (3) reduction in administrative costs. Long-run benefits should include the ability to increase and improve medical knowledge through research using patient data derived CPR systems.
As discussed in Chapter 4, the current distribution of costs and benefits of CPR systems may not provide adequate investment incentives for health care provider institutions. To overcome this problem, the committee believes that a better understanding of the costs and benefits of CPR systems (as discussed earlier in this chapter) and some sharing of CPR costs will be needed. Cost sharing would encourage health providers to invest in CPR systems and thus move the nation toward an optimal level of CPR system use. Further, the existence of cost-sharing mechanisms would send a signal to CPR developers regarding the strength of the CPR market and should increase the willingness of developers to invest in additional R&D.
The costs associated with CPR systems go beyond one-time procurement expenses, entailing expenditures for installation, training, maintenance, and other activities that must be planned for and appropriately budgeted. The committee therefore suggests that reimbursement mechanisms address three kinds of CPR system costs for all health care providers: (1) costs associated with procurement or leasing, (2) costs associated with installation and implementation (including training), and (3) costs associated with operation and maintenance.
The CPRI should take the lead in coordinating efforts to develop and implement reimbursement mechanisms that incorporate the costs of CPR systems. This process, which will require collaboration with representatives of practitioners, health care provider institutions, business, third-party payers, Congress, and federal and state government agencies (especially HCFA), could explore several CPR reimbursement mechanisms: incentives for data that are provided in electronic form, enhanced capital pass-through for CPR system acquisition, recognition of the costs of CPR operation in reimbursement rates, or a combination of the above. The committee urges organizations concerned with developing reimbursement levels or schedules (e.g., the Health Insurance Association of America, the Physician Payment Review Commission, the Prospective Payment Assessment Commission, and individual third-party payers) to make the establishment of acceptable CPR reimbursement mechanisms a high priority in the early 1990s.
CPR systems will greatly facilitate the creation of secondary databases for claims payment, health care policy, and clinical research by eliminating the need for manual data abstraction from records. In some cases, these databases can be constructed at a cost lower than that associated with current patient record systems; in other cases, desirable databases simply would not have been possible with current record systems. (The ability to select, retrieve, and aggregate desired data from CPRs will be of particular benefit to researchers.) Thus, users of such secondary databases should support the costs of data capture, processing, storage, and retrieval by CPR systems. The CPRI should develop an equitable plan to divide some of the costs of CPR systems that contribute to secondary databases among all such database users.
RECOMMENDATION 7. The committee recommends that health care professional schools and organizations enhance their educational programs for students and practitioners in the use of computers, CPRs, and CPR systems for patient care, education, and research.
An essential requirement for optimal functioning of CPR systems is efficient user operation of computers, CPRs, and CPR systems, including associated decision support, bibliographic retrieval, and other clinical aids. Because students and practitioners alike have educational needs in these areas, health care professional schools, programs, societies, and organizations all have a role to play in CPR education.
Such training will require curriculum modification, development of continuing postgraduate education programs, and preparation of faculty. In addition to formal training, professional schools, programs, societies, and organizations can reinforce computer skills by using computers to conduct routine business. (For example, professional societies could administer licensing examinations by computer.) The CPRI should facilitate this evolution
of education programs by serving as a resource for curriculum and continuing education development.
The number of health care professionals who can design, develop, support, and train others in the use of state-of-the-art CPR systems is far fewer than the number needed. Therefore, the committee suggests that the CPRI support training programs in health care to address these personnel shortages.
The committee notes the special training needs of registered record administrators (RRAs) with respect to CPRs. As the CPR becomes more commonplace, the role of RRAs should evolve to keep pace with the changes in patient records. The RRA of the future is likely to require greater knowledge of computing technologies (including database systems and software), quality control procedures, and the needs of all patient record users. Future RRA roles may also emphasize maintaining the quality and consistency of CPRs to support patient care and facilitate research using patient data.
The Institute of Medicine study committee set out to develop a plan for improving computer-based patient records and the systems in which they reside. As its first step, the committee examined why previous attempts had not resulted in wide acceptance of CPRs and asked if and how another effort might be successful. It identified five conditions in the current health care environment that it believes increase the likelihood of success: (1) ever-increasing uses of and legitimate demands for patient data, (2) availability of more powerful and more affordable technologies to support CPRs and CPR systems, (3) widespread acceptance of computers as a tool to increase efficiency in virtually all facets of everyday life, (4) an aging, mobile population, and (5) a widely held belief that needed reform in health care will not be easily achieved without routine use of CPRs.
To accomplish its task, the committee identified both the strengths and weaknesses of current patient record systems, detailed the users and uses of patient records, and defined user requirements for patient records and patient record systems. It reviewed available and emerging technologies and highlighted crucial emerging technologies whose development should be encouraged. Further, it identified nontechnological barriers to the development and diffusion of CPRs.
The committee believes its recommendations effectively address these potential barriers to routine CPR use. The first recommendation defines the CPR as the standard for future patient records. The second proposes an organizational framework within which CPR barriers can be systematically addressed and overcome. The committee's remaining recommendations then focus on specific barriers: needed research and development, promulgation
of standards for CPR data and security, review of legal constraints and remedies, distribution of costs for CPR systems, and education of health care professionals.
The committee recognizes that considerable work must be accomplished and practical difficulties resolved before CPRs become the standard mode of documenting and communicating patient information and before they are perceived and used as a vital resource for improving patient care. The challenge of coordinating CPR development efforts in the pluralistic health care environment is great. Resources are limited and must be used wisely. Further, achieving maximum benefit from CPR systems will require that they be linked to an information infrastructure (i.e., network) that allows patient data, medical knowledge, and other information to be transmitted and accessed when and where needed, subject to appropriate security and confidentiality measures.
The committee is convinced that with proper coordination and appropriate resources the goal of widespread CPR utilization within a decade can be achieved. The desire to improve the quality of and access to patient data is shared by patients, practitioners, administrators, third-party payers, researchers, and policymakers across the nation. CPRs and CPR systems can respond effectively to the health care system's need for a ''central nervous system" to manage the complexities of modern medicine. The CPR, in short, is an essential technology for health care.