HEALTH CARE AND THE NII Summary of Comments Committee On Applications and Technology Information Infrastructure Task Force September 8, 1994 J. Michael Fitzmaurice, Ph.D. Ellen Rossman Agency for Health Care Policy and Moshman Associates, Inc. Department of Health and Human Services INTRODUCTION In early 1994, eight authors were asked by the White House Information Infrastructure Task Force, Committee on Applications and Technology, to write an introduction and white papers on applications of the NII in seven specific areas. The seven areas are: education, electronic commerce, environmental monitoring, government services, health care, libraries, and manufacturing. The goal was to focus public attention on a national vision of the opportunities for the public to receive the benefits of advanced computing and communications technologies through NII applications in these areas. Another target was to improve public policy by identifying how the Federal government can bring these benefits to the forefront when it is in the public interest. In Putting the Information Infrastructure to Work , the papers were published with a call for public comment. This paper summarizes the public comments received for "Health Care and the NII." As of August 19, 1994, 81 groups and individuals provided comments on "Health Care and the NII," one of eight chapters in the document entitled Putting the Information Infrastructure to Work: A Report of the Information Infrastructure Task Force Committee on Applications and Technology. Of these commenters, approximately 40 percent represented health care and information management associations, foundations, and advocacy groups; 15 percent were members of the academic community; 15 percent were federal government personnel; and the remaining 30 percent were providers of health care, information management, and legal services. Commenters clearly believed the health-care chapter to be an important vehicle for presenting the NII-related needs and views of health professionals to policy and decision makers. Many of the comments submitted were two or more pages in length and some as long as six pages. The comments were characterized by their thoroughness, thoughtfulness, and attention to detail. They addressed issues ranging from the technical, theoretical, and philosophical to the grammatical. They documented the critical importance of the National Information Infrastructure (NII) to the health care provider and health care information management communities and the commitment of the members of these communities to play an active role in NII's development and implementation. To provide a relatively short synopsis of the extensive number of comments received, this summary will focus primarily on comments addressing those topics which appeared to be of most significance to the commenters. After a brief discussion of the commenters' response to the overall vision presented in the chapter, this summary will condense comments on 13 topics that were addressed by six or more individuals. (These topics and the number of commenters mentioning each are listed in Exhibit 1.) Finally, it will discuss briefly comments that targeted the special NII-related interests of particular groups. RESPONSE TO THE OVERALL VISION PRESENTED IN THE CHAPTER There is interest in the extent to which the comments indicated agreement (or disagreement) with the overall vision presented in the paper, i.e., how health care providers and institutions can exchange and pool information in order to improve the quality and contain the costs of health care. None of the commenters expressed disagreement with this overall vision. Rather, the vision appeared to be accepted as a "given" by commenters, whose remarks served to flesh out and expand upon components of the vision as it was presented in the chapter. While the comments documented some disagreement on the details of the exact process for ultimately achieving the vision, it was clear that this diverse group of commenters are committed to achieving a similar goal. ISSUES OF PRIMARY INTEREST TO COMMENTERS Far and away, the topic of standards development received the most attention: issues related to standards were mentioned by 32 commenters. Other frequently mentioned topics included the role of the federal government in developing and implementing a health care NII (23 commenters); issues pertaining to privacy, confidentiality, and security (22 commenters); and discussion related to research, demonstrations, and evaluation (19 commenters). Brief summaries of key points raised by the commenters on these topics are provided below. Development of Standards The following summarizes the variety of issues raised by the 32 commenters who mentioned standards. %The need for acceleration of standards development was expressed by four commenters. The federal government was urged to play a role in the acceleration process. %While five commenters indicated their support for the facilitation by the federal government of a public-private partnership for the development of health care information standards, six others stated their support for efforts of the American National Standards Institute's (ANSI's) Healthcare Informatics Standards Planning Panel (HISPP) in this area. One of the latter group expressed concern that the federally facilitated partnership might duplicate the efforts of HISPP. %Two commenters suggested specific types of standards that should be developed, including standards for data communications, data storage, and data encryption/security; standards for data compression for electronic imaging; and universal standards for information exchange. %Two commenters offered differing opinions on whether the federal government should mandate the use of standards. One stated that, while the private sector should not be required to use standards, the public sector should have this mandate. The second believed both the public and the private sector should be mandated to use the same standards. %Differing opinions were also offered by two individuals who suggested priorities for standards development. While one believed that standards for nomenclature, coding, structure, and the content of data sets should receive the highest priority, the other suggested standards for medical administrative transactions be given top priority, in order to reduce health care administration costs. The latter also believed that standards for clinical transactions should be a "close second," in order to improve health care quality. %Two commenters mentioned issues to be considered once standards have been developed. These included creation of "trading partner agreements" and "implementation guides" and regular updating of standards, to address changes in technology. Commenters also discussed the role of the federal government in the standards development process. Representative comments include the following: %The single most important role of the federal government in expediting the development of medical information flow is to foster the development of universal standards for information interchange. Any such effort must include major input from industry and the medical profession, but must be led by the federal government. Any other organization leading such efforts will be seen as potentially self-serving and be suspect by other participants. %Information standards should be developed within the current accredited standards committees with oversight and coordination by an ANSI panel or board which includes both the public and private sectors. The federal government should participate and then commit to accepting the developed standards or recommendations. Past experience shows that the government may participate but not commit to consensus recommendations and may resort to other techniques or not change the way its business is conducted. Any decision by the government for federal programs has a monumental impact on the private sector. %The federal government should not develop standards, it should promulgate and mandate the use of standards developed by ANSI HISPP. It may also be helpful to have the federal government facilitate the development of treaties among the feuding standards groups. Role of the Federal Government Twenty-three individuals mentioned various aspects of the role of the federal government in the development and implementation of the health care NII. As noted above, issues related to the government's role permeated commenters' discussion of standards and also were introduced into their discussion of many of the other topics related to the health care NII. As relevant, these comments are incorporated into the summaries on these topics which follow. In addition to standards, the two topics mentioned most often by commenters as areas in which the government has an important role to play included addressing the issue of privacy, confidentiality, and security and funding research, demonstrations, and evaluations. Privacy, Confidentiality, and Security Ten of the 22 individuals who commented on the issues of privacy, confidentiality, and security stated their support for national legislation to achieve uniformity in the way that uses of personally identifiable patient data are restricted. Only two of the 22 commenters were dubious about legislative solutions and questioned the assumption that new legal structures could deal with these issues adequately or completely. Seven commenters suggested strategies to be used along with or instead of legislation. Among these strategies were: %Ensuring that examples of benefits to patients resulting from increased sharing of information are available before attempting to enact the legislation, so that legislative efforts will not be derailed by fear; %Offering patients the choice of consenting to expanded use of their medical information by others; %Developing model legislation for use by states in revamping their privacy laws and offering fiscal encouragement to promote uniformity over time; and %Educating the public to be more realistic about the difficulty of eliminating all risk of disclosures. Finally, two commenters argued that privacy may not be as "thorny" an issue as it is perceived to be. One suggested that members of the public may not be aware of all of the issues involved and might be willing to sacrifice aspects of privacy now protected, if they understood this would achieve a better quality of health care at a lower cost. The other believed the issue may become less important once certain aspects of health care reform are implemented and penalties such as health-based insurance exclusion and job discrimination are eliminated. Research, Demonstration, and Evaluation All of the 19 individuals who mentioned research, development, demonstration, and evaluation of integrated health care information systems indicated their support for a federal program funding such activities. The vast majority of comments on this topic offered suggestions or support for particular types of research, demonstrations, or evaluations that should be funded. These are summarized in Exhibit 2. Two of the 19 commenters mentioned specific activities they believed the government should not fund, but were otherwise supportive of a federal funding program. Universal Patient Identifier Eleven commenters mentioned the concept of a universal patient identifier, many of whom pointed to the controversial and difficult nature of this issue. Of the three who commented on the possible use of the social security number as the identifier, two disagreed with the option because of its controversial nature and the relatively high likelihood of breach of confidentiality. The third believed the social security number was appropriate for identifying records, but not for authorizing access. Another commenter found a unique identificationnumber to be a more pragmatic and viable solution to identification than other options mentioned in the chapter (e.g., retinal scan, DNA blood typing) which would be more costly, both in resources and time. Public Access to Health Information Public access to health information was discussed by ten commenters. Four commenters had positive views on this subject and believed that NII will promote the distribution and access of health-related information to the public; support consumers' informed decision making about health; and redress the balance of power existing between the health care professions and the laity. However, four commenters were less optimistic about the benefits of increased access. They noted that the public is already overloaded with information received via the media and questioned consumers' ability to understand and use health information appropriately. One of these commenters, while agreeing that informed consumers will be a key benefit of NII, believed that substantial education will be necessary to have an effect on national health expenditures. Another concern of three commenters was that NII could increase the health status gap between the "haves" and the "have-nots," who may not have access to information technology. Finally, one commenter was concerned that the chapter's presentation of this issue suggested consumers could get the necessary information on their health care problems from computers, which would be a substitute for primary care. Data Repositories and Data Ownership Of the ten commenters who mentioned health care data repositories, six agreed there should be federal involvement in efforts to establish repositories. However, one of these believed successful pilot projects would eliminate the need for further federal funding of repositories, because communities and health care organizations would "scramble" to adopt information systems shown to have positive cost utility. The one commenter indicating disagreement with federal involvement believed such involvement would not be worthwhile because the private sector is already spending a good deal of money in this area. Commenters also noted that analysis, translation, and dissemination of depository data need to be addressed and that federal support of research and education regarding the usage, use, and impact of repositories would be of value. In addition, five of the 10 commenters believed the issue of data ownership must addressed before repositories can become a reality. Use of Existing Systems Eight commenters suggested that greater emphasis be placed on using, refining, linking, and making universally available existing systems and technologies. The following are examples of comments representing this view: %The federal government should not make a major investment to create an integrated health care information system, when such systems are already in place in private sector health care settings and the financial arena. Benchmarking and using or improving on existing systems would be a worthwhile place to start, rather than starting over. %Instead of focusing on development of sophisticated new technology, it would be more realistic to describe a future in which existing applications are universally available, such as easy access to lab data from other sites, immediate and rapid access to the National Library of Medicine data bases from office or hospital computer, and automatic checks of all prescriptions for potential drug-drug interactions. %Disseminating proven applications should be emphasized, such as the HELP system at Latter Day Saints, Indiana University's intelligent order entry system, and numerous commercially-available applications on such topics as literature searching and patient and professional education. We do not need to wait for futuristic developments. Data Quality The issue of data quality was raised by eight commenters. Most of their comments focused on the detrimental impact poor quality data could have on the perception of NII and on its usefulness for clinicians, researchers, and policy makers. Examples of key points made include the following: %Data that are of poor quality, antiquated state, or low relevance will increase uncertainty in information generated and decrease credence of decisions made from the system. Given the repercussions that incorrect data could have on quality of care and programmatic alternatives identified for policy makers, an ongoing program for improving and documenting the "wellness" of data is more than justified. %If studies are conducted using medical record data derived from many sources, there needs to be assurance that these data reach a certain and known level of accuracy. Lack of quality standards would decrease the value of the data bank, perhaps to the extent of making it meaningless. Data from fewer centers evaluated for accuracy would be of greater value than data from many sources of unknown accuracy. %Claims data have a reputation for some "creativity." Bias creeps into clinical data towards more favorable financial and administrative outcomes. There is a need for an audit system to assure data validity. However, two commenters suggested that features of an integrated information system themselves could lead to improved data quality. They noted that longitudinal data systems and uniform data structures standardizing data collection over a number of hardware platforms will increase data validity and reliability and that point-of-service data collection also will increase the probability of obtaining reliable and valid data. Coordination of Federal Agency Activities Eight commenters remarked on the need for coordination of federal activities to reduce unnecessary duplication of effort and to coordinate data and information requirements among various federal programs. Of these, six explicitly stated their support for establishing a federal work group for such purposes. Only one questioned the creation of the work group, noting that, while coordination and sharing across segments of the government is desirable,the benefits accrued may not exceed the energy required to establish the group, especially if there are no "teeth" in the requirement that agencies coordinate and avoid duplication. Development of the Computer-Based Patient Record Eight commenters remarked on the computer-based patient record (CPR). All were in support of the development of the CPR and three described the CPR's development as "high priority," "the foundation for everything else," and "essential for the US healthcare system." Training in the Use of NII The need for training in the use of NII was addressed by six commenters. These comments focused primarily on training health care providers. The commenters noted that proper use of electronic aides will require revision of work patterns taught in medical and nursing schools as well as reorientation of current practitioners. They believed the federal government should fund training programs to address these needs. The programs should target community-based practitioners as well as those in academic settings. Liability and Regulatory Issues Six commenters addressed liability and regulatory issues other than those related to privacy, confidentiality, and security. Five of these mentioned state "quill pen laws," one of whom commented that "until a standard for electronic signature exists, we will be stuck with a paper trail." Another noted that digital signatures are much more secure and reliable than hand written signatures. Two commenters identified liability and regulatory issues related to NII that will need to be addressed, including insurance coverage for teleconsultation, state regulations allowing practitioners from rural areas to engage in telemedicine with their urban counterparts, and the adequacy of current laws and legal precedents on issues of malpractice, ownership, contracts and torts, and privacy. Two others suggested the NII may result in reductions in malpractice suits and physicians' malpractice insurance, as practice guidelines are developed and comprehensive standards of medical practice emerge. SPECIAL NII-RELATED INTERESTS OF PARTICULAR GROUPS In addition to addressing the specific issues raised in the chapter, a number of the commenters emphasized the need for the NII to embrace the entire health community. These commenters urged that NII address not only the information needs of providers of ambulatory and hospital-based medical care and their patients, but also those in other settings, including consumers with chronic medical problems and the providers who care for these consumers in their homes. Commenters representing professionals in such disciplines as dentistry, preventive medicine, health promotion, mental health, and pharmacy described the importance of the NII to their fields and the consumers whose needs they address. Although many commenters praised the chapter for the comprehensiveness of its presentation of current activities related to health care information, 22 commenters, including many of those representing the particular groups mentioned above, provided additional examples of NII-related activities in which they or other groups were involved. These examples and comments are further evidence of both the great interest and the capacity ofthe many facets of the health professional community to be involved in developing and implementing the NII for health. In summary, the vision presented in "Health Care and the NII" represents desirable goals. Commenters remind the reader that important issues for health care policy makers, health care providers, and consumers must be addressed for progress to be made. Further, commenters believe that much of the vision has begun in the private sector and that reality must accompany the vision. The expected costs as well as benefits must be delineated, and the private sector must be recognized for what it has done and for what it will be called upon to do. The Federal government must provide leadership and partnership to the private sector. Consumers must be supported in their quest for increased healthiness as well in their decisions about treatments for acute illness. Exhibit 1 Topics Mentioned by Six or More Commenters Topic # of Commenters Development of Standards 32 Role of the Federal Government 23 Privacy, Confidentiality, Security 22 Research, Demonstration, Evaluation 19 Universal Patient Identifier 11 Public Access to Health Information 10 Data Repositories/Data Ownership 10 Use of Existing Systems 8 Data Quality 8 Coordination of Federal Activities 8 Computer-Based Patient Record 8 Training in the Use of NII 6 Liability and Regulatory Issues 6 Exhibit 2 Types of Research, Demonstrations, and Evaluations Mentioned in Comments %Model development for small institutions and local networks, including field demonstrations and planned pilot tests %Research on creative methods to ensure security and privacy of information in repositories %Community trials %Research to identify specific applications and systems where benefits exceed costs %Determination of costs and benefits of nationwide networks %Model development for health care information %Research to identify potential administrative and clinical cost savings %Identification of changes in health care service utilization and in the process of health care %Studies on uses, usage, and impact of longitudinal data in repositories %Determination of savings from access to medical effectiveness information %Research and analysis of legal and judicial aspects of a health NII, including the adequacy of current laws and legal procedures to address issues of malpractice (medical and other), ownership, contracts and torts, and privacy %Creation of open systems development test beds, including interoperability testing with other domain infrastructures %Research and development related to the information infrastructure as a mechanism for teaching and learning activities %Determination of whether standards promote cost-effectiveness %Demonstrations of community health information networks .