In our health care environment, managed care, capitated payments, and a growing national information infrastructure are becoming major forces that shape decisions about how medical resources are organized and used. Health care decision makers prize medical effectiveness information based on patient care data that are linked with other data, such as costs. Obtaining uniform, accurate patient care data requires determining conditions of access to the data and standards. Under the National Information Infrastructure Initiative, principles have been developed to guide users and providers of individually identifiable data, and U.S. standards developers are at work to improve the definitions and electronic transmission of patient care data. When aggregated, these data can serve many uses, including improving quality of care. Their use for computing clinical performance measures, such as the Health Plan Employer Data Set (HEDIS), and a study that classifies such sets are highlighted.

The technology exists to make health care better, safer, and less costly. The major barrier to successful integration and application of existing technology is organizational. The model presented here is that of procedural medicine, defines as nonpharmacological interactions between medical technology and patients. Our hypothesis is that an academia-based effort primarily focused on blending enabling technologies will not only provide the ideal environment for the clinical champion, industry and government, but will create a critical mass to more rapidly and systematically transfer technologies among disciplines. The impact on healthcare will be much greater, soon and broader than any individual effort. The clinical champion can be exposed to a wider field of technologies and applications, and specialties work together allowing a broader impact. Through this structure, representatives from industry can access a wider range of clinical specialties. Success will depend on creating centers of excellence to provide leadership and nurturing strategic alliances.

The cost of health care continues to be a major national concern. I believe that properly applied technology can help reduce the cost of health care while maintaining or improving quality. This paper presents a description of an approach to defining the proper role of technology in health care, provides examples of how technology from the national labs can help meet the needs of the medical community, and then describes how the national labs can work with industry, universities, and medical research facilities to advance the goal of properly applying technology to reduce health care costs.

The following paper, entitled "The Effective Use of the Health care Assets of the Federal Government", will focus on the health resources of the federal government which might provide improved health care delivery at lower cost. These under utilized or unrecognized assets could prove to be a tremendous resource. While the existence of many of these resources is well documented, others are less well known and reside in agencies such as NASA, NIST, ARPA and the Department of Agriculture. Given the billions of dollars spent on these "hidden health care assets", we must ask ourselves how we might make effective use of these resources. The management of these resources raises several questions.

Increased scrutiny of health care technologies is accompanied by greater attention to the quality of the information upon which technology policy decisions are made. In particular, there is greater understanding of, and demand for, technology evaluation methods that embody greater scientific rigor. Methods for evaluating health care technologies can be divided roughly into two main groups: primary data collection methods and synthetic or integrative methods. Improved understanding by analysts and policy makers of the relative strengths and weaknesses of these methods is improving the design and conduct of technology evaluations, as well as the interpretation of study findings for use in health care decision making.

Thank you for the opportunity to make a presentation before this group. I'd like to talk about what represents, I think, kind of the end stage of technology adoption, after technology assessment is done--that is, the market dynamics which determine whether a specific product is used or not used in the today's clinical environment.

This paper provides an overview of how outcomes research can contribute to controlling health care costs while improving the quality of care for patients. Outcomes research is a process of figuring out what works best in medicine, for whom and when. The paper covers three areas: First, a discussion of the objectives related to outcomes research -- how this effort can contribute to cost containment and quality enhancement. Second, a brief review of four case examples of instances where outcomes research is, in fact, accomplishing these objectives. Finally, I share my observations for the future of outcomes research.

Although medical innovation can reduce morbidity and mortality associated with diseases or their treatments, in most instances new interventions tend to increase the amount of resources expended on health care services. In this era of increasing cost consciousness, there is a perceived tension between the desire to improve health outcomes and the necessity to control the growth of health care costs. The dramatic changes in the organization, financing, and delivery of health care services, make it no longer acceptable to provide any and all services to every individual with only a remote probability of clinical benefit. An incentive structure which rewards the practice of cost-effective medical care is rapidly replacing the 'technological imperative' of decades past. As the expansion towards managed care continues, increasing scrutiny will be paid to the clinical and cost implications of our medical interventions.

It has been argued that technology is a major driver of health care costs. However, it is possible that the inappropriate use of technology accounts for some of this rise in costs. Thus, the development of tools for assessing the outcomes of patient care in many dimensions could lead to a more appropriate use of technology with attendant cost savings. However, the determination of outcomes is dependent on controlling for the severity of patients' primary and comorbid diseases. Recently, a variety of instruments have been developed and validated for the assessment of disease severity. These instruments, coupled with data regarding definitive and surrogate outcomes, provide a means for analyzing and perfecting the use of technology. Moreover, when these techniques are coupled with economic analysis it appears possible to model the health care interaction for any given disease condition and to identify figures of merit for technologies which, if developed, would provide cost savings while maintaining or improving the quality of care. Thus, the development of appropriate measures of outcomes and disease severity offer the opportunity to more properly and efficiently employ the technology of today, while pointing the way to technology which, if developed, would provide a greater cost savings tomorrow.

Thinking about the potential for technology to control and quantify health care costs led me to develop the automated patient record evolutionary process (APREP). The automated patient record (APR) came to mind as an area with great potential to control and reduce health care costs. The automated patient record is a keystone in the overall health care delivery process. Information technology vendors try to sell a computerized patient record as a 'product.' It is important to consider the automated patient record as a process. A process evolving as part of the overall evolution of the delivery of health care services. The APREP is designed to assist health care executives response to the overwhelming forces driving the health care market towards a capitated managed care environment.

Few information systems create a standardized clinical patient record in which there are discrete and concise observations of patient problems and their resolution. Clinical notes usually are narratives which don't support an aggregate and systematic outcome analysis. Many programs collect information on diagnosis and coded procedures but are not focused on patient problems. Integrated definition (IDEF) methodology has been accepted by the Department of Defense as part of the Corporate Information Management Initiative and serves as the foundation that establishes a need for automation. We used IDEF modeling to describe present and idealized patient care activities. A logical IDEF data model was created to support those activities. The modeling process allows for accurate cost estimates based upon performed activities, efficient collection of relevant information, and outputs which allow real- time assessments of process and outcomes. This model forms the foundation for a prototype automated clinical information system (ACIS).

Information systems that can be used as effective management tools in healthcare do not exist. This is because current information systems do not accurately reflect reality and because they do not provide information to important end-users, i.e., clinicians. To reflect reality, healthcare information systems must assess total health care costs. These not only include the direct economic costs (dollars paid) but also the indirect economic costs (dollars lost, spent, or saved) from having a person ill. These systems must also accurately assess the adjusted, qualitative costs of human life and human pain and suffering resulting from the illness and healthcare provided. Once information systems reflect reality, they can be used to manage healthcare by profiling utilization, projecting need, modeling programs, assessing quality of care and establishing guidelines.

This paper considers the role of feedback in controlling health care costs from three perspectives: (1) where we have come from, (2) where we are currently, and (3) where we are going.

This paper deals mainly with quality feedback systems in relationship to cost control.

Adverse drug reactions (ADRs) are a major source of preventable morbidity and mortality, especially among the elderly, who use more drugs and are more sensitive to them. The insurance industry has recently addressed this problem through the implementation of drug interaction alerts to pharmacists in conjunction with immediate online claims adjudication for almost 60% of prescriptions (expected to reach 90% within 5 years). These alerts are based on stored patient drug profiles maintained by pharmacy benefit managers (PBMs) which are updated whenever prescriptions are filled. While these alerts are very helpful, the pharmacist does not prescribe, resulting in time-consuming and costly delays to contact the physician and remedy potential interactions. We have developed and demonstrated the feasibility of the PINPOINT (Pharmaceutical Information Network for prevention of interactions) system for making the drug profile and interaction information easily available to the physician before the prescription is written. We plan to test the cost-effectiveness of the system in a prospective controlled clinical trial.

I propose that high quality health care -- including innovation and state-of-the-art technology -- can and must co-exist with society's desire to reduce costs. One need not threaten the other. In fact, they should be mutually supportive. In this paper I talk about how we assess value in health care and some of the principles that should inform sound economic decisions about quality care. First, I'd like to consider why consumers define quality differently in health care than they do in other markets, and why lower costs and improved quality can -- and must -- move together. I review examples of how we currently use less costly alternatives for delivering care and at the same time maintain or improve our performance in meeting quality health care goals. I discuss how mechanisms in our current system support continued cost and quality improvements. Finally, I'll conclude with thoughts on how we can facilitate this trend with information and continued innovation.

This article updates and quantifies the costs and net government savings of two of three new technological projects introduced in last year's proceedings ('Use of Technology to Reduce Health Costs,' pp. 196-7). The projects are microcomputer video for medical outreach and ride tracking. The projects focus on maintaining or improving the delivery of and access to health care, while reducing cost significantly, by enabling more efficient or effective practices. As calculated to date, IMI currently estimates the two projects can save federal and state governments up to $180 million net per year, i.e., $20 million from microcomputer video for medical outreach and $160 million from ride tracking. (IMI is currently calculating the cost and savings of the third project, health care card system.) The article begins with a summary of each project, includes new accomplishments and participating organizations and lists the costs, savings categories and calculated savings.

The bureaucracy of the FDA has stifled research and kept life saving products off the market. The author presents a personal perspective on the issue.

Changes over the last twelve months in the Office of Device Evaluation have created an atmosphere that is open to trying a new approach to device review. Statistics from the last two years are presented with emphasis on the 510(k) application. Initiatives that are already in place are described and new strategies are shared that will potentially lead to a more streamlined review process. One division's efforts are outlined and include elimination of a layer of management, reorganization of the staff, and the development of standard operating procedures for 510(k) review. The entire process has been flow-charted and from the flow chart, steps that can be modified or eliminated can be identified. Total quality management has been introduced as one of the tools to achieve success.

The National Information Infrastructure program offers a great opportunity for the United States to capitalize on remarkable technological advancements over a broad range of applications benefiting society. One such application, telemedicine, has the potential to offer widespread access to sophisticated medical care, curtailed health care delivery costs, and homogeneous health and health-related educational opportunities. However, there are a variety of barriers to widespread application of telemedicine once the technical infrastructure of the information highway is well established and ubiquitous. These barriers include technical limitations, reimbursement issues, equipment and networking costs, and appropriate scientific studies to document efficacy and cost effectiveness. These issues may prove to be only transient disincentives which can be surmounted. Additional barriers exist, however, that may not be as readily resolved by traditional methods of analysis and more widespread practice applications. These political and regulatory obstacles will require clarification of the issues and solutions based on national consensus. It is the purpose of this discussion to amplify on these particular barriers which include licensure and tort jurisdiction.

The expression "medical device" covers any diagnostic or therapeutic means which involves a specific object and exerts its effects by mechanisms other than pharmacological. As such the term "device" includes a broad variety of instrumentation ranging from artificial organs to dental and orthopedic prostheses, biomaterials, biosensors, implants of various kinds, tissue engineering products, tools for minimally invasive procedures, imaging and patient monitoring equipment, telemedicine, hospital support systems (organizational and managerial) used for screening, diagnostic or therapeutic purposes, and systems for human rehabilitation.

A framework of sixteen attributes has been developed for evaluating the effectiveness of the risk management system for FDA regulatory Class III medical devices. Fault/failure analysis was identified as a potentially cost-beneficial attribute. Mechanical heart valves are FDA regulatory Class III devices in that they are considered life-sustaining when working properly, but life-threatening in the event of failure. The benefit-cost difference (net benefit) has been suggested as a measure of effectiveness for individual attributes and defined as the value of averted patient morbidity and mortality. In this paper, the Bjork-Shiley 60 degree convexo- concave mechanical heart valve is subjected to a retrospective benefit-cost analysis for the fault/failure analysis attribute. A general finding is that fault/failure analysis would have been relatively inexpensive for enhancing the risk management system for the Bjork-Shiley heart valve -- less than $25,000 -- while having the potential to avert 151 mortalities. Even without placing a value-of-life figure on averted mortalities, fault/failure analysis would have been cost-beneficial in reducing the risk of morbidity from mechanical heart valve failure.

Medical images (angiography, CT, MRI, nuclear medicine, ultrasound, x ray) play an increasingly important role in the clinical development and regulatory review process for pharmaceuticals and medical devices. Since medical images are increasingly acquired and archived digitally, or are readily digitized from film, they can be visualized, processed and analyzed in a variety of ways using digital image processing and display technology. Moreover, with image-based data management and data visualization tools, medical images can be electronically organized and submitted to the U.S. Food and Drug Administration (FDA) for review. The collection, processing, analysis, archival, and submission of medical images in a digital format versus an analog (film-based) format presents both challenges and opportunities for the clinical and regulatory information management specialist. The medical imaging 'core laboratory' is an important resource for clinical trials and regulatory submissions involving medical imaging data. Use of digital imaging technology within a core laboratory can increase efficiency and decrease overall costs in the image data management and regulatory review process.

The Center for Healthcare Technologies at Lawrence Livermore National Laboratory is a partnership among government, industry, and universities that focuses on improving healthcare through development of cost-effective technology. With the guidance of healthcare providers, medical institutions, and medical instrument manufacturers, technology can be harnessed to reduce healthcare costs. The partnership is a miniature test case for a potential national strategy for development and adoption of technology specifically to reduce costs.

During the first Health Care Technology Policy conference last year, during health care reform, four major issues were brought up in regards to the efforts underway to develop a computer based patient record (CBPR), the National Information Infrastructure (NII) as part of the high performance computers and communications (HPCC), and the so-called 'patient card.' More specifically it was explained how a national information system will greatly affect the way health care delivery is provided to the United States public and reduce its costs. These four issues were: (1) Constructing a national information infrastructure (NII); (2) Building a computer based patient record system; (3) Bringing the collective resources of our national laboratories to bear in developing and implementing the NII and CBPR, as well as a security system with which to safeguard the privacy rights of patients and the physician-patient privilege; (4) Utilizing government (e.g., DOD, DOE) capabilities (technology and human resources) to maximize resource utilization, create new jobs, and accelerate technology transfer to address health care issues. This year a section of this conference entitled: 'Health Care Technology Assets of the Federal Government' addresses benefits of the technology transfer which should occur for maximizing already developed resources. This section entitled: 'Transfer and Utilization of Government Technology Assets to the Private Sector,' will look at both health care and non-health care related technologies since many areas such as information technologies (i.e. imaging, communications, archival/retrieval, systems integration, information display, multimedia, heterogeneous data bases, etc.) already exist and are part of our national labs and/or other federal agencies, i.e., ARPA. These technologies although they are not labeled under health care programs they could provide enormous value to address technical needs. An additional issue deals with both the technical (hardware, software) and human expertise that resides within these labs and their possible role in creating cost effective solutions.

The American public's perception of biomedical engineering is fuzzy, and consequently, the expectations for services provided by the profession vary widely. This becomes apparent whether one talks to scientists in academia; manufacturers of medical products who employ biomedical engineers; doctors who either see technology through the narrow view of their specialization or as generalists are one step removed from technological innovation; patients who under the stress of disease cannot distinguish between standard and experimental forms of treatment; and finally government agencies which in the main have failed to define a place for biomedical engineering in their programs, and therefore oscillate between the extreme perspectives of biomedical engineering as a basic medical science and that of a service profession. As President of AIMBE, the American Institute for Medical and Biological Engineering, an umbrella organization which groups the majority of bioengineering societies (Table 1), I have witnessed and rationalized this confused perception as the uneasy coexistence of two realities: a scientifically mature field of inquiry impacting in both medicine and engineering, and a globally perplexed, almost balkanized profession, scattered among so many subgroups that no global identity can be defined and presented to the public.

Perceptions of biomedical engineering are important because they can influence private and public decisions on R&D funding and public policy. A survey was conducted of a group of persons active in biomedical engineering research in an attempt to determine the perceptions of the general public and of the biomedical community regarding biomedical engineering. The public is believed to have 'a little' knowledge of biomedical engineering, and to have a wide range of opinions on what biomedical engineers do. The survey respondents believe they are in general agreement with the public on several questions regarding biomedical engineering. However, the public is believed to be more inclined than workers in the field to think that biomedical engineering increases the cost of health care, and to be less supportive of increased R&D funding for health care technology.

Analysis of large, complex systems is difficult. Short-cuts or approximations often are needed to reduce the problem 'to size.' As a result, critical detail is lost or emphasis is placed on too few of the factors involved. The Los Alamos HealthValue Simulation generates and assembles the details of health care delivery for an integrated health care system. There are two key features: following individual patients, and providing a time history of events. Methods for doing this in computer simulations are well developed, having been used for decades by physicists and engineers. Today's supercomputers have the speed and memory capacity which make it affordable to apply the same methods to problems like health care delivery.

The introduction of new health care technologies raises a number of ethical considerations that should be addressed by researchers, industry, clinicians, patients, funders, and policy makers. The ethical dimensions of new technologies should be evaluated with respect to: (1) their potential to benefit those by and for whom they are intended to be used and the risks of harm that they pose to patients and society; (2) the degree to which they create or foreclose meaningful options to patients and clinicians; (3) and whether they will reduce or increase societal inequalities regarding access to treatment and the allocation of goods and services. These principles should be considered relevant to five interrelated categories: (1) essential concepts and definitions; (2) diagnosis; (3) prevention and therapy; (4) research; and (5) allocation.

In the United States, the Food and Drug Administration has been charged with the job of determining the safety and effectiveness of new drugs and devices. It is a thankless task because there is no reward for taking a balanced risk approach, only criticism for taking too long or approving a product that subsequently has a problem. And making decisions in Washington D.C. that influence the physician's ability to 'do the right thing' for his or her patient regardless of local circumstances doesn't seem to be the socially responsible or ethical thing to do. Devices, of course, are very different from drugs. Their performance is strongly influenced by physician level of skill. A great deal of learning can be accomplished with models. Their mode-of-action can generally be tested before, during and after use. Imaging and accessory tools can significantly reduce risk and trauma as well as enhance their function. Advances in design and performance occur much more rapidly than with drugs. These and other factors suggest that a very different approach is warranted to evaluate their safety and efficacy, as well as to determine when it is ethical to use them on patients. There are many different categories of devices: complex or simple; high inherent risk or low; procedure specific or generic function; etc. Guidelines exist for regulatory approvals in these categories, but the 'bar has been raised' for approval to such an extent that physician, industry and patients groups are questioning the ethics of withholding or delaying the availability of technology and/or adding significantly to its cost without correspondingly significant benefits in reduction of risk.

Health care systems all around the world are struggling to provide care in an era of limited resources. In an article entitled, 'Straight Talk About Rationing,' Arthur Kaplan reviews the work of the Swedish Commission designed to prioritize health care for that country. The commission identified three core principles that they felt should underlie decisions about priorities for health care. Those principles were (1) all human beings are equally valuable; (2) society must pay special attention to the needs of the weakest and most vulnerable; and (3) all other things being equal, cost efficiency in gaining the greatest return for the amount of money spent must prevail. These are three extremely useful principles which can be helpful to us as we consider many of the issues confronted in this country about the allocation of resources for health. I would like to consider three major issues. The first issue is the current evolving nature of health care and the ethical dilemmas that exist in the present system. In balancing increased access to care with decreasing cost, particularly in managed care, all of us are concerned about ethical issues. I would like to emphasize that the current system -- the system that we have lived with and is changing -- has inherent in it a series of ethical dilemmas. Secondly, I would like to consider issues related to productivity and its measurement in relation to technology. This relates to the third item in the Swedish Commission, which is the principle that we ought to spend money in the most cost-efficient way. Finally, I would like to discuss the dilemma of decision making about health and how that impacts upon the ethics of health care in the application of technology.

Health care is at its best when both the practitioner and patient are well-informed. In many central urban and remote rural areas, however, health care is characterized by a lack of continuity and coordination among providers. In these areas, a local information infrastructure and a patient-centered system of primary care are missing. Decision-making and ability to follow through is hampered, with limited involvement of patients in planning care and insufficient aggregate data for cost analysis, outcome research, community health planning, and other purposes. A Children's Health Network has been designed to extend current information technology to these underserved areas. Our approach to improving quality of individual care and controlling costs emphasizes use of computerized clinical information networks for better decision making and continuity, and secondarily through data aggregation for financial, research, and public health functions. This is in distinction to information systems centered on billing and administrative needs and to cost-control efforts which rely on fiscal and managerial ('gatekeeper') mechanisms. A uniform data base among sites serving the same population will answer several clinical and public health needs.

The National Network/Libraries of Medicine is a program of the National Library of Medicine designed to promote accessibility to biomedical databases for U.S. health care providers.

For increasing safety in guidance techniques of endoscopes and instruments, fast radiologic imaging should be integrated. Magnetic resonance imaging (MRI), computer tomography (CT) and electron beam tomography (EBT) scanners permit transparency of the operative field; CT and EBT can be combined with fluoroscopy and ultrasound units. MRI avoids x ray exposure, but entails the possibility for 3 D localization. Open access and keyhole imaging allows nearly real time guidance of instruments. Combining minimally invasive techniques using endoscopes and tomographic guidance these technologies improve surgical access and reduce complications. This offers a safe access into the body and leads to the new field of interventional and surgical tomography. Important cost reduction for health care systems is possible, especially in the outpatient treatment of common diseases like disk herniation, back and tumor pain, metastasis, or arteriosclerosis. For realizing a long term cost reduction effect, these techniques have to be integrated in a quality management combining prevention, modern diagnosis, minimal access techniques and, if necessary, hospital stay with maximal access treatments as well as rehabilitation and secondary/tertiary prevention.

It's clear to all of us, including the FDA, that regulation does affect cost. It adds cost on top of the development of products, it adds cost on top of the use of products, and, therefore, it has an impact on the cost of health care and health care delivery in this country. This paper quickly runs through where those costs are, and, honestly, to balance them a bit with benefits. I am constantly asked, particularly this year, to re-examine the way we regulate medical devices, and look at a safety only model. My answer to that is I don't know how to look at safety only without looking at some effectiveness. I also don't know how to do risk only and not look at risk benefit. That is the type of work we at FDA do.

The discipline of risk assessment has developed primarily over the last two decades out of two principal public fears -- radiation and cancer. As a discipline, it has become an integral part of regulatory reform and management science. Three different cultures have been the primary practitioners of the risk analysis discipline: (1) engineers as applied to engineered systems, (2) health scientists primarily in relation to environmental impacts, and (3) social scientists with respect to public participation and societal threats. The engineers and physical scientists have been the most active in developing the discipline of probabilistic risk assessment -- or, as it is increasingly referred to, quantitative risk assessment (QRA). It is QRA that has been our field of interest for the past two decades. The purpose of this summary is to define QRA, suggest a possible role in the health care field, and to make some observations about QRA, health care, and government regulations.

The performance of trained human observers in diagnosing a medical situation through an endoscope can be represented by a receiver operating characteristic (ROC) curve. When the ROC plot is related to a plot of signal to noise ratio (SNR) of the endoscope system display versus system resolution, the operator performance for a given size target object can be determined from the ROC. The ROC curve gives probability statistics associated with detection. When the costs of errors are assigned, this method would quantify the risks associated with the use of the device. It is proposed as a method which would allow a regulatory agency to judge imaging devices based on quantified cost/benefits.

The goal of this paper is to examine the importance of private and public partnerships in bridging the gap between research and marketing and their implications for the development of a national policy in research support in imaging science and technologies. Breast cancer imaging will serve as a case study for the development of collaborations between government agencies, academic community, and industry as the means to facilitate development, evaluation, and implementation of promising diagnostic technologies.

The capacity to access, integrate, and analyze demographic, financial, and clinical data within a regional health care system represents an opportunity to ensure and enhance clinical quality and to reduce costs in a carefully planned and controlled manner. Properly used, such capability should improve health care delivery for local populations and provide the institution with a level of integration of services achieved by few health care organizations. The Baptist Health System (BHS), based in Birmingham, Alabama, is currently standardizing operating procedures among its various components and implementing a comprehensive, enterprise-wide information network. Clinical quality improvement and case management are being promulgated throughout the enterprise using a continuum-of-care model developed internally. Having successfully completed a pilot project using teleconferences for core lectures in internal medicine between two large teaching hospitals, BHS is taking advantage of enterprise- wide teleconference capability using a combination of fiberoptic (T3) and standard digital telephone (T1) transmission to speed installation and reduce the cost of implementation into two office buildings and eleven hospitals. The information system will serve to prepare BHS for the advent of managed care and other anticipated changes in health care, while ensuring continued ability to deliver high quality, cost-effective medical and health-related services.

Pushing the frontiers ofmedicine through research and development ofnew technologies has long been a standard of health care in the United States. Currently, the United States spends more than any other country on healthrelated research and development. In 1989 alone, health care research expenditures exceeded $1 .8 billion.1 Despite the magnitude of this cost, it continues to grow; national expenditures on health research increased by 50% inthe decade between 1983 and 1992.2

Health care technology often is considered as an independent entity; however, it is used within a context, a system, by health care providers who are professionals with varying levels of training and lay care givers. Despite the centrality of users of health care technology, the rarely are actively involved in the development of the technology, instructions for its use and maintenance; or the testing and acquisition of the technology. This lack of involvement can result in health care technology that is difficult to use safely and effectively. Such difficulty can lead to human error, adverse events, and adverse outcomes in terms of patient health status. In addition to end-user involvement in all phases of development, testing, and acquisition, standards as well as criteria and guidance can increase the safety and effectiveness of health care technology by decreasing the likelihood of human error.

The rapid growth of health care costs has intensified the debate over how to control them. The role of technology in spurring cost growth has been among the more hotly discussed issues in this debate. This paper reviews the data on health care cost growth and the factors that contribute to this trend, focusing on hospitals. The direct impact on costs of the diffusion of new technology is not large; however, to the extent that the availability of new services and procedures increases the amount of health care consumed, it may be a very important source of cost growth.

During the last three decades, development of new medical technology has been largely responsible for the spectacular advances in the diagnosis and treatment of many human diseases. This has contributed to improved medical care of our population. However, concerns have been raised that in today's managed care environment of health care, introduction of new medical technology will be difficult. Cost-sensitive health care providers should consider various ethical issues involved before demanding that only those technologies that save money and show highly positive cost benefit ratio will be reimbursed. The impact of such considerations on the innovations of new medical devices and their developments is discussed.

The need to set reasonable limits on expenditures for health care has led to increased discussion of rationing. Given the fact that no single vision of justice will dominate the allocation of health care, it is becoming increasingly important to establish open, democratic procedures for setting limits. Public awareness of the need for limits and public participation in establishing the limits is essential to the development of a just health care system.

Rising expenditures on health care have become a major cause for public concern. Attention focuses on the level of expenditures and the increasing share they take of GNP, but for most Americans, the real issue is not how much society spends, but what it gets for the money. There are several ways in which it could be said that the United States fails to get full value for the dollars spent on health care. Some care does not benefit, or even harms, those who receive it. Some care is beneficial but could be produced with fewer resources. Some care is efficiently produced and yields benefits, but the benefits are not worth their cost. And finally, despite the system's cost, many people are excluded from it and thus fail to receive care of great benefit. The need to address the problem of wasteful care is relatively uncontroversial. Everyone agrees that it would be desirable to eliminate care of no benefit and to produce beneficial care as efficiently as possible. There is also a growing consensus that steps must be taken soon to improve access. There is far less agreement on what, if anything, needs to be done about care whose benefits are not worth their cost. The public's limited understanding of this issue is an obstacle to good health policy. Meaningful debate about health care reform must include open and informed discussion of the extent to which different reform proposals will restrict beneficial care, how they will do it, and how well the results will reflect the preferences and values of the

When deployed in a rational way, technology usually leads to increased productivity and growth. There is no technical reason why technology can't achieve the same result when applied to health care that it has achieved in other sectors. With this in mind, this paper focuses on the utilization of technology to: (1) identify costs and benefits associated with specific health care services, and (2) reduce some of these costs.

Bioengineering professionals practice in a wide variety of subspecialties. Their practices vary from cellular engineering to rehabilitation engineering, and from biomaterial/biomechanics engineering to biomedical education. A major part of the bloengineering field is the one represented by the biomedical engineering professionals of which about 10% practice in the clinical engineering subspecialty focusing on issues involving utilization of technology in the delivery of health care services. Common to these subspecialties, being part of the bioengineering field, is the application of the concepts and methods of the physical and engineering sciences to enhance the development and deployment of safe and effective medical instrumentation. Like all of the other subspecialties clinical engineering, the applied field of biomedical engineering, faces poor public knowledge and lack of recognition for the contributions their professionals have made thus marking a path to improve the quality of our life. Engineering academia is not faring much better than the lay public in their lack of developing and offering of academic programs that will provide the training and skills needed to prepare these professionals for the challenges and responsibilities they will be facing when practicing in the clinical environment. At the root of this problem are the perception and attitude issues. To better understand these attitude and behavior issues we reviewed literature and conducted opinion surveys. In recent years, bioengineers, biomedical, and clinical engineering fields have sought an identity to define their profession. Like many other young professions, bio/biomedical engineering has encountered a professional identity crisis that presents more questions than answers. One issue in defining a profession is the presentation of some clearly illustrated assets and abilities supported by a formal education or accreditation requirements to a targeted customer. In other words, biomedical engineers must define who they are, what they profess to know, and what function they serve to many customers of which the important one is the general public.

The focus of this discussion is on the process of product development, generally and with the concept of allocating resources within this developmental process, specifically. At the outset, one must consider certain underlying assumptions which society makes in looking at the development of technology and the allocation of resources. Analysis of these assumptions frequently is not, but definitely should be, part of that developmental process.