A new kind of bioethics: eschewing the academic mainstream, Bush panel focuses on technology's dangers.
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The regulatory process for medical devices works well for products that involve incremental change to conventional technologies. The situation is not so clear when radically new technologies are introduced into clinical practice. This article discusses some of the issues that are involved and proposes some new solutions.
How health care should be reformed to address the current economic pressures and deliver a better future.
Healthcare expenditure in Ontario has been escalating at increasing rates and a growing proportion of this has come from medical devices and other technologies. A comprehensive evidence-based process for the assessment of new health technologies in Ontario was recently established (the Health Technology Policy Analysis [HTPA] process). Requests for funding for new technologies are directed through a department of the Ministry called the Medical Advisory Secretariat (MAS) who, using a systematic and evidence-based approach, provides information on the safety, effectiveness, and cost effectiveness of the technology to the Ontario Health Technology Advisory Committee (OHTAC). If the OHTAC determines that the evidentiary base for making recommendations is too uncertain, a request is made to reduce this uncertainty through the conduct of a 'real world' Ontario-based study. The Program for Assessment of Technology in Health (PATH) reduction of Uncertainty through Field Evaluation (PRUFE) framework is an iterative process for collecting new information, updating prior knowledge and providing new 'real world' evidence back to the Ministry regarding the cost effectiveness of new health technologies. MAS/OHTAC has undertaken evidence-based analyses for >50 new technologies. The PRUFE framework has been successful for reducing uncertainty and controlling healthcare expenditures while providing access and improving patient outcomes.
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The proliferation of medical technology during the past decade has doubtless surpassed that of any other recent period. We have witnessed and are continuing to witness rapid advances in human genetic engineering, reproductive technology, and biomedical intervention in the life process. Our population has benefitted from this technology as a result of its ability to extend the life of individuals, particularly the elderly sector of our society. This technological proliferation has caused philosophers, physicians, engineers, and policy strategists to focus upon questions of ethics and mortality relating to their application. In approaching the ethics of rationing, consideration must be given to both the deontological concepts of the individual and the utilitarian principles of societal preservation. This article continues a discussion of the issues of resource allocation that was begun in the February 1994 issue of Physician Executive.
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Increasing data from a few sites demonstrate that information technologies can improve physician decision making and clinical effectiveness. For example, computer-based physician order entry systems, automated laboratory alert systems, and artificial neural networks have demonstrated significant reductions in medical errors. In addition, Internet services to disseminate new knowledge and safety alerts to physicians more rationally and effectively are rapidly developing, and telemedicine to improve rural access to specialty services is undergoing substantial growth. However, even technologies demonstrated to yield beneficial effects have not yet achieved widespread adoption, though the pace of change appears to be increasing as the Internet takes hold. Scientific evaluation of many technologies is also lacking, and the dangers of some of these technologies may be underappreciated. Research on the effects of specific technologies should be a priority. Policies should be developed to press information technology companies, such as pharmaceutical and medical device manufacturers, to recognize the importance of clinical evaluation. Research could also analyze the characteristics of effective technologies and of physicians and organizations who implement these technologies effectively.