Medical computers from the manufacturer's viewpoint.
The recent surge in the scope of computer applications in medical care has brought with it great strides in patient care, but it has also created a variety of concerns to manufacturers of medical software. The spate of product liability suits, with its potentially crippling effects in terms of product development, makes it increasingly vital that manufacturers engage in prospective planning, to anticipate problems and take steps before legal action ensues, so that all parties--the manufacturer, the hospital, and ultimately, the patient--benefit from the availability of new technology. The Food and Drug Administration (FDA) and Congress are similarly grappling with the implications of this new technology, to assure that patient care is not compromised by products that have not yet been fully tested. The tension between the desire to make technology available to the public and the realities of the present regulatory and litigious climate is the key dilemma facing manufacturers of medical software.
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Department of Anesthesiology, University of Michigan Medical Center, Ann Arbor 48109.
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D003132:Commerce; D003201:Computers / Q000592:standards; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards; D007221:Industry; D007880:Legislation, Drug; D012984:Software / Q000191:economics / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration