27 October 1995 Impact of regulations on health care costs
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Proceedings Volume 2499, Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions; (1995); doi: 10.1117/12.225334
Event: Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions, 1995, Arlington, VA, United States
Abstract
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.
© (1995) COPYRIGHT Society of Photo-Optical Instrumentation Engineers (SPIE). Downloading of the abstract is permitted for personal use only.
Susan Alpert, "Impact of regulations on health care costs", Proc. SPIE 2499, Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions, (27 October 1995); doi: 10.1117/12.225334; https://doi.org/10.1117/12.225334
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KEYWORDS
Manufacturing

Medicine

Safety

Clinical trials

Control systems

New and emerging technologies

Reliability

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