Consumer/Patient Decision-Support Programs: Should They Be Regulated

By Joseph V. Henderson, MD

From April 1997, HHS panel discussion on consumer information.

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This article makes the case that Consumer/patient decision-support programs should not be regulated, but that policy should be applied to them. "Decision support programs" refers to interactive computer programs designed to present pertinent information to patients in order to keep them informed about their treatments, and to aid them in making decision regarding those treatments. The article addresses issues of program development that are challenges in themselves, and that make strict regulation of the industry counterproductive. Ensuring accuracy and appropriateness of content is difficult because it is either subjective or constantly changing. The article also covers bias, usability, and maintainability, in addition to background information on the kinds of problems inherent to development of software, both in general, and in the medical field. The article concludes that regulation, by nature, requires more objectivity, and ignores too much the rapidity of development in medicine than is reasonable or healthy for the programs in question. It does conclude, however, that certain policies supporting the development of decision-support programs and related technology would be valuable.