Part II: How is Healthcare Information Regulated?

As we mentioned in yesterday’s newsletter, healthcare regulation typically addresses safety and efficacy of products and practices.  We tend to overlook that information is also regulated.  In fact, that’s the most fundamental purpose of healthcare regulations.  The way in which information is structured shapes how questions of safety and efficacy get asked and answered.  The flow of information, like hormones in the body, has an awful lot to do with the growth, development and energy of the Body Politic.

By way of example, let’s look at two pending developments in healthcare reform. Recall our recent discussion about January’s GAO report on dietary supplements, and the recent news about H. Bill 875 that aims to create a new Food Safety Administration.  As we dig into these two developments, keep in mind these questions:

1.    What’s the source of healthcare information; and

2.    How is that information structured?

Both the GAO report and HB 875 address these two questions in ways that are at best incomplete.

•  “Consumers are not well-informed [about supplements].”

• “[T]he agency must continually market its desired message to effectively educate consumers.” (Emphasis ours.)

• “[The FDA’s] resources for consumer education are extremely limited . . . it may not be able to effectively conduct consumer education on its own.”

• “FDA recently announced a partnership with WebMD to expand consumer access to timely and reliable health information; however it is not clear to what extent FDA will use this partnership to increase consumer understanding about dietary supplements.”

[Note that WebMD is part of the publicly traded company HLTH, which is comprised of both WebMD and Porex.  Porex is a manufacturer of plastic components used in healthcare, industrial and consumer applications.  Note also that, insofar as we’ve been able to tell, WebMD has no naturopaths, oriental medicine practitioners, integrated or holistic physicians or any CAM provider on its executive board, in-house research staff or among its editors.]

• “The purpose of the Act . . is to provide a single focal point . .  for food safety leadership . . .”

• The new FSA will “collect and maintain information relevant to public health and farm practices,” and in issuing regulations will “consider all relevant hazards, including those occurring naturally.”

• The new FSA will “identify the priorities . . . for food safety research and data collection.”

• The new FSA will support “the design and implementation . . . of an active surveillance system that provides information” on food safety protocols, and based on that information will assess food safety policy.

• The new FSA will work with private and public organizations to establish programs that will provide food safety information to the public and to health care professionals.  (Emphasis ours.)

Within these statements lies the framework for the regulation of information.  This framework will directly affect how questions of safety and efficacy will be answered.  Consider the ways in which these statements consolidate, organize and structure the flow of information.  Consider also the many questions that are left unanswered.

As we close today’s chapter and prepare for the remaining parts of this series as described below, we leave you with this recent story from the NY Times.  Please read this.  The story bears directly on the two questions about information that we described above.

The challenge here isn’t one to be addressed through the filters of left & right, or red and blue.  This challenge is transpartisan, meaning in a sense beyond the bias.  This is going to take some work to address, and it’s time to do so.

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