Could mHealth Apps Be a Reprise of the EHR? The Need for Clinician Input

While the Population Health Blog continues to delight in the emerging science of "mHealth" as a newly minted start-up Chief Medical Officer, it ran across this interesting article on risk and patient safety.

Authors Thomas Lewis and Jeremy Wyatt worry that "apps" can lead to patient harm. 

They posit that the likelihood of harm is mainly a function of 1) the nature of the mistake itself (miscalculating a body mass index is far less problematic than miscalculating a drug dose) and 2) its severity (overdosing on a cupcake versus a narcotic).  When you include other "inherent and external variables," including the display, the user interface, network issues, information storage, informational complexity and the number of patients using it, the risks can grow from a simple case of developer embarrassment to catastrophic patient loss of life.

In response, they propose that app developers think about  this "two dimensional app space" that relies on a risk assessment coupled to a staggered regulation model.  That regulation can range from simple clinical self assessment to a more complex and formal approval process.

What's clear to the PHB is that hidebound mainframe entities like the Food and Drug Administration are no match for the app "ecosystem".  Rather than try to formulate a one-size-fits-all "not function as intended" model like this, maybe it should triage its oversight using the Lewis and Wyatt framework.

In addition, the PHB agrees with Lewis and Wyatt that safety is also a function of clinician input.  Docs and nurses can assess possible mistakes, their downside severity and the impact of all those variables.

The PHB couldn't have put it better:

".... many app developers have little or no formal medical training and do not involve clinicians in the development process and may therefore be unaware of patient safety issues raised by inappropriate app content or functioning."

Without the insights of seasoned real-world doctors and nurses, apps could end up with the same safety issues that are plaguing electronic health records, many of which were also developed with little regard to physician or nurse input. 

In other words, just because it's a "health" app doesn't mean its necessarily so.

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Mixing Social Media and Health Care: Concocting a Worst Case Scenario Using Big Pharma and Manipulated Web 2.0 Writers

Are there any downsides to the mixing of social media and health care? An interesting "Perspective" article by Boston academicians Jeremy Greene and Aaron Kesselheim in the latest New England Journal (not online yet, but check back for the link) says "yes" by taking the worst of both worlds: misinformed and manipulated Web 2.0 writers on one side and the misbehaving pharmaceutical industry on the other.

They point out that the pharmaceutical industry's marketing has generally been under very tight control by the Food and Drug Administration (FDA). Ironically, however, it was the FDA's guidelines surrounding direct to consumer (DTC) advertising that ultimately unleashed the glut of dry eye, erectile dysfunction and when diet 'n exercise-are-not-enough high cholesterol TV commercials. Well, following a November 2009 hearing on the matter, the FDA is now gearing up to issue guidance on the use of social media in pharmaceutical advertising. Once that happens, we can expect a considerable portion of the pharmaceutical industry's annual $4 billion budget to be spent on product-promoting bloggery, tweets and friending.

Which worries Drs. Greene and Kesselheim. They fear that authors of blogs, Facebook accounts and Twitter feeds that have only nice things to say about drugs or their manufacturers may be paid, biased, not credible or have hidden conflicts of interest. To deal with this, the authors suggest holding both the pharmaceutical industry and the FDA "responsible" for any significant misinformation and raise the possibility of creating a Web 2.0 FDA "seal of approval" to promote accurate content.

While worst case scenarios can be instructive, the DMCB isn't convinced that even the pharmaceutical industry's billions are up to the task of bending a truly massive and hyper-distributed social media global network to their will. What's more, pharma's tarnished reputation has already attracted the attention of legions of simultaneously smart and hostile bloggers, who seem more than ready to counter any product claims - including the credible ones. Last but not least, the DMCB is coming to doubt any laughably "responsible" Federal agency's ability to do anything quickly, cheaply or effectively. Better to let the bloggers establish their own reputations for transparency and pursue their own seals of journalistic/scientific excellence, perhaps through resources like this.

Last but not least, the DMCB is a believer in open and democratic discourse. Trying to influence the free flow of information, even if the filters are contrived by well-meaning do-gooders in some windowless room at the FDA, just seems to have too many downsides. If anything, the FDA should be working to promote an independent, skeptical and vibrant Web 2.0 scientific community. After that, they should get out of their way.

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