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NIH Director: mHealth needs to show results

By Kyle Murphy, PhD

While mobile health (mHealth) applications are growing in number as well as popularity, they and their developers have yet to demonstrate their effectiveness in improving patient outcomes in a tangible way, according to the head of the National Institutes of Health. Speaking before the 2012 mHealth Summit, NIH Director Francis Collins, MD, PhD, drew attention to the lack of evidence-based research showing how mHealth apps actually impact patient care.

In 2012 alone NIH has invested in more than 200 research projects focusing on mobile phone related research. And according to Collins, that trend will continue with the expansion of funding for innovative mHealth solutions. “We’re clearly in a zone here where technology is meeting health in exciting ways, and the future is very bright indeed,” Collins told the audience. “But we are also very concerned that as this technology comes forward so quickly, we need to be sure we’re collecting the right evidence to show that these mHealth applications actually improve outcomes.”

In order to gain validity from a scientific perspective, these mobile platforms, programs, and devices need to show objective results based on accepted procedures. However, Collins emphasized how this is not the case.  “Here at the end of 2012, surprisingly few mHealth interventions have been tested systematically in a standard that most scientists would accept approach as really demonstrating unequivocally and objective that the technology is working,” explained the NIH Director.

Four problems are negatively affecting how mHealth research is received by the medical community, noted Collins. The first is lack of sufficient testers/users in the studies themselves. The second deals with the quality of the individuals tested, who may in fact not resemble those to whom the technology actually applies. The third involves time and timeliness, which could render the research less meaningful if studies take too long to conduct. The last centers on a lack of disclosure because a great number of mHealth studies do not report their results, positive or negative, in a place where others can access and learn from them (e.g., ClinicalTrials.gov).

While mHealth apps and research on facing challenges on the front end, they are likewise encountering obstacles on the backend — that is, in their inability to interoperate with other applications and technologies. Writing for The Atlantic, Gabriella Rosen Kellerman has highlighted some emerging limitations that are preventing mHealth solutions from having a greater effect on healthcare:

The thousands of mobile health technologies currently available — sleep monitors, stress checkers, diet and fitness trackers — are more useful in aggregate than as individual applications. And yet, because each is developed independently, there are no means of making these applications talk to each other. Some of that is by design — companies are understandably protective of their products — but much of it results unintentionally from the software development process.

Coupled with the lack of interoperability is the uncertainty surrounding the regulation of digital health technologies when used by physicians versus consumers. The Food and Drug Administration (FDA) and Federal Communications Commission (FCC) are two of a handful of agencies with the legislative power to provide a regulatory framework for the mHealth industry. Because producing a consumer-oriented product does not require an FDA review, this path of less resistance has garnered more attention and left clinicians with many less options.

Although mHealth is an area with a considerable amount of potential for growth, it also appears to be one of confusion and uncertainty.

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