Jim Gearhart

by Jim Gearhart

Mobile Technology in Research: News and Developments

mHealth & Clinical ResearchMobile technologies in health care (also known as mHealth) continue to attract interest, with some interesting recent news articles.  A lot has been happening out there.

Centerwatch Monthly’s April issue (subscription or purchase of issue required) provides an informative overview about mHealth and clinical research. The article asks whether clinical research is ready to benefit from technological advances such as wearable heart monitors or smart phone accessories that can track an owner’s health readouts.

Centerwatch’s article suggests that mHealth’s time has not yet arrived for clinical research. For those interviewed, the added benefits of these technologies for clinical research have yet to be proven. Uncertainty remains about how the FDA might react to data collected by these apps and devices, although some studies have utilized these technologies for non-data purposes, such as texting reminders to study participants. Overall though, the article’s theme is that these are early days for mobile health products in research. For those of us interested in the possibilities for IRB reviews and informed consents, an unfortunate omission was any discussion about electronic consenting.

Mobile Technology in Health CareBut a few weeks ago, the Wall Street Journal (subscription required) reported on interesting developments in consenting. According to the article, the NIH is looking at interactive consent processes to provide more understandable information to autistic study participants. The interactive elements described capture some of the advantages that an electronic, interactive consent process might bring over the static, print-only consent forms  that we usually see in our clinical studies. (And in 2011, the Wall Street Journal also covered what it called the first all-electronic drug study)

Debate over the proper regulation of mHealth is heating up, too. Last September the FDA released final guidance about oversight of mobile medical applications, and this week the Office of the National Coordinator of Health Information Technology (ONC) weighed in. The ONC released  draft guidance that proposes risk-based guidelines for overseeing all health-related IT developments. That guidance came out just as each house of Congress introduced competing proposals about regulating health IT. The draft guidance from the ONC sought to keep mobile apps within existing risk-based guidelines; critics (including the sponsors of the new bills in Congress) charge that this ‘status quo’ approach will stifle innovation.

What do you think? Could mHealth change how we conduct clinical trials? Are government authorities taking the right approach to this fast-growing area of health care?

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