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FDA lacks bandwidth to evaluate mobile health apps

Posted Aug 18 2011 9:38am

by Jenn Riggle

Mobile medical apps promise to help people manage chronic diseases by putting information in people's hands. The question is: Will progress be hampered by the Food and Drug Administration (FDA) getting into the act?

If FDA guidance in the pharma industry about social media usage is any indication of what could happen in mobile health (mHealth), we should all be concerned.

The pharma industry has been waiting for direction from the FDA for a number of years. The FDA planned to lay out social media rules and regulations by the end of 2010 but never did. And in 2011, the FDA dropped social media from its guidance agenda. As a result, pharma companies are engaging in social media at their own risk.

With an estimated 17,000 mobile medical apps currently available, the FDA could be similarly overwhelmed in the mHealth space. The good news is that, according to the FDA's draft guidelines, it doesn't want to review all mobile apps. It only wants to oversee a small subset of them--the ones physicians would most likely use to diagnose or monitor a patient's medical condition. Although the FDA is right to have more interest in apps as diagnostic and treatment tools, these are also the apps that could have the greatest impact.

Early evidence shows health apps can make a difference. The Wall Street Journal reported that a recent study indicated a medical cell phone app helped people with diabetes reduce a key measure of blood sugar.

In addition, the Center for Technology and Aging (CTA) recently invested nearly $480,000 in five organizations that demonstrate the best ways to implement mHealth technologies for older adults with chronic health conditions. If used appropriately, these applications could cut down on the use of emergency rooms and hospitals in general, diminish the need to intensify higher-cost care settings, and reduce the burden on family and professional caregivers.

The question is whether the FDA is the right organization to review mobile apps, especially because it's already financially strapped, understaffed, and overloaded with too much on its plate. Its laundry list of responsibilities already include regulating and supervising the nation's food supply, tobacco products, dietary supplements, prescription and over-the-counter medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics. In addition, the U.S. House of Representatives recently cut the FDA's budget by $285 million .

We have to ask ourselves: Is this the best use of the FDA's limited resources?

Instead, other organizations could rise to the occasion and manage mHealth apps without impeding progress. This week, in an attempt to open dialogue, Facebook stopped pharma companies from closing their Facebook walls to public comments . But openness has its cost, and pharma companies now have to enhance monitoring for reports of adverse events.

Decision-making by a social media platform may not be the solution, but there are some organizations primed to manage mHealth, such as the CTIA , the International Wireless Association, and the Institute of Medicine . Together, these organizations know the telecommunications industry and aren't afraid to take a critical look at today's healthcare system.

As a promising and growing space, mHealth needs a fresh set of eyes to provide guidance. Between growing responsibility and budget cuts, the FDA could slow mobile's ability to impact public health and patient care.

Jenn Riggle is an associate vice president and social media leader of the Health Practice at CRT/tanaka. She has 20 years of public relations experience in issues, such as health care marketing and public relations, social media in health care, national media relations and strategic communications planning. She regularly engages in social media, both on Twitter (@riggrl) and frequently blogs about social media and health care issues for The Buzz Bin , a PR and marketing blog.

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