mHealth continues to grow, despite FDA guideline delays

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One of the great things about healthcare information technology is that it allows doctors to expand the scope of their services to increase patient accessibility to quality care. With devices like electronic health records digitizing practices like sharing patient medical histories, communicating with insurance companies, monitoring patient health outcomes remotely and streamlining billing operations, HIT gives doctors and their patients greater control over their medical treatment.

Thanks to support from the federal government under the Patient Protection and Affordable Care Act, EHR systems and other forms of HIT are becoming increasingly important in the healthcare industry. Recently, mobile health applications have become the latest trend in HIT development. These devices allow doctors to communicate with patients and manage their care from afar, which is particularly helpful for people living in underserved, rural areas of the U.S. However, there remains more work to be done before mHealth devices reach their true potential.

mHealth continues to grow in popularity
Like EHRs before them, mHealth applications are gradually being adopted by a variety of care organizations across the U.S., according to Healthcare IT News. A recent trends report on mHealth technology conducted by Research and Markets found that this form of HIT is expected to expand at a rapid rate in the coming years.

The Research and Markets report authors noted that mHealth technology is entering the intermediate stage of development where private organizations are rapidly expanding the capability of these devices for widespread implementation in the future. By 2017, the mHealth industry is likely to be worth a total of $26 billion, growing at a compounded rate of 61 percent every year. Additionally, the study showed that about 50 percent of people with mobile devices will download mHealth apps in the coming five years.

"In this phase, mHealth applications will become an integrated part of doctors' treatment plans. In this phase health insurers will become the main payer, especially for the more advanced mHealth solutions," wrote the study authors.

Waiting on FDA mHealth regulations
Despite the growing success of mHealth commercialization, the industry is still struggling to find its feet in the looming shadow of delayed regulatory guidelines from the U.S. Food and Drug Administration, reported Healthcare IT News. For more than a year, the FDA has promised regulations for mHealth technology. However, the organizations has failed to deliver clear information on these efforts and delayed an official release, recently stating that the rules would be available in October 2013.

According to Government Health IT, a sup-workgroup of the FDA has made some progress in communicating with the industry about mHealth regulations. This group is part of the FDA's Safety and Innovation Act team, and it has recommended certain exceptions be made for market regulations in relation to mHealth and other related HIT products.

"[The FDASIA Workgroup's mission is] not to design the regulatory system but to define the objectives that the agencies should consider when they design the regulatory system in the fall," Bradley Thompson, an attorney and co-chair of the FDA sub-workgroup, told the news source. "But we can determine oversight. The ultimate question is should the FDA actively oversee HIT?"

These recommendations came in the wake of the FDASIA taxonomy subgroup's request to categorize mHealth and HIT as unregulated by the FDA. This decision would leave room for exceptions in relation to oversight for certain devices, such as medical device data systems, medical device accessories for smartphones and specific types of clinical decision support software or applications.

These FDA regulations have been controversial for organizations in the growing mHealth industry. While many groups are frustrated about the delays in official guidelines, others are calling for the FDA to step out of the regulatory role entirely. App developers will have to wait until October 2013 to see where FDA final rules stand for mHealth.