We now live in a world where 87% of adults own a cell phone and, coincidentally, 87% of physicians use a smartphone or tablet in their practice.1 Technology is literally at our fingertips and we have to be diligent in our efforts to stay abreast of new developments. For example, do you use mobile health (mHealth) apps?
In 2010, more than $200 million was reported in sales of health care apps.1 Furthermore, 600 million health apps were downloaded in 2012, and we know that one in three smartphone owners have at least one mHealth app.1 By 2015, an estimated 500 million smartphone users worldwide will be using health care apps.1
There are more than 40,000 mHealth apps on the market today to assist health care professionals in improving patient care and educating consumers to manage their own health and wellness.1 This influx of innovation is fraught with its own set of difficulties.
The speed at which this technology has advanced has not matched the speed in which the regulatory landscape has developed. In fact, there is currently little to no barrier preventing or guiding entry into the emerging mHealth app market.
On the one hand, this is good. It encourages technologically sophisticated developers who are eager to make their mark in the industry, while simultaneously providing consumers and health care providers with the tools to transform a patient’s health.
On the other hand, this leaves the industry open to pitfalls. No credibility is required to launch a new app, which leaves the industry quite vulnerable to a new breed of inventors who have an idea and the technological capability, but no professional health credentials—to say nothing of charlatans and shysters who also muddy the waters.
In response, private industry has developed and released credentialing programs such as Happtique, Inc., a certification program to be used as a tool for clinicians and patients to identify technically and professionally valid mHealth applications. Happtique is also developing mRx, a mobile health platform that doctors can use to “prescribe” apps, videos and educational documents to patients through their mobile device.2 Someday soon we may be prescribing as many medical apps as we do prescription medicines and lenses.
The rapid expansion and broad applicability of the mHealth industry prompted the FDA to issue a draft guidance in 2011 “to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms.”3 Regardless of the platform, if a mobile app is intended for a medical function, it is considered a medical device and subject to regulations.
The draft guidance clarifies the types of mobile apps to which the FDA intends to apply its authority and excludes mobile apps that are electronic copies of textbooks or reference materials, apps that log records or track general health and wellness, and apps that perform the functionality of an electronic health record system or personal health record.4 This past week, the FDA further clarified its intention not to tax mobile devices—relieving a concern of many in the industry that the mobile devices could be viewed as a medical device used for delivery or collection of health data.3
We still have many unanswered questions about privacy, security and legal issues, as well as incentives and reimbursement for health care providers. In this newly emerging field, we can surely expect a few wrinkles as the specifics are ironed out. Nevertheless, it will be exciting to see how the eye care profession carves its niche within this new technological arena.
My advice: If you have a good idea for an app, go for it! There is no better time than now.
1. Chodor B. Testimony presented to Committee on Energy And Commerce Subcommittee on Communications and Technology hearing on health information technologies. 2013 Mar 19.
2. Happitque: Your prescription for mobile health. Available at: www.Happtique.com. Accessed March 2013.
3. Device advice: comprehensive regulatory assistance. FDA. 2011 Jul 21. Available at: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm. Accessed March 2013.
4. FDA releases draft guidance on mobile medical apps. FDA. 2011 Jul 19. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm263340.htm. Accessed March 2013.