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The world of mobile applications has expanded far beyond Angry Birds and Facebook over the past few years, now featuring numerous medical apps for smartphone-using, tablet-wielding doctors.
But now, coming straight from the no-good-deed-goes-unpunished department, the Food and Drug Administration said it will subject certain medical apps to strict class regulations.
“The use of mobile medical applications on smartphones, tablets, and other communication devices by health care professionals to diagnose and treat patients is revolutionizing health care,” an FDA spokesperson told Emergency Medicine News in an interview. “The FDA has a public health responsibility to oversee the safety and effectiveness of a small subset of mobile medical applications that present a potential risk to patients if they do not work as intended.”
The FDA will scrutinize medical apps that act as an accessory to a medical device and those that transform the mobile device into a medical device. A draft guidance issued by the FDA includes an extensive list of applications that will have to undergo review. Examples of apps that fall under the regulatory oversight are:
- Applications that allow the user to view medical images, such as digital mammography or digital images of potentially cancerous lesions on a mobile platform, and those that perform a health analysis or provide a diagnosis by trained health care professionals.
- Applications that allow the user to view patient-specific lab results.
- Applications that connect to a home use diagnostic medical device to collect historical data, or to receive, transmit, store, analyze, and display measurements from connected devices.
“While the majority of mobile apps will not fall under our proposed oversight, the apps in this subset present a potential risk to patients,” the spokesperson said.
The majority of medical apps will not need FDA review, such as electronic copies of medical textbooks or teaching aids, apps used to log and evaluate statistics related to general health and wellness, and generic aids to simply assist users (without specific medical indications). But the mobile medical apps that do require oversight will be classified in three categories, class I, II, or III.
“There are a handful of mobile medical apps already on the market that have been submitted to the FDA,” the agency spokesperson said. “Thus far, these apps have been either Class 1 devices, which do not need premarket review but must comply with general manufacturing and registration requirements, or Class II devices, which require a 510(k) submission. We expect that most of the mobile medical apps will likely be Class I. While there is potential for a mobile medical app to be considered a high-risk Class II device, which would require a PMA [premarket approval], we have not seen one thus far.”
These reviews, though, do cost money, and one of the main concerns of mobile medical app developers, some of whom happen to be clinicians, is that this new regulation will have negatively affect their finances and production of apps.
“Overall, I believe safety is the most important item when it comes to providing patient care,” said Harvey Castro, MD, an app developer (www.deeppocketseries.com) and emergency physician. “Unfortunately, I believe this will hurt small businesses and entrepreneurs by making it cost-prohibitive to enter the market.”
Dr. Castro said the regulations will inevitably deject independent app developers, and give way only to companies who can afford the steep regulation costs.
“It will hurt individuals that would like to create apps,” Dr. Castro said. “For example, I know an individual that wants to create a telemedicine application. He will likely have to stop his work. He has used up all his savings, and now will have to take a loss.
“Applications will be dominated by a few companies capable of paying the high fees to get FDA approval. I will be saddened to see these changes in the future.”
No definitive deadline has been set for the regulations to go into effect, according to the FDA. The period for public comments on the draft guidance concluded in October, and the FDA will review the comments and determine the best way to proceed. While commentary on the draft itself is over, the FDA said the regulatory requirements will not impede the advancement of medical apps. “We are eager to support the continued development of mobile medical apps without the burdensome regulations that would stifle innovation,” the spokesperson said.
