The explosion of mobile applications for health care providers has been one of the biggest clinical health care stories of 2011, allowing clinicians and patients the opportunity to not only record information but also mimic the use of medical devices — for instance, stethoscopes and glucose readers — to a handheld smart phone. And as the number of apps leaps into the stratosphere, the FDA has inevitably entered the game, announcing last week the release of draft guidance on mobile medical applications.
In particular, the guidance impacts three categories of apps; those that store and use patient-specific data, or turn the device into a functional medical device by including similar functionalities, or those that analyze or interpret data from medical devices. Other mobile applications, including copies of medical textbooks, wellness apps that track physical fitness and diet and apps for general office functions, are not covered by the guidelines.
In other words, the FDA wants to regulate the mobile applications that mimic the functions of existing, regulated medical devices or analyze or record patient-data; the apps that serve as reference materials or personal health records are left alone.
For the affected apps, though, the FDA "strongly recommends that manufacturers of all mobile apps that may meet the definition of a device follow the Quality Systems regulations (which include good manufacturing practices) in the design and development of their mobile medical apps and initiate prompt corrections to their mobile medical apps, when appropriate, to prevent patient and user harm."
Already, the blogosphere, especially for device manufacturers, is filling up with analysis on the impact of the regulation, and how it'll impact the future development of new applications. Other accounts, meanwhile, accept the inevitability of the FDA's interest in mobile applications.
I'm probably closer to that sentiment; if anything, the announcement is merely federal confirmation of what the health care industry has already realized — that mobile apps and devices are going to play a major role in the future of care, as this H&HN article explored in April. Back in February, HIMSS CEO Steve Lieber told me that he sees the migration to mobile applications in the context of a broader embrace of technology that can move more patient care out of the hospital and the doctor's office and into their homes. And in March, during the release of the iPad2, Steve Jobs and the rest of the Apple team used a sizeable chunk of their presentation to hype its many medical uses.
If mobile medical applications used on smart phones and tablets are indeed the future of care, both inside and outside the four walls of a hospital, then they deserve the same scrutiny as other medical devices that are closely regulated to protect against patient safety lapses and potential errors. If anything, my surprise is that it's taken this long for the FDA to weigh in.