Remember the last time you “had a hunch” that your child had an ear infection, but you took her to the pediatrician anyway for a diagnosis, just to make sure? Well, your smartphone (and accompanying app and hardware attachment) can now perform the same task and save you the trip to doctor’s office by sending secure and encrypted photos and videos directly to a physician! And the smartphone app, or mobile enabled device app you use will be held to the same Food and Drug Administration (FDA) standards as the echoscope used by your pediatrician, according to the new FDA mobile health-related app guidelines issued on Monday.
After two years of feedback and comment periods, the long awaited FDA guidelines are intended to regulate health-related software applications on smartphones, tablets and mobile computing devices. If a mobile app is intended for use in performing a medical device function, such as providing disease diagnosis or disease prevention recommendations, that app will be considered a medical device, regardless of the platform on which it is run. According to this new guidance, a mobile app that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) is intended: to be used as an accessory to a regulated medical device, or; to transform a mobile platform into a regulated medical device.
While mobile handsets are not addressed under this guidance, the impact of their technological evolution cannot be ignored. Handsets in the near future will feature components that allow for real-time data processing from the devices’ gyroscopes, accelerometers and electromagnetic compasses.
The juxtaposition of this mobile technology and these new guidelines shows great promise in mHealth and a propensity for the FDA to be an involved partner with the industry via its guidance. The process put to this point has been very fluid, with many key stakeholders such as innovators, investors, practitioners, and care delivery teams being deeply involved in the emergence of the new guidance. The rapid revolution of mHealth is allowing patients to increasingly become deeper participants in their own health. As the healthcare ecosystem continue to become more patient-centric, this will help facilitate new modalities of care.
This recently released guidance has provided greater clarity into what is considered a health-related app under FDA regulation, and is significant for narrowing the scope of interpretation. Currently, there are thousands of health-related apps available in the mobile ecosystem, from calorie counters to physical fitness trackers. However, most of these do not perform the functions of a “medical device” and pose negligible medical issues to consumers, according to Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiologic Health. It is now safe to say that these apps (including the nearly 100 apps that have already been approved under these guidelines) as well as app interfaces that act either as a medical device or as a conduit for a “medical device,” will be regulated by the FDA under these guidelines.
The latitude given by the FDA guidance for apps that can contribute to our wellbeing without being regulated allows developers to broaden the scope of applications offered to people who can derive personal benefit – and data – that can be powerful self-help tools.
For example, a coprocessor that can access data as you walk, run, breathe, sleep, can give patients tremendous insight into their health. The data gathered can be (and already is being) used as primers for patients’ physicians and caregivers. The days of “I’ve fallen…” are gone. Now, if you fall, your phone may instantaneously alert your clinic, physician, nurse or caregiver.
Using the example mentioned earlier in this post, the cost savings potential achieved via a “mobile” ear infection diagnosis is considerable. The patient and caregiver can initiate the care process from the convenience of their own home (which saves them time and money); the physician can make a tele-health or remote diagnosis (which reduces overhead expenses and time needed to make the diagnosis), which can ultimately provide a cost savings to the entire system.
The “structured” freedom delivered by the FDA to developers will allow continued innovation in the mHealth space and allow them to keep pace with technological advancements. The results will enable current and future medical app innovators to adhere to common standards that will help ensure improved access, cost and quality – the pillars of healthcare transformation – to patients and society.
Marcus Gordon, Vice President, Digital Health and Provider Communications, Atlanta. Follow Marcus on Twitter: @tri3mg
Rich Sharp, Senior Vice President, Digital Health, Chicago. Follow Rich on Twitter: @richs
Portions of this post also appeared on Edelman.com
Image credit: IntelFreePress