If you asked me a few months ago if any pharma brand should build an app, my answer probably would have been no.
Because there are tough questions to ask ourselves when looking to venture down the app route:
- What value are we really bringing to our customers?
- How will we maintain a spot on the coveted smartphone home screen?
- Which devices and/or operating systems should we support and build for?
- What level of FDA regulation will this app require?
We usually get through the first few considerations using our science-based approach with a heavy dash of creativity, coming up with the specific moments an app can deliver significant value to a patient, caregiver, or physician, but when we get to that last bullet – that’s when the tone starts to change.
An article from MobiHealthNews goes into detail on the different classes of app regulations, but summarizes it pretty well saying that the “FDA regulates any smart phone apps intended for use in the diagnosis or treatment of disease or other conditions. And that intended use is determined mostly by examining the developer’s promotional claims as well as the features of the app.”
When they mention features of the app – they mean the actual code. That’s right, you need to build it first and submit to source code for review.
But good news is on the horizon. Last month, the FDA released a new proposed framework for public comments that says they would treat low-risk apps as promotional material. Essentially removing the code-level submission requirement.
The proposed framework specifically mentions medication reminders, alerts, and “enabling a physician to provide dosing modification instructions to a patient.”
You can think of these low-risk apps almost like branded companion apps – tools to set up and manage dosing schedules, alerts for missed or upcoming doses, patient education, and hopefully a way to facilitate a more data-focused Physician and Patient discussion.
The intent of this new framework is really to improve adherence, and reduce the barriers to do so. Which is great to see, and can only lead to creating better and more robust digital experiences that meet in the sweet spot where technology and healthcare converge that ultimately drive better outcomes.