Just as we are going to press with this August print issue, the FDA has issued a set of draft guidelines for mobile medical apps. This may not be quite as exciting as it first seems: by the agency's definition “medical mobile apps” refers only to those that augment regulated medical devices or turn phones into medical devices.
What this piece of guidance does not cover are digital versions of medical reference materials; patient tracking logs, counters, reminders and the like; and apps that perform medical office functions or store personal health records or EHRs.
Still, after two long winters of discontent at the lack of any digital guidelines from the FDA, this activity should be applauded amid the hope that there is much more to come. (The agency is seeking comments on the medical mobile apps draft guidance until October 19.)
The iPad phenomenon makes this guidance especially urgent—by the end of 2011, almost 70% of doctors are expected to own one. And as Monique Levy, VP of research at Manhattan Research, told MM&M in June: “There's a whole band of things that physicians wouldn't have done on their smartphone that they are interested in doing on their iPad. More than 40% of physicians who are planning to purchase an iPad this year said they'd be interested in showing images, video or other information to a patient. Almost 30% want to use it for remote patient monitoring. And more than 40% are thinking of using it to write clinical notes.”
Of course, here in the US, it has become commonplace for HCPs to refer to their mobile devices/mobile apps during consultations with patients. In fact, around 40% claim to do this, or to have done this before, and this number is only likely to increase as physicians' love affair with smartphones (greater than 80% adoption, and counting) becomes engrained ever deeper.
But what about the global picture? Are we seeing the same kind of adoption and use of mobile technology from physicians the world over? And how, as a pharmaceutical manufacturer, do you go about developing and distributing clinical apps internationally with the regulatory environment differing so wildly from country to country?
In this month's cover story, Mobile Conquest (pages 34-38), Marc Iskowitz investigates some of these questions, with the help of a fascinating case study involving Novo Nordisk and its global app NovoMedLink. The app, a compendium of diabetes consulting tools for HCPs, hits “a real sweet spot,” which is how Novo's Aaron Uydess describes the point-of-care window during the patient consultation.
See, while the adoption of smartphones overseas varies wildly (e.g., Brazil 51%, India 17%, according to Manhattan Research), one thing that docs are doing en masse across the globe is searching for patient education (yes, patient education). The near-universal regulatory constraints on branded consumer marketing outside the US has created a huge demand for patient education, particularly in Europe and Asia. And by delivering messages (a lot of which are unbranded) to patients via their doctors, no lines are being crossed.
Novo Nordisk's app leverages educational and other content from its NovoMedLink web portal. So far, the app, which was launched out of the company's Copenhagen headquarters, has seen 1,800 downloads in numerous countries.
And how do they handle multiple sets of regulatory requirements? You'll just have to read the article.