Did you know the FDA has been approving mobile medical apps since 2007 (source), and apps have been reimbursed by insurers since 2013 (source)? Beyond the pill is not wishful thinking; mHealth is growing up before our eyes.

FDA-Approved Apps and App-Controlled Devices
As delineated by FDA guidance, apps that are educational, automate office processes, or provide non-diagnostic tools usually aren’t considered devices and don’t require 510(k) clearance. Others, though, provide unique new abilities to patients, caregivers and healthcare professionals, either through a phone or by connecting with external tools, and qualify as devices. Here are just a few of the many dozens of apps — and the devices they support — that have been approved by the FDA:

  • Shirts with an app that monitors biometrics for athletes, soldiers and even the Chilean miners that were trapped underground (source)
  • Smart scales that report not only your weight, but also your body fat, pulse and even the quality of the air in the room (source)
  • Toothbrushes that let families compete in brushing contests and alert you when your kids have brushed (source)
  • ECG patches that call your doctor (source)
  • Inhaler caps that sense when and where asthma attacks strike (source)

Apps in Clinical Trials
Increasingly, either clinical trials are facilitated by apps or apps are being tested in trials themselves. ClinicalTrials.gov, run by the National Institutes of Health, tracks hundreds of studies testing apps’ effects on outcomes. From cancer to depression, diabetes to addiction, hypertension to schizophrenia, investigators are harnessing the portable power of mobile devices.

Pharma Going Beyond the Pill
It’s clear that mHealth isn’t just the province of startups or the biotech industry. Big pharma has been hard at work to move beyond the traditional pill-box offering.

  • In 2011, Pfizer attempted an entirely virtual, mobile-enabled trial of DETROL® LA. It was discontinued, but Pfizer executives characterized the study as an experiment and expressed confidence that this method would change the game (source).
  • Sanofi launched GoMeals® in 2009 to help people living with diabetes make healthy food choices. Since then, the app has been downloaded thousands of times and remains one of the top three most-downloaded pharma apps — along with a pollen forecaster from Claritin® and Johnson & Johnson’s 7 Minute Workout (source).
  • Several apps are being tested in clinical trials now to see whether their addition to a medication regimen improves outcomes. This includes several from the biggest of big pharma for serious chronic conditions.

Apps and the Bottom Line
Several different business models can be used to make mHealth apps profitable (source).

  • “Freemium” apps (offered free but requiring payment for additional functionality) are common, and consumers are increasingly comfortable with them. Consumer mHealth will probably follow this path. It gives users the ability to try before buying and builds a level of comfort, which is especially important with sensitive personal information.
  • Licensed apps (in which users purchase the tool) or apps prescribed by a healthcare professional and reimbursed by insurance are additional options. This is the model followed by WellDoc’s BlueStar and will likely remain preferred by healthcare professionals, as these are processes familiar in healthcare and can often be easier to integrate into a provider’s business.

Whether a free tool or FDA-approved, whether focusing on a single patient’s issue or an entire hospital network’s function, mHealth apps are here to stay and are literally changing the world.
(infographic source: http://mobihealthnews.com/45759/in-us-uk-and-germany-top-10-pharma-apps-make-up-66-percent-of-downloads/ )