mHealth apps reach 165,000; clinical value still in question

Mobile health (mHealth) apps will either revolutionize healthcare or be the latest smartphone/social-media/Internet fad—or, most likely, something in between. Definitions are still fluid: is a jogging distance tracker as medically meaningful as a monitor of drug levels in the bloodstream? The IMS Institute for Health Informatics (Parsippany, NJ), in the update of a 2013 study, uses the WHO definition: “medical and public health practice supported by mobile devices such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices,” which encompasses many wellness or fitness apps as well as medical devices that might be useful to the pharma industry, FDA and healthcare providers. With that definition, the current number of smartphone or mobile apps is currently 165,000, says IMS.

A measure of growth in this arena is IMS’ count of Apple (iOS)-based mHealth apps, which have grown from 43,689 in 2013 to 90,088 in 2015—a 106% increase (in the full study, IMS looks at both iOS and Android apps). Those apps can be segmented into “health,” “fitness” and “medical;” 65% of them are in health and wellness, and 24% are medical. IMS (among other organizations) rates the apps’ functionality with a proprietary AppScript score, based on endorsements from health-related organizations, app store consumer reviews and app features. On that basis, top wellness apps include Fitbit (from Fitbit Inc.), Calorie Counter (MyFitnessPal, Inc.) and Runtastic (Runtastic), among others; top disease-management and treatment apps include Medisafe Meds & Pill Reminder (MediSafe Project), Glucose Buddy (Azumio) and MedicineList+ (NPS Medicinewise).

The top AppScript disease-management apps that also have been reviewed and cleared by FDA are Diabetes Logbook (mySugr GmbH), AliveECG (AliveCor), a link between a wireless electrocardiogram and a smartphone, and Propeller Health (Reciprocal Labs), which links a sensor for COPD and asthma inhalers to time- and location-stamp inhaler usage.

There is a strong value to linking the app to a wearable sensor, a lively area of current innovation, but only one in ten apps does so currently, says IMS. Similarly, while 26% of apps linked to social networks in 2013, it has increased only to 34% in 2015. “The ability to directly connect with healthcare providers for informing and managing health conditions is also important. However, integrating mHealth with electronic medical records (EMRs) is complex and presents many challenges for full and seamless implementation,” says IMS, while noting that several EMR vendors have projects under development.

mHealth in pharma

While IMS, in reviewing clinical trials on the ClinicalTrials.gov website, found a doubling of trials using mHealth apps from 2013 to 2015, most of these trials appear to be related to testing the apps themselves, and not as part of a drug trial protocol. There is a lively growth in technology for patient-reported outcomes, or PROs, in trial protocols, and there is some overlap between that and mHealth apps generally. Three-quarters of the trials are being sponsored by institutions (universities, hospitals) and 8% sponsored by the pharma industry.

The fast-paced growth of the healthcare app market has outpaced the ability to develop oversight and guidance for accuracy of clinical content contained in mHealth apps,” says IMS. “This environment leads to provider reluctance in prescribing mHealth apps given the unknowns about accuracy, efficacy as well as security.” Besides government efforts to address this, IMS cites a just-started effort led by Vitality Institute and others to develop “personalized health technology” guidelines.

The IMS Institute report is available here.