Mobile apps that collect, store and transmit health-related data have been around for several years now. They’re a critical element of remote patient monitoring (RPM) and diagnostics, since your smartphone or tablet can serve as the storage repository for health data collected by other sources and IoT-connected devices. Doctors and others in the healthcare field certainly believe that mobile apps have the potential to improve patient care and health. For example, a 2016 study of health professionals found that remote monitoring has the greatest market potential for mobile health apps (Source: research2guidance; eMarketer).
Early concerns with mobile health apps
The FDA writes that mobile health apps “can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it” (“Medical Mobile Applications”). Early on, providers and consumers alike shared many about surrounding the security and efficacy of these apps:
- Is my health data secure?
- Will using this app really help me to better manage my diabetes?
- As a provider, will I be held legally responsible if this app is ineffective or causes a patient harm?
…among a myriad of other concerns. In the past few years, however, the FDA has begun more tightly regulating mobile health apps. In so doing, health care providers can more confidently “prescribe” use of these apps to their patients, and patients themselves can feel more comfortable using them.
Capabilities of mobile health apps
The FDA classifies a mobile healthcare app as any of the following:
- Medical devices that are mobile apps, or meet the definition of a medical device
- An accessory to a regulated medical device
- Transform a mobile platform into a regulated medical device
(Source: “Medical Mobile Applications”)
A mobile health app may be as simple as a patient key entering health data such as what they’ve eaten or blood pressure readings they’ve taken at home. Or, the app may be fully integrated to automatically receive readings from a blood pressure machine or glucose monitor, for example, and then securely send that data to the provider’s office. In the event of readings or data that cause alarm and need quick intervention, the app can even be set to trigger an alert to the patient, a caretaker (in the event of an elderly or disabled person) or even the rescue squad.
Technology access and mobile healthcare apps
5 years ago, a lot fewer people had smartphones or tablets. So, access to these technologies to run mobile health apps was certainly a legitimate concern. However, these days, patients of all ages and demographics are increasingly likely to own a smartphone. Of the leading global markets, the United States has the highest smartphone penetration, with 63.5% of Americans expected to use a smartphone in 2017. This shows a substantial increase from the 40% of Americans who had a smartphone in 2012 (Smartphones in the U.S.). So, this access barrier is becoming less and less of an issue as the years go by and even the older populations are familiar with smartphones and tablets.
Additional oversight coming to mobile health apps
In late 2015, an additional governing body for mobile health apps came into fruition, born out of leadership from some prestigious American health organizations. A joint effort between the American Medical Association (AMA), the American Heart Association (AHA), Healthcare Information and Management Systems Society (HIMSS) and the digital health non-profit DHX Group, Xcertia will provide guidelines for creating and using mobile health (mHealth) apps. The new organization won’t actually certify mobile health apps – that’s for the FDA to do – but “Xcertia’s guidance is intended for others to use when developing, evaluating or recommending mHealth apps” (O’Reilly).
Leaders of this effort say that the guidelines they provide will help providers realize the full capabilities of mobile health apps – to more proactively manage their patients’ health and enable their patients to live fuller, healthier lives. Eric Peterson, MD, chair of the AMA’s Center for Health Technology and Innovation, said of the power of Xcertia: “The AHA is an evidence-based organization, so we can add an emphasis on evaluation that is critical for the mHealth space to realize its full potential and, truly, deliver better outcomes for patients” (O’Reilly). Time will tell the impact that Xcertia will have on the utilization and quality of mobile health apps, but its founding undoubtedly signals an important step in this technology: the American medical elite taking a true leadership and ownership position in the advancement of mobile apps.
“Medical Mobile Applications.” U.S. Food & Drug Administration. Last updated 22 Sept 2015. Accessed online.
O’Reilly, Kevin B. “Safety, efficacy guidelines in store for mobile health apps.” AMA Wire. American Medical Association. Published 13 Dec 2016. Accessed online.
Research2guidance; eMarketer. Greatest market potential of mobile health app categories according to mHealth professionals as of 2016. Accessed from Statista.
Smartphones in the U.S. – Statista Dossier. Accessed from Statista.