There are more than 165,000 mobile health apps and they are changing how patients and hospitals engage with the health system. But are they effective? Private? Safe? And who cares?

Ready or not, hospitals, healthcare providers and patients are seeing mobile health apps move into almost every aspect of care delivery. From operating room scheduling on your phone and patient information questionnaires on iPads to automatic medication reminders for the chronically ill, wherever information needs to flow, apps are filling the system gaps.

Mom & Baby To Be #app from Niagara Region Public Health offers interactive prenatal guides. The University Health Network’s (UHN) BANT app is downloaded around the world by patients with diabetes to graph and trend blood glucose data. Albertans can use the province’s health services app to plan care and even check emergency department wait times in Edmonton, Calgary and Red Deer.

The effect it is having on care delivery is encouraging and profound. And it marks a fundamental shift in how patients are engaging in their healthcare.

But not all apps are created equally.  As the number of apps dedicated to health reaches over 165,000, questions arise over their effectiveness and safety, not to mention issues of privacy over apps gathering patient information.

Mobile ubiquity

Still, the sheer ubiquity of mobile devices (two thirds of Canadians own a smartphone and almost half own a tablet) is pushing the innovation agenda forward under a momentum of demand, driven as much by consumers as by health professionals.

Then there’s the push to digital health. A 2013 study commissioned by Canada Health Infoway found most Canadians recognized the importance of leveraging digital health tools and capabilities. Although the study didn’t ask specifically about #mHealth, 89 per cent said they felt it was important that they personally take full advantage of digital health capabilities.

There’s little data on how Canadians are using mHealth apps, in part because apps cross operating systems and geographic borders, but there are some trends on usage as reported by developers.

According to the Connecticut-based IMS Institute for Healthcare Informatics, of all the mHealth apps on the Apple iOS and Google platforms in 2015, two-thirds were wellness related apps like MyFitnessPal, serving to track exercise and count calories. These come mainly from app developers and their accuracy and effectiveness is ultimately judged by marketplace reviewers. But there’s another 24 per cent that are focused on disease and treatment management, and only two per cent deemed specific to health care providers.

The chronically ill market

Apps are collecting important amounts of data from the chronically ill. IMS says an evidence base for mHealth app use is emerging from studies of type II diabetes, multiple sclerosis and Parkinson’s disease, cardiovascular health and obesity. It also found that in the last two years the number of clinical trials using mHealth apps more than doubled. As might be expected, the trials focused mostly on the treatment and prevention of disease in seniors.

A 2015 study from German firm research2guidance on mHealth app developer economics explains that the focus on chronic diseases comes from the high cost of treating those patients and that if apps can help to change behaviours, they have the potential to reduce these costs.

“In most cases, this is still an unfulfilled promise, as most of the apps are failing to retain their users for even a few weeks,” it reported.

From app to medical device

In Canada, mHealth apps are not specifically addressed in regulation but any smartphone or tablet enabled to function as a medical device is considered subject to the Medical Devices Regulations. What makes it a medical device depends on such things as its intended use. If it calculates a drug dosing regimen, for example, it’s a device. Apps that help with administrative functions like appointment scheduling, or with education, like a disease guide, are not likely to fall under the legislative definition of medical device.

While the U.S. Food and Drug Administration also sees apps as a matter of medical device versus not a medical device, it isn’t a simple determination. As a proactive measure, all the apps developed (six to date) at the University Health Networks ’s Centre for Global eHealth Innovation developed were submitted to Health Canada to determine whether they fell into medical device categories, notes Melanie Yeung, a manager with the Centre. “But there aren’t a lot of app developers that have even considered submitting to regulators because many don’t know that this is a practice for medical device manufacturers,” she says.

Even if they aren’t considered medical devices, most hospital and health provider apps follow a process.

Apps and development

At Alberta Health Services (AHS), Canada’s first and largest provincewide, fully-integrated health system, requests for mobile app development come from internal teams who want to share information, rather than from external developers.

“These have been less frequently at the facility-level than at a team or project level,” says Kass Rafih, AHS’ executive director for Online and Creative Services. “While the AHS mobile app was developed by a third-party, it was started as an internal project to share emergency department wait times with Albertans in Calgary, Edmonton and Red Deer.”

“These have been less frequently at the facility-level than at a team or project level,” says Kass Rafih, AHS’ executive director for Online and Creative Services. “While the AHS mobile app was developed by a third-party, it was started as an internal project to share emergency department wait times with Albertans in Calgary, Edmonton and Red Deer.”

In Toronto, UHN’s Centre for Global eHealth Innovation works closely with clinical teams developing apps using input from specific stakeholders. It started developing apps for ‘dumb’ Nokia phones almost 15 years ago and uses a traditional academic approach to vet the work.

Its products are put through randomized control trials similar to what is required for new drugs, explains Yeung. It is peer reviewed and the UHN’s own IT governance committee evaluates the app, examining the development team’s quality management process before the final product can be posted to an app store.

“That’s the academic gold standard, but it takes years to do. We’re looking at how we can evaluate health apps differently, the way Google and others in the consumer space test product,” says Yeung.

Ensuring patient safety

At issue, of course, is the fear that an app may compromise patient safety. In 2013, the University of Pittsburgh studied four apps designed to diagnose skin lesions using a smartphone’s camera. It found three of the apps incorrectly classified 30 per cent or more of melanomas as “unconcerning.”

Much of what is moderating the proliferation of apps in hospital administration and in disease treatment and management categories is the scientific rigour and governance applied by health providers and medical device manufacturers behind them. But clinical trials and peer reviews take time.

“By then, consumers have moved on,” says Dr. Puneet Seth, a Toronto-based hospitalist and CMO of InputHealth, whose software is used on iPads in over two dozen hospitals and providers across Canada to collect and analyze patient-centered data.

“Clinical utility is a big piece. That’s where a lot of these apps fail,” says Dr. Seth. He’s beginning to see a demand for clinical research to re-examine the process for digital health. One that maintains the depth and precision of these studies while enabling a faster workflow.

Regulation and peer reviewed development is one thing, but with over 1,100 apps for diabetes alone, for example, the number of mHealth choices providers and patients face is a problem in itself.

Prescribing apps

The Canadian Medical Association released guiding principles on apps last year, and many hospitals offer guidelines to choosing an app, as well, some third-party platforms have appeared that evaluate and rate mHealth apps for health providers. But determining the suitability of an app for a particular patient comes down to being a shared responsibility between doctor and patient.

Seth sees a strong parallel between prescribing an app and prescribing over-the-counter medication.

“You don’t prescribe a specific brand of cold medication. Instead you give them an idea of what might work for them, who is making the medication, what is it used for and then going back and reviewing how it is being used by the patient,” he explains.

It may also be helpful to think of it as another shift in the information revolution. Google has yielded a more informed class of patient: many have come to understand what a trusted source looks like from among the thousands of hits a disease search can yield. Apps fall into a similar eco-system where a great number of choices yield only a handful of trustworthy contenders. Until a more robust means of rating mHealth is developed, providers and patients will have to share the responsibility.

How do you know a particular process or task is right for an app?

Alberta Health Services asks that submissions consider a number of things, among them:

• What is the size and specificity of the intended audience of the app?
• Does an app actually improve the end-user experience?
• Does this need to be an app or would some other medium be better suited?
• Would anyone actually use this? There should be a demonstrable purpose for it to be an app, and the audience should be broad enough (or specific enough) that the resources dedicated to building it are justified.

These are just the start of a conversation with the various stakeholders. AHS does not maintain a rigid list of requirements before an app is considered