Few health apps today undergo rigorous scientific testing. That could be changing

Dr. Kumanan Wilson has bonafide research chops. He sits on the faculty of one of Canada’s largest teaching hospitals. He’s had papers published in major medical journals. He’s received funding through the Bill and Melinda Gates Foundation to study newborn health outcomes.

And yet Wilson might be a classic example of a new breed of digital health entrepreneur, one who’s using his research background to help bring new digital health technologies — rather than, say, drugs and medical devices — to market.

Wilson is the founder of the Ottawa Hospital mHealth Research Team and one of the inventors of an app called CANImmunize, which creates a digital immunization record for Canadian residents.

The software provides a bridge between different provinces, which each have their own vaccine schedule, and allows parents to keep track of medical records if they move or travel.

“We basically had to make an international app to work in Canada,” Wilson said. “The beauty of the mobile solution is that we can customize it to each situation out there.”

As the number of health apps has proliferated, so too have the opportunities for researchers to study whether they actually improve health outcomes, straddling the line between scientist and product developer. Wilson’s app in particular is intended to digitize the yellow immunization cards that are familiar to Canadian parents. He said he got the idea shortly after the H1N1 influenza outbreak, while he was talking to a mother who was complaining about having to keep separate yellow cards for each child.

He didn’t have the coding skills to build the app himself, so he turned to a friend who was studying engineering at McGill University. CANImmunize creates a digital medical record that can be updated from birth, or what Wilson describes as a “health scrapbook.”

The Public Health Agency of Canada saw the benefit of the idea and helped to adapt the tool for each province’s unique vaccine schedule and create bilingual content for French-speaking regions.

The goal now is to create a bidirectional communications tool, allowing parents to report immunization records to public health officials and in turn receive health alerts, like reminders to get vaccinated on time. It could also record other important health information like allergies or medications.

CANImmunize has also partnered with the Harvard HealthMap to see whether it could layer on data about disease outbreaks so families can make sure their children are protected.

Ultimately, CANImmunize could be useful for temporary residents, like students studying abroad in Canada, and serve as a means of transferring health records from other countries. It could also provide a solution in other places where vaccine records are decentralized, like in the United States.

Where the scientific method meets tech

CANImmunize received $3.5 million in 2016 from the Public Health Agency of Canada to fund its growth. Since its funding comes from the public sector, proving its utility with sound scientific evidence is particularly important.

But one of the challenges for health apps overall is that — while many make claims about how they can improve health and prevent disease — few undergo the same rigorous testing as highly regulated pharmaceutical or medical device products.

Most of the hundreds of thousands of health apps marketed to consumers tend to be what Pamela Spence, the global health sciences and wellness industry leader at consulting firm EY, describes as lighter, lifestyle-focused tools. But the app catalogue is rapidly growing to include offerings such as wearable sensors and telemedicine.

Most tech companies closely guard their algorithms as trade secrets, instead of opening them up to peer-review, a process familiar to and essential for scientists.

These apps could also have serious data security flaws, according to a report last month from EY and the United Kingdom’s International Longevity Centre. While millions of people could potentially benefit from health apps, the report calls on the U.K.’s National Health Service to establish a system for validating the best options.

“The value of having an accreditation system is that it helps you navigate that level of quality assurance,” Spence said. “That gives me huge comfort … and enables me to have complete confidence.”

Clinicians as product managers

Ottawa Hospital’s mHealth Research Team includes both clinicians as well as engineers. “We started helping other scientists build things,” Wilson said, pointing to, for example, an app that creates a digital recovery program for stroke patients. “I realized that digital health is going to change the entire landscape.”

Still, he draws a distinction between the hours he’s spent looking at blood samples from newborn health screens and the work he’s doing with scientists and engineers to create digital health tools.

The scientific method requires research studies to be very standardized, with all parameters kept the same, in order to assess exactly what’s causing the results. But that’s impossible in the fast-moving field of technology, where operating systems and devices rapidly become obsolete and are replaced by newer versions.

Healthcare providers aren’t the only ones who want to use health apps to improve patient care; the pharmaceutical and medical device industries are also looking to incorporate them to collect data from clinical trials.

That means regulatory bodies around the world are looking at drafting guidance for vetting these tools. While the opportunities for collaboration are growing fast, research universities are just starting to catch up.

“As an academic, I don’t get credit for developing apps,” Wilson said. “I get credit for writing papers. Research is research and this isn’t research. It’s a different mindset.”