Regulators scrutinise safety of mobile healthcare apps

From taxicabs to hotels, some of the oldest areas of economic activity in the world have been upended by mobile apps like Uber and Airbnb. Healthcare, on the other hand, another industry that traces its roots to ancient times, has remained relatively impervious to digital disruption.

The vast majority of patients still seek the services of a healthcare professional when they want to test their “vital signs”, or use cumbersome analogue devices that are little changed compared with those of about 50 years ago.

At the same time, there is a large consumer appetite for a new generation of health apps and connected, digital devices, which would allow people to track their own health.

Some products already exist, such as glucose meters that link up with an app on a consumer’s smartphone and relay the readings to their doctors, who are alerted if the patient is ill.

The pace of digital disruption has been slow, however, not least because the consequences of getting things wrong are severe. If Uber or Airbnb goes amiss, it could ruin a night out or a holiday; when health apps fail people might end up paying with their lives. Regulators have pledged, therefore, to crack down on unapproved or dangerous products

Bakul Patel, associate director for digital health at the US Food and Drug Administration (FDA), says the question that developers should focus on is whether or not their app could be categorised as a “medical device” — something that could be used in the diagnosis, cure, treatment, mitigation or prevention of a disease or illness.

The FDA puts health apps into three brackets, says Mr Patel: those that are not medical devices, such as most fitness trackers; those that technically qualify as devices but pose such a low risk to patients that they do not need to be regulated; and those that do need regulation.

An app that converts a smartphone into a glucose reader or an EKG heart monitor would need to be regulated, for instance, as would one that uses your phone as a remote for an existing medical device.

Mr Patel says the FDA will not only examine the quality of the product, but also whether the company has the organisational capability to address faults and customer complaints.

“If problems arise you should have a business organisation that can spot it, fix it and make sure your products are not hurting people,” he says.

Walter De Brouwer, the chief executive of Scanadu, is seeking FDA approval for his Vitals device, which measures blood pressure, temperature heart rate and the level of oxygen in a person’s blood.

The user presses the small, cylindrical device against their forehead for a few seconds and the readings are sent to an app on their smartphone via bluetooth, where it can be read using the Scanadu app.

While Mr De Brouwer says getting FDA approval takes time, he thinks a high regulatory bar is essential.

“We believe that consumers have the right to their own data, but they also have the right to accurate data,” he says. “Just suppose they change their behaviour based on something that is not true.”

For some start-ups and entrepreneurs, seeking regulatory approval from the FDA is an arduous and daunting process that many would prefer to avoid. Similarly, larger organisations find the process takes too long.

“A lot of this is about speed,” says John Conrad, who advises digital health companies for Deloitte. “It’s about capturing that market before anyone else does. One of our clients was launching something globally and it took 18 months to get out what was quite a simple app.”

He adds: “That’s way too long, so the question is how do we get that down to four months?”

If problems arise you should have a business organisation that can spot it, fix it and make sure your products are not hurting people

One option is for tech companies to partner with a larger medical devices company that knows how to navigate the regulatory approval process.

“I believe for all of this to be successful you want to team a life sciences organisation with a high-tech company,” says Mr Conrad.

“A tech company or pharma group going at it alone may struggle but when they come together it can work extremely well.”

Mr Patel thinks that the larger tech groups will eventually create developer tools that help companies build apps which are compliant with FDA rules.

“I think about the Apples, Googles, Samsungs of the world as people who create standards that are in a way platforms that other people can iterate on,” he says.