Digital health advocates are ecstatic over new regulatory changes that will make their jobs a whole lot easier and less risky—if they live and work in the United States.
The US Food and Drug Administration (FDA) recently announced its 21st Century Cures Act, which includes a Digital Health Innovation Plan. The plan overhauls the regulatory landscape for digital health companies and greatly clarifies which restrictions apply. The industry hopes the changes will ease the process of releasing new products while stimulating new innovation in the field of digital healthcare.
In Canada, however, change has not been quite so quick in coming. Right now, there are approximately 165,000 health-related apps available to Canadians, and more than one quarter of Canadians use wearable fitness devices. Yet the country’s regulatory framework is woefully unequipped to embrace these digital healthcare trends. Though Health Canada and the Canadian Medical Association have started looking at the possibility of new, innovation-focused changes, these changes are far from ready for implementation.
As Canada strives to capitalize on the potential of digital health and clear away roadblocks to Canadian innovators, there are some specific changes that will almost certainly need to be made.
Widen the digital healthcare development bottleneck
In Canada today, it’s often difficult for innovative healthcare companies to know where their services fall relative to the outdated wording of Canadian law. This not only makes it harder to secure insurance coverage and plan for future expenses, but it can also scuttle new projects altogether by making it impossible to know whether a particular service will be able to be sold. It’s not even possible for physicians to collect payment for services delivered online in many provinces.
One of the core goals of Health Canada’s ongoing digital healthcare review is to communicate and engage with stakeholders—to ask them what they want and why they want it, so it can make smart decisions about how to structure Canadian healthcare policy. It plans to increase its review capacity and the efficiency of its collaboration with other technological assessment organizations, like the Canadian Agency for Drugs and Technology in Health.
These are admirable initiatives, but if Health Canada wants them to succeed and allow Canadians to keep up with American competitors, it will have to watch the FDA’s approach and copy what turns out to be the most successful.
Get out of the way of innovation
Of particular note in the American plan is the FDA’s decision to explicitly step away from regulation of “certain digital health technologies—such as clinical administrative support software and mobile apps that are intended only for maintaining or encouraging a healthy lifestyle.” Since these products can have a major positive impact but only a limited negative impact on people’s lives, the US government has said they should not be subject to drug-like regulation.
Another similar idea has been described by the FDA’s associate director for digital health, Bakul Patel, as similar to the TSA’s pre-check program. Such a system would involve “trusted companies getting a lighter regulatory touch, while companies with a problematic history would undergo a more thorough vetting.”
These types of changes, in which the government chooses to reduce its own role rather than update it, could cause a boom in the development of services that previously had to worry about unforeseeable government interference. If Canada isn’t right behind with its own concurrent or nearly concurrent changes, it could get left behind as America attracts all the most eager and ambitious innovators.
Regulate for healthcare cyber risk
Healthcare, and particularly digital healthcare, is an area where complete deregulation would be a mistake—even from the perspective of researchers and service providers. Without robust regulation in place to enforce strong security and encryption standards for apps handling sensitive healthcare data, it’s inevitable some high-profile data breach will undermine public trust.
That could be disastrous for every business developing such products—not just those that failed to invest in security—and so, it’s in every business’s best interest to support across-the-board enforcement of regulations. It comes down to placing the need to enforce security not just on app developers but on system administrators, as well. When printing a document from a recent online appointment, customers need to trust their information is secured by the app, the network, and even the print server. If even one of these points of ingress is compromised, it could taint mind-share and slow the momentum of digital healthcare trends for years to come. It’s also the surest way to have people demand the government enforce truly restrictive regulations. Better to focus on compliance now to save time and money later.
The Government of Canada plans to have its new digital health reforms in place by 2020—so, for now, developers of innovative healthcare technologies should focus on remaining agile enough to adapt to whatever comes and work to have their voices heard over the coming years of consultation. If they do, Canada should maintain its position as one of the hottest countries for innovative technology development and secure its piece of the quickly oncoming healthcare tech revolution.