The Regulatory Challenge of Mobile Health: Lessons for Canada

Mobile health (mHealth) is the provision of health or medical services enabled by portable devices. This field is rapidly expanding as the global market for mobile devices grows. mHealth “apps” pose benefits and risks to their users that governments have attempted to address through regulation. There is substantial variability across regulatory bodies in the scope, specificity and robustness of mHealth regulations, with Canada's regulatory framework lacking in two major domains: (1) specificity of existing regulations for mHealth and (2) regulatory clarity for what apps require regulation. If Canada is to be a leader in digital health, it requires a new framework that encourages the growth of an mHealth market that can bring innovative solutions to contemporary healthcare challenges while maximizing user benefits and minimizing harms.