Strengthening Canada’s M-health and Software as a Medical Device (SaMD) regulations: lessons from global best practices in the U.S., U.K., Australia, and New Zealand: a rapid review using qualitative comparative policy analysis

The rapid growth of mHealth applications and SaMD has outpaced existing regulatory systems, raising concerns around safety, effectiveness, and privacy. This research conducts a comparative policy analysis of Canada’s regulatory framework against those of the United States, United Kingdom, Australia, and New Zealand. Drawing on Risk-Based, Responsive, and Smart Regulation theories, the study evaluates strengths, weaknesses, and best practices across jurisdictions. Using both grey literature and peer-reviewed sources, the research constructs a comprehensive evidence base and theoretical assessment. Findings reveal that Canada struggles with inconsistent enforcement, insufficient oversight of wellness applications, and a lack of adaptive regulatory mechanisms. To address these gaps, the study recommends the adoption of risk-tiered oversight, stronger stakeholder engagement, enhanced post-market surveillance, and innovation-friendly regulatory tools. Ultimately, the research proposes an equilibrium framework that balances the protection of patient safety with digital health innovation, ensuring that Canada can effectively govern the evolving mHealth and SaMD landscape.

Name thesis:degree_name

Master of Health Sciences (MHSc)

Discipline thesis:degree_discipline

Community, Public and Population Health

Grantor

University of Ontario Institute of Technology

Year dc:date.issued

2025

Author dc:creator

• Abdo, Alissar

Advisor dc:contributor.advisor

• Gamble, Brenda

Language dc:language.iso

en

Handle dc:identifier.uri

https://hdl.handle.net/10155/1996

OAI identifier oai:identifier

oai:ontariotechu.scholaris.ca:10155/1996