Smartphone applications provide unique opportunities for health research. Prospective participants may be recruited, give consent, and may share personal health information with researchers with unparalleled efficiency. Mobile health apps thus have the potential to profoundly alter the way health research is conducted, thereby contributing to more effective and more equitably distributed clinical interventions. But the regulation of this kind of research is uncertain. The absence of regulatory guidance may limit mobile health's promise.

The mobile health research landscape in Canada is considered in the context of the existing regulatory framework, academic literature, and current applications.

This paper outlines regulatory issues in the Canadian context, suggesting three key issues to which researchers and regulators ought to be attentive to ensure public trust: consent, return of results, and privacy and security.

Further consideration of regulatory and ethical issues is needed if mobile health will earn the public's trust and promote public participation.