{"id":{"repo_id":"uoit","oai_identifier":"oai:ontariotechu.scholaris.ca:10155/1996"},"canonical_url":"https://search.dev.ndltd.org/etd/uoit/oai:ontariotechu.scholaris.ca:10155/1996","repository":{"repo_id":"uoit","name":"Ontario Institute of Technology","base_url":"https://ontariotechu.scholaris.ca/server/oai/request"},"display":{"title":"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","abstract":"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.","abstract_html":"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.","abstract_has_math":false,"creators":["Abdo, Alissar"],"institution":"University of Ontario Institute of Technology","degree_name":"Master of Health Sciences (MHSc)","degree_level":null,"degree_discipline":"Community, Public and Population Health","degree_department":null,"school":null,"contributors":[],"advisors":["Gamble, Brenda"],"committee_chairs":[],"committee_members":[],"year":2025,"date_issued":"2025-08-01","date_published":"2025-08-01","updated_at":"2026-07-24T05:35:20Z","subjects":[],"languages":["en"],"rights":[],"rights_urls":[],"identifier_entries":[]},"links":{"outbound_url":"https://hdl.handle.net/10155/1996","outbound_label":"Handle","outbound_source":"dc:identifier.uri"},"metadata_groups":[{"id":"people","label":"People","entries":[{"key":"dc:contributor.advisor","label":"Advisor","values":["Gamble, Brenda"]},{"key":"dc:creator","label":"Author","values":["Abdo, Alissar"]}]},{"id":"academic_context","label":"Academic Context","entries":[{"key":"dc:date.accessioned","label":"Dc Date Accessioned","values":["2025-09-19T14:15:55Z"]},{"key":"dc:date.available","label":"Dc Date Available","values":["2025-09-19T14:15:55Z"]},{"key":"dc:date.issued","label":"Date","values":["2025-08-01"]},{"key":"dc:type","label":"Dc Type","values":["Thesis"]},{"key":"thesis:degree_discipline","label":"Discipline","values":["Community, Public and Population Health"]},{"key":"thesis:degree_name","label":"Degree Name","values":["Master of Health Sciences (MHSc)"]},{"key":"thesis:institution_name","label":"Thesis Institution Name","values":["University of Ontario Institute of Technology"]}]},{"id":"language_rights","label":"Language and Rights","entries":[{"key":"dc:language.iso","label":"Language (ISO)","values":["en"]}]},{"id":"identifiers","label":"Identifiers","entries":[{"key":"dc:identifier.uri","label":"Identifier URI","values":["https://hdl.handle.net/10155/1996"]}]},{"id":"additional","label":"Additional Metadata","entries":[{"key":"dc:description.abstract","label":"Abstract","values":["The rapid growth of mHealth applications and SaMD has outpaced existing regulatory systems, raising concerns around safety, effectiveness, and privacy. 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