Currently submitted to: JMIR Preprints
Date Submitted: May 19, 2026
Open Peer Review Period: May 19, 2026 - May 4, 2027
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Regulated or Exempt: Why Equitable Digital Therapeutic Governance Matters for Population Health
ABSTRACT
Digital therapeutics (DTx) represent a transformative opportunity to advance health equity and expand access to evidence-based care. However, Canada’s fragmented regulatory approach risks widening, rather than narrowing, existing health inequities. While Health Canada’s risk-based classification framework appropriately distinguishes Class I from Class II devices, regulatory ambiguity, institutional variation, and limited transparency prevent life-saving innovations from reaching vulnerable populations who need them most. Drawing on community engagement across healthcare and academic institutions, this viewpoint argues that DTx governance is fundamentally a public health issue and proposes three public health-oriented reforms: standardized institutional quality management, Artificial Intelligence (AI) transparency and accountability, and integrated Research Ethics Boards-Health Canada pathways, alongside a stronger lifecycle governance approach for dynamic digital tools.
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Copyright
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