Regulation, assessment, and adoption of digital health technologies in Canada

20.500.12592/pt2nwn

Regulation, assessment, and adoption of digital health technologies in Canada

21 Mar 2023

However, in Canada, there is a lack of clear processes and Regulations for DHTs in the US, the UK, guidelines for the regulation, evaluation, and and Canada adoption of DHTs, a major barrier to the Regulations for market access advancement of digital health adoption and Given the large numbers of new DHTs delivery. [...] Regulations for DHTs in the US, class/category the SaMD falls into include: the UK, and Canada • the significance of the information The scope, specificity, and robustness of the provided by the technology to the health premarket assessment and post-market care decision (e.g., whether the purpose of the technology is to drive or inform surveillance are major questions in the clinical decisions), r. [...] The Guidance documents for the interpretation focus of the guidelines, frameworks, and of the existing regulations for medical toolkits ranges from mobile health (mHealth) devices in the context of DHTs are important and apps (70, 71) to virtual care (72) and AI steps toward ensuring the safety and (73) and from specific health conditions (e.g., effectiveness of technologies that are subject diabe. [...] The actual (e.g., usability of individual technologies and decision-making about the adoption of and real-world effectiveness in the local context investment in DHTs occurs on the provincial of different health care systems and and territorial levels and the local level of organizations) (67) and do not offer health systems and organizations. [...] Yet, the of the Indigenous Peoples of Canada are one value of DHTs and the potential return on important aspect to consider when investing in DHTs are contingent on the evaluating the appropriateness and successful adoption and integration of the acceptability of DHTs in the Canadian technology (83).

Authors

Elena Lopatina

Pages
25
Published in
Canada