Health Canada paving the way for more AI/ML medical devices

Since 2018, Health Canada has undertaken an initiative to adapt its regulatory approach to better support digital health technologies, specifically medical devices. Key focus areas include artificial intelligence, software as a medical device, cybersecurity, medical device interoperability, wireless medical devices, mobile medical apps and telemedicine. To meet this goal, Health Canada established the Digital Health Division under the Medical Devices Bureau and has been increasing its efforts to build in-house expertise. On October 27, 2021, Health Canada, the US Food and Drug Administration (FDA), and the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) jointly published the Good Machine Learning Practice for Medical Device Development: Guiding Principles. The document consists of 10 guiding principles to help promote safe, effective, and high-quality use of artificial intelligence and machine learning (AI/ML) in medical devices.