Health Canada Adapts to Digital Health TechnologiesPublished on May 29, 2018
Author: Pinky Mazumder
Digital health technologies are a rapidly growing area in the area of healthcare. These technologies encompass a wide range of products, from single software applications to wearables, and to hardware systems that can been connected to smartphones and computers. There technologies present the significant potential to improve access to healthcare for patients including those in rural or remote locations and to assist with timely diagnosis and treatments of many conditions. With the widespread use of internet and mobile devices, this is also a sector of the industry that is expected to rapidly progress in upcoming years. So how does the federal regulator perceive and prepare for this change?
Health Canada is showing its support for digital health technologies by establishing a new division in the Medical Device Bureau of the Therapeutic Products Directorate. As announced in the Regulatory Review of Drugs and Devices, the new Digital Health Review Division will enable a targeted pre-market review of proposed digital health technologies in order to rapidly adapt to emerging therapeutic products in digital health and allow the innovative devices to enter the market and assist healthcare. In addition, Health Canada will also be establishing a Scientific Advisory Committee for Digital Health Technology to increase its expert review capacity of such proposed medical device technologies and arrive at decisions regarding market approval. Current key technological areas of focus for Health Canada include:
· Wireless medical devices
· Mobile medical apps
· Software as a medical device (SaMD)
· Artificial intelligence
Establishing this new regulatory division will tend towards the development of a targeted review process for such innovative devices and better align with the regulatory review processes of other regulatory agencies and Health Technology Assessment organizations. This will allow Health Canada to quickly adapt to fast paced innovations and continue to maintain and enforce its standards for medical device safety and effectiveness
Thank you for reading Regulated Affairs, the CAPRA blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media
Notice: Health Canada’s Approach to Digital Health Technologies
Rare Diseases and Orphan Drugs Regulatory Framework in Canada: Recent Initiatives by Government of Canada
What are Rare Diseases and How do They Affect Canadians? According to Health Canada, rare diseases are life-threatening, debilitating, or serious and chronic conditions that...
Health Canada changes filing requirements for product monographs
Did you know, effective immediately, Health Canada is changing the submission requirements for second language product monographs for human drugs? This is for only post-life...
Pragmatic Clinical Trials: Testing Treatments in the Real-World
What is a Pragmatic Clinical Trial? Clinical trials can be designed to be either pragmatic or explanatory. Explanatory trials are designed to find out whether a treatment...