Notice: Health Canada’s Approach to Digital Health Technologies

April 10, 2018

Our file number: 18-104077-808

Given the fast pace of innovation in digital health technologies specifically in relation to medical devices, Health Canada is undertaking an initiative to adapt its approach to support better access to therapeutic products based on healthcare system needs. Under the “Regulatory Review of Drugs and Devices” initiative, Health Canada is establishing a new division within the Therapeutic Products Directorate’s Medical Devices Bureau to allow for a more targeted pre-market review of digital health technologies, to adapt to rapidly changing technologies in digital health, and to respond to fast innovation cycles.

Adoption and use of digital health technologies has the potential to make the delivery of health care more accessible, convenient and cost-effective.

Digital health technologies can include stand-alone software applications as well as integrated hardware and software systems which can utilize platforms, such as computers, smart phones, tablets and wearables. These technologies can improve access to health care information, facilitate more timely diagnoses and treatments, and improve access to care for patients at home, at health care facilities, as well as in rural and remote communities.

The digital health technology sector is expected to continue to grow at a fast pace in the coming years. This growth is being fuelled by the nearly ubiquitous access to the internet, the widespread adoption of mobile devices and increasing demand from patients and health care systems.

As the federal regulator of medical devices, Health Canada is supporting the market emergence of current and future medical devices using a digital health technology in order to meet the growing demand from patients, health care systems and industry, while ensuring that they remain safe and effective for the people of Canada.

The new Digital Health Review Division brings increased expert review capacity for medical devices integrating digital health technologies and will also develop a targeted review process and work towards better alignment with other regulatory agencies and stakeholders. Health Canada expects that this initiative will benefit Canadian patients and the health care system by improving access to innovative digital health technologies that have rapid development cycles while potentially saving health care system costs.

Key areas of focus for Health Canada under this initiative include:

• Wireless Medical Devices
• Mobile Medical Apps
• Telemedicine
• Software as a Medical Device (SaMD)
• Artificial Intelligence
• Cybersecurity
• Medical Device Interoperability

The establishment of this division is a first step towards a regulatory approach adapted to keep pace with innovation and advances in the medical device and digital health technology sectors, while maintaining the existing high standards for medical device safety and effectiveness.