Scientific Advisory Committee on Digital Health Technologies (SAC-DHT)

Meeting Announcement

Ottawa, Ontario
June 7, 2018

Background

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.

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.

Health Canada is convening this Scientific Advisory Committee to ensure that Canadians continue to have access to safe and effective digital health technologies.

Announcement of meeting

The purpose of this Notice is to announce an upcoming meeting of Health Canada’s SAC-DHT.

The first meeting, tentatively scheduled for the fall of 2018, will examine cybersecurity and its impact on medical devices.

Mandate of the SAC-DHT

Members will advise Health Canada on matters relating to Digital Health Technologies, which include but are not limited to the following:

• Cybersecurity
• Artificial intelligence
• Software as a Medical Device
• Telemedicine
• Wireless medical devices
• Mobile medical apps
• Medical device data systems
• Medical device interoperability

Meeting format

Health Canada will make a presentation to the committee summarizing background information, to provide context for the questions posed. This will be followed by presentations from stakeholders.

Upon completion of the presentations and associated discussion, the committee will deliberate in a closed meeting before providing their final advice to Health Canada.

Agenda

The detailed agenda for the meeting will be posted at a later date.