Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Terms of Reference
The Scientific Advisory Panel (SAP) on Software as a Medical Device (SaMD) will provide advice on current and emerging issues related to software as a medical device. While the Panel provides Health Canada with advice and recommendations, decision-making responsibility remains with Health Canada.
The mandate of SAP-SaMD is to provide timely scientific, technical and medical advice on current and emerging issues related to software as a medical device.
The Panel will fulfill its mandate by advising Health Canada on the following issues:
- The definition of SaMD and scope of what would be regulated as a medical device, and
- Provide feedback on a preliminary draft SaMD guidance document.
2. Reporting Structure
The Panel reports to the Director General (DG), Therapeutic Product Directorate (TPD), who acts as the Executive Secretary to the Panel. The TPD will provide support to the Panel as appropriate.
3.1 Selection of members
Potential members of the SAP-SaMD are selected from a broad range of sources, including but not limited to health professionals, scientists or scientific societies, academia, government agencies and lay representation. In order to preserve the independence of both the advisory body and the federal government as decision-maker, Health Canada employees may not serve as members of the SAP-SaMD.
This process is designed to ensure requisite expertise and experience, a variety of perspectives, and promote diversity and inclusiveness.
The Executive Secretary selects and appoints a Chair from among the existing members or nominees, whereas other members may be selected by the Executive Secretary in consultation with the Chair.
Membership of the SAP-SaMD will reflect an appropriate combination of gender and regional representation, and will cover various areas of expertise, knowledge, and perspectives. Expertise should include, but is not limited to:
- software including Software as a Medical Device (SaMD);
- mobile medical apps;
- artificial Intelligence.
3.2 Types of Members
The Panel members are selected based on their scientific/medical/technical expertise and knowledge or credentials as patient representatives.
Members are appointed by the Executive Secretary for a single meeting. If necessary, a second meeting and/or teleconference may be organized.
3.4 Size of the Panel
The SAP-SaMD will be comprised of up to ten members (nine members and one Chair).
3.5 Statement of Agreement
All members are required to complete Health Canada's Visiting Worker/Visitor's Statement of Agreement.
3.6 Affiliations & Interests
As a condition of appointment, potential members of the SAP-SaMD are required to complete and return the "Affiliations and Interests Declaration Form for Advisory Body Members". This form is used to disclose to the Secretariat (TPD) any circumstances that may place, or be seen to place the member in a real, apparent, or potential conflict of interest.
In keeping with the Privacy Act, this completed Affiliations and Interests Declaration Form is considered confidential. The TPD will not make public any information in the form without the member's permission. However, as a condition of membership, members will allow the TPD to publish on Health Canada's web site a "Summary of Expertise, Experience, and Affiliations and Interests", which will be based in part on the completed Declaration Form. Members will be asked to review the content of the Summary for accuracy before its release.
It is incumbent upon the member to update his/her declaration in writing, should his/her personal situation change, or where the matters before the Panel may affect the conflict of interest situation of a member. Declarations will be assessed by the TPD prior to appointment and on an ongoing basis as updates occur.
At the beginning of the meeting, the Executive Secretary or the Chair will ask members to make a verbal statement of their relevant affiliations and interests. The level of participation of a member with potential conflict is determined by the Chair in consultation with the other members of the Panel.
Members are expected to conduct themselves in an appropriate manner, that is, the use of their positions cannot be reasonably construed to be for their private gain or that of any other person, company, or organization.
All members are expected to protect and maintain as confidential any trade secret or privileged information divulged during the work of the Panel. Members must not discuss this information with persons not on the Panel, or divulge information obtained from the work of the Panel, including presentations made to it, until this information has been officially released for public distribution. Documents leaving Health Canada, including electronic and word processing records must be securely stored at all times and must be returned to Health Canada or permanently deleted on request.
3.7 Indemnification and Legal Assistance
All members serve on the SAP-SaMD on a volunteer basis. In keeping with the Treasury Board's "Policy on Legal Assistance and Indemnification", members are eligible for the same protection against personal civil liability as federal employees when faced with comparable risks while acting within the mandate of the SAP-SaMD and serving as volunteers.
3.8 Travel and Expenses
Members are reimbursed for expenses incurred during their work on the SAP-SaMD such as travel and accommodation, according to the Treasury Board's "Directive on the Management of Expenditures on Travel, Hospitality and Conferences".
4. Roles and Responsibilities
Members of the SAP-SaMD have a responsibility to Health Canada and by extension to Canadians, to offer their independent and objective advice. Other responsibilities include:
- being available and prepared to participate in the meeting;
- participating in any discussions surrounding the preparation of meeting reports, if necessary;
- notifying the Secretariat and the Chair of any changes in the status of their affiliations and interests relevant to the mandate; and
- making a verbal statement of affiliations and interests at the beginning of the meeting when asked by the Executive Secretary or the Chair.
In addition to all the responsibilities of a member, the Chair is responsible for the following:
- providing input to and consulting with the Executive Secretary on the selection of members;
- consulting with the Executive Secretary to determine whether to limit the participation of a member in the meeting, depending on the nature of the person's affiliations or interests;
- overseeing and chairing the meeting, and facilitating discussion among members in answering Health Canada's questions; and
- ensuring that all members agree with (or note their disagreement with) the advice in the report to Health Canada.
The Bureau of Policy, Science and International Programs (BPSIP) of the TPD acts as the Secretariat of the SAP-SaMD. The Secretariat liaises between members and Health Canada, and acts as a resource for members. It also provides leadership and strategic advice in the management of the SAP-SaMD and works closely with the Chair. In addition, the Secretariat:
- coordinates membership processes such as the affiliations and interests declarations, security clearances and a membership list;
- coordinates the preparation of the meeting agenda, prepares background information packages for the SAP-SaMD and marks it according to the level to which it is protected under the "Government Security Policy", and drafts the record of proceedings for membership and the Chair's approval;
- maintains any information about the SAP-SaMD, its mandate, or work that may be posted on Health Canada's web site;
- helps to prepare the member designated as media spokesperson, as appropriate;
- coordinates requests for travel reimbursement;
- monitors and evaluates the efficiency and effectiveness of the SAP-SaMD; and
- carries out additional duties as appropriate in support of the SAP-SaMD.
4.4 Executive Secretary
The Executive Secretary is the Director General (TPD) who represents Health Canada and makes decisions related to the SAP-SaMD and its advice. The Executive Secretary provides leadership and strategic advice in the management of the SAP-SaMD and works closely with the Chair and Secretariat.
4.5 Media and Communications
All members are expected to protect and maintain as confidential any trade secret or privileged information divulged during the work of the Panel. Discussion of SAP-SaMD work with the media or at conferences or other external events should only be done when authorization is given by the Executive Secretary.
In the case of media requests, the Executive Secretary will coordinate a response in consultation with the Chair and Health Canada Media Relations and will appoint a member to be the media spokesperson when circumstances warrant this.
5. Management and Administration
Health Canada is committed to ensuring transparency as an operating principle by:
- ensuring that the meeting schedule is predictable, where possible; and
- posting SAP-SaMD materials, with confidential and personal information removed (when appropriate), on Health Canada's web site including:
- Terms of Reference;
- Summary of Expertise, Experience, and Affiliations and Interests;
- Biographies of members;
- Agenda; and
- Records of Proceedings (RoP) and/or formal reports.
5.2 Meeting agenda
The agenda and specific questions and issues for SAP-SaMD discussions will be determined by the Executive Secretary in consultation with the Chair and the Secretariat.
5.3 Meeting Notices and Invitations
This meeting is held at the call of the Executive Secretary in consultation with the Chair. Meeting attendance is by invitation only. The notice is sent by the Secretariat. Members receive the agenda, briefing material and presentations, in advance of the meeting.
5.4 Frequency, Type, and Location of meeting
This meeting will be held in the National Capital Region. An additional meeting and/or teleconference may be held as needed at the discretion of the Executive Secretary in consultation with the Secretariat. A meeting cannot be held unless quorum is achieved. The quorum is determined to be at least one-half the number of existing core members, one of which must be the Chair.
For all teleconferences, members should make every effort to ensure that a secure line is used for the call and that no person who has not been approved by the Chair and Secretariat can listen to the proceedings.
The SAP-SaMD may be required to hold a meeting, or parts of a meeting, in public to allow the public to observe the presentations to the panel and understand the issues under consideration.
5.5 Deliberations and Reports
Panel deliberations during the meeting are held in camera in order to foster open, frank, and free-flowing discussion. All members have equal status during discussion, and are expected to demonstrate fairness and a commitment to in-depth examination of matters under review. Only topics that fit within the mandate of the SAP-SaMD will be discussed.
At the discretion of the Executive Secretary and with the approval of the Chair, specific stakeholders may be invited to make presentations to the Panel in writing or in person. The Chair and the Executive Secretary may grant observer status, for all or part of the Panel deliberations, to selected individuals, including Health Canada employees who would benefit from the deliberations of the Panel.
Members provide advice to Health Canada in the form of recommendations. These recommendations are captured in a RoP. The RoP will be the only record of the meeting. The SAP-SaMD is encouraged to reach a consensus in providing advice whenever possible. When a consensus is not possible, the RoP will reflect the diversity of opinions. The reasons for a lack of consensus, if any, must be clearly identified and substantiated. In such cases, the SAP-SaMD shall make a recommendation with respect to further study of the issue and a proposal for resolution. In cases where there is a real divergence of opinion, the different opinions will be documented, and the number of members supporting each opinion recorded.
A draft RoP is prepared by the Secretariat and circulated to members for review, and final approval by the Chair and Executive Secretary. As a condition of membership, members agree to the audio recording of the meeting to facilitate preparation of the draft RoP only. The RoP will be the only permanent record of the meeting and will be published on Health Canada's web site. This agreement will be confirmed verbally at the start of the meeting. The final RoP will summarize the proceedings to reflect the advice offered. The Secretariat is responsible for the distribution of the RoP.
The agenda and the record of proceedings will be posted on Health Canada's web site in both official languages. Issues discussed on a particular submission are considered confidential and those meeting documents will become part of the Central Registry file.
The Health Products and Food Branch's "Health Canada Policy on External Advisory Bodies (2011)" governs the Terms of Reference, and the management and administration of the SAP-SaMD.
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