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Regulatory Experimentation Expense Fund (view source)

Revision as of 19:27, 16 November 2023

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=='''Step 2: Expression of Interest'''==

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Departments submit a high-level [https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2F1%2F17%2FExpression_of_Interest_%2528EOI%2529_Template_.docx&wdOrigin=BROWSELINK Expression of Interest (EOI)] that is used by the CRI to determine the eligibility of the project. To be eligible for funding, proposed experiments must clearly demonstrate how their funding request meets the criteria as outlined in the [https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2Fd%2Fdd%2FREEF_Guide_-_2022.docx&wdOrigin=BROWSELINK REEF Guide]. It is highly recommended that applicants informally confirm the eligibility of their project by scheduling an informal consultation with the CRI before completing an EOI. EOI submissions are due '''January 16, 2024.'''<p class="highlighted mw-collapsible-content"></p>

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|Innovation Science and Economic Development (ISED) – Standards Council of Canada (SCC)

| Piloting an Accreditation Program for the Assessment of Artificial Intelligence Management Systems (AIMS)

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|The purpose of this experiment is to pilot a prototype accreditation program to understand whether the main SCC Requirements and Guidance document that works in conjunction with ISO/IEC 17021-1:2015 Conformity assessment is clear and appropriate and obtain feedback from the certification bodies and Artificial Intelligence (AI) companies about the program. This information is necessary to improve and refine the prototype.

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|The purpose of this experiment is to pilot a prototype accreditation program to understand whether the main SCC Requirements and Guidance document that works in conjunction with ISO/IEC 17021-1:2015 Conformity assessment is clear and appropriate and obtain feedback from the certification bodies and Artificial Intelligence (AI) companies about the program. This information is necessary to improve and refine the prototype.

The SCC is also looking to gather information on whether the AIMS could have an impact on the level of risk of AI products to inform potential use of AIMS for regulators.

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|Health Canada (HC)

|Machine Learning Enabled Medical Device (MLMD) Sandbox Development

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|Health Canada is developing a sandbox to test new regulatory approach for MLMDs. Currently, MLMD can be marketed in Canada if the device algorithm behaviour is locked to remain the same overtime as what was presented in the product’s market authorization application. Any change to the algorithm behaviour requires the submission of an amendment to the licence. Health Canada wants to test a new regulatory approach that would use a different method of risk management than requiring a licence amendment so that the device can change its behaviour over time as it learns from new data it acquires over time. The current project scope is limited to accessing the legislative authorities to establish the sandbox and developing the sandbox application scheme.

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|Health Canada is developing a sandbox to test new regulatory approach for MLMDs. Currently, MLMD can be marketed in Canada if the device algorithm behaviour is locked to remain the same overtime as what was presented in the product’s market authorization application. Any change to the algorithm behaviour requires the submission of an amendment to the licence. Health Canada wants to test a new regulatory approach that would use a different method of risk management than requiring a licence amendment so that the device can change its behaviour over time as it learns from new data it acquires over time. The current project scope is limited to accessing the legislative authorities to establish the sandbox and developing the sandbox application scheme.

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! colspan="3" |[[CRI Supported Projects|Click here to see a list of the CRI’s '''completed''' '''projects''' and experimentation reports]]

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