This principle-based framework establishes new norms for AI innovation, ethical artificial intelligence and trustworthy uses of LLMs as it emphasizes accountability, validity, safety, compliance, transparency and protective of human rights across vulnerable supply chains.

Datarisk Canada announced the release of the AI Guidance for Canadian Small and Mid-Size Organizations Assessment Pack, a regulator-informed governance and risk assessment resource designed to help organizations evaluate their use of artificial intelligence against Canadian privacy and human rights obligations. The Assessment Pack has initially been designed for plug-and-play application to the MedTech and HealthTech sectors for organizations subject to health privacy compliance requirements and cybersecurity concerns.

The Assessment Pack is grounded in the Principles for the Responsible Use of Artificial Intelligence jointly issued by the Office of the Information and Privacy Commissioner of Ontario and the Ontario Human Rights Commission. It translates those principles into a practical, assessment-ready framework that organizations can apply across the full life cycle of AI systems, including generative AI, for organizations that play key roles in healthcare and Canadian supply chains.

The guidance is also intended for medical technology organizations and SMEs that develop, deploy, or use AI systems whose outputs inform decisions, recommendations, or content. It provides a structured method for identifying governance gaps, documenting controls, and preparing regulatory or oversight inquiries.

Claudiu Popa, cybersecurity author and Canadian risk governance expert, said the release responds to a growing need for defensible AI oversight in the most vulnerable business sectors of the Canadian economy:

“Canadian health & medical organizations are moving quickly with AI adoption, but many lack a clear way to demonstrate accountability when regulators or oversight bodies ask how risks were assessed. This Assessment Pack for SME gives organizations a disciplined, evidence-based way to show how privacy, safety, and human rights considerations were addressed before harm occurs, across the supply chain.”

The AI Guidance Assessment Pack helps organizations:

1. Establish an AI governance baseline explicitly framed by Canadian privacy and human rights authorities
2. Apply responsible AI principles across design, deployment, operation, and decommissioning
3. Produce board ready summaries and documentation suitable for audits, investigations, or public accountability for key vendors and IT suppliers
4. Identify control gaps related to safety, cybersecurity, bias, transparency, and lawful authority, particularly in situations where healthcare, medical and safety concerns impact compliance and PHI protection.

The Assessment Pack for SME includes a principle-based Alignment Scorecard, evidence register, prioritized control gap list, and a clear scoring method that supports consistent internal reviews and external scrutiny. It is designed to complement existing risk, privacy, and security programs, and can be mapped to broader management system approaches where required.

At a time when artificial intelligence is increasingly linked to societal risk, civil liberties concerns, and public trust, Datarisk Canada emphasizes that responsible adoption must be demonstrable, not assumed, in order to create a web of trust across interconnected supply chains in Canada.

“Regulators have been clear that intent is not enough,” Popa added. “Organizations must be able to explain what they built, why they built it, how it is governed, and what safeguards are in place if something goes wrong, across a broad spectrum of suppliers of all sizes.”

The AI Guidance for Canadian Organizations Assessment Pack for SME is now available through Datarisk Canada and Managed Privacy Canada as a complementary add-on for organizations with existing risk management programs. Additional information and advisory support are available to medical and healthcare organizations that seek to integrate with their existing processes.

The AI Guidance for Canadian Organizations Assessment Pack is a complimentary toolkit which is designed to empower organizations to adopt authoritative guidance for standardized data protection. This resource is called the Compliance Action Pack (CAP™). For help with deployment, project management, training, validation or independent auditing, contact your certified Risk Advisor at [email protected] or [email protected]