New Position Statement Aims to Guide the Use of AI Methods in Health Technology Assessment

Canada’s Drug Agency has published a new position statement on the use of artificial intelligence (AI) methods in health technology assessment (HTA).

The work of Canada’s Drug Agency is grounded in the independent assessment and evaluation of evidence, which is provided to health system leaders along with expert advice, enabling them to make informed decisions on drugs, health technologies, and health systems.

Our organization recognizes that the evidence we assess to help shape our recommendations and advice will increasingly be informed by AI. Because of this, we have taken proactive steps to better understand the use of AI methods within the context of HTA and developed a position statement, which details how we will consider evidence that has been generated or reported using AI methods.

Equipping our organization to evaluate AI-informed evidence is particularly important, as questions exist around the appropriateness, transparency, trustworthiness, and ethics of using AI in evidence generation and reporting. Any potential benefits of using AI methods must be balanced against anticipated and/or known risks.

What We Did and Why We Did It

To develop our position statement, we reviewed and leveraged an existing position statement from the National Institute for Health and Care Excellence (NICE) in the UK. While we aligned our statement with all of the positions outlined by NICE, minor additions and modifications were made to contextualize the content to our own organization’s work and the broader HTA environment in Canada.

More specifically, our position statement is intended to articulate our unique organizational perspective on how we will consider AI-informed evidence that has been submitted for appraisal. The position statement is also intended to help our deliberative committees and other external assessment groups better understand and appraise evidence that has been informed by AI methods.

What We Found

The position statement includes 2 key sections. The first section outlines the potential uses of AI methods for HTA-related purposes for all users. Given that AI is a rapidly developing field, the list of possible uses is neither exhaustive nor an endorsement or acceptance of the methods. Instead, we aim to emphasize the potential applications at this time. For example, AI could support (and in some cases automate) evidence identification as well as data extraction and synthesis for systematic reviews. It could also be used to design clinical trials, identify and adjust for limitations in clinical data, produce synthetic data, or generate executive summaries.

The second section outlines the responsibilities of those who use AI methods in the generation and/or reporting of evidence. In this section, we emphasize the importance of weighing potential benefits against anticipated or known risks, such as algorithmic bias, cybersecurity issues, and reduced human oversight. We note that any use of AI should be done judiciously, leveraging the strengths of AI to support and enhance the generation and reporting of evidence only when it is suitable, aligns with Canadian regulations, and adds value.

Our position statement will be regularly reviewed and updated as significant new evidence emerges on the use of AI methods in evidence submissions. Additionally, updates related to AI methods may be incorporated into modular updates to our Methods Guide, which outlines the processes for conducting HTA at Canada’s Drug Agency.

Other Work on AI at Canada’s Drug Agency

In addition to the development of this position statement, Canada's Drug Agency has been actively exploring the use of AI and its potential impact on the broader health care ecosystem, including how AI can drive innovation in the development and application of health technologies aimed at enhancing efficiencies and improving patient care. Earlier this month, we published our 2025 Watch List, an annual report that presents emerging technologies and issues that have the potential to shape the future of health care in Canada. This year’s list focused on the use of AI technologies in health care, such as AI for notetaking, disease diagnosis, and remote monitoring, and the issues that may arise with the implementation of these technologies.