About the Activity
AI-based tools are increasingly integral to clinical practice, supporting diagnosis, triage, and treatment planning across diverse specialties. Yet healthcare professionals (HCP) often encounter a significant information gap when it comes to understanding how these systems are built, validated, and maintained. Many tools enter the market with documentation that is either too technical for clinicians or too general to support informed decision-making.
To address this gap, the HCP AI Factsheet is proposed as a standardized, structured document to be completed by developers and made available to healthcare professional users. In effect, the Factsheet translates complex technical and regulatory documentation into a concise and clinically meaningful format, allowing healthcare professionals to assess the reliability, scope, and risks of an AI tool before and during use.
This AI Factsheet could serve multiple purposes: it could enable compliance with transparency obligations, enhance interpretability for HCP end-users, and promote a culture of responsible AI use. Since AI literacy is yet not mature among HCPs, the Factsheet can offer the needed information while contributing to build that literacy. The factsheet might help in post market monitoring and compliance (e.g. with human oversight). The Factsheet could also help align developer practices with evolving European or other global standards for trustworthy AI.
The Factsheet concept is equally relevant to AI tools that qualify as Medical Devices (MDs) under the EU Medical Device Regulation (MDR), and those that do not. However, this distinction should be explicitly recognized, since regulatory obligations and liability frameworks differ.
Goals of the Activity
- Development of a pre-standards workstream to explore the potential for a standards framework for the AI Health Factsheet to include computable headings with semantic tags.
- Production of at least one webinar to educate and gain feedback on the progress and market appetite for use of the fact sheet
- Development of a white paper or reference article explaining the market impact and adoption of the work within this program
Getting Involved
Who Should Get Involved
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AI technology developers
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Healthcare professionals (practice, clinical, researchers)
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Government health ministry professionals
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Researchers and ethicists
How to Get Involved
To learn more about the program and how to join the Bridging the AI Transparency Gap:
A Factsheet Framework for Healthcare Professionals, please express your interest by completing the Bridging the AI Transparency Gap: A Factsheet Framework for Health Care Professionals interest form.