Developing and evaluating patient information leaflets for artificial intelligence use in healthcare

Background

The introduction of artificial intelligence (AI) in healthcare raises issues of transparency, trust and informed patient choice. While patient information leaflets are standard for medication, similar resources for AI applications are lacking. Regulatory frameworks (e.g., the EU AI Act) and Dutch patient advocacy groups emphasize the need for clear patient information on the use of AI. This study aimed to develop and evaluate a template for AI information leaflets in healthcare, using an ambient listening application as an example.

Methods

A two-stage, stakeholder-driven approach was used. In the first stage, a co-creation session with nine stakeholders (communications officers, clinicians, ethicists, legal experts, patient representatives and data scientists) identified key themes and optimized the template, applying it to an ambient listening application. Next, a focus group with members of the public will evaluate the clarity, usefulness and completeness of the prototype leaflet.

Results

The co-creation produced a draft template and a prototype leaflet for the ambient listening application. Key themes included benefits for patients and healthcare professionals, data use and institutional safeguards. Most participants favoured short and general information to avoid overwhelming patients, though more detailed versions were also supported to ensure patient right to information. Both versions will be discussed during the focus group.

Conclusions

This collaborative approach produced an expert-reviewed template and a prototype leaflet addressing a critical gap in AI communication in healthcare. By prioritizing clarity, these resources support more equitable patient engagement, ensuring that diverse populations can participate in informed decision-making. Aligned with existing policy directions, these efforts provide a foundation for responsible, patient-centred, and equitable adoption of AI.

Key messages

• By providing clear AI information, we promote equitable patient engagement and support informed decision-making regarding AI use in healthcare.

• Key themes identified for AI leaflets included patient benefits, data use and safeguards; ensuring information is relevant, transparent and trustworthy.