Use of artificial intelligence to draft a mini-HTA report on a new medical device belonging to class IIb–III

The rapid evolution of artificial intelligence (AI) in the pharmaceutical and medical device (MD) sectors has prompted interest in its potential role in supporting health technology assessment (HTA). This editorial presents an innovative project aimed at facilitating and expanding HTA activities for high-risk MDs (Class IIb-III) in Italy, where structured HTA processes for MDs are inconsistently implemented. The project centers on a freely accessible AI-based web tool designed to generate preliminary mini-HTA reports. The tool operates through two steps: users provide essential device information via an online form, and ChatGPT produces a structured draft report, including PICO statements, coverage of the nine EUnetHTA domains, and a preliminary summary of relevant PubMed evidence. Although these AI-generated reports are imperfect and require expert verification and refinement, they offer substantial practical advantages by reducing the initial workload and enabling rapid production of a first draft-within minutes rather than hours. The project includes detailed operational instructions and real application examples, such as an artificial iris device, presented in supplementary appendices. Future developments include the release of an English-language version to support broader international use. While AI cannot replace expert judgment, the editorial highlights its value as an accelerative tool that can streamline early HTA steps and promote more systematic evaluation of MDs across Italian regions. Continued iterative use is expected to improve system performance and enhance integration into HTA workflows.