Gokce B. Laleci Erturkmen

A. Anil Sinaci, Senan Postaci, Dogukan Cavdaroglu et al.

Objective: To develop the AI Product Passport, a standards-based framework improving transparency, traceability, and compliance in healthcare AI via lifecycle-based documentation. Materials and Methods: The AI Product Passport was developed within the AI4HF project, focusing on heart failure AI tools. We analyzed regulatory frameworks (EU AI Act, FDA guidelines) and existing standards to design a relational data model capturing metadata across AI lifecycle phases: study definition, dataset preparation, model generation/evaluation, deployment/monitoring, and passport generation. MLOps/ModelOps concepts were integrated for operational relevance. Co-creation involved feedback from AI4HF consortium and a Lisbon workshop with 21 diverse stakeholders, evaluated via Mentimeter polls. The open-source platform was implemented with Python libraries for automated provenance tracking. Results: The AI Product Passport was designed based on existing standards and methods with well-defined lifecycle management and role-based access. Its implementation is a web-based platform with a relational data model supporting auditable documentation. It generates machine- and human-readable reports, customizable for stakeholders. It aligns with FUTURE-AI principles (Fairness, Universality, Traceability, Usability, Robustness, Explainability), ensuring fairness, traceability, and usability. Exported passports detail model purpose, data provenance, performance, and deployment context. GitHub-hosted backend/frontend codebases enhance accessibility. Discussion and Conclusion: The AI Product Passport addresses transparency gaps in healthcare AI, meeting regulatory and ethical demands. Its open-source nature and alignment with standards foster trust and adaptability. Future enhancements include FAIR data principles and FHIR integration for improved interoperability, promoting responsible AI deployment.

Yildiray Kabak, Gokce B. Laleci Erturkmen, Mert Gencturk et al.

In this study, we propose FHIR-RAG-MEDS system that aims to integrate Health Level 7 Fast Healthcare Interoperability Resources (HL7 FHIR) with a Retrieval-Augmented Generation (RAG)-based system to improve personalized medical decision support on evidence-based clinical guidelines, emphasizing the need for research in practical applications. In the evolving landscape of medical decision support systems, integrating advanced technologies such as RAG and HL7 FHIR can significantly enhance clinical decision-making processes. Despite the potential of these technologies, there is limited research on their integration in practical applications.