AI4HF System Requirements: A FUTURE-AI-Aligned, ISO/IEC/IEEE 29148 Requirements Dataset for Trustworthy Heart Failure Decision Support

AI4HF System Requirements Overview This dataset releases the consolidated set of 173 system requirements elicited and specified within the AI4HF project (Trustworthy Artificial Intelligence for Personalised Risk Assessment in Chronic Heart Failure) for an AI-based Clinical Decision Support System (CDSS) addressing chronic heart failure. The requirements were defined as part of Work Package 1 and consolidated in Deliverable 1.3 (November 2024). This open access release supports the project's open science commitments at M36 (May 2026) and is intended to enable reuse by researchers, developers, regulators, and HTA practitioners working on trustworthy clinical AI. Scope and methodology The specification operationalises high-level trustworthy AI principles into engineering-grade requirements through two complementary instruments.Normative coverage is provided by the FUTURE-AI framework (Lekadir et al., BMJ 2025). Each requirement is mapped to a sub-principle of its taxonomy, which is organised around six guiding principles (i.e., Fairness, Universality, Traceability, Usability, Robustness, and Explainability) and a set of cross-cutting General recommendations applicable across the AI lifecycle. Syntactic and structural rigour is provided by the ISO/IEC/IEEE 29148:2011 standard on requirements engineering. Each requirement statement follows the prescribed natural language template and is classified as either functional (FR) or non-functional (NFR). Requirements were elicited from heterogeneous stakeholder workstreams including patients, healthcare professionals, ethical, legal and societal experts, health technology assessment experts, and AI Product Passport developers. Additional inputs were drawn from foundational project documents such as the Description of Action and the Grant Agreement. All requirements were subsequently harmonised, deduplicated, and verified for traceability against the FUTURE AI principles. File contents The dataset is distributed as a single workbook containing two sheets. Requirements This sheet contains the 173 system requirements, one requirement per row, with the following fields: ID, System requirement, Rationale, Stakeholder(s) affected, FUTURE-AI principle, Source, Type, and Means of verification (MoV). Codebook This companion sheet documents the meaning of each column, the interpretation of the Source field, the complete acronym glossary, and the FUTURE AI principle taxonomy applied throughout the dataset. Related publications Lekadir, K. et al. (2025). FUTURE AI: international consensus guideline for trustworthy and deployable artificial intelligence in healthcare https://doi.org/10.1136/bmj-2024-081554 AI4HF (https://www.ai4hf.com) Funding This work was supported by the European Union's Horizon Europe research and innovation programme under the AI4HF project (Grant Agreement No. 101080430).