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Without careful dissection of the ways in which biases can be encoded into artificial intelligence (AI) health technologies, there is a risk of perpetuating existing health inequalities at scale. One major source of bias is the data that underpins such technologies. The STANDING Together recommendations aim to encourage transparency regarding limitations of health datasets and proactive evaluation of their effect across population groups. Draft recommendation items were informed by a systematic review and stakeholder survey. The recommendations were developed using a Delphi approach, supplemented by a public consultation and international interview study. Overall, more than 350 representatives from 58 countries provided input into this initiative. 194 Delphi participants from 25 countries voted and provided comments on 32 candidate items across three electronic survey rounds and one in-person consensus meeting. The 29 STANDING Together consensus recommendations are presented here in two parts. Recommendations for Documentation of Health Datasets provide guidance for dataset curators to enable transparency around data composition and limitations. Recommendations for Use of Health Datasets aim to enable identification and mitigation of algorithmic biases that might exacerbate health inequalities. These recommendations are intended to prompt proactive inquiry rather than acting as a checklist. We hope to raise awareness that no dataset is free of limitations, so transparent communication of data limitations should be perceived as valuable, and absence of this information as a limitation. We hope that adoption of the STANDING Together recommendations by stakeholders across the AI health technology lifecycle will enable everyone in society to benefit from technologies which are safe and effective.

During the COVID-19 pandemic, artificial intelligence (AI) models were created to address health-care resource constraints. Previous research shows that health-care datasets often have limitations, leading to biased AI technologies. This systematic review assessed datasets used for AI development during the pandemic, identifying several deficiencies. Datasets were identified by screening articles from MEDLINE and using Google Dataset Search. 192 datasets were analysed for metadata completeness, composition, data accessibility, and ethical considerations. Findings revealed substantial gaps: only 48% of datasets documented individuals’ country of origin, 43% reported age, and under 25% included sex, gender, race, or ethnicity. Information on data labelling, ethical review, or consent was frequently missing. Many datasets reused data with inadequate traceability. Notably, historical paediatric chest x-rays appeared in some datasets without acknowledgment. These deficiencies highlight the need for better data quality and transparent documentation to lessen the risk that biased AI models are developed in future health emergencies.

A growing number of artificial intelligence (AI)-based clinical decision support systems are showing promising performance in preclinical, in silico evaluation, but few have yet demonstrated real benefit to patient care. Early-stage clinical evaluation is important to assess an AI system’s actual clinical performance at small scale, ensure its safety, evaluate the human factors surrounding its use and pave the way to further large-scale trials. However, the reporting of these early studies remains inadequate. The present statement provides a multi-stakeholder, consensus-based reporting guideline for the Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI). We conducted a two-round, modified Delphi process to collect and analyze expert opinion on the reporting of early clinical evaluation of AI systems. Experts were recruited from 20 pre-defined stakeholder categories. The final composition and wording of the guideline was determined at a virtual consensus meeting. The checklist and the Explanation & Elaboration (E&E) sections were refined based on feedback from a qualitative evaluation process. In total, 123 experts participated in the first round of Delphi, 138 in the second round, 16 in the consensus meeting and 16 in the qualitative evaluation. The DECIDE-AI reporting guideline comprises 17 AI-specific reporting items (made of 28 subitems) and ten generic reporting items, with an E&E paragraph provided for each. Through consultation and consensus with a range of stakeholders, we developed a guideline comprising key items that should be reported in early-stage clinical studies of AI-based decision support systems in healthcare. By providing an actionable checklist of minimal reporting items, the DECIDE-AI guideline will facilitate the appraisal of these studies and replicability of their findings.

In silicotrial methods promise to improve the path to market for both medicines and medical devices, targeting the development of products, reducing reliance on animal trials, and providing adjunct evidence to bolster regulatory submissions. In silicotrials are only as good as the simulated data which underpins them, consequently, often the most difficult challenge when creating robust in silicomodels is the generation of simulated measurements or even virtual patients that are representative of real measurements and patients. This article digests the current state of the art for generating synthetic patient data outside the context of in silicotrials and outlines potential synergies to unlock the potential of in silicotrials using virtual populations, by exploiting synthetic patient data to model effects on a more diverse and representative population. Synthetic data could be defined as artificial data that mimic the properties and relationships in real data. Recent advances in synthetic data generation methodologies have allowed for the generation of high-fidelity synthetic data that are both statistically and clinically, indistinguishable from real patient data. Other experimental work has demonstrated that synthetic data generation methods can be used for selective sample boosting of underrepresented groups. This article will provide a brief outline of synthetic data generation approaches and discuss how evaluation frameworks developed to assess synthetic data fidelity and utility could be adapted to evaluate the similarity of virtual patients used for in silicotrials, to real patients. The article will then discuss outstanding challenges and areas for further research that would advance both synthetic data generation methods and in silicotrial methods. Finally, the article will also provide a perspective on what evidence will be required to facilitate wider acceptance of in silicotrials for regulatory evaluation of medicines and medical devices, including implications for post marketing safety surveillance.