Explanation and elaboration of MedinAI: guidelines for reporting artificial intelligence studies in medicines, pharmacotherapy, and pharmaceutical services.

Abstract

The increasing adoption of artificial intelligence (AI) in medicines, pharmacotherapy, and pharmaceutical services necessitates clear guidance on reporting standards. While the MedinAI Statement (Bottacin in Int J Clin Pharm, https://doi.org/10.1007/s11096-025-01905-3, 2025) provides core guidelines for reporting AI studies in these fields, detailed explanations and practical examples are crucial for optimal implementation. This companion document was developed to offer comprehensive guidance and real-world examples for each guideline item. The document elaborates on all 14 items and 78 sub-items across four domains: core, ethical considerations in medication and pharmacotherapy, medicines as products, and services related to medicines and pharmacotherapy. Through clear, actionable guidance and diverse examples, this document enhances MedinAI's utility, enabling researchers and stakeholders to improve the quality and transparency of AI research reporting across various contexts, study designs, and development stages.