Needs for a shared operational methodology to draft guidelines and good practices in legal medicine.

INTRODUCTION: Article 5 of Law n. 24/2017 established the obligation for medico-legal professionals to adhere to guidelines and good clinical-care practices, except in specific cases. However, the methodologies developed for clinical practice are not entirely applicable to the field of legal medicine, which presents unique characteristics in terms of regulatory context, objectives, and evaluative processes. Legal medicine does not primarily focus on diagnosis or treatment but on standardized assessment procedures, legal defensibility, and consistency of judgments. OBJECTIVES: Starting from the experience of the Central Health Department (Sovrintendenza Sanitaria Centrale, SSC) of the Italian National Institute for Insurance against Accidents at Work (Istituto Nazionale per l'Assicurazione contro gli Infortuni sul Lavoro, INAIL), the goal is to develop a dedicated manual outlining the appropriate methods for developing guidelines and best practices in legal medicine, proposing a methodological framework. METHODS: The authors conduct a review of the literature on the topic related to the methodology for developing guidelines and best practices in forensic medicine. They took inspiration from the methodological manual for the production of clinical practice guidelines by the Italian National Institute of Health (Istituto Superiore di Sanità, ISS). DISCUSSION: The authors highlight the lack of literature specifically addressing the development of guidelines and best practices in forensic medicine. The methodological manual for the production of clinical practice guidelines by the Italian National Institute of Health (ISS) requires some adaptations but certainly represents a highly useful tool for creating relevant recommendations for legal medicine. Therefore, the authors propose a specific methodology and a dedicated manual tailored to legal medicine. The manual should be adapted from the ISS methodologies used in clinical settings, revised to reflect the unique needs of medico-legal practice, and developed in close collaboration with the relevant scientific societies and institutions. CONCLUSIONS: The method used for INAIL's SSC recommendations has proven effective in guiding internal medico-legal practices. Building on the ISS methodological manual, the authors propose a tailored approach for developing guidelines (LGML) and best practices (RBPML) in legal medicine. Given the unique challenges of the discipline - often not fully addressed by existing regulations or literature - standardized solutions are necessary to ensure consistent, high-quality medico-legal outcomes. Therefore, the establishment of a dedicated Working Group in collaboration with the ISS is essential to develop a structured methodology. INAIL's prior experience in this field provides a solid foundation for this initiative.