Risk Management for a Legally Valid Informed Consent.

ABSTRACT: Gelli-Bianco law (Law no. 24/2017) intervenes both in order to divide healthcare liability between the healthcare professional and the facility in which he/she exercises and to incentivize the latter to adopt an organizational model suitable for managing the risk associated with the provision of any healthcare service, including the information for consent. In fact, the healthcare facility must guarantee clear, complete and adequate information on the specific case, which, therefore, cannot consist of standard forms to be signed by the patient, under penalty of a flawed consent to treatment and consequent healthcare liability in the event of an adverse event. The regulation mandates that safety must be guaranteed through proper prevention tools and health care risk management, in con-junction with the most effective use of structural, technological and organizational resources available. It further spells out the obligation of health care professionals to contribute to risk prevention while administering health care procedures. For this reason, the consent information constitutes a source of risk for the responsibility of the healthcare provider and the Facility and it must necessarily be managed. Risk Management is the management tool that can allow the healthcare facility to improve the quality and safety of the services provided, optimizing the risk of adverse events through proper moni-toring of the same. This paper will be published, following a special agreement, on the two journals "Igiene e Sanità Pubblica" and "La Clinica Tera-peutica", in Italian and in English, in order to increase the diffusion to a wider audience.

Risk management and Healthcare responsibility. How to guarantee legal protection in Medicine.

Having regard to the increasing attention to the issue of safety and health of patients and workers by low, the hypothesis that this topic will be the growing trend in the next years does not seem to be manifestly unfounded. For this reason, it is wise for healthcare professionals to already be aware that any violation of the interests underlying the legislation in question entails a ruling on civil and/or criminal liability. It is therefore necessary to identify the most suitable means to prevent undue harm occurring, partly to exempt healthcare professionals and hospitals from compensation costs, thereby providing them with recourse to insurance coverage. Healthcare facility organisations must adopt Risk Management techniques as a tool to simultaneously guarantee the effectiveness of health services (in this case), the efficiency of the management economy, and finally compliance with all legally required precautions. This will relegate the occurrence of an adverse event to remote and unpredictable hypotheses, thus guaranteeing useful recourse to insurance coverage to compensate any harm that does occur.