Carboni, Alberto (2015) Linee guida e colpa del medico. Doctoral Thesis.
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The paper aims to analyze the impact of the dissemination of Clinical Practice Guidelines (CPGs) in medical malpractice litigations and focuses on some of the problematic aspects that their use will highlight, in an attempt to facilitate prudent integration of medical science into the law.
The work is divided into three major chapters.
The first part concerns Clinical Practice Guidelines and provides an overview of Evidence Based Medicine, CPGs, and their relationship.
A similar approach has therefore been necessary to focus, first, on the genesis of the phenomenon, on the nature of CPGs developers and on the main development processes. Are then discussed the primary problems, limitations, and biases inherent Clinical Practice Guidelines in relation to their use in the legal context.
The second part of the work is focused on the important innovations introduced by the so-called "decreto Balduzzi", which marked the restriction of criminal responsibility of health care workers who have complied with Clinical Practice Guidelines and best practices accredited by the scientific community only to cases of gross negligence.
Are then treated the many questions that the new legislation has placed to legal practitioners: the identification of the notion of "esercenti la professione sanitaria" and "propria attività", the specification of the characteristics which ought to clinical practice guidelines and best practices pursuant to article 3 of Law n. 189 of 2012 and the possibility of including in that category also Clinical Practice Guidelines that take into account the need of cost containment.
In the third part, in order to give the reader a more complete picture that can provides insights into a prospect “de iure condendo”, are analyzed the ways in which the major European and North American jurisdictions have dealt with the regulatory guidelines.
Finally, in the concluding section of the present work there is a review of case law that collects all the rulings of the Supreme Court which have solved malpractice cases by resorting, to exclude or to establish a charge of guilt against the accused, on Clinical Practice Guidelines or other diagnostic-therapeutic protocols.
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