Pratica Medica & Aspetti Legali
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Le “Accountability Measures” in ambito medico legale: la cartella clinica
No full text[The "Accountability Measures" in forensic medicine: medical records]National and international healthcare systems are increasing attention for safety and improvement of diagnostic and therapeutic practices today, according to the latest, scientifically accepted, good clinical practice indications and management.The assets of clinical risk management are important. These, on the one hand, are designed to reduce possible adverse events for patients, on the other hand enable the optimization of human, managerial, economic resources. Health records and medical records study and evaluation are of great importance both in relation to health care targets (quality of services offered) and legal targets (professional liability).The Hospital "Azienda Ospedaliero Universitaria - Ospedali Riuniti di Trieste", JCI accredited since 2008, is evaluating medical records periodically, in accordance with the law and with the procedures for accreditation and in order to assess the performance and improvement indicators.Our work has evaluated 2840 Medical Records, from 2010 to 2013, and their adherence to quality standards.The collected data were analyzed year after year. We detected critical, proposed and implemented solutions. We also have consolidated areas of excellence and recognized a significant improvement in different evaluation items.In conclusion, this activity is foundamental. It provides data and information on health care quality and standards of good clinical practice that the hospital and staff offer to safeguard patients health
La bi-direzionalità funzionale tra processo di consenso informato e mediazione sanitaria
Full text link[The bi-directionality among informed consent process and mediation applied to healthcare conflicts] Informed consent in the hospital as in any other healthcare setting is - before anything else - a process of communication and relationship which must involve the patient in a decision directly affecting his/her health. In this article, we focus our attention on the bi-directionality existing among an informed consent process and the instrument of alternative dispute resolution constituted by mediation applied to healthcare conflicts. The link between the two legal institutions is bidirectional because informed consent is a fundamental premise of a good mediation and mediation - in turn - can be an important stimulus to continuously improve the process of informed consent. This bi-directionality for both legal institutions is fueled by the element of "trust". While trust in informed consent is the result of a continuous dialogue and listening between the doctor, the staff and the patient, in mediation it represents the crucial element to be redialed. Therefore, mediation in health care is an effective tool for managing conflicts to the extent that goes to latch on to a real and previous communicative relationship that actually materialized between the parties around the relationship of care. The emotional reality of the patient and his family - as well as that one regarding health professionals themselves - can emerge in an effective way during mediation, through the co-presence of the parties in a facilitated dialogue. This same reality can motivate health professionals to acquire a thorough and in-depth training on the aspects of values, techniques and tools necessary for the realization of a genuine process-based informed consent within an effective doctor-patient communication. All this can and must be done - in an organization sensitive to these issues - according to a virtuous cycle that feeds on itself and creates a renewed wellness for physicians as well as for patients in their inseparable relationship of care
Responsabilità civile del medico: responsabilità da inadempimento o probatio diabolica? Il punto di vista della III Sezione Civile della Corte di Cassazione nella sentenza n° 12264 del 30.05.2014.
No full text[Medical Liability: liability by frustration or probatio diabolica? The point of view of the3rd Civil Section of the Supreme Court in the judgment n. 12264 of the 30.05.2014]The Authors analyze, under a judicial and medico-legal profile, the judgment n. 12264 of the 30.05.2014 of the 3rd Civil Section of the Supreme Court. In this judgment, they examine the omissive behavior by a physician of an ASL who, for the entire length of the pregnancy and having performed the proper diagnostic tests, failed to notice foetal malformations which resulted in birth defects such as agenesis of two fingers and femoral hypoplasia.The verdict brought a new criterion for distributing the evidential responsibilities of the concerning parties, the expecting mother and the physician, establishing that «it’s the accusing party’s responsibility to allege and demonstrate, if in fact informed of the malformations of the conceived foetus, she would have interrupted the pregnancy, since such proof can’t be deduced only by the fact of requesting to be subjected to examinations with the purpose to verify the existence of eventual foetal anomalies»
Le fondazioni di ricerca e di assistenza sanitaria: alcuni aspetti giuridici
Full text link[Foundations of research and health care: some legal aspects]IRCCS Foundations have been recently created by Legislative Decree number 288 (16th October 2003) as part of the reorganization of the Institutes of hospitalization and treatment of scientific value (IRCSS – Istituti di ricerca e cura a carattere scientifico). The decree allows the IRCCS to change into IRCCS Foundations with a national importance, open to the participation of public and private entities. IRCCS have been defined by the Ministry of Health as hospitals of excellence aimed at research in the biomedical field and in the organization and management of the health service. Due to the recognition of their “scientific value”, since they deal with particular pathologies of national importance, they have been qualified as IRCCS. Moreover, they can enjoy a public fund and a regional fund, which allow them to carry out their research in specific areas such as oncology, disabling chronic degenerative diseases, pediatric psychiatry, rehabilitation and organ transplants, etc. IRCCS are defined as public or private entities with “national relevance” provided with autonomy and juridical personality which aims at two main goals: a) biomedical research and clinical and translational; b) the organization and management of healthcare services. The creation of Foundations was the consequence of the economic crisis that hospitals were going through: the new legal entities have brought in fresh aids, both public and private, that Foundations can use with the obligation of non-profit and to invest in research all the incomes from other activities. The Foundations have been included into the National Health Service. With the Legislative Decree n. 288/2003, IRCCS-Foundations show a new model of administration. The aim of the Legislative Decree n. 288/2003 is also oriented to the reorganization of IRCCS, promoting a new but non conflicting relationship between public and private sectors working together to achieve the same goals
Ustione corneale durante intervento di facoemulsificazione: contributo casistico e considerazioni medico-legali
No full text[Corneal burn during phacoemulsification surgery: case report and medico-legal considerations]The authors report a case of severe corneal burn, occured a few seconds later the beginning of the surgical procedure of phacoemulsification on a 63 years old woman affected by cataract.The authors analyzed the case as a result of claims for damage to the surgeons and the hospital by the patient.In terms of assessment of responsibility, medico-legal investigation is aimed at identifying whether the responsibility of the event of damage to the patient is to be attributed to the negligent conduct of the surgeon or to defects or damage to the equipment used by the same. The authors underline the importance of an accurateknowledge of the procedures for using in safety the instrumentation and monitoring the adverse reactions connected to the use of the instrumentation itself, even in the global risk management
Direttiva Europea 2001/20/EC sulla sperimentazione clinica: implicazioni sulla ricerca clinica in Italia
No full text[The European Directive 2001/20/EC on clinical trials in Italy]The European Directive 2001/20/EC legally ensured the implementation of the principles of good clinical practice in clinical trials on medicinal products in Europe. The Directive establishes, specific provisions regarding clinical trials conduction in all Member States, including multicenter trials on human subject involving medicinal products and harmonizes the practice of Independent Ethics Committees (IEC) and administrative provisions. In Italy, the European Directive was implemented by the Legislative Decree 211/2003 that considers three subsequent phases in the activation procedure of multicenter clinical trials: first, the clinical trial application submission to the IEC of both the coordinating and the participating centres as well as the administrative agreement submission to the Competent Authority of participating centres; second, the issuance of the “single” opinion by the IEC of the coordinating centre and, in case of positive opinion, the acceptance or refusal by the IEC of each participating centre; third, in case of acceptance, the trial contracts signature between the coordinating and each participating centre. Moreover, the European Directive defines the time required for issuing of opinion by the IEC. However, the high variability of documentation “centre-specific” required by independent ethics committee (IEC) plays a critical role in the time required for activation of participating centres of multicenter clinical trials. The harmonization of IECs practice in Italy and the reduction of the total number of IECs are the first step to facilitate multicenter clinical trials. Similar efforts should be made to standardize administrative procedures concerning the approval of clinical trials
Le linee guida nella nuova legge di riforma della responsabilità medica
No full text[The guidelines in the new law reforming the medical liability]The increasing complexity of clinical practice has significantly strengthened the need for guidelines that provide physicians with clear professional standards for inspiration and, not infrequently, cling to withstand the wind of a sometimes excessive responsibility of their activities. Clinical guidelines are defined as «systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances».The fact that the guidelines indicate the rules of proper practice of the profession has led many doctors to hope that, according to them, they could avoid incurring liability. The doctrine has long held that the rules contained in the guidelines can have an abstract value, but the assessment of the behaviour of the physician must be conducted in the light of all the data of the individual and concrete clinical cases, which certainly can not be taken into consideration by the drafters of the guidelines. Although the medical-legal relevance of the guidelines was reduced by the Supreme Court in some cases, the legislature has decided to focus on guidelines to curb the phenomenon of defensive medicine and restoring tranquility to the doctors in the exercise of profession.Purpose of our article is to present a commentary on Article 3 of Decree Law no. 158/2012 (so-called "Decreto Balduzzi"), to highlight some critical points that are likely to frustrate the objective of the legislature
Ricorso avverso il giudizio del medico competente: case report
No full text[Appeal against the judgment of the physician in charge: a case report]Health surveillance is only one of the roles of the competent physician: his duties and responsibilities are governed by Legislative Decree 81/08. The case report is described to reflect on the roles of the various components (employee, employer and physician) in compliance with the Constitution (articles 35-40) and the Workers’ Statute (Law 300, 20 May 1970)
Accessibilità e sicurezza dei farmaci in pediatria
No full text[Accessibilty and safety of drugs in pediatrics]Many of pediatric drugs have not been tested and evaluate in children. The risks associated with the off-label use of drugs without pediatric indications include adverse effects, inefficacy, and improper formulation. Furthermore the use of magistral or officinal formulations to treat the pediatric population may be of poor quality. The objectives of EU Regulation 1901/2006 on medicinal products for pediatric are to improve the health of children by facilitating the development and availability of medicines for children, ensuring that medicines for use in children are of high quality, ethically researched and authorised appropriately, and improving the availability of information on the use of medicines for children. Peyona (caffeine citrate) is authorised for the treatment of primary apnea of premature newborns and it’s a good example of drug tested and evaluate in children
Il contenzioso sanitario previdenziale. Il nuovo procedimento di accertamento tecnico preventivo
No full text[Social protection and litigation. The new technical preventive assessment]This article examines the Italian situation related to legal litigations in case of civil invalidiy. Since the number of litigation and processes in this particular field is extremely high, there’s the need to simplify and better organize procedures an techniques. In recent years, INPS (the Italian National Social Security Institute) has developed many simplified procedures for invalidity proceedings. These include not only invalidity and disability allowance, but also old age and pension benefits. In particular, the article describes the new procedure called “accertartamento tecnico preventivo” (technical preventive assessment)