Advance care directives: Citizens, patients, doctors, institutions.

Italian Law no. 219/2017 established the advance care directives ("Disposizioni anticipate di trattamento" - DAT), a legal document specifying the person's wishes in relation to health, drawn up in case of the possible future incapacity to make informed decisions. DAT are an important instrument of empowerment for a person who is not necessarily a "patient" and enable the dialogue between healthcare providers and patient to continue when the latter is no longer able to take part consciously. DAT can only be implemented by guaranteeing the fundamental rights of the person, i.e. by ensuring the "non-complicated" use of this instrument and easy access to the DAT whenever it may be necessary. Furthermore, on the one hand, the requirement of adequate prior medical information has to contend with the fact that the wishes expressed in the document may have been formed outside of the therapeutic relationship; on the other hand, institutions must ensure that DAT are collected and recorded in such a way as to ensure their availability whenever and wherever necessary.

Genetic Testing and Professional Responsibility: The Italian Experience.

Responsibility means responding to the damaging consequences of technical work and in this binding perspective the general principles of guilt in genetic diagnostics and related activities are not different from any other medical performance. Performing a genetic test however, especially when it has predictive characteristics, offers absolutely peculiar technical deontological issues. It is not and should not be considered as a mere habitual laboratory test but as a complex set of interactions that presupposes adequate information as a valid consensus to formalize absolutely in written form.

Genetic Testing: Ethical Aspects.

The aim of this article is to provide an analysis of the main issues related to the application of predictive medicine by analysing the most significant ethical implications. Genetic medicine is indeed a multidisciplinary matter that covers broad contexts, sometimes transversely. Its extreme complexity, coupled with possible perceived repercussions on an individual's life, involves important issues in the ethical, deontological and legal medical field. The aspects related to the execution of genetic testing have to be addressed at different levels, starting with the correct information about the "cognitive" meaning they intend (by forcefully disassociating it from the strange "preventive aspect") to the legal medical issues that can be aroused in the field of forensic pathology, medical responsibility and insurance. There is no doubt that in recent years, from the decoding of the human genome, genetic research has exponentially expanded with an equally exponential increase in its use in clinical practice and the ethical and social evolution of it.

Blood Transfusion in Children: The Refusal of Jehovah's Witness Parents'.

In Italy, both parents have parental responsibility; as a general principle they have the power to give or withhold consent to medical procedures on their children, including consent for blood transfusion; however these rights are not absolute and exist only to promote the welfare of children. METHODS: The Authors discuss ethical and legal framework for Jehovah's Witness parents' refusal of blood transfusion in Italy. They searched national judgments concerning Jehovah's Witness parents' refusal of blood transfusion - and related comments - in national legal databases and national legal journals, and literature on medical literature databases. RESULTS: In the case of Jehovah's Witness parents' refusal of blood transfusion for their child, Italian Courts adopt measures that prevents the parents from exercise their parental responsibility not in the child's best interest. DISCUSSION: In the event that refusal by the parents, outside of emergency situations, exposes the child's health to serious risk, health workers must proceed by notifying the competent authority, according also to the Italian Code of Medical Ethics. CONCLUSION: When the patient is a minor, the child's best interest always come first.

Aesthetic Dental Procedures: Legal and Medico-legal Implications.

Dental treatments, as well as simple anatomical and functional repair work, can also be for aesthetic purposes. This is because the anatomical area concerned, i.e. the oral cavity, has a great power of attraction. Aesthetic treatments in general - in particular dental treatments - have been on the rise in recent years, and this has also meant an increase in claims due to patient dissatisfaction with the results obtained. Numerous laws have been introduced that emphasise the need for comprehensive prior information in order to acquire valid consent. This has resulted in the elimination of the distinction between the obligation of means and obligation of result, with achievement of the normally expected result required in any case.

Ethical and Legal Issues in Gestational Surrogacy.

This study originated from events that occurred in 2014 in an Italian hospital, where the embryos of a couple, obtained by means of homologous insemination, were mistakenly implanted into the uterus of another woman who, along with her husband, underwent the same treatment. Faced with this serious adverse circumstance, that gives rise to ethical and legal issues, the authors conducted a comparative examination of how to consider the division of maternity (between biological mother and uterine mother) and the related division of paternity (between genetic father and legal father, husband or partner of the gestational mother). Some preliminary observations are made concerning parenthood and filiation within the context of currently applicable Italian law. The following is a detailed analysis of the arguments in favour of the parental figures involved (gestational mother/genetic mother).

The protection of health in the care and trust relationship between doctor and patient: Competence, professional autonomy and responsibility of the doctor and decision-making autonomy of the patient.

The Authors review Law No. 219/2017, with its important contribution to defining the roles and responsibilities of subjects in care relationship - a dynamic relationship (over time, for the condition of the interested party, to people who may be involved) - and regulating advance directives and shared planning of care. The Law promotes and enhances the relationship of care and trust between doctor and patient, which includes the competence, professional autonomy and responsibility of the doctor and the decisional autonomy and right to self-determination - to make an informed and voluntary choice about treatment proposed by the doctor - of the patient. For concrete implementation of the Law, an adequate information system and all the measures to guarantee certainty about the consequences of behaviour and protection of the rights of all the subjects involved are now essential. In addition, for advance directives, it is essential to reflect on the adequacy of medical information required by the Law itself for its drafting, considering that the citizen can contact qualified professionals and also independently find this information autonomously, selecting the sources of information.

Malfunctions of robotic system in surgery: role and responsibility of surgeon in legal point of view.

Robotic surgery (RS) technology has undergone rapid growth in the surgical field since its approval. In clinical practice, failure of robotic procedures mainly results from a surgeon's inability or to a device malfunction. We reviewed the literature to estimate the impact of this second circumstance in RS and its consequent legal implications. According to data from the literature, device malfunction is rare. We believe it is necessary to complement surgical training with a technical understanding of RS devices.

Donation of the body for scientific purposes in Italy: ethical and medico-legal considerations.

In recent years in Italy (and in the other European Countries) a new debated topic involves anatomists and the scientific world: donation of the body after death for scientific purposes. The aim of our analysis is to analyze the issue of voluntary body donation in Italy focusing first of all, on key principles of the disciplines of donation. Considering the rise of exhibitions and events in which death is spectacularized, the debate is focus on will, on respect and overall on the purpose for which the body is donated. Anatomical dissection is considered necessary in the direct learning of the human body, of surgical practices and new scientific techniques but the scarcity of programmes and regulations regarding the donation of bodies for study and research make it an uncommon practice. After discussing what are the constitutional principles underlying the issue we want to emphasize the need of a more effective and updated regulation to set limits and methods of a practice still essential for scientific progress.

Voluntary termination of pregnancy (medical or surgical abortion): forensic medicine issues.

In Italy, Law 194 of 22 May 1978 provides for and regulates the voluntary termination of pregnancy (VTP). Medical abortion became popular nationwide after Mifepristone (RU-486) was authorized for the market by AIFA (Italian Drug Agency) in July 2009. We searched articles in medical literature database with these terms: "medical abortion", "RU486", "surgical abortion". We also searched laws and judgments concerning abortion in national legal databases. Ministerial guidelines were searched on official website of Italian Ministry of Health. We found many medical studies about medical and surgical abortion. We found also ministerial and regional guidelines, which were analyzed. From the point of view of legal medicine, the issues related to abortion with the pharmacological method consist in verifying compatibility and consistency with the safety principles and the parameters imposed by Law n. 194 of 1978, using off-label Misoprostol, what inpatient care should be used and informed consent. The doctor's job is to provide the patient with comprehensive and clear information about how the procedure will be performed, any complications and the time period needed for both procedures.

Iatrogenic splenic injury: review of the literature and medico-legal issues.

INTRODUCTION: Iatrogenic splenic injury is a recognized complication in abdominal surgery. The aim of this paper is to understand the medico-legal issues of iatrogenic splenic injuries. We performed a literature review on PubMed and Scopus using iatrogenic splenic or spleen injury and iatrogenic splenic rupture as keywords. Iatrogenic splenic injury cases were identified. Most cases were related to colonoscopy, but we also identified cases related to upper gastrointestinal procedures, colonic surgery, ERCP, left nephrectomy and/or adrenalectomy, percutaneous nephrolithotomy, vascular operations involving the abdominal aorta, gynecological operation, left lung biopsy, chest drain, very rarely spinal surgery and even cardiopulmonary resuscitation. There are several surgical procedures that can lead to a splenic injury. However, from a medico-legal point of view, it is important to assess whether the cause can be attributed to a technical error of the operator rather than being an unpredictable and unpreventable complication. It is important for the medico-legal expert to have great knowledge on iatrogenic splenic injuries because it is important to evaluate every step of the first procedure performed, how a splenic injury is produced, and whether the correct treatment for the splenic injury was administered in a judgment.

Cosmetic surgery: medicolegal considerations.

Cosmetic surgery is one of the two branches of plastic surgery. The characteristic of non-necessity of this surgical speciality implies an increased severity in the evaluation of the risk-benefit balance. Therefore, great care must be taken in providing all the information necessary in order to obtain valid consent to the intervention. We analyzed judgments concerning cosmetic surgery found in national legal databases. A document of National Bioethics Committee (CNB) was also analyzed. CONCLUSION: The receipt of valid, informed consent is of absolute importance not only to legitimise the medical-surgical act, but it also represents the key element in the question concerning the existence of an obligation to achieve certain results/use of certain methods in the cosmetic surgery.

Medically Assisted Procreation and Fast-Moving Developments in Science and Law: Ethical and Legal Issues in Heterologous Procreation in Italy.

Significance for public healthContinual scientific progress is making new applications available, with significant medical, ethical, legal and social implications, not only for the persons directly concerned. In the area of medically assisted procreation, the use of heterologous techniques is able to overcome problems of sterility or infertility for those requesting access to methods of this kind. On the other hand, legislation is required to regulate the many correlated issues, also with regard to other parties such as ova or sperm donors and the offspring resulting from the use of these techniques: the protection of the health of the offspring; the management of laboratory results obtained during donor selection tests; the protection of confidentiality; the donor-child traceability; the number of donations; and individuals' rights to be fully informed about their biological origins are just some of the questions confirming that the implications of new procreation techniques are not restricted merely to the couples who access them.

What about the dentist-patient relationship in dental tourism?

Dental tourism is patients travelling across international borders with the intention of receiving dental care. It is a growing phenomenon that raises many ethical issues, particularly regarding the dentist-patient relationship. We discuss various issues related to this phenomenon, including patient autonomy over practitioner choice, patient safety, continuity of care, informed consent and doctor-patient communication, among other factors. In particular, patients partaking in medical tourism should be informed of its potential problems and the importance of proper planning and post-treatment care to guarantee high-quality treatment outcomes.

Care for the Person, Protection of Health and Respect for the will of the Patient in Italy: Support Administration as a Tool to Jointly Promote Health and Respect for Autonomy in Incompetent Patients.

In Italy, advance health care directives are a subject of considerable debate in both legal theory and practice. This debate focuses in particular not only on the appropriateness of approving ad hoc statutory regulations but also on the extent to which similar advance indications of a person's wishes are applicable under the existing legal system, albeit in the absence of a law regulating them. The authors of this paper consider, in particular, guidelines relating to the possible use of the mechanism of support administration (amministrazione di sostegno) (Law No. 6/2004) as a procedure to be used for the legal recognition of advance health care directives, particularly in the light of the legal provision for the possible designation in advance of a support administrator by a beneficiary in anticipation of an eventual situation of incapacity. This underlines how the concept of health does not only exist in the abstract, but must be measured in relation to the particular patient in the particular situation and how beneficence and respect for autonomy are both essential elements in the choices aimed at promoting the health and the wellbeing of its citizens. Significance for public healthThe concept of health includes not only the physical, but also the psychosocial dimension in accordance with the will of people. The reference to the personal concept of quality of life, values, ethical and religious opinions of each subject are key components underlying the decision-making process concerning a given patient in a given clinical condition: the concept of health does not only exist in the abstract, but must be measured in relation to the specific patient in the specific situation. The authors analyse the Italian debate about the possible designation in advance of the support administrator on the part of the beneficiary in anticipation of a potential situation of incapacity, as a tool to enforce advance care directives, to show how beneficence and respect for autonomy are both essential elements in the choices of the legal system aimed at promoting the health and the wellbeing of its citizens.

Consent in dentistry: ethical and deontological issues.

In Italy, consent for health treatment, aside from being an ethical and deontological obligation, constitutes an essential requirement for any medical treatment according to articles 13 and 32 of the National Constitution and also in accordance with the Council of Europe's 'Convention on Human Rights and Biomedicine'. An essential requirement for the validity of consent is that clear, exhaustive and adequate information be provided to the patient himself: the practice of informed consent is a communicative relationship in which the patient can express doubts, perplexities and clarification requests to the dentist. Furthermore, dental treatment has specific peculiarities: the relationship between dentistry and aesthetics, the concomitant presence of pathologies requiring different treatments, the elongated care process and the establishment of a trustworthy relationship and familiarity with the patient represent important aspects in the configuration of the dentist-patient relationship and in the process of acquiring informed consent. The dentist must offer correct information on diagnosis, prognosis, the therapeutic perspective and the likely consequences of therapy, alternative therapy and refusal of therapy, as well as eventual commitments for the period after treatment. Particular consideration must be given to minors and patients of unsound mind: the dentist's approach to these patients needs to be clear and appropriate to the person's age and understanding ability, even if the decisional power for sanitary treatment may be in the hands of a third person.

HIV-positive status and preservation of privacy: a recent decision from the Italian Data Protection Authority on the procedure of gathering personal patient data in the dental office.

The processing of sensitive information in the health field is subject to rigorous standards that guarantee the protection of information confidentiality. Recently, the Italian Data Protection Authority (Garante per la Protezione dei Dati Personali) stated their formal opinion on a standard procedure in dental offices involving the submission of a questionnaire that includes the patient's health status. HIV infection status is included on the form. The Authority has stated that all health data collection must be in accordance with the current Italian normative framework for personal data protection and respect the patient's freedom. This freedom allows the patient to decide, in a conscious and responsible way, whether to share health information with health personnel without experiencing any prejudice in the provision of healthcare requested. Moreover, data collection must be relevant and cannot exceed the principles of treatment goals with reference to the specific care of the concerned person. However, the need for recording information regarding HIV infection at the first appointment, regardless of the clinical intervention or therapeutic plan that needs to be conducted, should not alter the standard protection measures of the healthcare staff. In fact, these measures are adopted for every patient.