Trusting telemedicine: A discussion on risks, safety, legal implications and liability of involved stakeholders.

OBJECTIVES: The main purpose of the article is to raise awareness among all the involved stakeholders about the risks and legal implications connected to the development and use of modern telemedicine systems. Particular focus is given to the class of "active" telemedicine systems, that imply a real-world, non-mediated, interaction with the final user. A secondary objective is to give an overview of the European legal framework that applies to these systems, in the effort to avoid defensive medicine practices and fears, which might be a barrier to their broader adoption. METHODS: We leverage on the experience gained during two international telemedicine projects, namely MobiGuide (pilot studies conducted in Spain and Italy) and AP@home (clinical trials enrolled patients in Italy, France, the Netherlands, United Kingdom, Austria and Germany), whose development our group has significantly contributed to in the last 4 years, to create a map of the potential criticalities of active telemedicine systems and comment upon the legal framework that applies to them. Two workshops have been organized in December 2015 and March 2016 where the topic has been discussed in round tables with system developers, researchers, physicians, nurses, legal experts, healthcare economists and administrators. RESULTS: We identified 8 features that generate relevant risks from our example use cases. These features generalize to a broad set of telemedicine applications, and suggest insights on possible risk mitigation strategies. We also discuss the relevant European legal framework that regulate this class of systems, providing pointers to specific norms and highlighting possible liability profiles for involved stakeholders. CONCLUSIONS: Patients are more and more willing to adopt telemedicine systems to improve home care and day-by-day self-management. An essential step towards a broader adoption of these systems consists in increasing their compliance with existing regulations and better defining responsibilities for all the involved stakeholders.

Constitution and common law in bioethics.

In recent years legal intervention in bioethical matters has increased notably following various paths: court decisions, parliamentary acts, codes of conduct and solemn declarations (i.e. European Bioethics Convention, 1997, or the UNESCO Genome Declaration, 1997). Body and liberty, as a question of fundamental legal rights, are constitutionalized along two paths. The former is vertical (a text created at central level is open to ratification and domestic implementation to finally become the rule in concrete cases). The latter is, above all, horizontal. It is characterized by the existence at world level of a number of centres and institutions, with the judiciary and judge-made law playing a major role. The most important new rights and freedoms in bioethics have been recognized in this ever-changing and troubled environment. The horizontal way has the great advantage of considering the differences as a resource and not as a limit. In the case law on bioethics a sort of jurisprudential model seems to be at work, that goes some way toward a judge-made law at a universal level. Cases such as Cruzan, Bland and Massimo held the fundamental concept of self-determination with surprising similarity. But we don't know if one of them has influenced the others, always supposing that the judges were aware of them. Today's first duty is to raise the consciousness of judges as to how common their problems are and how often their rulings are similar to each other's.

[The liberty of care]. / La libertà di cura.

In our societies everybody has a right to decide in order to treatments on her/his own body, according to her/his ideas, sensibility and wills. Physicians cannot answer to the patient's world only in terms of scientific rationality. The future challenge is to find the way to improve, at the same time, the scientific standard of medical treatments and the response to single patient's needs.

The code of conduct of the volunteer.

Voluntary service has experienced a considerable expansion and a substantial change over the last two decades. The role of the volunteer has gradually come to interact with activities undertaken by other professionals, but without interfering. Since the role of the volunteer naturally involves autonomy and discretion on his/her behalf, the associations concerned increasingly feel the need to refer to standards defining a voluntary service ethic. Within a refresher course with a set number of places for non-profit-making organisations, which was arranged by the Italian League against Cancer, Milan, a consensus conference for the ratification of a code of conduct on voluntary service was held. The aim was to reach a consensus together with others who work in an "organised" manner every day, on ethical concepts that should inspire voluntary service: the common good, mutual respect, freedom of choice, a non-profit-oriented vision. After exhaustive discussions by three panels, the text of a code of conduct unanimously approved was elaborated. All concerned with this code tried to avoid giving it a "sanitary" imprint. It is in fact our opinion that whatever the area covered by voluntary service, its aim and its final objective is to ensure the wellbeing of mankind and his environment.

Attitudes toward euthanasia of physician members of the Italian Society for Palliative Care.

BACKGROUND: The problems related to requests for euthanasia by terminal patients; the variations in attitude of palliative care physicians and the possibility that availability of the best palliative care might obviate the problem by eliminating requests for euthanasia, are under discussion. DESIGN: A mailed survey with no possibility of follow-up of all 685 physician members of the Italian Society for Palliative Care (SICP) in 1994. RESULTS: Of the 359 (52.4%) responders, 139 (39%) had received requests for euthanasia; 16 of them (4% of the responders but 11.5% of those who received requests) had complied at least once, while 216 (60%) had not; 125 (35%) thought that euthanasia was 'wrong' under all circumstances; 115 (32%) thought that situations could occur, even in the context of palliative care, in which euthanasia might be ethically 'correct'; 185 (52%) thought that the best palliative care might solve the problem of euthanasia, while 109 (30%) believed otherwise. The variable most strongly associated with a negative attitude toward euthanasia and with the opinion that the best palliative care might be a solution to the problem is religious belief (P < 0.0001). CONCLUSIONS: The attitudes of physicians practising palliative care in Italy are not different from those reported by previous studies which investigated the attitude of other health professionals. There was no agreement about whether the best palliative care might reduce requests for euthanasia by terminal patients.