Nowadays science and technology offer us artificial intelligence (AI) “embodied” in robots. They are able to self-learn, self-organize and self-reproduce, thanks to genetic algorithms, artificial neural networks and other tools. The focus of this research includes results from the diffusion of a social phenomenon consisting in the application of robots in the most disparate realities (industrial and domestic). Robotics is the AI branch whose aim is to build machines that are able “to feel, to think and to act”. A robot is a complex system that integrates many AI results: such as vision, natural language, study of the movement, communication, machine learning, and knowledge representation and planning. Robotics presents a fascinating and unexpected scenario. Everything we have seen until now - cars, computers, mobile phones and internet - is an AI product and robots in a near future will be used in factories, in yards, in offices, and they will work as nurses in hospitals and in households. The development of robots raises new ethical, legal and social issues, such as the allocation of civil liability when a robot harms a human being. If software agents can process and take decisions autonomously who will be held liable in case of harmful consequences of these decisions? The manufacturer, the programmer, the owner, or other subjects? The answer requires an analysis on both ex ante and ex post tortious event.

 * * *
Aujourd’hui science et technologie nous offrent l’intelligence artificielle (AI) «incarnes» dans les robots. Ils sont capables d’apprendre, de s’organiser et de se reproduire, grâce a des algorithmes genetiques, reseaux de neurones artificiels et d’autres outils. L’objectif de cette recherche comprend les resultats de la diffusion d’un phenomene social consistant dans l’application de robots dans les realites les plus divers (domestiques et industriels). Robotique est le secteur du AI dont le but est de construire des machines qui sont en mesure de «sentir, penser et agir». Un robot est un systeme complexe qui integre de nombreux resultats du AI: tels que la vision, la langue naturelle, l’etude du mouvement, la communication, l’apprentissage machine, et la representation de la connaissance et de la planification. Robotique presente un scenario fascinant et inattendu. Tout ce que nous avons vu jusqu’a present - les voitures, les ordinateurs, les telephones mobiles et Internet - est un produit du AI et les robots dans un proche avenir seront utilises dans les usines, les gares, les bureaux et ils vont travailler comme infirmieres dans les hopitaux et dans les menages. Le developpement de robots souleve de nouvelles questions ethiques, juridiques et sociales, telles que l’attribution de la responsabilite civile quand un robot nuit un etre humain. Si des agents logiciels peuvent traiter et prendre des decisions de maniere autonome qui sera tenu responsable en cas de consequences nefastes de ces decisions? Le fabricant, le programmateur, le proprietaire, ou d’autres sujets? La reponse exige une analyse relative ex ante et ex post le fait generateur.

/pdf/regulation-on-safety-and-civil-liability-of-intelligent-2uw3fxst9c.pdf

Regulation on Safety and civil Liability of intelligent autonomous Robots: the case of smart Cars

In biomedical research and translational medicine, the ancient war between exclusivity (private control over information) and access to information is proposing again on a new battlefield: research biobanks. The latter are becoming increasingly important (one of the ten ideas changing the world, according to Time magazine) since they allow to collect, store and distribute in a secure and professional way a critical mass of human biological samples for research purposes. Tissues and related data are fundamental for the development of the biomedical research and the emerging field of translational medicine: they represent the “raw material” for every kind of biomedical study. For this reason, it is crucial to understand the boundaries of Intellectual Property (IP) in this prickly context. In fact, both data sharing and collaborative research have become an imperative in contemporary open science, whose development depends inextricably on: the opportunities to access and use data, the possibility of sharing practices between communities, the cross-checking of information and results and, chiefly, interactions with experts in different fields of knowledge. Data sharing allows both to spread the costs of analytical results that researchers cannot achieve working individually and, if properly managed, to avoid the duplication of research. These advantages are crucial: access to a common pool of pre-competitive data and the possibility to endorse follow-on research projects are fundamental for the progress of biomedicine. This is why the "open movement" is also spreading in the biobank's field. After an overview of the complex interactions among the different stakeholders involved in the process of information and data production, as well as of the main obstacles to the promotion of data sharing (i.e., the appropriability of biological samples and information, the privacy of participants, the lack of interoperability), we will firstly clarify some blurring in language, in particular concerning concepts often mixed up, such as “open source” and “open access”. The aim is to understand whether and to what extent we can apply these concepts to the biomedical field. Afterwards, adopting a comparative perspective, we will analyze the main features of the open models – in particular, the Open Research Data model – which have been proposed in literature for the promotion of data sharing in the field of research biobanks.
After such an analysis, we will suggest some recommendations in order to rebalance the clash between exclusivity - the paradigm characterizing the evolution of intellectual property over the last three centuries - and the actual needs for access to knowledge. We argue that the key factor in this balance may come from the right interaction between IP, social norms and contracts. In particular, we need to combine the incentives and the reward mechanisms characterizing scientific communities with data sharing imperative.

/pdf/intellectual-property-open-science-and-research-biobanks-1a8ntms9dm.pdf

Intellectual Property, Open Science and Research Biobanks

For many years the problem of food security has been addressed only in relation to developing countries, due to the fact that people in developed nations had a relatively abundant supply of food. This is not anymore true both because of the economic crisis and an increasing demand of food at the global level. Therefore, food surplus in the food chain both at the production level and at household consumption could become a resource. In this respect, legal rules (e.g., the Good Samaritan Act in the United States) may provide incentives to economic agents for recovering food surplus. This paper examines in a comparative way legal remedies provided by United States and European Union to address food surplus. Some suggestions are provided to further improve the systems as well.

/pdf/they-collected-what-was-left-of-the-scraps-food-surplus-as-8drjmclv3k.pdf

"They Collected What Was Left of the Scraps": Food Surplus as an Opportunity and Its Legal Incentives

Determining how best to obtain valid consent for the use of human biological samples collected for research is a challenging issue for investigators, sponsors, and institutional review boards (IRBs) because the goals of maximizing participants’ autonomous decisionmaking and advancing scientific research may conflict Some participants want control over their samples to avoid research projects that they find morally objectionable In this article, we argue that the use of exclusion clauses in informed consent can minimize risks to participants and social groups and promote accountability and trust without significantly deterring research

Exclusion clauses are written statements used during informed consent to (1) exclude the use of biological samples and personal health information for certain types of research and (2) limit sharing of biological samples and personal health information with specific researchers, biobanks, or organizations—for example, investigators working on certain types of research projects, insurance companies, government or law enforcement agencies, advocacy organizations, and private companies, that is, employers Exclusion clauses are meant to capture contentious research that could risk discrimination or stigmatization of individuals or groups and sharing with organizations the public perceives as less trustworthy Exclusion clauses are statements included in consent forms by the researchers on areas of contentious research in which they will not take part in the future and organizations they are unlikely to share with Although exclusion clauses may limit unrestricted use and global sharing, they can be useful for smaller biobanks with specific purposes

Incorporating exclusion clauses into informed consent for biobanking.

Knowledge-sharing strategies differ depending on the nature of the research objectives of public–private partnerships, but information about such strategies is often vague.

Intellectual property policies in early-phase research in public-private partnerships

Comparative Issues in the Governance of Research Biobanks

In the last few years, the boom in biobanking has prompted a lively debate on a host of interrelated legal issues, such as the Gordian knot of the ownership of biological materials, as well as privacy concerns. The latter are due to the difficulty of accepting that biological samples must be completely anonymous without making it practically impossible to exploit their information potential. The issues also include the delicate role and the changing content of the donors informed consent as the main legal tool that may serve to link the privacy and property interests of donors with the research interests and the set of principles that should be at the core of the biobanking practice. Lastly, the IP issues and the patentability of biological samples as well as the protection of databases storing genetic information obtained from the samples are covered. Collecting eighteen essays written by eminent scholars from Italy, the US, the UK and Canada, this book provides new solutions to these problems. From a comparative viewpoint, it explores the extent to which digital technology may assist in tackling the numerous regulatory issues raised by the practice of biobanking for research purposes. These issues may be considered and analyzed under the traditional paradigms of Property, Privacy, Informed Consent and Intellectual Property.

Comparative Issues in the Governance of Research Biobanks: Property, Privacy, Intellectual Property, and the Role of Technology

E-health has become a central feature in the agenda of many European legislators. Health information technologies open up new legal issues in the transition from a paper-based framework to a digital one. The paper focus on a specific issue emerging in this transition, the treatment of the so-called «supersensitive data» of minors processed within the legal framework of the «Fascicolo Sanitario Elettronico» (FSE), a patient-centred ehealth system that has been recently defined and regulated in Italian law. After having outlined the general discipline of this system, the paper shows how the right to control their information (in some cases even against the parents’ right to access these information) recognized to minors by a growing body of sources of law and case law interpretations is challenged in this new scenario and need to be taken in account when designing the rules and the information flows permitted by FSE systems. In conclusion, some recommendations to ensure the proper design and implementation of a FSE system according to the minors’ right to control their information are provided.

/pdf/the-privacy-of-minors-within-patient-centered-ehealth-3gzul49lf1.pdf

The Privacy of Minors within Patient-Centered eHealth Systems

Legal aspects of biobanks.

Witnessing an injured skier being airlifted by helicopter from a winter ski resort is an unforgettable event, reminding us of the risks of snow-based winter sports, particularly alpine skiing. The world’s media attention for the ski accident suffered by Michael Schumacher for example, illustrated a collective concern for the safety of ski areas (Allen, 2014), showing how even the slightest inattention on the part of the skier, combined with the lack of optimal precautions of the ski area, may cause serious, and potentially fatal, injuries.

https://www.entsportslawjournal.com/article/829/galley/3966/download/

Safety and Liability in the practice of Skiing: How Law and Cognitive Sciences shape the driving factor of Winter Tourism

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