Rossana Ducato

From electronic health records to personal health records: emerging legal issues in the Italian regulation of e-health

In 2012, the Italian Legislator has provided an appropriate legal framework for the realisation of the national Electronic Health Records (EHR) system, in which the patient plays a pivotal role: with the implementation of the Fascicolo sanitario elettronico (FSE), patients will have access to their EHRs through the online platform, and decide which data to share and with whom. In this perspective, one of the most interesting innovations is the so-called ‘taccuino’, a digital space of patients’ FSE in which they can autonomously record data and information relating to their health. Patients’ ability to access their own health data and EHR at any time and to enter information by themselves in a personal area is a unique form of power at a European level, but their legal consequences are still vague. The aim of this contribution is to offer a first review of the Italian e-health reform, showing the most critical aspects.

Legal issues in governing genetic biobanks: the Italian framework as a case study for the implications for citizen’s health through public-private initiatives

This paper outlines some of the challenges faced by regulation of genetic biobanking, using case studies coming from the Italian legal system. The governance of genetic resources in the context of genetic biobanks in Italy is discussed, as an example of the stratification of different inputs and rules: EU law, national law, orders made by authorities and soft law, which need to be integrated with ethical principles, technological strategies and solutions. After providing an overview of the Italian legal regulation of genetic data processing, it considers the fate of genetic material and IP rights in the event of a biobank’s insolvency. To this end, it analyses two case studies: a controversial bankruptcy case which occurred in Sardinia, one of the first examples of private and public partnership biobanks. Another case study considered is the Chris project: an example of partnership between a research institute in Bolzano and the South Tyrolean Health System. Both cases seem to point in the same direction, suggesting expediency of promoting and improving public-private partnerships to manage biological tissues and biotrust to conciliate patent law and public interest.

Open Access, Open Science, Open Society

Open Access’ main goal is not the subversion of publishers’ role as driving actors in an oligopolistic market characterised by reduced competition and higher prices. OA’s main function is to be found somewhere else, namely in the ability to subvert the power to control science’s governance and its future directions (Open Science), a power that is more often found within the academic institutions rather than outside. By decentralising and opening-up not just the way in which scholarship is published but also the way in which it is assessed, OA removes the barriers that helped turn science into an intellectual oligopoly even before an economic one. The goal of this paper is to demonstrate that Open Access is a key enabler of Open Science, which in turn will lead to a more Open Society. Furthermore, the paper argues that while legislative interventions play an important role in the top-down regulation of Open Access, legislators currently lack an informed and systematic vision on the role of Open Access in science and society. In this historical phase, other complementary forms of intervention (bottom-up) appear much more “informed” and effective. This paper, which intends to set the stage for future research, identifies a few pieces of the puzzle: the relationship between formal and informal norms in the field of Open Science and how these impact on intellectual property rights, the protection of personal data, the assessment of science and the technology employed for the communication of science.

Cloud computing for s-health and the data protection challenge: Getting ready for the General Data Protection Regulation

The recently approved General Data Protection Regulation (GDPR) will change deeply the European privacy framework. Despite the aim of updating the legislative provisions to the challenges of the information society, the GDPR leaves open serious questions and shortcomings, especially in the context of cloud computing for s-health. The purpose of the paper is twofold: after having outlined the major innovations of the new GDPR for ensuring data protection in cloud environments, paying particular attention to the processing in the healthcare sector, the main unresolved issues will be critically addressed.

Opening Research Biobanks: An Overview

In biomedical research and translational medicine, the ancient war between the exclusive right (private control over information) and public access to information is struggling on a new battlefield: research biobanks. The latter are becoming increasingly important (one of the ten ideas changing the world, according to Time magazine) because they 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 biomedical research and the emerging field of translational medicine, because they represent the “raw material” for every kind of biomedical study. For this reason it is crucial to understand the boundaries of IP in this prickly context. After an overview of the complex interactions among the different stakeholders involved in the process of the production of knowledge, in this paper we will thin out some blurring of language concerning concepts often mixed up, such as “open source”, “open access”, and their precipitates. Then, the aim is to understand if we can use the concepts in the biomedical context, and which are the open models proposed in literature specifically for research biobanks in order to avoid the tragedy of anticommons.