Pharmaceuticals Policy and Law - Volume 19, issue 3-4

Authors: Finocchiaro, Giusella

Article Type: Other

DOI: 10.3233/PPL-180462

Citation: Pharmaceuticals Policy and Law, vol. 19, no. 3-4, pp. 121-123, 2017

Authors: Bottari, Carlo

Article Type: Research Article

Abstract: Health is assuming a dimension, necessarily, of international importance, useful to face the emergencies that the historical and contingent conditions impose with increasing intensity and relevance. The migratory phenomena, the spread of diseases and epidemics, many of which are little known, require a constant and constant effort and, above all, generally shared. The IT tools thus assume a fundamental role whose underestimation could represent a social retreat and a substantial lack in the implementation of certain fundamental rights of the citizen, guaranteed constitutionally. First, the one to protect health.

Keywords: Electronic health records, electronic clinical history, national health service, EU law, free movement of persons, comparative law

DOI: 10.3233/PPL-180453

Citation: Pharmaceuticals Policy and Law, vol. 19, no. 3-4, pp. 125-132, 2017

Authors: Lorenzetti, Diego

Article Type: Research Article

Abstract: Mobility freedoms as an element at the base of the European Union’s policy is nowadays also of fundamental importance in health matters. In fact, the phenomenon of the so-called healthcare mobility is increasingly common, so that more and more EU citizens require medical services in a Member State other than their own. Therefore, in order to fully protect the right to health from a supranational and international level, a community discipline is necessary to provide the full guarantee of this fundamental right. The Directive 2011/24/EU is the starting point with which to build a European health system as interoperable as …it is efficient to guarantee the citizen the opportunity to move freely within the single market and demand the health care of which he is entitled in reasonable time and according to high quality and safety standards. Show more

Keywords: Healthcare mobility, cross-border healthcare, European healthcare system, interaction, health protection, free circulation

DOI: 10.3233/PPL-180459

Citation: Pharmaceuticals Policy and Law, vol. 19, no. 3-4, pp. 133-140, 2017

Authors: Califano, Licia

Article Type: Research Article

Abstract: The right to protection of personal data has recently been redefined by the Regulation EU 2016/679, which has also introduced innovations on data concerning health. In this framework the Author, after a short mention of the experience of the health dossier, examines carefully the development of the Electronic Health Record (EHR) in the Italian legal system, throughout Parliamentary Acts, Ministerial Regulations and Data Protection Authority’s (DPA) contributions with guidelines, prescriptions and opinions. The purpose is to demonstrate that the debate among the main institutions involved, including the DPA, supports a better balancing of all the interests, starting from the right …to protection of personal data. Show more

Keywords: Right to the protection of personal data, Regulation EU 2016/679, data concerning health, Electronic Health Record (EHR), Data Protection Authority (DPA)

DOI: 10.3233/PPL-180454

Citation: Pharmaceuticals Policy and Law, vol. 19, no. 3-4, pp. 141-159, 2017

Authors: Tuzii, Jennifer

Article Type: Research Article

Abstract: The e-Health has been introduced in the last twenty years as a new paradigm of healthcare organization: it allows the use of new technological devices to manage health data in a rational way, with the dual aim to make service provision more efficient and to reduce public expenditure in healthcare. According to the italian Constitution, digital healthcare answers to the institutional aim of health protection, by giving concrete solutions for the equal satisfaction of this fundamental right through the new digital tools adopted by the national healthcare system: electronic healthcare record, telemedicine and e-prescription are some of the most …important ones. Although the European Union has encouraged the realization of projects, initiatives and regulations to create a proper common space for digital healthcare, actually e-Health has gradually been formally recognized also in the Italian national law, but regional contributions, entitled to implement the same regulation, allowed only a qualitatively uneven development of e-health services. The national healthcare system must necessarily take the changes occurred in today’s national social scene into consideration, in order to change itself and answer the new needs emerged, and must face to this lack of application uniformity of digital services. Show more

Keywords: e-Health, digitization, healthcare system, constitution, regulation, data, information, communication, technology, digital, efficiency, telemedicine, electronic healthcare record, equality, patient, citizen, italian, European union, public service

DOI: 10.3233/PPL-180460

Citation: Pharmaceuticals Policy and Law, vol. 19, no. 3-4, pp. 161-176, 2017

Authors: Donati, Daniele

Article Type: Research Article

Abstract: In this paper are considered two very different subjects, Personal Health Record and Big Data in their application to Healthcare organizations, both showing the growing relevance of new technologies in this field, and the continuous struggle juridical systems fight in determining rules applicable and, even more, in understanding their potentialities and limits. As an essential feature, we consider the urgency of balancing citizen rights (specially a person right for privacy about her/his health conditions), the value of transparency and access to data, the need Health professionals have for a complete and accurate information, either for scientific advances and a …determining the most appropriate cure to every single case. The paper focuses then on the regulation applicable to the two subjects, especially after the recent approval of the new EU General Data Protection Regulation, trying on one hand to show how new technologies can be controlled by rulings in act and, on the other, what still eludes any legal restrain. Show more

Keywords: Personal health record, big data, gdpr, citizen rights, privacy, digitalization

DOI: 10.3233/PPL-180456

Citation: Pharmaceuticals Policy and Law, vol. 19, no. 3-4, pp. 177-195, 2017

Authors: Cavo, Giovanni Maria

Article Type: Research Article

Abstract: The need to simplify both the collection and transmission of “health data”, and to more carefully control the prescriptions to patients, led to starting – since the early 2000s – projects of computerization and electronic circulation of drug prescriptions. This paper aims at analyzing the Italian legislation concerning computerization of drug prescriptions, in order to identify its strengths and weaknesses and its capacity to improve health and pharmaceutical care, as well as to rationalize health care costs. In the end, the chapter analyzes the National Electronic Drug Prescription and its connection with Electronic Health Record.

Keywords: Pharmaceutical care, electronic drug prescription, pharmaceutical spending, computerization of drug prescriptions, electronic health record, national health care system

DOI: 10.3233/PPL-180455

Citation: Pharmaceuticals Policy and Law, vol. 19, no. 3-4, pp. 197-208, 2017

Authors: Ferrandu, Giovanni

Article Type: Research Article

Abstract: The protection of individuals with regard to the processing of personal data is a fundamental right which, as such, deserves the broadest protection of the legal system. In health matters, even more, the guarantee of this protection assumes primary importance considering the sensitive data object of the treatment. Beyond that, in a supranational context it is of fundamental importance that the circulation of such data is regulated with a view to a balance between protection of personal data, freedom of circulation and protection of health. Here is the new European Regulation for the protection of personal data that repeals Directive …95/46/EC and introduces new figures and new security measures to ensure compliance with fundamental principles and rights in this area. Show more

Keywords: Privacy, data protection, digital healthcare, freedom of circulation, accountability, Data Protection Officer, privacy by design, EU Regulation

DOI: 10.3233/PPL-180457

Citation: Pharmaceuticals Policy and Law, vol. 19, no. 3-4, pp. 209-218, 2017

Authors: Laus, Federico

Article Type: Research Article

Abstract: To be effective the digitization of health data in the EU needs interoperability, in terms of ability of two or more electronic health record systems to exchange both computer interpretable data and human interpretable information and knowledge. That’s why EU purpose and regulation need a full implementation of EHR national systems in order to achieve a cross-border health care. The author aims to investigate the level of actualization of health management systems of EU Member States.

Keywords: Electronic health records, electronic clinical history, national health service, EU law, free movement of persons, comparative law

DOI: 10.3233/PPL-180458

Citation: Pharmaceuticals Policy and Law, vol. 19, no. 3-4, pp. 219-233, 2017

Authors: Barbieri, Paolo Nicola | Bolin, Kristian

Article Type: Research Article

Abstract: The use of information technology (IT) in health care has the potential to facilitate care over distance in almost any clinical specialties, reducing time to diagnosis, improve equity of access for patients in remote areas, and improve quality of life and patient satisfaction. In particular, electronic health records (EHRs) offer the possibility of accessing fast and updated patients’ information. With the potential of making easier for individuals to be more concern in their own health and care, by increasing contact between individuals and health care providers; but also by providing more efficient support systems for medical staff. In this paper, …we present the Swedish current experience and future development in the use of EHRs, in order draw upon such example to apply this methodology for data sharing and collection in other European countries. Show more

Keywords: Electronic health records, Sweden, digitalization, health data

DOI: 10.3233/PPL-180452

Citation: Pharmaceuticals Policy and Law, vol. 19, no. 3-4, pp. 235-245, 2017