Internet of healthcare (law): privacy and data protection aspects in an internet of everything

The purpose of this research study is to discuss privacy and data protection-related regulatory and compliance challenges posed by digital transformation in healthcare in the wake of the COVID-19 pandemic. The public health crisis accelerated the development of patient-centred remote/hybrid healthcare delivery models that make increased use of telehealth services and related digital solutions. The large-scale uptake of IoT-enabled medical devices and wellness applications, and the offering of healthcare services via healthcare platforms (online doctor marketplaces) have catalysed these developments. However, the use of new enabling technologies (IoT, AI) and the platformisation of healthcare pose complex challenges to the protection of patient’s privacy and personal data. This happens at a time when the EU is drawing up a new regulatory landscape for the use of data and digital technologies. Against this background, the study presents an interdisciplinary (normative and technology-oriented) critical assessment on how the new regulatory framework may affect privacy and data protection requirements regarding the deployment and use of Internet of Health Things (hardware) devices and interconnected software (AI systems). The study also assesses key privacy and data protection challenges that affect healthcare platforms (online doctor marketplaces) in their offering of video API-enabled teleconsultation services and their (anticipated) integration into the European Health Data Space. The overall conclusion of the study is that regulatory deficiencies may create integrity risks for the protection of privacy and personal data in telehealth due to uncertainties about the proper interplay, legal effects and effectiveness of (existing and proposed) EU legislation. The proliferation of normative measures may increase compliance costs, hinder innovation and ultimately, deprive European patients from state-of-the-art digital health technologies, which is paradoxically, the opposite of what the EU plans to achieve.

Big data and AI applications for health and research. Co-regulation mechanisms as a prosed solution for data protection law issues

Big data and AI are paving the way to promising scenarios in clinical practice and research. However, the use of such technologies might clash with GDPR requirements. Today, two forces are driving the EU policies in this domain. The first is the necessity to protect individuals’ safety and fundamental rights. The second is to incentivize the deployment of innovative technologies. The first objective is pursued by legislative acts such as the GDPR or the AIA, the second is supported by the new data strategy recently launched by the European Commission. Against this background, the thesis analyses the issue of GDPR compliance when big data and AI systems are implemented in the health domain. The thesis focuses on the use of co-regulatory tools for compliance with the GDPR. This work argues that there are two level of co-regulation in the EU legal system. The first, more general, is the approach pursued by the EU legislator when shaping legislative measures that deal with fast-evolving technologies. The GDPR can be deemed a co-regulatory solution since it mainly introduces general requirements, which implementation shall then be interpretated by the addressee of the law following a risk-based approach. This approach, although useful is costly and sometimes burdensome for organisations. The second co-regulatory level is represented by specific co-regulatory tools, such as code of conduct and certification mechanisms. These tools are meant to guide and support the interpretation effort of the addressee of the law. The thesis argues that the lack of co-regulatory tools which are supposed to implement data protection law in specific situations could be an obstacle to the deployment of innovative solutions in complex scenario such as the health ecosystem. The thesis advances hypothesis on theoretical level about the reasons of such a lack of co-regulatory solutions.

Decentralized systems for the protection and portability of personal data

The General Data Protection Regulation (GDPR) has been designed to help promote a view in favor of the interests of individuals instead of large corporations. However, there is the need of more dedicated technologies that can help companies comply with GDPR while enabling people to exercise their rights. We argue that such a dedicated solution must address two main issues: the need for more transparency towards individuals regarding the management of their personal information and their often hindered ability to access and make interoperable personal data in a way that the exercise of one's rights would result in straightforward. We aim to provide a system that helps to push personal data management towards the individual's control, i.e., a personal information management system (PIMS). By using distributed storage and decentralized computing networks to control online services, users' personal information could be shifted towards those directly concerned, i.e., the data subjects. The use of Distributed Ledger Technologies (DLTs) and Decentralized File Storage (DFS) as an implementation of decentralized systems is of paramount importance in this case. The structure of this dissertation follows an incremental approach to describing a set of decentralized systems and models that revolves around personal data and their subjects. Each chapter of this dissertation builds up the previous one and discusses the technical implementation of a system and its relation with the corresponding regulations. We refer to the EU regulatory framework, including GDPR, eIDAS, and Data Governance Act, to build our final system architecture's functional and non-functional drivers. In our PIMS design, personal data is kept in a Personal Data Space (PDS) consisting of encrypted personal data referring to the subject stored in a DFS. On top of that, a network of authorization servers acts as a data intermediary to provide access to potential data recipients through smart contracts.

Comment appliquer les règles de protection des données aux transferts de données personnelles dans une société à la fois globale mais également multi-économique et multiculturelle ?

Dans son texte, l’auteur répond à une question posée lors d’une Conférence organisée conjointement par l’US Department of Commerce et le Groupe de l’article 29 et qui appelle à déterminer la façon dont les règles de protection des données doivent s’appliquer lors des transferts de données personnelles dans une société globale, multi-économique et multiculturelle. La question est pertinente dans une telle société, caractérisée par le besoin, d’une part d’assurer, sans considération de frontières, un certain régime de protection des données et d’autre part, de respecter la diversité des réalités économiques et culturelles qui se côtoient de plus en plus. L’auteur rappelle d’abord comment l’Europe a progressivement mis en place le système du droit à la protection des données personnelles. Il explique ensuite comment l’Union européenne a considéré la question de la réglementation des flux transfrontières pour en arriver au développement d’un système de protection adéquat et efficace lors des transferts de données hors de l’Union européenne. Toutefois, un tel système mis en place ne semble plus répondre de nos jours à la réalité des flux transfrontières, d’où la nécessité éventuelle de le réformer.

La protection des données sur Internet en droit suisse

La protection des données personnelles en Suisse trouve son fondement dans la constitution et se concrétise avant tout dans une loi fédérale adoptée avant l'avènement d'Internet et la généralisation de la transmission d'informations personnelles sur des réseaux numériques. Cette réglementation est complétée par les engagements internationaux de la Suisse et notamment la Convention européenne des Droits de l'Homme du Conseil de l'Europe. L'article délimite tout d'abord le champ d'application de la législation, qui joue un rôle pour le traitement de données personnelles par des particuliers comme par les autorités de l'administration fédérale. Suit une brève analyse des principes fondamentaux (licéité, bonne foi, proportionnalité, finalité, exactitude, communication à l'étranger, sécurité, droit d'accès) et de leur application sur Internet. Enfin, la protection du contenu des messages électroniques privés est brièvement abordée sous l'angle du secret des télécommunications et à la lumière d'une jurisprudence récente du Tribunal fédéral.

Principe de finalité, protection des renseignements personnels et secteur public : étude sur la gouvernance des structures en réseau

Thèse réalisée en cotutelle avec l'Université de Montréal et l'Université Panthéon-Assas Paris II

Anonymisation, Deanonymisation and Data Management

Speaker: Dr Kieron O'Hara Organiser: Time: 04/02/2015 11:00-11:45 Location: B32/3077 Abstract In order to reap the potential societal benefits of big and broad data, it is essential to share and link personal data. However, privacy and data protection considerations mean that, to be shared, personal data must be anonymised, so that the data subject cannot be identified from the data. Anonymisation is therefore a vital tool for data sharing, but deanonymisation, or reidentification, is always possible given sufficient auxiliary information (and as the amount of data grows, both in terms of creation, and in terms of availability in the public domain, the probability of finding such auxiliary information grows). This creates issues for the management of anonymisation, which are exacerbated not only by uncertainties about the future, but also by misunderstandings about the process(es) of anonymisation. This talk discusses these issues in relation to privacy, risk management and security, reports on recent theoretical tools created by the UKAN network of statistics professionals (on which the author is one of the leads), and asks how long anonymisation can remain a useful tool, and what might replace it.

Sistema de protección de Habeas Data

El desarrollo que está presentando el tema, hace que la información al respecto resulte algo limitada, no es mucha la literatura que hasta el momento se haya producido, especialmente en países donde la vida del Habeas Data es más corta. Por ello es que nuestra investigación resulta una herramienta

Online data processing consent under EU law: a theoretical framework and empirical evidence from the UK

This article analyses the results of an empirical study on the 200 most popular UK-based websites in various sectors of e-commerce services. The study provides empirical evidence on unlawful processing of personal data. It comprises a survey on the methods used to seek and obtain consent to process personal data for direct marketing and advertisement, and a test on the frequency of unsolicited commercial emails (UCE) received by customers as a consequence of their registration and submission of personal information to a website. Part One of the article presents a conceptual and normative account of data protection, with a discussion of the ethical values on which EU data protection law is grounded and an outline of the elements that must be in place to seek and obtain valid consent to process personal data. Part Two discusses the outcomes of the empirical study, which unveils a significant departure between EU legal theory and practice in data protection. Although a wide majority of the websites in the sample (69%) has in place a system to ask separate consent for engaging in marketing activities, it is only 16.2% of them that obtain a consent which is valid under the standards set by EU law. The test with UCE shows that only one out of three websites (30.5%) respects the will of the data subject not to receive commercial communications. It also shows that, when submitting personal data in online transactions, there is a high probability (50%) of incurring in a website that will ignore the refusal of consent and will send UCE. The article concludes that there is severe lack of compliance of UK online service providers with essential requirements of data protection law. In this respect, it suggests that there is inappropriate standard of implementation, information and supervision by the UK authorities, especially in light of the clarifications provided at EU level.

Open Season for Data Fishing on the Web: The Challenges of the US PRISM Programme for the EU. CEPS Policy Brief No. 293, 18 June 2013

The revelation of the top-secret US intelligence-led PRISM Programme has triggered wide-ranging debates across Europe. Press reports have shed new light on the electronic surveillance ‘fishing expeditions’ of the US National Security Agency and the FBI into the world’s largest electronic communications companies. This Policy Brief by a team of legal specialists and political scientists addresses the main controversies raised by the PRISM affair and the policy challenges that it poses for the EU. Two main arguments are presented: First, the leaks over the PRISM programme have undermined the trust that EU citizens have in their governments and the European institutions to safeguard and protect their privacy; and second, the PRISM affair raises questions regarding the capacity of EU institutions to draw lessons from the past and to protect the data of its citizens and residents in the context of transatlantic relations. The Policy Brief puts forward a set of policy recommendations for the EU to follow and implement a robust data protection strategy in response to the affair.

Gestionnaire de vie privée : un cadre pour la protection de la vie privée dans les interactions entre apprenants

L’évolution continue des besoins d’apprentissage vers plus d’efficacité et plus de personnalisation a favorisé l’émergence de nouveaux outils et dimensions dont l’objectif est de rendre l’apprentissage accessible à tout le monde et adapté aux contextes technologiques et sociaux. Cette évolution a donné naissance à ce que l’on appelle l'apprentissage social en ligne mettant l'accent sur l’interaction entre les apprenants. La considération de l’interaction a apporté de nombreux avantages pour l’apprenant, à savoir établir des connexions, échanger des expériences personnelles et bénéficier d’une assistance lui permettant d’améliorer son apprentissage. Cependant, la quantité d'informations personnelles que les apprenants divulguent parfois lors de ces interactions, mène, à des conséquences souvent désastreuses en matière de vie privée comme la cyberintimidation, le vol d’identité, etc. Malgré les préoccupations soulevées, la vie privée en tant que droit individuel représente une situation idéale, difficilement reconnaissable dans le contexte social d’aujourd’hui. En effet, on est passé d'une conceptualisation de la vie privée comme étant un noyau des données sensibles à protéger des pénétrations extérieures à une nouvelle vision centrée sur la négociation de la divulgation de ces données. L’enjeu pour les environnements sociaux d’apprentissage consiste donc à garantir un niveau maximal d’interaction pour les apprenants tout en préservant leurs vies privées. Au meilleur de nos connaissances, la plupart des innovations dans ces environnements ont porté sur l'élaboration des techniques d’interaction, sans aucune considération pour la vie privée, un élément portant nécessaire afin de créer un environnement favorable à l’apprentissage. Dans ce travail, nous proposons un cadre de vie privée que nous avons appelé « gestionnaire de vie privée». Plus précisément, ce gestionnaire se charge de gérer la protection des données personnelles et de la vie privée de l’apprenant durant ses interactions avec ses co-apprenants. En s’appuyant sur l’idée que l’interaction permet d’accéder à l’aide en ligne, nous analysons l’interaction comme une activité cognitive impliquant des facteurs contextuels, d’autres apprenants, et des aspects socio-émotionnels. L'objectif principal de cette thèse est donc de revoir les processus d’entraide entre les apprenants en mettant en oeuvre des outils nécessaires pour trouver un compromis entre l’interaction et la protection de la vie privée. ii Ceci a été effectué selon trois niveaux : le premier étant de considérer des aspects contextuels et sociaux de l’interaction telle que la confiance entre les apprenants et les émotions qui ont initié le besoin d’interagir. Le deuxième niveau de protection consiste à estimer les risques de cette divulgation et faciliter la décision de protection de la vie privée. Le troisième niveau de protection consiste à détecter toute divulgation de données personnelles en utilisant des techniques d’apprentissage machine et d’analyse sémantique.

Mass Surveillance of Personal Data by EU Member States and its Compatibility with EU Law. CEPS Liberty and Security in Europe No. 61, 6 November 2013

In the wake of the disclosures surrounding PRISM and other US surveillance programmes, this paper assesses the large-scale surveillance practices by a selection of EU member states: the UK, Sweden, France, Germany and the Netherlands. Given the large-scale nature of these practices, which represent a reconfiguration of traditional intelligence gathering, the paper contends that an analysis of European surveillance programmes cannot be reduced to a question of the balance between data protection versus national security, but has to be framed in terms of collective freedoms and democracy. It finds that four of the five EU member states selected for in-depth examination are engaging in some form of large-scale interception and surveillance of communication data, and identifies parallels and discrepancies between these programmes and the NSA-run operations. The paper argues that these programmes do not stand outside the realm of EU intervention but can be analysed from an EU law perspective via i) an understanding of national security in a democratic rule of law framework where fundamental human rights and judicial oversight constitute key norms; ii) the risks posed to the internal security of the Union as a whole as well as the privacy of EU citizens as data owners and iii) the potential spillover into the activities and responsibilities of EU agencies. The paper then presents a set of policy recommendations to the European Parliament.

The Political and Judicial Life of Metadata: Digital Rights Ireland and the Trail of the Data Retention Directive. CEPS Paper in Liberty and Security No. 65, May 2014

This paper examines the challenges facing the EU regarding data retention, particularly in the aftermath of the judgment Digital Rights Ireland by the Court of Justice of the European Union (CJEU) of April 2014, which found the Data Retention Directive 2002/58 to be invalid. It first offers a brief historical account of the Data Retention Directive and then moves to a detailed assessment of what the judgment means for determining the lawfulness of data retention from the perspective of the EU Charter of Fundamental Rights: what is wrong with the Data Retention Directive and how would it need to be changed to comply with the right to respect for privacy? The paper also looks at the responses to the judgment from the European institutions and elsewhere, and presents a set of policy suggestions to the European institutions on the way forward. It is argued here that one of the main issues underlying the Digital Rights Ireland judgment has been the role of fundamental rights in the EU legal order, and in particular the extent to which the retention of metadata for law enforcement purposes is consistent with EU citizens’ right to respect for privacy and to data protection. The paper offers three main recommendations to EU policy-makers: first, to give priority to a full and independent evaluation of the value of the data retention directive; second, to assess the judgment’s implications for other large EU information systems and proposals that provide for the mass collection of metadata from innocent persons, in the EU; and third, to adopt without delay the proposal for Directive COM(2012)10 dealing with data protection in the fields of police and judicial cooperation in criminal matters.