Missing Links in the Proposed EU Data Protection Regulation and Cloud Computing Scenarios: A Brief Overview

Applying location-focused data protection law within the context of a location-agnostic cloud computing framework is fraught with difficulties. While the Proposed EU Data Protection Regulation has introduced a lot of changes to the current data protection framework, the complexities of data processing in the cloud involve various layers and intermediaries of actors that have not been properly addressed. This leaves some gaps in the regulation when analyzed in cloud scenarios. This paper gives a brief overview of the relevant provisions of the regulation that will have an impact on cloud transactions and addresses the missing links. It is hoped that these loopholes will be reconsidered before the final version of the law is passed in order to avoid unintended consequences.

EU Data Protection Law and Targeted Advertising: Consent and the Cookie Monster - Tracking the crumbs of online user behaviour

This article provides a holistic legal analysis of the use of cookies in Online Behavioural Advertising. The current EU legislative framework is outlined in detail, and the legal obligations are examined. Consent and the debates surrounding its implementation form a large portion of the analysis. The article outlines the current difficulties associated with the reliance on this requirement as a condition for the placing and accessing of cookies. Alternatives to this approach are explored, and the implementation of solutions based on the application of the Privacy by Design and Privacy by Default concepts are presented. This discussion involves an analysis of the use of code and, therefore, product architecture to ensure adequate protections.

Online Personal Data Processing and EU Data Protection Reform. CEPS Task Force Report, April 2013

This report sheds light on the fundamental questions and underlying tensions between current policy objectives, compliance strategies and global trends in online personal data processing, assessing the existing and future framework in terms of effective regulation and public policy. Based on the discussions among the members of the CEPS Digital Forum and independent research carried out by the rapporteurs, policy conclusions are derived with the aim of making EU data protection policy more fit for purpose in today’s online technological context. This report constructively engages with the EU data protection framework, but does not provide a textual analysis of the EU data protection reform proposal as such.

The Feasibility of Applying EU Data Protection Law to Biological Materials: Challenging ‘Data’ as Exclusively Informational

Though controversial the question of applying data protection laws to biological materials has only gotten a little attention in data privacy discourse. This article aims to contribute to this dearth by arguing that despite absence of positive intention from the architects to apply the EU Data privacy law to biological materials, a range of developments in Molecular Biology and nano-technology—usually mediated by advances in ICT—may provide persuasive grounds to do so. In addition, paucity of sufficient explication of key terms like ‘data/information’ in these legislations may fuel such tendency whereby laws originally intended for the informational world may end up applying to the biological world. The article also analyzes various predicaments that may arise from applying data privacy laws to biological materials. A focus is made on legislative sources at the EU level though national laws are relied on when pertinent.

Personal Data and Encryption in the European General Data Protection Regulation

Encryption of personal data is widely regarded as a privacy preserving technology which could potentially play a key role for the compliance of innovative IT technology within the European data protection law framework. Therefore, in this paper, we examine the new EU General Data Protection Regulation’s relevant provisions regarding encryption – such as those for anonymisation and pseudonymisation – and assess whether encryption can serve as an anonymisation technique, which can lead to the non-applicability of the GDPR. However, the provisions of the GDPR regarding the material scope of the Regulation still leave space for legal uncertainty when determining whether a data subject is identifiable or not. Therefore, we inter alia assess the Opinion of the Advocate General of the European Court of Justice (ECJ) regarding a preliminary ruling on the interpretation of the dispute concerning whether a dynamic IP address can be considered as personal data, which may put an end to the dispute whether an absolute or a relative approach has to be used for the assessment of the identifiability of data subjects. Furthermore, we outline the issue of whether the anonymisation process itself constitutes a further processing of personal data which needs to have a legal basis in the GDPR. Finally, we give an overview of relevant encryption techniques and examine their impact upon the GDPR’s material scope.

Refocusing regulatory exclusivities: Regulatory data protection and marketing exclusivity as forms of pharmaceutical innovation policy

Protection of innovation in the pharmaceutical industry has traditionally been realised through protection of inventions via patents. However, in the European Union regulatory exclusivities restricting market entry of generic products confer tailored, industry specific protection for final, marketable products. This paper retraces the protection conferred by the different forms of exclusivity and assesses them in the light of recent transparency policies of the European Medicines Agency. The purpose of the paper is to argue for rethinking the role of regulatory data as a key tool of innovation policy and for refocusing the attention from patents to the existing regulatory framework. After detailed assessment of the exclusivity regime, the paper identifies key areas of improvement calling for reassessment so as to promote better functioning of the regime as an incentive for accelerated innovation. While economic and public health analysis necessarily provide final answers as to necessity of reform, this paper provides a legal perspective to the issue, appraising the current regulatory framework and identifying areas for further analysis.

The issue of data protection and data security in the (pre-Lisbon) EU third pillar

The key functional operability in the pre-Lisbon PJCCM pillar of the EU is the exchange of intelligence and information amongst the law enforcement bodies of the EU. The twin issues of data protection and data security within what was the EU’s third pillar legal framework therefore come to the fore. With the Lisbon Treaty reform of the EU, and the increased role of the Commission in PJCCM policy areas, and the integration of the PJCCM provisions with what have traditionally been the pillar I activities of Frontex, the opportunity for streamlining the data protection and data security provisions of the law enforcement bodies of the post-Lisbon EU arises. This is recognised by the Commission in their drafting of an amending regulation for Frontex , when they say that they would prefer “to return to the question of personal data in the context of the overall strategy for information exchange to be presented later this year and also taking into account the reflection to be carried out on how to further develop cooperation between agencies in the justice and home affairs field as requested by the Stockholm programme.” The focus of the literature published on this topic, has for the most part, been on the data protection provisions in Pillar I, EC. While the focus of research has recently sifted to the previously Pillar III PJCCM provisions on data protection, a more focused analysis of the interlocking issues of data protection and data security needs to be made in the context of the law enforcement bodies, particularly with regard to those which were based in the pre-Lisbon third pillar. This paper will make a contribution to that debate, arguing that a review of both the data protection and security provision post-Lisbon is required, not only in order to reinforce individual rights, but also inter-agency operability in combating cross-border EU crime. The EC’s provisions on data protection, as enshrined by Directive 95/46/EC, do not apply to the legal frameworks covering developments within the third pillar of the EU. Even Council Framework Decision 2008/977/JHA, which is supposed to cover data protection provisions within PJCCM expressly states that its provisions do not apply to “Europol, Eurojust, the Schengen Information System (SIS)” or to the Customs Information System (CIS). In addition, the post Treaty of Prüm provisions covering the sharing of DNA profiles, dactyloscopic data and vehicle registration data pursuant to Council Decision 2008/615/JHA, are not to be covered by the provisions of the 2008 Framework Decision. As stated by Hijmans and Scirocco, the regime is “best defined as a patchwork of data protection regimes”, with “no legal framework which is stable and unequivocal, like Directive 95/46/EC in the First pillar”. Data security issues are also key to the sharing of data in organised crime or counterterrorism situations. This article will critically analyse the current legal framework for data protection and security within the third pillar of the EU.

Data protection by design in the e-health care sector: theoretical and applied perspectives

In the digital age, e-health technologies play a pivotal role in the processing of medical information. As personal health data represents sensitive information concerning a data subject, enhancing data protection and security of systems and practices has become a primary concern. In recent years, there has been an increasing interest in the concept of Privacy by Design, which aims at developing a product or a service in a way that it supports privacy principles and rules. In the EU, Article 25 of the General Data Protection Regulation provides a binding obligation of implementing Data Protection by Design technical and organisational measures. This thesis explores how an e-health system could be developed and how data processing activities could be carried out to apply data protection principles and requirements from the design stage. The research attempts to bridge the gap between the legal and technical disciplines on DPbD by providing a set of guidelines for the implementation of the principle. The work is based on literature review, legal and comparative analysis, and investigation of the existing technical solutions and engineering methodologies. The work can be differentiated by theoretical and applied perspectives. First, it critically conducts a legal analysis on the principle of PbD and it studies the DPbD legal obligation and the related provisions. Later, the research contextualises the rule in the health care field by investigating the applicable legal framework for personal health data processing. Moreover, the research focuses on the US legal system by conducting a comparative analysis. Adopting an applied perspective, the research investigates the existing technical methodologies and tools to design data protection and it proposes a set of comprehensive DPbD organisational and technical guidelines for a crucial case study, that is an Electronic Health Record system.

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.

Privacy and Data Protection in Elderly Healthcare: Threats and Legal Warranties

The progressive aging of the population requires new kinds of social and medical intervention and the availability of different services provided to the elder population. New applications have been developed and some services are now provided at home, allowing the older people to stay home instead of having to stay in hospitals. But an adequate response to the needs of the users will imply a high percentage of use of personal data and information, including the building up and maintenance of user profiles, feeding the systems with the data and information needed for a proactive intervention in scheduling of events in which the user may be involved. Fundamental Rights may be at stake, so a legal analysis must also be considered.

Data mining framework for fatty liver disease classification in ultrasound: a hybrid feature extraction paradigm

PURPOSE: Fatty liver disease (FLD) is an increasing prevalent disease that can be reversed if detected early. Ultrasound is the safest and ubiquitous method for identifying FLD. Since expert sonographers are required to accurately interpret the liver ultrasound images, lack of the same will result in interobserver variability. For more objective interpretation, high accuracy, and quick second opinions, computer aided diagnostic (CAD) techniques may be exploited. The purpose of this work is to develop one such CAD technique for accurate classification of normal livers and abnormal livers affected by FLD. METHODS: In this paper, the authors present a CAD technique (called Symtosis) that uses a novel combination of significant features based on the texture, wavelet transform, and higher order spectra of the liver ultrasound images in various supervised learning-based classifiers in order to determine parameters that classify normal and FLD-affected abnormal livers. RESULTS: On evaluating the proposed technique on a database of 58 abnormal and 42 normal liver ultrasound images, the authors were able to achieve a high classification accuracy of 93.3% using the decision tree classifier. CONCLUSIONS: This high accuracy added to the completely automated classification procedure makes the authors' proposed technique highly suitable for clinical deployment and usage.

A Data Mining Framework for Electric Load Profiling

This paper consists in the characterization of medium voltage (MV) electric power consumers based on a data clustering approach. It is intended to identify typical load profiles by selecting the best partition of a power consumption database among a pool of data partitions produced by several clustering algorithms. The best partition is selected using several cluster validity indices. These methods are intended to be used in a smart grid environment to extract useful knowledge about customers’ behavior. The data-mining-based methodology presented throughout the paper consists in several steps, namely the pre-processing data phase, clustering algorithms application and the evaluation of the quality of the partitions. To validate our approach, a case study with a real database of 1.022 MV consumers was used.

Data Protection Manual (MS Word 461KB)

Departmental Data Protection manual

DHSSPS Data Protection Policy (MS Word 67KB)

Statement of departmental data protection policy