Prosthetic bypass for restenosis after endarterectomy or stenting of the carotid artery

OBJECTIVE: The objective of this study was to evaluate the results of prosthetic carotid bypass (PCB) with polytetrafluoroethylene (PTFE) grafts as an alternative to carotid endarterectomy (CEA) in treatment of restenosis after CEA or carotid artery stenting (CAS). METHODS: From January 2000 to December 2014, 66 patients (57 men and 9 women; mean age, 71 years) presenting with recurrent carotid artery stenosis ≥70% (North American Symptomatic Carotid Endarterectomy Trial [NASCET] criteria) were enrolled in a prospective study in three centers. The study was approved by an Institutional Review Board. Informed consent was obtained from all patients. During the same period, a total of 4321 CEAs were completed in the three centers. In these 66 patients, the primary treatment of the initial carotid artery stenosis was CEA in 57 patients (86%) and CAS in nine patients (14%). The median delay between primary and redo revascularization was 32 months. Carotid restenosis was symptomatic in 38 patients (58%) with transient ischemic attack (n = 20) or stroke (n = 18). In this series, all patients received statins; 28 patients (42%) received dual antiplatelet therapy, and 38 patients (58%) received single antiplatelet therapy. All PCBs were performed under general anesthesia. No shunt was used in this series. Nasal intubation to improve distal control of the internal carotid artery was performed in 33 patients (50%), including those with intrastent restenosis. A PTFE graft of 6 or 7 mm in diameter was used in 6 and 60 patients, respectively. Distal anastomosis was end to end in 22 patients and end to side with a clip distal to the atherosclerotic lesions in 44 patients. Completion angiography was performed in all cases. The patients were discharged under statin and antiplatelet treatment. After discharge, all of the patients underwent clinical and Doppler ultrasound follow-up every 6 months. Median length of follow-up was 5 years. RESULTS:No patient died, sustained a stroke, or presented with a cervical hematoma during the postoperative period. One transient facial nerve palsy and two transient recurrent nerve palsies occurred. Two late strokes in relation to two PCB occlusions occurred at 2 years and 4 years; no other graft stenosis or infection was observed. At 5 years, overall actuarial survival was 81% ± 7%, and the actuarial stroke-free rate was 93% ± 2%. There were no fatal strokes. CONCLUSIONS: PCB with PTFE grafts is a safe and durable alternative to CEA in patients with carotid restenosis after CEA or CAS in situations in which CEA is deemed either hazardous or inadvisable

Limits of the Supremacy of a European Patent Over a National Patent

A decision by the Enlarged Board of Appeal of the European Patent Office that is under revision is not final even though the request for revision does not have suspensive effects. Therefore, such a decision cannot be grounds for the discontinuance of an action of invalidity of an Italian patent, because this only proceeds when the legal grounds for the action no longer exist. This can only occur when there is a final decision on a related matter. When a European patent is revoked, the Italian patent does not automatically become invalid, because the latter is an autonomous right

Testing Art. 102 TFUE in the Digital Marketplace: Insights from the Bundeskartellamt’s Investigation Against Facebook

On 20th March 2016, the German Competition Authority launched a proceeding against Facebook for abuse of its dominant position in the market for social networks, based on its misleading terms and conditions for user data.1 In the view of the German antitrust authority, Facebook has a dominant position in the German market for social networks because it collects a vast amount of data from various sources and it uses this data for the creation of profiles enabling its advertisement customers to better target their advertisement activities. The BKA suspects that such market dominance enables Facebook to impose unclear and misleading terms and conditions on its users

The Algorithmic Governance of Administrative Decision-Making: Towards an Integrated European Framework for Public Accountability

The first section illustrates the features of the ‘algorithmized’ public administration, showing how the increasing reliance on data-driven systems, obliges the public sector to lean on private companies’ technical expertise and infrastructure. In light of the peculiarities of the emerging environment, the second section will enquire the (in)effectiveness of traditional European administrative law tools in respect to accountability objectives. Hence, the analysis will turn to the consideration of the new provisions of the General Data Protection Regulation. The study will conclude with some systemic considerations regarding the need to adopt an integrated approach between traditional administrative law tools and business-centred provisions entailed in the GDP

Access

In respect of data access a vertical and a horizontal regulatory dimension can be distinguished. The first one regards access to data and related processing information by single data subjects vis-à-vis data controllers. From this perspective, access rights are a substantiation of the principle of transparency and are an essential means for the protection of data subjects’ fundamental rights, first of all the fundamental right to data protection. The horizontal perspective relates to access to data among third parties, such as other businesses or public institutions. From this perspective, thus, access regimes and corresponding rights advance the free flow of personal data within the internal market for the ultimate promotion of market innovation objectives

Fairness

Although there is no definition as such of the principle of fairness in positive European data protection law, fairness of the processing is related to the balancing of competing interests and more precisely of fundamental rights and freedoms of the subjects involved, that is, on the one side the data subject and on the other the data controllers and processor

A European Transparency challenge: can commercial confidentiality in clinical trials data be overcome?

The study aims to define a legal framework of clinical trials data, by testing international the European rules of data secrecy against the expanding demands for disclosure. We argue that information embedded in clinical trial protocols turn out to be a precious source for the evaluation of drug’s safety and efficacy, the awareness of which is thus to be considered essential for protecting patients’ and consumers’ health. However clinical trials data do not only have an important public informational value, but also an intrinsic regulatory- and therefore commercial- value, being key to the granting of drugs’ marketing license. We compare the general disclosure provision provided by art. 84 of the recent European Clinical Trials Regulation, establishing a publicly accessible European clinical trials database, with specific intellectual property measures, providing guarantees of exclusivity to clinical testing data used to obtain marketing approval. Research-based companies aiming to protect their “sweat of the brow” from competitors’ free-riding, have invoked art. 39.3 TRIPS and the European data exclusivity regimes, as a legal basis for regulatory agencies’ non-disclosure obligation. Also privacy concerns have been called upon as a legal barrier to disclosure, due to the vast amount of personal data embedded in the results of test data. We illustrate how drug’s safety information disclosure is not prevented by both clinical trials protection rules and the privacy normative framework. To the contrary we demonstrate a systemic justification for disclosure. In our analysis we read public interest of transparency and accountability in clinical trials information through the subsequent lenses of the human right to health as defined by International Human Rights Treatises and the Human rights case law, of the public goods dimension of research and knowledge production, and finally of the legal framework protecting consumer rights as defined by the correspondent European Directives

From data subjects to data suspects : challenging e-proctoring systems as a university practice

Peer reviewedPublisher PD

From data subjects to data suspects: challenging e-proctoring systems as a university practice

E-proctoring is a set of software and tools to monitor students’ behaviour during online examinations. Many universities have implemented this type of invigilation in response to the lockdowns during the pandemic to guarantee the validity and the integrity of exams. However, the intrusiveness of such technology into the students’ personal environment along with major accuracy problems (e.g., in authenticating black students) has attracted the scrutiny of various European data protection authorities and, more recently, equality bodies. In this paper, we critically approach the European normative framework available in countering the risks and situations of harms generated by e-proctoring through the lenses of data protection and anti-discrimination law. This work, in particular, is one of the first to systematise and analyse the corpus of online proctoring-related decisions that have emerged in the EU over the past three years. After an overview of the technical aspects of such technology and an outline of the legal issues debated in the literature, the paper will reconstruct and discuss the convergences and divergences in how courts and independent authorities have assessed the lawfulness of online invigilation tools. In our analysis, we observe that such instruments were evaluated differently depending on the concrete features implemented. However, with some notable exceptions, the General Data Protection Regulation and the anti-discrimination framework have largely proven helpful to combat the most intrusive forms of e-proctoring deployment or to mitigate their risks. Nevertheless, to ensure a safer and fairer educational environment, we conclude that a few crucial issues—including the effectiveness of the collective enforcement of rights, discriminatory effects for people not covered by a protected ground, and the governance of edTech within the university—should be further taken into account