AbstractWhen complying with appropriate safeguards, the processing of personal data for scientific research under the GDPR benefits from a special regime which is of interest for biobank research. On the one hand, under this condition, the further processing of personal data will not be incompatible with the initial purposes for which the data were originally collected and processed and it allows for retaining data for longer periods of time for scientific research. Complying with this condition is a condition to lift the prohibition to process special categories of personal data in the context of scientific research. On the other hand, complying with this condition makes it possible to derogate to some extent to several data subjects’ rights such as the right of access, the right to rectification, the right to the restriction of processing and the right to object to the processing.Possible safeguards range from specific procedures to support the exercise of data subjects’ rights to the use of anonymous data or (where necessary) of pseudonymised data, the appointment of a data protection officer, enforcing a procedure to ensure a feedback to data subjects on the results of the research, requiring specific professional accreditations, creating a specific supervisory body for the biobank research, or the creation of a specific Code of conduct for biobank research activities.This double regime under the GDPR is finally compared with the 2009 OECD Guidelines in biobanks and genetic research databases.

Abstract This chapter explores contemporary regulation of medical privacy in the United States and Europe and its challenges. The need for privacy is a fundamental human necessity. Privacy relates to human beings’ ability to maintain their dignity and avoid disclosure of information that might be deemed unpleasant. It is also associated with personal autonomy and informational self-determination. At the same time, however, some degree of data sharing is essential to the appropriate treatment of patients as well as to the proper functioning of society in general and the healthcare system in particular. Thus, privacy cannot be limitless. Hence, this chapter discusses regulatory strengths and shortcomings and highlights gaps in the law. It also suggests further safeguards that policy-makers should implement in order to protect patients and data subjects.

La protection des données à caractère personnel et le respect de la vie privée sont des droits fondamentaux majeurs. Le Parlement européen a toujours insisté sur la nécessité de maintenir une approche équilibrée entre renforcement de la sécurité et sauvegarde des Droits de l’homme, notamment en ce qui concerne la protection des données et la vie privée. De nouvelles règles de l’Union relatives à la protection des données, qui renforcent les droits des citoyens et qui, à l’ère numérique, simplifient les règles que les entreprises doivent respecter sont entrées en vigueur en mai 2018.

This article aims at opening discussions and promoting future research about key elements that should be taken into account when considering new ways to organise access to personal data for scientific research in the perspective of developing innovative medicines. It provides an overview of these key elements: the different ways of accessing data, the theory of the essential facilities, the Regulation on the Free Flow of Non-personal Data, the Directive on Open Data and the re-use of public sector information, and the General Data Protection Regulation (GDPR) rules on accessing personal data for scientific research. In the perspective of fostering research, promoting innovative medicines, and having all the raw data centralised in big databases localised in Europe, we suggest to further investigate the possibility to find acceptable and balanced solutions with complete respect of fundamental rights, as well as for private life and data protection.

Obstacle avoidance systems for autonomous vehicles combine multiple sensing technologies (i.e. LiDAR, Radar, Ultrasound and Visual) to detect different types of obstacles across the full range of lighting and weather conditions. Sensor data are fused with vehicle orientation (obtained for instance from an Inertial Measurement Unit and/or compass) and navigation subsystems. Power hungry, they require powerful computational capability, which limits their use to high-end vehicles and robots.

Secondary use of personal data is particularly challenging for research, especially in paediatrics. The new EU General Data Protection Regulation (GDPR) enables a new legal framework for the data protection and personal data processing. This article analyses the GDPR provisions with the aim to verify if paediatric peculiarities are taken into account in the new framework and if GDPR provides adequate and clear rules to favour the secondary use of paediatric data for research purpose in international contexts. The analysis points out the lack of specific provisions covering paediatric peculiarities in the rules introduced by the GDPR, especially in the case of secondary use of data in international research projects. It concludes underlying the importance to develop new overall governance of personal data processing for health research in order to reduce the risk of infringements of fundamental and child' rights. The need of further safeguards and tools for the standardisation of practices is also emphasised.

Environment perception is crucial for the safe navigation of vehicles and robots to detect obstacles in their surroundings. It is also of paramount interest for navigation of human beings in reduced visibility conditions. Obstacle avoidance systems typically combine multiple sensing technologies (i.e., LiDAR, radar, ultrasound and visual) to detect various types of obstacles under different lighting and weather conditions, with the drawbacks of a given technology being offset by others. These systems require powerful computational capability to fuse the mass of data, which limits their use to high-end vehicles and robots. INSPEX delivers a low-power, small-size and lightweight environment perception system that is compatible with portable and/or wearable applications. This requires miniaturizing and optimizing existing range sensors of different technologies to meet the user's requirements in terms of obstacle detection capabilities. These sensors consist of a LiDAR, a time-of-flight sensor, an ultrasound and an ultra-wideband radar with measurement ranges respectively of 10 m, 4 m, 2 m and 10 m. Integration of a data fusion technique is also required to build a model of the user's surroundings and provide feedback about the localization of harmful obstacles. As primary demonstrator, the INSPEX device will be fixed on a white cane.

Inspired by the abilities of contemporary autonomous vehicles to navigate with a high degree of effectiveness, the INSPEX Project 1 seeks to minaturise the sensing and processing technology involved, to produce devices which can help navigate within an environment in a smart way, enabling their use in a wide variety of applications.The project is focused on producing an advanced prototype for a device which can be attached to a VIB person's white cane, and which, through the use of a variety of minaturised sensors, and of the processing of their data via sophisticated algorithms, can offer the user a richer palette of information about the environment than the use of the unadorned white cane alone could furnish.The various strands contributing to the project are overviewed, and the prospects for further enhancements are contemplated.

Data protection rules applies to biobanks' activities to the extent that they fall under the scope of the General Data Protection Regulation, which is already susceptible to raising some difficult issues to solve. If subjected to it, biobanks' activities will have to comply with the applicable substantive rules governing data processing, data subject's rights, obligations of data controller and processor, without omitting the specific authorities and mechanisms ensuring data protection effectiveness.

The article investigates the issue of knowing whether or not the proposal for a general data protection regulation could improve the patient's safety. This has been analyzed through the four main contributions that should be expected at least from data protection to the patient's safety. In our view, data protection should help supporting efficient information systems in healthcare, increasing data quality, strengthening the patient's rights and drawing the legal framework for performing quality control procedures. Compared to the current legal framework, it is not sure that the proposal might improve any of these contributions to the patient's safety.