Suchergebnisse

For all activities funded by the European Union, ethics is an integral part of research from beginning to end, and so is ethical compliance. Ethical compliance can be achieved through the performance of an ethics assessment that should address the following issues: human embryos and foetuses, human beings, human cells or tissues, personal data, animals, non-EU countries, environment, health & safety, dual use, exclusive focus on civil applications, potential misuse of research results and any other ethics issues not included in this list. This report highlights the points to be taken into consideration while conducting such an assessment; Relevant questionnaires to the same end have been drafted and are provided to all project partners to be filed in and submitted, as appropriate.

Management of intellectual property rights plays an important role in all Horizon 2020 research projects. Based on guidance by the European Commission as well as the applicable EU law framework, aim of this report is to map the intellectual property options and tools available to the SPHINX project partners for protection of the IP created during the project execution. To this end the analysis includes a presentation of protection and exploitation methods of IP Rights (such as trademarks, patents, copyright and transfer and licensing agreements). This generic presentation is followed by a first approach of how SPHINX's results could be protected and exploited in the future. Given the early stage of project development, this report's main purpose is not to bring forward a final protection and exploitation plan but instead to provide project partners with timely and comprehensive guidance on efficient and competent protection of their project-related IP rights. This includes for instance advice on a dissemination policy, confidentiality and trade secret practices, as well as exploitation strategy.

Purpose of this report is the identification and analysis of the regulatory and ethical framework relevant to the SPHINX project. Its findings need therefore to be taken into account by all project partners while executing their tasks. SPHINX aims to introduce a universal cyber security toolkit that will enhance the cyber protection of Health IT Ecosystems and ensure patients' data privacy and integrity. The SPHINX toolkit will be adapted or embedded on existing medical, clinical or health available infrastructures. In the context of the project, SPHINX's cyber-security ecosystem shall be validated and evaluated against performance, effectiveness and usability indicators at three different countries (Romania, Portugal and Greece). Hospitals, healthcare providers and IT solution providers participating in the project's pilots will deploy and evaluate the solution at business-as-usual and emergency situations across various use case scenarios. This report takes into account the SPHINX project characteristics and particularises them onto legal and ethical findings. Its first three parts elaborate upon the applicable legal and ethical framework for SPHINX project purposes. In this context, the ethical principles applicable are discussed in Chapter 1, while EU personal data protection law and EU cybersecurity law are analysed in Chapters 2 and 3 respectively. The analysis takes into account primary and secondary legislation, as well as, guidance issued by the European Commission and other EU bodies and agencies. Its aim is to formulate a comprehensive text of reference for all ethical and legal issues that are of relevance to the project. Findings of the first three Chapters of this report are made concrete onto actual SPHINX circumstances in Chapter 4. While structurally the already applied pattern is followed in this Chapter as well (subchapters 4.3, 4.4 and 4.5 focusing on ethical, personal data protection, and cybersecurity issues respectively), attention has been given to drafting concrete and specific guidance ...

The NIS Directive is the first horizontal legislation undertaken at EU level for the protection of network and information systems across the Union. During the last decades e-services, new technologies, information systems and networks have become embedded in our daily lives. It is by now common knowledge that deliberate incidents causing disruption of IT services and critical infrastructures constitute a serious threat to their operation and consequently to the functioning of the Internal Market and the Union. This paper first discusses the Directive's addressees particularly with regard to their compliance obligations as well as Member States' obligations as regards their respective national strategies and cooperation at EU level. Subsequently, the critical role of ENISA in implementing the Directive, as reinforced by the proposal for a new Regulation on ENISA (the EU Cybersecurity Act), is brought forward, before elaborating upon the, inevitable, relationship of the NIS Directive with EU's General Data Protection Regulation

The NIS Directive is the first horizontal legislation undertaken at EU level for the protection of network and information systems across the Union. During the last decades e-services, new technologies, information systems and networks have become embedded in our daily lives. It is by now common knowledge that deliberate incidents causing disruption of IT services and critical infrastructures constitute a serious threat to their operation and consequently to the functioning of the Internal Market and the Union. This paper first discusses the Directive's addressees particularly with regard to their compliance obligations as well as Member States' obligations as regards their respective national strategies and cooperation at EU level. Subsequently, the critical role of ENISA in implementing the Directive, as reinforced by the proposal for a new Regulation on ENISA (the EU Cybersecurity Act), is brought forward, before elaborating upon the, inevitable, relationship of the NIS Directive with EU's General Data Protection Regulation.