• In May 2017, a new Regulation on medical devices, Regulation (EU) 2017/745 entered into force that will come into effect in spring 2020. This new Regulation sets forth reinforced rules for the generation of clinical evidence: for instance, clinical investigations for high-risk devices will be compulsory and the requirements regarding the clinical evaluation throughout the product lifetime are more stringent.

Cell and gene-based therapies have the potential to treat many debilitating diseases and conditions. However, the pace of their clinical development does not meet public expectations. They face difficulties reaching patients because inter alia the complexity and costs of product development, regulatory hurdles and the non-harmonized procedures for reimbursements. In addition, there are concerns over patient safety due to the use of unproven treatments.

European Reference Networks (ERNs) have been established under the Directive on Patients' rights in cross-border health care in view of tackling complex or rare diseases and conditions that require highly specialised diagnostic tools and treatments. ERNs in collaboration with other European initiatives will gain major research potential due to their network structure bringing together highly specialised multidisciplinary expertise

Implementation of timely and correct diagnostics for infectious diseases (ID) that will speed up the identification of the causative infectious disease pathogens, possible drug resistances and drug susceptibility is crucial for tailoring the antimicrobial treatment, thus ensuring appropriate antimicrobial drug use.

The challenge is to enable public procurers to collectively implement PCPs in order to close the gap between supply and demand for innovative integrated care solutions. The objective is to bring radical improvements to the quality and efficiency of public services and service delivery by encouraging the development and validation of breakthrough solutions through Pre-Commercial Procurement.

The number of people with chronic illness is growing and almost half of them have multiple chronic conditions. Patients with complex chronic conditions (CCCs) have chronic multi-morbidities or chronic disease complications that require the attention of multiple health care providers or facilities as well as home-based care.

The Human Brain Project (HBP) has launched four calls for expression of interest for projects that wish to participate in the development of its research infrastructure. Proposals can be submitted until 2 December. The selected projects will contribute to the development of the EBRAINS research infrastructure and increase the scope of its application in terms of innovation, neuroscience and clinical research.

Technological innovation has triggered an unprecedented increase in data production in health research and healthcare. The need to make EU health research data FAIR (i.e., Findable, Accessible, Interoperable and Re-usable) becomes more pressing than ever before if European health research is to reap the full benefits of this valuable resource.

The availability of appropriate decision support tools for healthcare practitioners can promote uptake of personalised medicine in health care. There is a need to carry out research activities aiming to develop and validate such decision tools that would integrate available and/or emerging diagnostic means for the area concerned, enabling increased precision of diagnostics and clinical decision making.

The European Commission is launching a tender for two studies to survey and analyse progress on the digital transformation of the health and care in the EU, in particular with regard to citizens' access to their electronic health records (EHR) in the EU Member States and the development, adoption and use of artificial intelligence (AI) technologies in the health and care sector in the EU.