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European health data space

Briefing 11-12-2023

The COVID-19 pandemic shone a light on the growing importance of digital health technologies, both to enable remote medical care and to facilitate the health response by international, national and local authorities. At the same time, personal health data have been key for containment measures such as the EU digital COVID certificate. The Commission's May 2022 proposal for a regulation on a European health data space aims to improve individuals' access to and control of their electronic personal ...

Overall, the IA describes the scope of the problem sufficiently well, and explains briefly, but convincingly, the need for EU action, although proportionality does not appear to have been dealt with in any depth. The IA does not define any operational objectives, which would illustrate what the deliverables of the specific policy actions are, although it identifies monitoring indicators for the specific objectives. The sufficient range of retained policy options is structured according to increasing ...

The European Health Data Space

Mad-Daqqa t’Għajn 12-12-2022

This research paper provides an assessment of the legislative proposal for “The European Health Data Space”, including linkages with other EU measures and with Member State rules and laws. It also includes recommendations on further steps needed in order to achieve, facilitate and improve health data sharing, exchange and re-use across the EU.

In recent years, the use of artificial intelligence (AI) in medicine and healthcare has been praised for the great promise it offers, but has also been at the centre of heated controversy. This study offers an overview of how AI can benefit future healthcare, in particular increasing the efficiency of clinicians, improving medical diagnosis and treatment, and optimising the allocation of human and technical resources. The report identifies and clarifies the main clinical, social and ethical risks ...

The European Commission has proposed a regulation on health technology assessment (HTA). HTA is a research-based tool that supports decision-making in healthcare by assessing the added value of a given health technology compared to others. The proposal would provide the basis for permanent EU-level cooperation in four areas. Member States would still be responsible for assessing the non-clinical (economic, ethical, social, etc.) aspects of health technology, and for pricing and reimbursement. While ...

This At a glance note summarises the study that analyses the role of Cohesion Policy as regards cross-border cooperation in healthcare, with a particular focus on the 2014-2020 Interreg V-A programmes. The study also reviews the issue of governance related to such projects and the impact of the COVID-19 pandemic. Finally, it identifies possible solutions and puts forward policy recommendations to facilitate patient and healthcare staff flows, to improve the cross-border supply of healthcare and to ...

Access to medicinal products

Studju 01-05-2021

There are many factors that can prevent a patient from being able to obtain the medicine they need, ranging from selective marketing decisions by companies to products being too expensive or pharmacy stock-outs. Because of national differences in health systems and market characteristics, access to medicine is not evenly distributed across the European Union. In response to observed problems with access to medicine, in 2017 the European Parliament adopted a resolution containing 58 recommendations ...

The impact assessment (IA) accompanying the Commission proposal on strengthening EU cooperation on Health Technology Assessment clearly defines the problem, as well as the general and specific objectives. However, the IA does not appear to have succeeded in presenting a very convincing range of options. The analysis of impacts focuses on the economic dimension, which is consistent with the manner in which the problems have been defined. In light of the reported concentration of SMEs in the medical ...

European Reference Networks (ERNs) are newly established virtual platforms for voluntary cross-border collaboration between specialists in rare and complex diseases. ERNs were set up under Directive 2011/24/EU on the application of patients' rights in cross-border healthcare, and go back to a 2009 Council recommendation on an action in the field of rare diseases. Since specialist knowledge of rare diseases is both scarce and scattered across countries, the EU-level cooperation afforded by ERNs is ...

Medical devices and in vitro diagnostic medical devices cover a wide array of products. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012. Following Parliament's first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the trilogues, agreement was reached on 25 May 2016. This was endorsed by the Council's Permanent Representatives Committee on 15 June ...