The proposal for a regulation on Health Technology Assessment (HTA) covers new medicines and certain new medical devices, providing the basis for permanent and sustainable cooperation at the EU level for joint clinical assessments in these areas. Member States will be able to use common HTA tools, methodologies and procedures across the EU, working together in four main areas: 1) on joint clinical assessments focusing on the most innovative health technologies with the most potential impact for patients; 2) on joint scientific consultations whereby developers can seek advice from HTA authorities; 3) on identification of emerging health technologies to identify promising technologies early; and 4) on continuing voluntary cooperation in other areas. Individual EU countries will continue to be responsible for assessing non-clinical (e.g. economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement.
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Digital healthcare / health insurance - Related Opinions
The EESC supports the European Digital Single Market Strategy proposed by the Juncker Commission, which is an extension of existing digital strategies and programmes. Its intention is to end the fragmentation of European digital policy into 28 strategies and national digital markets and merge them within a European approach, so as to guarantee a leading position for the EU in the global digital economy, a privilege that has become the preserve of third countries.
The EESC is convinced that the European Union, which has at its disposal excellent skills and considerable experience in certain aspects of digital technology, can still catch up. With this in mind, the EESC strongly recommends developing multidisciplinary research poles and European synergies in the European Research Area, in spheres such as cloud computing, nano-electronics, the storage and processing of big data, appliances that can be consulted or controlled remotely (connected objects), and smart services.
The EESC welcomes the Green Paper, because of the contribution that mHealth can make to European healthcare systems, which are facing increasing challenges as a result of demographic change.
The Committee considers that the priority must be to improve healthcare, not to cut costs. The success of mHealth requires the participation of healthcare professionals, dialogue with patient organisations, the promotion of mutual trust between patients and professionals and the provision of incentives and training plans for the latter. Dialogue also needs to be established with industry in this field.