The main European objectives defined in the Europe 2020 strategy are linked to economic growth and development, European competitiveness, healthcare and quality of life, all based on continuous and growing innovation in the healthcare sector in Europe.

Old populations and the increasing prevalence of chronic diseases, present European countries with new challenges in their ability to provide better integrated and sustainable health and social services, including expensive and innovative treatments. Thus, guidance and regulation must be continuously adapted and updated to allow the development of innovative clinical and more complex therapeutics solutions (for example, layered and personalised medicine, advanced therapies, etc.).

The use of e-health information, medical records, personal data and "Information and communication technologies - ICT" questions their secondary use, particularly in research and on regulation terms.

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