1.5. Methods and data

The integration of infrastructures and information structures and sources (including those derived from cohort studies, protocols, data collections, indicators, health examination surveys etc.) as well as the standardisation, interoperability, storage, sharing of and access to data, will be supported to enable such data to be sustainable in the long-term and properly exploited. Attention should be given to data processing, knowledge management, modelling, visualisation, ICT-security and privacy-related issues. In particular, availability of information and data on negative results and adverse effects of treatment need to be improved. There is a need to support research, development, integration and use of scientific tools, methods and statistics for rapid, accurate and predictive assessment of the safety, efficacy and quality of health interventions and technologies including new drugs, biologics, advanced therapies and medical devices. This is particularly relevant for new developments in domains concerning biopharmaceuticals, vaccines, antimicrobials, cell/tissue and gene therapies, organs and transplantation, specialist manufacturing, biobanks, new medical devices, combination products, diagnostic/treatment procedures, genetic testing, interoperability and e-health, including privacy aspects. Similarly, support for improved risk assessment methodologies, compliance frameworks, testing approaches and strategies relating to environment and health is required. There is also a need to support the development of relevant methods for assisting the assessment of ethical aspects of the above-mentioned domains. Computer simulation-based medical systems using patient-specific data and building on systems medicine approaches and physiological modelling can be used to predict susceptibility to disease, disease evolution and the likely success of medical treatments. Model-based simulation can be used to support clinical trials, predictability of treatment response, and the personalisation and optimisation of treatment.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-04 · Text as adopted (Official Journal); later amendments are not incorporated in this text.