Establishing the European health data space

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 levels of regulatory intervention, and appears to be convincing. However, the IA would have benefited from providing a more user-friendly description of some of the envisaged measures. On the whole, the IA appears to have analysed aspects of the economic impact satisfactorily, while the analysis regarding environmental impacts is very limited, although this appears justified based on the problem definition and the objectives identified. As regards social impacts, the IA quantifies the benefits, expressed in terms of savings in health expenditure, for healthcare providers, patients, researchers and innovators. The analysis regarding the impact on SMEs is rather weak, not least considering that 95 % of the companies operating in the medical technologies sector are SMEs. The analysis of the impact on innovation is not dealt with comprehensively, whereas this would perhaps have been warranted considering that increasing innovation in health products and services is part of the general and specific objectives, while the analysis regarding competitiveness is almost non-existent. The IA appears to have addressed the RSB's comments only partially. The proposal appears to be consistent with the analysis carried out in the IA as regards the envisaged measures included in the preferred options.