Over recent decades, the possibilities for the prevention, diagnosis and treatment of disease have expanded throughout the EU. As a result, health policy decision makers and public funders are faced with the challenge of making choices for health investments to improve the healthy life expectancy of Europeans within the context of constrained resources. Health investments include any new technology for the diagnosis, prevention or treatment of disease. It is not clear to which extent recent decisions on such health investments have been optimal. Public funders sometimes evaluate the impact of health investments, but there is a lack of standardised procedures and criteria. This is even more the case for investments related to screening and diagnosis of disease, and in particular gene technologies.The objectives of this study are: 1. to set up a set of common criteria (a ‘tool’) for the evaluation of health investments related to screening and diagnosis (HISD) in Europe, with a special focus on gene technologies; 2. to guide the better alignment of procedures between all (old and new) MS; and 3. to improve the effectiveness and cost-effectiveness of future HISD.Literature reviews will identify existing methods for evaluating health investments and summarise existing procedures and criteria within member states (MS) for making and evaluating decisions on HISD. In parallel, stakeholders will be invited to participate in a survey allowing a better understanding of the commonalities and differences between MS. Based on this, a draft tool, comprising procedures and criteria for evaluating HISD will be proposed. The draft tool will be assessed by a panel of experts guiding its iterative development. A list of recent HISD in MS will then serve as subject for testing the practical applicability of the tool. Finally, ways for implementing the tool and for the evaluation of HISD in MS will be proposed together with recommendations and political implications at EU level.