The European Commission has proposed creating a European Health Data Space (EHDS) that will make it easier for developers and manufacturers of medicinal products to access data for research.
Currently, most health-related data held in the European Union is inaccessible to researchers and other stakeholders that could use it to inform the development of medicinal products. According to officials at the Commission, businesses “face important obstacles in accessing the data they need to develop new products,” notably because in many cases “consent is the only way to access data” for purposes other than its original use.
“It is very costly and cumbersome for researchers to get consent from every patient to use the patient’s data in their research. Even when the patient consents, data holders are sometimes reluctant to provide data for reasons other than data protection and prefer to keep the health data for their activities. The current regulatory fragmentation between Member States hampers research and innovation by small players, as well as cross-border research,” the Commission wrote in a communication to other EU bodies…
