The European Commission is expected to propose next month a new governance framework for health data, called the European Health Data Area (EHDS), with the aim of connecting national health systems to facilitate secure and efficient transfer of data between the systems of different European countries.
The move is expected to help encourage evidence-based healthcare, spur research into the development of therapies and treatments, and inform health-related policy decisions.
Sharing health data is particularly important for rare disease communities, where the limited number of people with a disorder often makes it difficult to conduct large studies, according to a EURORDIS press release. The group, an alliance of almost 1,000 rare disease patient organizations from 74 countries, is directly involved in the development of the new framework.
“Given the high relevance of the upcoming legislative proposal for the rare disease patient community, EURORDIS will actively contribute to shaping this legislation, which will be outlined in a position paper to be published this summer,” said the alliance. “In particular, we will ensure that the legislation reflects the needs of patients – both in terms of developing robust standards to ensure secure, ethical and responsible data sharing and in enabling the transparent sharing of health data at across borders for the benefit of every person living with a rare disease. in Europe.”
Because health data is highly personal, a number of European Union regulations tightly control if and how this data can be shared. At the same time, analyzing health data is a crucial part of scientific research that can help improve care.
According to EURORDIS, 97% of people with a rare disease say they are willing to share their data to help promote research into their disease. Almost as many are willing to share their data if it helps advance research on diseases other than their own.
At the same time, 80% of patients with rare diseases want to be in control of their health data, to prevent this information from being used without their express permission.
EHDS aims to provide a framework that will facilitate the sharing of health data for research purposes across national borders, while ensuring adequate data security. Its design is based on three main pillars: strict rules governing the exchange of data, high quality data and a solid infrastructure to manage the data.
“Overall, it promises to advance research, diagnosis, treatment and care for people with rare diseases through increased and meaningful data sharing,” EURORDIS reported.