European Health Data Space clears the last hurdle in Parliament
The European Parliament adopted on Wednesday (24 April) the European Health Data Space Regulation, a key step for Europe’s digital healthcare that should facilitate access to cross-border medical data, by 445 votes in favour and 142 against.
This was the final vote on creating a European Health Data Space meant to improve access to personal health data of patients across Europe. The regulation aims to help the interoperability of healthcare systems and improve outcomes for patients.
Croatian MEP Tomislav Sokol (EPP) said the new rules will be “truly life-changing”. “The new law will make it possible for doctors to quickly find the information they need from your health care records”.
Sokol argued that the new legislation will also be an important boost for the development of new medicines and medical devices:
“The Health Data Space can help us to leverage the data we have in a safe and secure manner, giving vital research into new treatments a major boost. At the same time, opt-outs will ensure that patients have a say, and that the system is trustworthy. It will be a major step forward for digital healthcare in the EU.”
The use of anonymised or pseudonymised data is increasingly recognised for its ability to revolutionise research, this can be particularly important to finding treatments for rare diseases that, according to Rare Disease Europe (EURORDIS), impact 30 million people across Europe.
MEPs were also concerned that this sharing of data should be subject to robust data protection given that it is highly personal and often sensitive information. There are, nonetheless, some public-interest exemptions.
MEPs warned that the benefits of the regulation will be limited if countries do not have sufficient funding to successfully implement changes to their current data management systems.
The Council will need to give their final approval before it becomes law, but there are unlikely to be any surprises.
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