The European Parliament as well as the Council of the EU have gone on to reach a deal on the European Health Data Space- EHDS, a piece of legislation that looks forward to improving individual access as well as control when it comes to their health data across Europe and also so as to facilitate cross-border research as well as innovation in health.
Until the week ending March 16, 2024, political groups within the Parliament as well as the member states happened to be struggling to reach agreement as far as giving people the right to opt out of the secondary usage of their data, a choice that was not included in the original proposal of the Commission.
As per the provisional agreement that has been reached, it is going to be up to the member states to decide whether or not there has to be an opt-out, except as far as cases of public interest such as public health research, policy-making, as well as statistical analyses are concerned.
According to Belgian deputy prime minister and minister of Social Affairs and Public Health, Frank Vandenbroucke, the new law agreed, will allow patients to access their health data wherever they happen to be in the EU, while at the same time offering scientific research for important reasons of public interest with a wealth of secure data that will go on to greatly benefit development when it comes to health policies.
The EPP, S&D, as well as the Renew groups were satisfied with the agreement and pushed for inclusion when it came to the opt-out mechanism.
S&D negotiator for the European Parliament’s civil liberties, justice, and home affairs committee, Peter Vitanov, said that he is proud that they stood their ground and secured people’s control  in terms of their health data, while also ensuring the possibility in terms of data to be made available, under the strict conditions, for the purposes of significant public interest.
The agreement signed on the European Health Data Space happens to mark a new era for the healthcare industry, opined MEP Lucia Duris Nicholsonova, who is the Renew shadow rapporteur as far as the Committee on Civil Liberties, Justice, and Home Affairs goes. On one hand, it will go on to help the improvement in terms of patient healthcare in both domestic and cross-border cases, and on the other hand, it will go ahead and contribute to medical growth through research, innovation, and better policy-making.
But, hospitals as well as stakeholder groups went on to tell Science|Business before the deal of the concerns on the opt-out concession due to the substantial risk in terms of data bias.
While the EHDS is all set to allow significantly seamless mobility of patients across Europe due to the access by hospitals as well as doctors to their health records, a dearth of harmonisations among the EU states could even thwart this.
So as to address this issue, the proposed regulation goes on to mandate that all electronic health record- EHR systems adhere to the specifications of the European electronic health record exchange format, which guarantees interoperability all throughout the EU.
The next step when it comes to the EHDS so as to become law happens to be for the Council and Parliament to endorse it as well as, at some point, adopt it.
