Stakeholders Push Forth Recommendations Before the European Commission Adopts the EHDS Regulation

This article was exclusively written for The European Sting by one of our passionate readers, Mr Enrique De La Cruz, a student researcher in the public health The opinions expressed within reflect only the writer’s views and not necessarily The European Sting’s position on the issue.

As the European Commission plans to adopt the European Health Data Space (EHDS) regulation before 2026’s first quarter ends, here are three meaningful recommendations, which may become published in the proposal, that stakeholders tabled. 

The U.S-based biohealth think-tank Revitalised Medicine concurred with ideas on strengthening the European Health Data Space (EHDS) through collaborations with public service institutions and promoting interactions between the EHDS board and the eHealth Network, which connects national authorities with activity involving electronic patient data. 

The organisation believes that communication between organisations across member states that regulate electronic health data would foster accountability between providers and patients. Allusions were made to previous policies, where stakeholders recommended that oversight amongst stakeholders on issues on patient data is pivotal in furthering the handling of medical information in ethical manners. 

In advancing the means through which this data is utilized, the stakeholder emphasized that the EHDS board should adopt a medical data framework adapted to evolving technological systems, aligning with stakeholder and institutional recommendations. Such appropriate intervention will not further an ethical process in sharing medical data across member states, but ensure that this framework is standardized and thus, effective, with the highest data handling standards. Stakeholders who have been working closely with the European Commission on these matters strive to impact regulation that can fulfill this objective. 

In a direct suggestion to the current draft that outlines the ideas the EHDS regulation may adopt to improve patient outcomes through advanced data sharing, Revitalised Medicine hinted at current issues in guideline standardization. To improve this aspect of the regulation, the biohealth organization proposes that the data sharing and utilization standards in clinical and research institutions throughout the European Union could be more elaborate. In this way, enforced intervention of ethical and technologically advanced EHDS standards can take place. 

Mirroring Revitalised Medicine’s concerns on the current lack of elaborateness in ensuring that patient data sharing is as elaborate as possible, pharmaceutical stakeholder Astrazeneca shares its recommendations for healthcare information exchange among member states: “The nuances of interoperability of different platforms needs to be detailed to include privacy and security for patient information. Further collaboration and information exchange need to be defined at a high level.”

The idea surrounding the need for advances in ethical data sharing has also been incorporated into other recommendations that the European Commission could consider in the EHDS regulation. Swiss EUROCAM member European Reiki Group (ERG) advocates for an ethical patient-centred approach that emphasizes a new approach to conventional healthcare treatment frameworks under the Traditional, Complementary and Integrative Medicine practice. It is noted that personalised care would tailor therapy to individual needs and healthcare outcomes. The patient-centric, human aspect behind this notion complements ERG’s recommendation that the EHDS should institute standardised regulations that enable institutions throughout the European Union to exchange health data through interoperable and secure manners. While supporting optimal physical and mental well-being, this move would add another layer to the action providers execute to support patients: ensuring privacy, a right these individuals are entitled to. 

ERG believes that EHDS can promote efficient clinical data usage that protects privacy and promotes transparency between institutions and patients. The stakeholder specifically emphasizes that the “work of the EHDS Board in developing standards, technical specifications and guidance” would allow it to meet this objective. 

Amidst the ideas that these stakeholders believe should be incorporated into medical data sharing, there has been praise for the European Commission in making progress in employing stakeholders’ ideas on improving transparency in activity around confidential patient information. When recommendations to improve the EHDS are integrated, it paves the way for a medically-advanced Europe that will only keep improving with respect to how it protects patients’ rights.