Irish policymakers draw on report to implement forthcoming EU health data law

As the European Parliament adopted the proposal on Wednesday (13 December) to create a European Health Data Space (EHDS) to improve access to personal health data across the bloc, Ireland has high hopes for the results of its implementation.

With the EHDS passing the hurdle of the European Council on 6 November and Parliament earlier this week, the way has been paved for a robust law making it easier to exchange and access health data in the EU.

Sinead Keogh, Director of BioPharamChem Ireland (BPCI), told Euractiv that the EHDS will enable “patients to have access to their data across borders, which will support more accurate diagnosis; policymakers will have access to trends to help make more informed decisions about the performance of health systems; and research and innovation organisations, to have access to largescale data sets for analysis via national bodies supported by decentralised infrastructure.”

“These data sets”, she said, “will provide insights to support the development of new innovative products and therapies, ultimately enhancing European competitiveness.”

Getting ready

But with such significant changes and impacts on the horizon, stakeholders are already preparing the ground.

EIT Health Ireland-UK published a new report on ‘Implementing the European Health Data Space in Ireland,” setting out recommendations for policymakers on moving forward.

The European Commission first published a proposal in May 2022 for a regulation creating a European Health Data Space (EHDS). The proposal identified the first of nine European sector- and domain-specific data spaces in its 2020 communication, ‘A European strategy for data’.

The EIT Health report took an Irish perspective, focusing on the secondary use of data for research and innovation, and made recommendations across six dimensions of implementation: governance; capacity and skills; resources and funding; data quality; closing the loop: the relationship between primary and secondary use; awareness, education, and communication: and how to move towards a data-driven culture in healthcare.

Speaking at the report launch, Sinéad O’Connor, Adjunct Assistant Professor of Emerging Technologies in Healthcare from Trinity College Dublin’s School of Medicine, said: “As each country is at a different stage of digital health record availability, the EHDS could be timely for Ireland, as lessons can be taken from European neighbours that are further ahead on health data standardisation and management.”

Keogh added that from an industry perspective, it’s important that the EHDS set forth clear definitions and can intersect with other legal frameworks such as the AI Act, Data Act, and GDPR.

“The EHDS should specify the scope of electronic health data categories for secondary use, as well as make all measures necessary to preserve the confidentiality of IP rights and trade secrets that might subsist in a dataset,” she said.

Research and innovation “gamechanger”

O’Connor explained that Ireland is a hub for MedTech and pharmaceutical companies, with a highly educated workforce and renowned academic institutions. As such, “It could become a leader in innovation utilising health data with sensors, nanotechnologies, genomics and artificial intelligence, enabling better treatments and patients’ self-management of their conditions.”

Elaine Murray, Public Affairs Lead at EIT Health Ireland-UK, told Euractiv: “The EHDS could be a game-changer for how healthcare is delivered and how health research is carried out in Ireland and across Europe.”

She described the EIT-Health Ireland report as “providing a blueprint for policymakers preparing for implementation.”

But, for Ireland to move forward, “a significant cultural change is required, transitioning from a focus on data protection to striking a balance between data protection and data sharing to further research that enables improved patient care. Investment in digital technologies will be required, as well as upskilling the healthcare workforce,” she added.

Ongoing negotiations

The Council’s position developed the European Commission’s proposal in several thematic areas, adding “clarity” on issues such as the scope of the regulation, alignment with the General Data Protection Regulation (GDPR) and the criteria for providing access to electronic health data steering groups.

The EU Council presidency confirmed it in early December with Spanish Minister for Health, Mónica García, stating, “The digitisation of health data in the EU carries potentially vast benefits for patients, medical professionals, and the research community, yet this potential has not been realised.”

Parliament adopted the proposal on Wednesday with 516 votes for, 95 against, and 20 abstentions and will serve as its negotiating mandate for the final talks with the European Council.

Parliament emphasised strong privacy measures, including an opt-out system for secondary data use and mandatory explicit consent for sensitive data like genetic information, according to a press release after the vote.

Furthermore, the Parliament wants to broaden the ban on secondary uses in sectors like labour and finance and ensure that shared data contributes to medical advancements without falling under intellectual property rights.

The infrastructure already in place to facilitate the cross-border exchange of electronic health data, MyHealth@EU, will be expanded, and EU countries will also be required to set up a digital health authority to implement the new provisions.

(By Brian Maguire, Edited by Vasiliki Angouridi | Euractiv.com)

Read more with Euractiv