Stakeholders’ consensus response to the proposed European Health Data Space

Stakeholders’ consensus response to the proposed European Health Data Space

On 20 October, OPTIMA joined a group of 29 stakeholders in welcoming the European Commission’s proposal on the European Health Data Space.

The stakeholders, which include medical professional and research organisations, patient representatives, industry associations and data collaborations strongly support the aims of the EHDS as proposed by the European Commission. We believe the adoption of the new legislation “can bring important European alignment to, and rapidly scale up, well-governed access to health data sets for the delivery of healthcare services but also for a wide range of secondary use purposes for better health outcomes.”  

The consensus statement encourages decision-makers to strongly support this Regulation and to engage with stakeholders to ensure the final Regulation optimises its potential. The statement also formulates several recommendations to consider when developing the more specific implementation plans to put this Regulation into practice across the Member States:

  1. A broad range of stakeholders must be strongly involved from the outset of the process to guarantee the success of the EHDS.
  2. The EHDS must align with all relevant horizontal and sectoral European laws.
  3. There must be harmonised interpretation and implementation of the Regulation across the EU.
  4. Approvals for secondary use of health data must be consistent and harmonised across Europe.
  5. The scope of EHR systems must be defined clearly within the Regulation.
  6. The successful implementation of the EHDS must be adequately resourced.
  7. Existing health data infrastructures must be leveraged to allow continuity and build on existing expertise.

Will the European Health Data Space unleash the power of data?

Will the European Health Data Space unleash the power of data?

OPTIMA coordinator Prof. James N’Dow (WP1 lead, WP9 lead) and Sarah Collen (WP8 member) co-chair the Health Data Sharing Taskforce of the Biomed Alliance. On 14 December, the Alliance released a new statement ahead of the upcoming European Commission legislative proposal on the European Health Data Space (EHDS). The new EHDS can play a key role in facilitating health data sharing for healthcare provision, health research and policy making if certain key aspects are taken into account. The EAU has much relevant experience to offer from leading two international Big Data consortiums funded by the EU Innovative Medicines Initiative (IMI) and experience with EAU Research Foundation experience with patient registries and clinical trials.  OPTIMA’s goal is to design, develop and deliver the first interoperable, GDPR-compliant real-world oncology data and evidence generation platform in Europe, to potentially advance treatment for patients with solid tumours in the three cancers. 

The BioMed Alliance Task Force on Health Data Sharing, in close cooperation with the European Association of Urology (EAU) and the European Organisation for Research and Treatment of Cancer (EORTC) have therefore proposed a set of recommendations for the governance, implementation and incentivisation of adoption of the EHDS. 

The statement particularly highlights the need to involve a broad range of stakeholders and to align different legislative approaches with a clear and enabling EU legal framework which will give legal clarity to researchers.

Read the full statement here.

 

Will the European Health Data Space unleash the power of data?

Lutter contre le cancer grâce à des données du monde réel
et l’intelligence artificielle