News

Health Organisations define EHDS’ opt out required for life saving research

Published on: 06/06/2023

Health Organisations define EHDS’ opt out required for life saving research
Data, Thought Leadership

On 6 June, ECHAlliance and The Digital Health Society joined together with 31 other health stakeholders to share views on specific recommendations for a potential opt-out mechanism in the future EHDS.

These organisations and initiatives have joined forces because they all share the view that health data are precious and renewable resources that can power decision-making for clinical care, deliver life-saving innovations, and strengthen health systems in the 21st century.

Discussions in the EU policy-making process now include proposals for an opt-out mechanism for citizens to withdraw their data from secondary use purposes (that is, from research, regulatory purposes and evidence based policy making). The original European Commission proposal did not include this mechanism.

The group of stakeholders support the approach taken in the Commission’s original legislative proposal from May 2022 as it strikes a sensible balance between protection of personal data while enabling the use of data for research and innovation to create tangible benefits for patients and citizens. The stakeholders raise concerns about the real risk that data bias will form part of the EHDS from its inception and thus undermine its principal value for secondary use research purposes if an opt-out or opt-in mechanism is approved, and call for an impact assessment that will inform implementation of this policy option. 

If the proposals for opt-out are approved in the final EHDS legislation, the group make six recommendations. They believe the opt-out mechanism should:

  • be applicable across all Health Data Access Bodies in EU Member States, limiting the scope of national derogation and ensuring that the technical specifications are aligned.
  • consider the impact on health and care professionals and for other data holders
  • be capable of implementation across the EU, without limiting lawful and ethical data sharing for secondary purposes. 
  • be routinely monitored as part of a regularly updated HealthData@EU data governance framework.
  • have a limited, but well-defined, consistent and transparent scope. 
  • have necessary investment, infrastructure and budget to ensure sufficient transparency so that citizens are well informed of the opt-out.

Finally, the current debate on enabling secondary use of health data in Europe highlights the need to achieve stakeholder alignment where possible on the implementation journey ahead for the EHDS. It also speaks to the need for implementation decisions to be highly informed by those with experience and responsibilities for on-the-ground implementation. This reiterates a need for strong, balanced and inclusive stakeholder representation within the governance model of the EHDS such as its Board of Directors.

NEWS​

Related News

HLTH Brought the Energy to Amsterdam. Now It’s Vegas’ Turn.

26 Jun 2025
Next up: HLTH USA, October 19–22 in Las Vegas.

From Abandonment to Belonging: Hands 4Life’s Vision for Generational Healing

26 Jun 2025
Hands 4Life is a nonprofit organization addressing the global aging crisis by empowering communities in economically developing nations—beginning with...

Strengthening Elderly Care Innovation Across Europe: ECHAlliance at the NOTRE Project Meeting in Lille

26 Jun 2025
ECHAlliance participated in the latest partner meeting of the NOTRE Project, hosted in Lille, France by our Hauts-de-France ecosystem led by Eurasanté...

Africa Health Business Co-founder Dr Amit Thakker Honoured with Top Civilian Award

26 Jun 2025
Dr. Amit N. Thakker, Co-founder of our partner Africa Health Business, receives one of the highest civilian awards from the President of Kenya.

Highlights from the Global Health Connector Partners Programme at HLTH Europe 2025

25 Jun 2025
Our Global Health Connector Partners Programme returned to HLTH Europe this June with an energising series of sessions, conversations and connections ...

That’s a Wrap from HIMSS Europe 2025!

24 Jun 2025
From Paris with purpose: Gnomon Informatics SA returned to HIMSS Europe for a third year of bold ideas, smart tech, and stronger-than-ever momentum in...

Become a member

Join ECHAlliance to amplify your organisation’s message, grow your networks, connect with innovators and collaborate globally.
 
First name *
Last Name *
Email Address *
Country *
Position *
First name *
Last Name *
Email Address *
Country *
Position *