European Health Data Space (EHDS) Results Framework

𝟮𝟵𝟭 𝗽𝗮𝗴𝗲𝘀 𝗼𝗳 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀 on the European Health Data Space (EHDS) could be, mmm, dry—but it’s actually about something exciting:

Access to 𝗹𝗮𝗿𝗴𝗲𝗿 amounts of 𝗵𝗶𝗴𝗵-𝗾𝘂𝗮𝗹𝗶𝘁𝘆, 𝗿𝗲𝗽𝗿𝗲𝘀𝗲𝗻𝘁𝗮𝘁𝗶𝘃𝗲 data, when developing healthcare solutions—without compromising privacy. 

Imagine what we can do with that! Take rare diseases, for example—one of the clearest cases where larger, cross-border sample sizes are essential. We can also have much more data to train AI models more effectively (we still have to ask the right questions and get the right data, if they exist, but it helps to have more options).

Thanks to Sinead A. O'Connor, Adjunct Associate Professor, School of Medicine, Trinity College Dublin, for reminding me of this important point during the webinar: Focus on the potential, not the length of the 291-page PDF of EHDS regulations.

What Are the Objectives of EHDS? Who Benefits?

European Health Data Space Regulations have three key objectives:

1. Empower individuals to take control of their health data and enable its exchange for healthcare across the EU (primary use of data)

2. Foster a genuine single market for electronic health record systems

3. Enable secondary use of health data for research, innovation, policymaking, and regulatory activities

So The EHDS will impact all of us who live or work in Europe.

How Are We Measuring the Success of EHDS Implementation?

As an evaluation specialist, when faced with a new initiative or policy, I am always looking for concrete measures to understand what people really mean. So when the proposal for EHDS first came out, I created this results framework for my own use. You can download it if it helps you to understand what actual benefits are to be expected from implementing EHDS (link to PDF is under the table ). You will also see a list of indicators. These are there to show us how the regulators envisioned success, at least in the proposal stage. I would imagine this list will evolve but I am not sure what the plan is for a final comprehensive M&E framework.

European Health Data Space Results Framework.pdf

Download PDF • 155KB

EHDS and the Horizontal EU Frameworks

The EHDS builds on key existing horizontal EU legal frameworks ('Horizontal' meaning they are not sector-specific and they apply to all sectors), including:

• General Data Protection Regulation (GDPR)

• Data Governance Act

• Data Act

• AI Act

• Network and Information Systems Directive

I will zoom in on one of the most talked about and most recent one, The AI Act, in another blog post.

Call to Action

1. Maybe don't try to read all 291 pages in one sitting. Break it into chapters. That's what we are doing in Sinead's class and it's the way to go. And more importantly, focus on the potential of these regulations for innovation and improving healthcare. That way the uncertain future about how we should all implement and comply these regulations become less daunting.

2. If you know where I can find the 'final' and official results framework, please tell me!