Artificial Intelligence, Data protection, digital policy and cyber security

Health Data Opportunities, Challenges and Innovation: Data Protection, EHDS and AI

This course explores the legal, technical, and ethical considerations of health data governance in the European Union. Over three days, participants will gain an in-depth understanding of the General Data Protection Regulation (GDPR), the European Health Data Space (EHDS), and the evolving role of Artificial Intelligence (AI) in healthcare.

About this course

This course explores the legal, technical, and ethical considerations of health data governance in the European Union. Over three days, participants will gain an in-depth understanding of the General Data Protection Regulation (GDPR), the European Health Data Space (EHDS), and the evolving role of Artificial Intelligence (AI) in healthcare. The course will feature expert-led sessions, case studies, and hands-on exercises designed to equip participants with practical knowledge on safeguarding health data, implementing compliance strategies, and leveraging AI responsibly within the healthcare sector.

What you will learn

By the end of the course, you will be able to:

  • Understand the legal framework governing health data
    • Identify key GDPR provisions relevant to health data processing
    • Apply data protection principles to clinical data sharing, anonymisation, and security measures
    • Assess compliance requirements for cross-border health data transfers
  • Navigate the European Health Data Space (EHDS)
    • Analyse the EHDS regulation and its interplay with GDPR
    • Recognise challenges and opportunities in EHDS implementation at different administrative levels
    • Evaluate the implications of data portability, secondary use of data, and interoperability in healthcare
  • Assess AI’s impact on healthcare data governance
    • Examine the EU’s regulatory framework for AI in healthcare
    • Understand the purpose of regulatory mechanisms such as AI Regulatory Sandboxes for advancing medical and health innovation
    • Identify risks and opportunities in AI-driven healthcare solutions, including liability considerations
  • Apply best practices in health data protection and compliance
    • Conduct risk assessments and Data Protection Impact Assessments (DPIAs)
    • Implement safeguards to uphold data subject rights and prevent data breaches
    • Engage with practical case studies to develop hands-on expertise in regulatory compliance.

Course methodology

  • Engaging learning format: The course includes a mix of lecture-style teaching, complemented by group discussions, hands-on exercises, and real-world case studies.
  • Interactive discussions: The sessions provide ample opportunities to ask questions, exchange experiences, and discuss challenges with experts and fellow participants.
  • Practical application: Dedicated time for reflection and knowledge sharing will help participants translate key insights into actionable strategies for their daily work and organisational practices.

 

You will be able to

  • Develop a clear understanding of key data protection principles and their application in the healthcare sector.
  • Gain insights into the European Health Data Space Regulation, its implementation, and its impact on healthcare organisations.
  • Navigate the complexities of international data transfers involving sensitive health data.
  • Improve your ability to engage with individuals and third parties while ensuring compliance with data protection regulations.
  • Stay informed about emerging challenges related to data sharing and data protection in the healthcare sector.
  • Prepare your organisation for the implementation of the European Health Data Space.
  • Recognise the risks and opportunities associated with using health data for innovation and research.
  • Explore technical tools for managing health data, including the role of AI systems.
  • Understand the current and future impact of AI on healthcare, including implications for patients and healthcare providers.
  • Strengthen compliance mechanisms for the responsible implementation of AI systems in healthcare settings.

Upon enrolment in our training, participants are admitted to EIPA’s dedicated community of practice together with former participants. You will also have access to the course materials for three months after the course.

This course is designed for professionals working in healthcare regulation, data protection, digital health policy, and AI governance, providing them with the necessary tools to navigate the evolving landscape of health data management in the EU.

This includes, but is not limited to:

  • Lawyers, consultants and DPOs from public and private sectors working in the healthcare sector
  • Healthcare IT professionals
  • National, regional and local administrations that handle health data
  • Public health officials.

Project number: 2511501

Online Course
For this online course we make use of Webex.

Project Officer
Marieke Lardinois
Tel: +31 (0)43 32 96 205
m.lardinois@eipa.eu

Discounts
EIPA member fee
EIPA offers a discount to all civil servants working for one of EIPA’s supporting countries, and civil servants working for an EU institution, body or agency.

Who are the supporting countries?
Civil servants coming from the following EIPA supporting countries are entitled to get the reduced fee: Austria, Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden.

For all other participants, the regular fee applies.

Early bird discount
The early bird discount is not cumulative with other discounts or promo codes, except for the EIPA member fee.

Loyalty coupon
As a token of appreciation we offer all our participants a loyalty coupon for one of our future courses. The offer can be shared with colleagues and relevant networks. The coupon will expire one year after its release. This discount is not cumulative with other discounts, except for the EIPA member fee.

Confirmation
Confirmation of registration will be forwarded to participants on receipt of the completed online registration form.

Payment
Prior payment is a condition for participation.

Cancellation policy
For administrative reasons you will be charged € 50 for cancellations received within 7 days before the activity begins. There is no charge for qualified substitute participants.

EIPA reserves the right to cancel the activity up to 1 week before the starting date. In that case, registration fees received will be fully reimbursed.

A few days before the start of the course you will receive the log-in details for accessing the course materials. You can log in here.

Our experts

Programme

Module I – Data Protection Legal Strategies and Framework for the Healthcare Sector
08.45Opening of the online platform
09.00Welcome to the course

Florina Pop, Data Protection Expert, EIPA, Maastricht (NL)

09.15A Refresher of the Basic Principles and Provisions: Main GDPR Obligations in the Healthcare Sector and Legal Bases to Process Health Data

Florina Pop

10.15Q&A
10.30Coffee break
11.00Clinical Data and GDPR: data sharing, publication and anonymisation of personal data

Anne-Sophie Henry-Eude, Head of Transparency, European Medical Agency (EMA), Amsterdam (NL)

12.00Q&A
12.15EMA’s Approach to Personal Data in Clinical Documents and Processing Data Breaches (Hands-on Exercise)

Anne-Sophie Henry-Eude

13.00Q&A
13.15Lunch break
14.45Cross-border Health Data Transfers: Balancing GDPR with other Legal Frameworks

Marta Moretti, Senior Legal Counsel, Europe and New Markets – Senior Director at BeOne Medicines, Basel (CH) (TBC)

15.30Q&A
15.45Coffee break
16.15Protecting Privacy in the Healthcare Sector: Risk Assessment and Compliance (including Case Study)
Victoria Derumier, DPO & Associate Entity Director, MyData-Trust, Brussels (BE)
17.00Health Data and Data Subject Rights & Requests (including Case Study)
Desislava Borisova, Data Protection Expert, Europol, The Hague (NL)
17.45Q&A
18.00Concluding Remarks – End of Module I
Module II – Analysing the European Health Data Space: Opportunities and Implementation of Common Data Space
08.45Opening of the online platform
09.00Welcome
Florina Pop
09.15The European Health Data Space: a deep Dive into the current Legal Framework and its Interplay with the GDPR
Ricard Martinez Martinez, Director of the Chair for Privacy and Digital Transformation, Microsoft-UV/Lissit University of Valencia, Valencia (ES) (TBC)
10.30Q&A
10.45Coffee break
11.15The European Health Data Space Implementation: Challenges and Opportunities (Examples from National, Regional and Local Administration
Michele Calabro, Director, European Regional and Local Health Authorities (EUREGHA), Brussels (BE) (TBC)
12:30Q&A
13.00Lunch break
14.15Data Portability in the European Health Data Space: Benefits, Risks and Challenges
Andras Sule, Former President, EAHP & Chief Pharmacist, Peterfy Hospital, Budapest (HU)
15.15Q&A
15.30Coffee break
16.00Health Innovation and Research: Secondary Use of Data in the EHDS
Jerome de Barros, Policy Officer, European Commission, DG SANTE, Brussels (BE) (TBC)
17.00Q&A
17.15Closing Remarks – End of Module II
Module III – AI and Health: Navigating the Current and Future Landscape
08.45Opening of the online platform
09.00Introduction to Module III
Florina Pop
09.05The EU Legal Framework for the Use of AI in the Health Sector
Mindy Nunez Duffourc, Assistant Professor of Private Law, Maastricht University, Maastricht (NL)
10.00Q&A
10.15Coffee break
10.45Artificial Intelligence and Health Data in the Healthcare Sector: Opportunities and Risk in the Use of AI for Patients’ Solutions
Manuel Cassio, Programme Evaluator, Healthcare Generative AI Commission, Zurich (CH)
11.30Q&A
11.45Digital Ecosystem and Regulatory Sandboxes: Medical Devices as a Use Case for AI and Cybersecurity Regulation
Filippo Bagni, PhD Candidate in Cybersecurity, IMT School for Advanced Studies Lucca (IT)
12.30Q&A
12.45AI and Medical Liability in the Healthcare Sector
Mindy Nunez Duffourc
13.15Q&A
13.30Concluding Remarks and End of the Course

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Health Data Opportunities, Challenges and Innovation: Data Protection, EHDS and AI

Confirmed
29 Sep 2025 - 1 Oct 2025
Online
Register before: 28 Sep 2025
 1.625 per attendee
 1.460 for EIPA members
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