Data Protection in the Healthcare Sector: Challenges and Opportunities

This course aims to provide an overview of how personal data protection affects the healthcare sector, from legal frameworks to current challenges.

Module I will provide you with the basic principles of personal data protection under the GDPR in the healthcare environment and the key insights of the Clinical Trials Regulation, which came into force in 2022.

Module II will provide a deep dive into the upcoming new European Health Data Space regulation, and all the challenges and opportunities facing the healthcare sector with regards to data protection. In particular, the recent challenges faced, the complexities of data protection in clinical trials and research, the ways protecting patients’ privacy. Furthermore, all the open questions that remains with the implementation of the Artificial Intelligence in the Healthcare sector will be open to discussion.

What you will learn

Module I:

• A refresher of the basic GDPR principles of data protection in relation to the healthcare sector
• GDPR obligations – transparency, records of processing activities and documentation system, international data flows in EU and global multi-centre trials.
• Clinical Trials Regulation and the GDPR – the relations and prevalence between the two disciplines, with a focus on consent to treatment and to data processing
• Risk assessments and the DPIA – methodology and operational phases, data protection by design and default in the health research process, interactions with individuals e.g. data protection notice and consent, data subjects’ rights
• Interactions with third parties – roles of actors in the GDPR and healthcare sector: data controllers, data processors, data subjects, DPOs, sponsors, CROs, CRAs, investigators, monitors, laboratory, ethical committee.

Module II:

• Regulation on the European Health Data Space – explanation of the proposal, how it revolutionises the potential of health data, how it will benefit citizens, how it will benefit researchers on the one side and the critique by the EDPB/EDPS on the other side. Next steps and key insights regarding its implementation.
• How the patients’ rights can be protected under the new common data space.
• The right to data portability and its configuration in the European Health Data Space.
• Tools to manage health data from a technical perspective.
• Artificial Intelligence in the Healthcare Sector – state of the art of artificial intelligence and its applications in the Healthcare Sector.

Course methodology

We believe that practical know-how is the key to effective learning. This course therefore includes:

• Individual preparation for the course – you are invited to bring along any information about the mission, vision, values and data protection framework and governance within your organisation for case study;
• Group and individual assignments; including case studies.
• An interactive approach: the module’s structure will give you the opportunity to ask questions and share and discuss experiences, knowledge, needs and challenges with the trainers and other participants;

You will be able to

• Understand the key data protection principles applicable to the healthcare sector
• Understand the upcoming configuration of the European Health Data Space.
• Implement a risk-based approach in risk assessment and the DPIA
• Understand how to better interact with individuals and third parties from a data protection standpoint
• Understand and stay aware of recent challenges to data sharing and data protection within the healthcare sector
• Understand the impact of the Clinical Trials Regulation and how it is impacted by the GDPR
• Understand the technical tools applied to the management of health data
• Gain insights into the impact artificial intelligence has and will have on the healthcare sector

After taking this course, you can join 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.

• Research & Development teams
• Medical scientific research operators
• Pharmacy and clinical operators
• Employees, lawyers, consultants and DPOs from public and private sectors working in the healthcare sector
• International organisations focused on healthcare
• EU institutions
• Clinical research laboratories.

Project number: 2411501

Hybrid course
Experience our course in a way that suits you best! This hybrid course offers the flexibility to join in-person or online through a live stream. In the registration form, you will have the opportunity to select your preferred option.

Face to Face venue
European Institute of Public Administration (EIPA)
O.L. Vrouweplein 22
6211 HE, Maastricht
the Netherlands

Senior Project Officer
Ms Eveline Hermens
Tel: +31 43 3296259
e.hermens@eipa.eu

Fee
The fee includes documentation, refreshments and lunches. Accommodation and travel costs are at the expense of the participants or their administration.

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?
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.

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.

Meals
Dietary preferences can be indicated on the registration form.

Hotel reservations
EIPA has special price arrangements with a number of hotels. The hotels are within walking distance from EIPA. If you wish to take advantage of this option, please click on the hotel name to book directly using the link. Payment is to be made directly and personally to the hotel upon checking out.

• Eden Design Hotel
  designhotel@edenhotels.nl
  +31 (0)43 328 25 25
• Townhouse
  info@townhousehotels.nl
  +31 (0)43 323 30 90
• Mabi
  info@hotelmabi.nl
  +31 (0)43 351 44 44
• Derlon
  info@derlon.com
  +31 (0)43 321 67 70

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 €150 for cancellations received within 15 days before the activity begins. There is no charge for qualified substitute participants. EIPA reserves the right to cancel the activity up to 2 weeks before the starting date. In that case, registration fees received will be fully reimbursed. EIPA accepts no responsibility for any costs incurred (travel, accommodation, etc.).

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.