LIST OF ABBREVIATIONS 5

LIST OF FIGURES 7

LIST OF TABLES 7

EXECUTIVE SUMMARY 8

1. INTRODUCTION 10

2. THE APPLICATION OF AI AND ITS VALUE FOR MEDICINE 12

  2.1. Artificial Intelligence: Definition and Use Cases 12

    2.1.1. Definition 12

    2.1.2. AI Use Cases in Healthcare 12

3. REVIEW OF THE EU FRAMEWORK FACILITATING THE USE OF DATA FOR THE DEVELOPMENT OF AI IN HEALTH: CURRENT CHALLENGES AND OPPORTUNITIES 15

  3.1. The European Strategy for Data and the European Data Union Strategy 15

  3.2. The European Health Data Space Regulation 17

    3.2.1. Background 17

    3.2.2. Secondary Use of Electronic Health Data 17

    3.2.3. Purpose 18

    3.2.4. Data altruism in the EHDS 20

    3.2.5. Data quality 21

    3.2.6. IP and trade secrets protection 22

    3.2.7. Duties of health data users: Publication of results 23

  3.3. General Data Protection Regulation 23

    3.3.1. Legal basis for the processing of personal data and special categories of personal data 24

    3.3.2. Data protection principles 25

    3.3.3. Data anonymisation 25

    3.3.4. Automated individual decision-making, including profiling 27

  3.4. Artificial Intelligence Act 27

  3.5. Cybersecurity 29

  3.6. The Digital Omnibus Proposal 30

  3.7. AI Liability 31

    3.7.1. EU level 32

    3.7.2. A national perspective 33

4. ETHICAL CONSIDERATIONS 35

5. CONCLUDING REMARKS AND POLICY CONSIDERATIONS 37

REFERENCES 40