PART IV - CONCLUDING REMARKS AND RECOMMENDATIONS FOR THE FUTURE

Summary

This final part presents a retrospective of the undertaken research. We aimed to understand the European legal framework that protects the patient as a data subject and the impact of societal and technological evolutions together on the Western normative position of the patient. The retrospective of the research undertaken is followed by conclusions concerning the three selected mechanisms of European data protection law: informed consent, anonymisation and purpose limitation. Finally, recommendations for the future are provided to address current fragilities in European data protection law.

SECTION 1. UNDERSTANDING THE MODERN HEALTHCARE SYSTEM AND ITS IMPACT ON THE PATIENT AS A DATA SUBJECT

The research questions – To understand the patient's position as a data subject, the concepts of data protection law and the technological and societal developments that lefttheir mark on Western healthcare (systems) were studied. Throughout the analysis, we focused on two central research questions. Can the concepts of privacy and patient autonomy be matched with e-health and personalised healthcare, two phenomena that characterise the predominant ethos in modern healthcare systems? And, given this predominant ethos, what changes are needed to ensure the durability of the legal framework protecting the patient as a data subject?

Research method – Part I focused on insights gained from observing the technological and societal developments. Part II focused on insights gained through the analysis of the legal developments towards a patient's right to data protection and the definition of the subject of protection, i.e. the patient's personal data. Understanding the context and developments was necessary to, in Part III, assess the mechanisms embedded in data protection law that

• – allow patients to act autonomously, such as informed consent;

• – delineate the patient's right to autonomy, such as anonymisation; or

• – ensure both, such as purpose limitation.

The focus of the assessment was on the functioning of these mechanisms in the context of modern healthcare systems, which build on big data, machine learning, and artificial intelligence and in which patient empowerment and personalisation are central concepts. To complete that assessment, we considered Anglo-American and Western-European normative positions on healthcare and European legal frameworks.