“First, do no harm” in the digital era: examining the practicality of the European Health Data Space proposal and ethical implications of artificial intelligence- A systematic literature review

BACKGROUND: This systematic review aims to synthesize the current knowledge about the applications and challenges of Artificial Intelligence (AI) technologies in healthcare, while evaluating the extent to which the European Union (EU) AI Act and the European Health Data Space (EHDS) contribute to ensuring responsible, secure, and ethically sound adoption of AI in clinical practice. METHODS: This review adheres to the guidelines set by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) and has also been registered in PROSPERO. The PubMed®, Web of Science™, Scopus and ScienceDirect® databases were used as scientific search strategy. In addition, records identified through other sources (grey literature) were also assessed for eligibility and included. All studies published between 2020 and 2024 about the application of AI and its regulation and ethical implications, particularly in healthcare, were included. Eligible studies were assessed for potential risk of bias during data extraction and quality evaluation screening. RESULTS: A total of 76 studies were included. Although AI technologies have several applications in the healthcare sector such as disease diagnosis, treatment, clinical data management, automated surgery, remote health monitoring, elderly patient care and/ or biomedical research, important ethical issues are raised when using AI, namely data privacy, safety, lack of transparency, explainability, trust and potential biases. CONCLUSIONS: A proper application and compliance with established ethical principles, and legal regulations such as the EU AI Act and the EHDS are fundamental to ensure a responsible, safe, sustainable and trustworthy use of AI in healthcare.