Regulatory Aspects on AI and Pharmacovigilance for COVID-19

The chapter looks at current and perspective legislative and regulatory scenario, identifying rules governing the use of Artificial Intelligence in the health sector at European Union level with a focus on the impact of AI in pharmacovigilance activities. After some preliminary considerations on definitory issues, attention will be paid to the challenges posed by AI to pharmaceutical industry in developing medicinal products and monitoring their quality, safety and efficacy. The European strategy addressing the use of AI in pursuing a better health policy will then be outlined, followed by some caveat concerning ethical implications and protection of personal data.