Sofia Palmieri is a Post-Doctoral Fellow in Medicine, Artificial Intelligence, and the Law at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. She holds a PhD in Health Law from Ghent University and graduated with honours in Law from the University of Bologna. Her research lies at the intersection of law, ethics, artificial intelligence, and healthcare, with a particular focus on the EU regulatory frameworks governing the safe, patient-centred, and evidence-based use of AI in medicine.
Her PhD research, culminating in the dissertation “Ensuring the Trustworthy Use of AI in Healthcare: A Legal Perspective”, developed an integrated legal analysis structured around three interrelated pillars: the safety and product regulation of medical AI systems, including medical device regulation and data protection requirements; the standard of care, professional competences, and liability in AI-assisted healthcare; and the protection and empowerment of patients through informed consent, transparency, and digital literacy.
Before joining Harvard Law School, she was an FWO Postdoctoral Fellow within the Metamedica research group at Ghent University, where her postdoctoral research focused on the clinical validation of medical AI systems under EU law. This work examines whether AI systems warrant differentiated regulatory treatment compared to conventional medical devices and identifies additional safeguards and methodological requirements needed to ensure robust clinical evidence, given the adaptive and data-dependent nature of AI.
In parallel, Sofia Palmieri serves as Healthcare AI Policy and Compliance Officer at the European Institute for Innovation through Health Data (i~HD), where she contributes to multiple EU-funded projects on AI governance in healthcare. Her current research increasingly focuses on AI literacy, human oversight, and accountability, analysing how regulatory obligations under the AI Act can be operationalised through clearly defined competences and institutional practices within healthcare organisations. She also serves as Managing Editor of the European Journal of Health Law and has held leadership roles within the European Association of Health Law. She is currently Task Force lead in the Digital Health Literacy and Policy Hub funded by the Nanopoulous foundation.
Sofia’s scholarship has been published in peer-reviewed journals, including npj Health System, JAMA and Health Affairs.