Source: Petrie-Flom Center – Harvard Law School

Petrie-Flom Center at Harvard Law School explores how AI and big data are redefining the doctrine of informed consent in healthcare. The traditional model—based on discrete decision points and clearly explained risks—is increasingly incompatible with AI systems that make probabilistic, dynamic predictions using massive datasets.

The article argues that patients often cannot fully understand how AI systems work or how their data is used, raising questions of validity and voluntariness in consent processes. It proposes new models of consent, including dynamic, layered, and ongoing consent frameworks, tailored to predictive health technologies.

Legal scholars advocate for updated ethical standards, transparency obligations, and regulatory frameworks that reflect the realities of AI in medicine.