“Hey Siri, How Am I Doing?”: Legal Challenges for Artificial Intelligence Alter Egos in Healthcare

Abstract

In this chapter, the law scholar Christoph Krönke focuses on the legal challenges faced by healthcare AI Alter Egos, especially in the European Union. Firstly, the author outlines the functionalities of AI Alter Egos in the healthcare sector. Based on this, he explores the applicable legal framework as AI Alter Egos have two main functions: collecting a substantive database and proposing diagnoses. The author spells out that concerning the database, European data protection laws, especially the GDPR, are applicable. For healthcare AI in general, the author analyses the European Medical Devices Regulation (MDR). He argues that MDR regulates the market and ensures high standards with regard to the quality of medical devices. Altogether, the author concludes that AI Alter Egos are regulated by an appropriate legal framework in the EU, but it has to be open for developments in order to remain appropriate.