A Pathway from Law to Care: How the Artificial Intelligence Act, the Medical Device Regulation, and the Public Procurement Directive Can Contribute to Ensuring Quality in Healthcare.

Abstract

Artificial intelligence (AI) is increasingly embedded in healthcare delivery, and when systems are scaled across clinical workflows, errors may have system-wide consequences. The Artificial Intelligence Act (AIA) and the Medical Device Regulation (MDR) establish important safety requirements for AI-based medical devices placed on the EU market, but they do not, in themselves, guarantee that AI tools deliver quality care for patients in real-world clinical settings. This article examines how the EU Public Procurement Directive (PPD) can complement the AIA and MDR to strengthen quality assurance when AI tools are adopted in healthcare systems across EU Member States. The article proposes specific procurement mechanisms as a prerequisite for adoption, thereby translating regulatory safeguards into practice. The article also argues that healthcare providers play a critical role in shaping the quality of AI. Beyond CE-marking, procurement should require evidence of clinical relevance, context-specific documentation, transparency in system design, and clearly defined quality criteria, including diagnostic accuracy and patient outcomes. Embedding legal and ethical requirements in procurement provides a pathway from law to care, ensuring that AI supports safe, equitable, and high-quality healthcare.