Regulatory Compliance and Data Governance in AI‐Driven Healthcare

The integration of artificial intelligence (AI) technology has brought new advancements to patient care, diagnostics, treatment, and healthcare in general. Such advancements, however, give rise to new intricate legal and regulatory matters, particularly issues for compliance and data control. This chapter addresses the most relevant concerns for healthcare providers with AI systems regarding applicable laws on data, privacy, and security. Healthcare institutions across the globe contend with the European Union's General Data Protection Regulation and the US Health Insurance Portability and Accountability Act. These have some provisions on the subset of sharing, accessing, and protecting sensitive patient information, data that are often required in bulk amounts for AI systems, thereby complicating intra organizational processes. Effective data governance, which maintains the quality, security, privacy, and overall integrity of information, is very important. Compliance aside, there are deeper ethical matters surrounding the application of AI in healthcare. The European Commission, for instance, has developed Ethical Guidelines for Trustworthy AI, which provide point of references in addressing such governance issues. The questions of ownership, accountability, and liability are equally concerning. Who is entitled to information created by AI systems and who is to be blamed for system bias or inaccuracy become pressing questions that legal frameworks need to answer. Healthcare AI stewardship requires proactive data governance, compliance with legal frameworks, and responsible AI design policies.