Managing legal risks in health information exchanges: A comprehensive approach to privacy, consent, and liability

Abstract

Health Information Exchanges (HIEs) are revolutionizing healthcare by facilitating secure and timely patient data sharing across diverse organizations. However, their rapid expansion has introduced significant legal and ethical challenges, particularly regarding privacy, informed consent, and liability risks. This paper critically assesses the effectiveness of existing legal frameworks, including Health Insurance Portability and Accountability Act (HIPAA) and General Data Protection Regulation (GDPR), in addressing these challenges, revealing gaps in their application within HIEs. It argues that current consent models fail to provide meaningful control for patients, while privacy protections are weakened by issues such as re-identification and jurisdictional inconsistencies. Moreover, liability in data breaches remains complex due to ambiguous responsibility among stakeholders. The study concludes that reforms are needed, including dynamic consent models, standardized liability frameworks, and enhanced data governance structures, to ensure secure, ethical, and effective data sharing. These changes are essential to fostering patient trust, improving healthcare delivery, and aligning with Sustainable Development Goal (SDG) 3—ensuring healthy lives and promoting well-being for all.