A Comparative Legal Research for Patient-Generated Health Data in the United States, Australia, and South Korea (Preprint)

BACKGROUND The healthcare service paradigm is shifting towards patient-centered care, which necessitates integrating patient-generated health data (PGHD) with electronic health records (EHRs) to provide a comprehensive understanding of their health. This integration faces legal and technical challenges when connecting and utilizing PGHD in medical institutions. As digital health technologies advance, the legal landscape surrounding PGHD regulation becomes increasingly complex, highlighting the need for comparative legal research to analyze and compare the legal frameworks governing it. OBJECTIVE This comparative legal research aims to analyze and compare the legal frameworks governing PGHD in the United States, Australia, and South Korea. Employing a functional approach, the study seeks to identify key legal issues, including the right to data portability, exceptions to information blocking, interoperability, user authentication, and non-legal instruments in research ethics. The objective is to provide insights into the legal landscape surrounding PGHD and highlight areas for improvement and harmonization. METHODS The study conducted a comprehensive review of legal documents, including statutes, regulations, and academic articles, as well as reports from government agencies and non-governmental organizations. Data collection and analysis were conducted to identify similarities and differences in the legal frameworks across the three countries. RESULTS The study explored key legal issues such as the right to data portability, exceptions to information blocking, interoperability, user authentication, and non-legal instruments in research ethics. It observed variations in implementing the right to data portability, with South Korea recently introducing relevant provisions. Countries varied in their interoperability strategies, addressing challenges in data exchange. Concerns about user authentication prompted measures such as healthcare identifiers. Non-legal instruments, including soft norms and codes of conduct, complemented legal frameworks, providing additional privacy protection in research. Challenges include ensuring PGHD's trustworthiness and encouraging healthcare provider participation. CONCLUSIONS The study underscores the necessity of regulations tailored to each country's healthcare system, prioritizing patient rights, data quality, interoperability, and information protection in the evolving digital healthcare landscape.