Surveilling Care, Protecting People: Legal Reforms for the Data-Driven Clinic

Area of Science:

• Health Informatics
• Legal Studies
• Bioethics

Background:

• Healthcare big data offers significant potential for precision medicine, public health, and drug development.
• The sensitive nature of medical data and re-identification risks create legal tensions between data use and privacy protection.

Purpose of the Study:

• To conduct a comparative legal analysis of U.S. and Korean frameworks governing healthcare big data.
• To identify inconsistencies and regulatory gaps in current laws.
• To propose reforms for effective governance of healthcare big data.

Main Methods:

• Comparative legal analysis of U.S. laws (HIPAA, 21st Century Cures Act) and Korean laws (Medical Service Act, Bioethics and Safety Act).

Main Results:

• Legal frameworks lag behind technological advancements in data security.
• Ambiguous definitions of pseudonymized/anonymized data and inconsistent de-identification standards create challenges.
• Limited flexibility in consent mechanisms hinders data utilization.

Conclusions:

• Refine legal definitions for pseudonymized and anonymized data.
• Introduce flexible consent mechanisms and enhance de-identification standards.
• Strengthen technology-based security safeguards and reconcile legal inconsistencies to foster responsible data use.