Content area
In the era of “AI plus healthcare”, personal health data has shifted from static records into dynamic and time-sequential data flow covering a full lifecycle. While it has become an important element of production in healthcare industry, it also faces new risks and challenges and the current legal framework of personal health data protection in China cannot satisfactorily address these challenges. The ambiguous rules on personal health data ownership and the ineffective individual empowerment model of data governance fail to respond to the dual needs for protection of personal health data and extraction of data value. In view of diversified and sometimes conflicting values and interests embodied in personal health data, it is therefore recommended that the agile governance model, characterized by dynamic adaptability and multistakeholders collaboration, be adopted. The bundle of rights over data should be allocated among data subjects, data processors and the government; a differentiated consent mechanism based on risk classification should be constructed; the principle of purpose limitation and minimum necessary should be reinterpreted in an expansive and generalized manner within the limits of reasonable expectation and risk control; and, anonymization measures and tort liability rules should be improved by clarifying obligations of stakeholders and balancing their rights and responsibilities. Through dynamic risk control by collaboration of multiple stakeholders, the agile governance model can reach the balance between sufficient protection and rational utilization of personal health data in data processing.
Details
Classification;
Collaboration;
Empowerment;
Health care industry;
Personal health;
Ambiguity;
Risk;
Medical diagnosis;
Big Data;
Stakeholders;
Data integrity;
Data processing;
Ownership;
Rights;
Decision making;
Algorithms;
Protection;
Health information;
Governance;
Tort;
Precision medicine;
Personal information;
Accuracy;
Deep learning;
Extraction;
Health services;
Drug development;
Information sharing;
Liability;
Privacy;
Research & development--R&D;
Artificial intelligence;
Wearable computers;
Data collection;
Digitization
1 Zhongnan University of Economics and Law, Department of Civil and Commercial Law, School of Law, Wuhan, P.R. China (GRID:grid.443621.6) (ISNI:0000 0000 9429 2040)
2 Jinan University, School of Humanities, Zhuhai, P.R. China (GRID:grid.258164.c) (ISNI:0000 0004 1790 3548)