associate professor Peking University, United States
Background: Electronic health records (EHRs) are online records of patients’ personal clinical health data. The Personal Information Protection Law (PIPL) covers personal information of people in China. In the research context, all personal information is included in the regulation scope of the PIPL, which did not consider the big data research.
Methods: The study was approved by a University Institutional Review Board. All participants provided written informed consent. Participants The inclusion criteria were: (1) current residence in the hospital and informed consent; (2) the ability to take a semi-structured interview; (3) over 18 years. Design A qualitative study, using semi-structured interviews to explore patients’ views on current and desirable practice for sharing their identifiable EHRs data for research purposes with a broad consent but not an explicit consent.
Results: There was both strong willingness to give broad consent for secondary data use (18 of 20 responders, 90.0%) among study participants. Participants had a general positive attitude towards the value of EHRs used in research. Majority (15/20, 75%) agreed that their EHRs can be shared with international research organizations, but only (4/20, 20%) supported collaboration with companies. The main reasons for participants’ willingness to donate were advancement of medical research and societal benefits, whereas misuse of confidentiality breaches was their main concern for EHRs share in research.
Limitations: The participants were recruited from a group who expressed interest and willingness to participate in research interview, they may be more likely to be supportive of donation EHRs for medical research, or at least more interested than the general public in research.
Discussion: It was found that use of broad consent for EHRs donation is widely supported by the patients and therefore warrants further consideration for an adjustment of the national law PIPL. Although many patients heard that EHRs may be used in research, they had limited knowledge about the risks and rights. A knowledge gap exists among these stakeholders, which should be covered by different educational activities. They had concerns about commercialization.
