In recent years,with the gradual maturity of achievable remote collection of digital health technology,more and more clinical research have applied this technology to improve the quality of data collection and reduce the burden on subjects.However,its technological characteristics of detachment from the diagnostic and treatment environment and real-time transmission of sensitive information also pose corresponding risks to the protection of subjects'rights and interests and data standardization management,among which personal information protection and data control permissions are more prominent issues.Based on risk analysis and regulatory review,this paper explored the responsibilities of multiple parties,including the sponsors,researchers,clinical trial institutions,and ethics committee,as well as proposed five elements of special concern for ethical review,with a view to providing a reference for promoting the standardized development of digital health technology in clinical research.

Objective To investigate the value of the volume percentage of solid component in differential diagnosis of stage Ⅰ lung adenocarcinoma subtypes,and to predict the optimal critical CT value of solid component.Methods A total of 962 nodules with sur-gical pathological findings confirmed as adenocarcinoma in situ(AIS)or pulmonary adenocarcinoma and manifested as subsolid nod-ules on thin-section CT were analyzed retrospectively,and divided the lesions into:(1)AIS(n=350)or pulmonary adenocarcinoma(n=612)groups;and(2)minimally invasive adenocarcinoma(MIA)(n=213)or invasive adenocarcinoma(IAC)(n=399)groups based on pathological findings.The volume percentage of solid components within pulmonary nodules was measured via CT density histogram analysis at different thresholds,the diagnostic efficacy of different thresholds was analyzed and the optimal critical CT val-ues of solid component was found.Results In the AIS versus pulmonary adenocarcinoma groups,age,mass,and volume percentage of solid component were statistically significant(P＜0.001);the CT threshold of-350 HU had the highest diagnostic efficacy[area under the curve(AUC)0.859,accuracy 81.69％,sensitivity 85.60％,and specificity 74.86％,respetively],and the critical value of volume percentage of solid component determined under this threshold was 8.3％.In the MIA versus IAC groups,age(P=0.017),mass(P＜0.001),and volume percentage of solid component(P＜0.001)were statistically significant;the CT threshold of-350 HU had the highest diagnostic efficacy(AUC 0.857,accuracy 78.27％,sensitivity 82.91％,and specificity 69.48％,respectively),and the critical value of volume percentage of solid component determined under this threshold was 16.9％.Conclusion The volume percentage of solid component measured based on CT density histogram analysis may be helpful in the differential diagnosis of early stage lung ade-nocarcinoma subtypes.