Answer： ISO 14155 6.7 Subject privacy and confidentiality of data: Confidentiality of data shall be observed by all parties involved at all times throughout the clinical investment All data shall be secured against unauthorized access The principal investor or institution shall provide direct access to source data during and after the clinical investment for monitoring, audits, EC review and regulatory authority inspections The privacy and confidential information of the subjects appear in the medical records and original trial files of the hospital, in accordance with the requirements of medical, GCP, and local laws and regulations. If the privacy and confidential information of the subjects are transmitted outside the hospital and/or obtained by the sponsor (except for monitoring, auditing, and examination conducted within the hospital), there is a risk of the subject's privacy and confidential information being leaked. In this case, it can be considered that an engineer authorized by the applicant can review the subject's imaging in the hospital. The engineer needs to sign a confidentiality agreement and obtain the consent of the hospital and researchers; Alternatively, technical means can be used to mask the privacy and confidential information of the subjects before transmitting the images for remote review. Both of the above methods require informed consent from the subject.