Legal Compliance and Ethical Considerations, Personal Information Protection, Information Management Policies, and Conflicts of Interest
Legal compliance and ethics considerations
All medical research concerning human beings and using medical information shall comply with guidelines established by the Ministry of Education, Culture, Sports, Science and Technology and other entities, and shall be reviewed and approved by the Osaka University Hospital Clinical Research Review Committee before it is carried out. This research was thoroughly reviewed by the committee, and approved on August 31, 2020.
When new specific R&D themes are added to the research, they will be reviewed and approved by the Data Access Review Committee before they are carried out. For joint research, the status of conflicts of interests shall be managed and identified.
Personal information protection policy
(Privacy Policy)
This hospital recognizes that the protection of patient privacy and personal information is a fundamental part of medical care, and also a social responsibility. This research shall be carried out in accordance with the following personal information protection policy.
Information management policy
(Security Policy)
The Osaka University Hospital Databank is based on the Osaka University Information Security Regulations, and robust, stable, and efficient protection of medical information shall be carried out in accordance with the rules prescribed by Osaka University Hospital for management of medical information. Measures for security management of medical information include organizational, human, physical, and technical security management measures.
1. Organizational security management measures
Appropriate organizational systems shall be constructed for safe management of medical information. Continual improvements to the implementation and operation of security management shall be carried out by evaluating and reviewing programs for information management.
2. Human security management measures
Only staff of the Department of Medical Informatics who possess technical knowledge related to medical information management shall be permitted to access the databases of the Osaka University Hospital Databank. When allocating information, the staff of the Department of Medical Informatics shall process it into a suitable data form by means including an anonymizing process. The necessary education, training, and other measures shall be carried out for handling of information by the entity which receives the access to this information.
3. Physical security management measures
The databases of the Osaka University Hospital Databank shall be installed in a room that can be locked, that includes biometric identification entry management, and where recording by security cameras is performed. Physical security measures shall be enacted to prevent incidents such as unauthorized access to, or destruction, leakage, or unauthorized modification of medical information.
4. Technical security management measures
The Osaka University Hospital Databank shall be installed on a safe network constructed within Osaka University Hospital, and unauthorized external access shall be prevented by means of a firewall and unauthorized access detection system. Appropriate authority administration shall be carried out for access to the Osaka University Hospital Databank, and management by recording operation logs shall be performed.
Conflicts of interest
This research is carried out using research funds from the Strategic Innovation Promotion Program (SIP) titled “Advanced Diagnosis and Treatment Systems at AI (Artificial Intelligence) Hospitals”. If declarations of conflicts of interest involving the research administrators and researchers of a research institution become necessary, the declaration shall be reviewed and approved by the conflict of interest review committee or similar body established by the research institution that the researchers are affiliated with.
