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Planning and Design
- Requirement 01 Risk management plan for AI system and execution of the plan
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Requirement 02 Organization of an AI governance system
- 02-1 Have you established guidelines and policies on AI governance?
- 02-2 Have you formed an AI governance group and reviewed the composition of the group?
- 02-3 Is the AI governance being supervised to ensure proper implementation?
- 02-4 Has the AI governance group reviewed the differences between the new and previous systems?
- Requirement 03 Development of a plan to test trustworthiness in the AI system
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Data Collection and Processing
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Requirement 04 Provision of detailed information for data utilization
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04-1 Is there detailed information to support the accurate comprehension and utilization of data?
- 04-1a Have you explained the data attributes before and after cleansing?
- 04-1b Have you sorted data into training data and metadata and is there a specification document for each of them?
- 04-1c Have you explained the reason for selecting the protected attributes and whether they were reflected?
- 04-1d Were data labelers trained and have you provided them with work instructions?
- 04-2 Is data provenance documented and managed?
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04-1 Is there detailed information to support the accurate comprehension and utilization of data?
- Requirement 05 Inspection of abnormal data to ensure data robustness
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Requirement 06 Removal of bias in the collected and processed training data
- 06-1 Have you prepared measures to mitigate bias due to human and physical elements in data collection?
- 06-2 Have you analyzed features used in training and prepared selection criteria?
- 06-3 Have you checked and prevented potential biases in data labeling?
- 06-4 Have you conducted sampling to prevent bias in data?
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Requirement 04 Provision of detailed information for data utilization
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AI Model Development
- Requirement 07 Ensuring security and compatibility of the open-source library
- Requirement 08 Removal of bias in the AI model
- Requirement 09 Establishment of defensive measures for AI model attacks
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Requirement 10 Explanation of AI model specifications and the inference results
- 10-1 Do you provide evidence for users to accept the generation process of the model’s inference results?
- 10-2 Have you transparently provided the specification of the model on the AI model specification document?
- 10-3 When needed, do you provide an explanation about the inference results of the AI model?
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System Development
- Requirement 11 Removal of potential bias in the implementation of the AI system
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Requirement 12 Safe mode of AI system and establishment of a process for notification of problems
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12-1 Have you implemented a safe mode that can respond to problems such as attacks, low performance, and social issues?
- 12-1a Have you prepared an exception handling policy for such problems?
- 12-1b Have you implemented a security technique to reinforce the security of the AI system?
- 12-1c Have you considered a decision-making method that includes humans to mitigate the uncertainty of the AI system?
- 12-1d Are guidance and action on handling expected user error provided?
- 12-2 Does the system perform the function of alerting the operator if a problem occurs in the AI system?
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12-1 Have you implemented a safe mode that can respond to problems such as attacks, low performance, and social issues?
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Requirement 13 Improvement of users’ comprehension of the explanation of the AI system
- 13-1 Have you analyzed user characteristics and constraints in the AI system?
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13-2 Have you provided a thorough explanation based on user characteristics?
- 13-2a Have you established criteria for the evaluation of explanation according to user characteristics?
- 13-2b Have you used terms that are appropriate to user characteristics?
- 13-2c Have you used accurate expressions to lead users to specific behaviors and comprehension?
- 13-2d Are the location and timing where an explanation is needed appropriate?
- 13-2e Have you utilized various user survey techniques to evaluate user experience?
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Operation and Monitoring
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Requirement 14 Ensuring traceability and modification history of the AI system
- 14-1 Have you established measures to track the AI system’s decision-making?
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14-2 Have you obtained the modification history of training data and managed the impact of data modifications?
- 14-2a Have you prepared measures to track the data flow and lineage?
- 14-2b Have you developed measures to monitor modifications in the data source?
- 14-2c Have you managed the versions during data change?
- 14-2d Do you provide information to stakeholders when data change?
- 14-2e When new data have been collected, do you reevaluate the performance of the AI model?
- Requirement 15 Explanation about the scope of services provided and the subject of interactions
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Requirement 14 Ensuring traceability and modification history of the AI system
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03-1bHave you obtained a simulator if the AI system needs a virtual test environment?• Unlike the general sector, the approval process for the real-world testing or clinical trial may be complicated due to the nature of the healthcare sector. You can save time and cost by conducting the test using a simulator in a virtual test environment before the actual test. In particular, you may create a virtual test environment for AI systems that include scenarios with risks of directly harming the patients during the test to mitigate risks. The following are virtual test simulators currently in development and examples of their use in healthcare.✓ Treatment prediction and virtual surgery through virtual patient simulation: Medical twin
✓ Examples of using medical twin- High-precision cardiovascular twin technology based on medical image fusion and multiphysics modeling
- Acceleration of twin production using AI and enhancement of disease diagnosis and prognosis prediction performance
- 3D twin-based carotid artery stenosis progression and plaque rupture prediction technology
- Diagnosis and developmental prediction technology for coronary ischemia
- Automated navigation technology for simulation-based cerebrovascular intervention
- Development of a haptic procedural guide based on real-time matching with 3D vascular information
- Brain aneurysm growth and rupture prediction technologies based on cerebral aneurysm mesh