-
Planning and Design
- Requirement 01 Risk management plan for AI system and execution of the plan
-
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
-
Data Collection and Processing
-
Requirement 04 Provision of detailed information for data utilization
-
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?
-
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
-
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?
-
Requirement 04 Provision of detailed information for data utilization
-
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
-
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?
-
System Development
- Requirement 11 Removal of potential bias in the implementation of the AI system
-
Requirement 12 Safe mode of AI system and establishment of a process for notification of problems
-
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?
-
12-1 Have you implemented a safe mode that can respond to problems such as attacks, low performance, and social issues?
-
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?
-
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?
-
Operation and Monitoring
-
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?
-
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
-
Requirement 14 Ensuring traceability and modification history of the AI system
-
09-2Do you have a defense technique in place against model evasion attacks?Determine applicability: Consider this question if expedients are expected in medical insurance fraud, drug clinical trial subject selection, and/or emergency patient selection when developing AI diagnosis services, and determine if the requirement has been satisfied.
• A model evasion attack is a type of adversarial attack, which is a technique that disrupts the performance of an AI model by tampering with input data in a minimal way (so that it is imperceptible to humans). Anticipated scenarios in medical services include adversarial attacks aimed at fraudulent receipt in the free-for-service system, the generation of adversarial patients for selection of clinical trial participants, and adversarial attacks aimed at changing the order of emergency patient examinations [43].
• Particularly AI that utilizes images such as X-ray images, MRI images, and ultrasound images can be highly susceptible to model evasion attacks, so techniques such as adversarial training, gradient masking/distillation, and feature squeezing can be considered to mitigate this.
