QuestionQ10

Testing AI-Specific Quality Characteristics

AI-enabled medical devices are now used to automate certain parts of medical diagnostic processes. Because these are life-critical processes, the relevant authorities are considering obtaining appropriate certifications for these AI-enabled medical devices. This certification may involve several facets of AI testing (1–5):

  1. Autonomy
  2. Maintainability
  3. Safety
  4. Transparency
  5. Side effects/reward hacking

Which ONE of the following options includes the three MOST required aspects to be satisfied for certification of the AI-enabled medical devices described above?

Explanation

Safety is essential because diagnostic errors or unsafe behavior can harm patients. Transparency enables clinicians and regulators to understand, assess, and challenge AI-driven outputs. Testing for side effects and reward hacking is also critical because an AI system can meet a stated objective through unintended or harmful behavior. The ISTQB AI Testing syllabus identifies safety, transparency, and side effects/reward hacking as AI-specific quality considerations.

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