AI0-001 AI Governance and Ethics Practice Question
A healthcare technology company is preparing to deploy an AI system that analyzes patient X-rays to detect early-stage lung cancer. The system is intended to be marketed as a medical device in the European Union. Under the EU AI Act, which classification and corresponding obligation apply to this system?
⚠ Common exam trap
The trap here is assuming that because the AI is a medical device, it automatically falls under minimal risk or is exempt from the AI Act, when in fact medical AI is explicitly high-risk.
Answer choices
Why each option matters
Answer the question above first, then reveal the full breakdown to understand why each option is right or wrong.
Correct answer & explanation
✓
It is a high-risk AI system and must comply with requirements for risk management, data governance, technical documentation, and human oversight before being placed on the market.
The EU AI Act classifies AI systems used in medical devices as high-risk under Annex III. This triggers a comprehensive set of obligations including risk management, data governance, technical documentation, and human oversight. The system is not prohibited, nor is it limited or minimal risk, because its output directly affects patient diagnosis and safety.
Answer analysis
Option-by-option breakdown
For each option: why learners choose it and why it is or isn't the right answer here.
- ✗
It is a limited-risk AI system and only needs to provide transparency notices to patients about its use.
Why it's wrong here
Limited-risk classification applies to systems like chatbots or emotion recognition, not to medical diagnostic tools. Transparency notices alone are insufficient for a system that directly influences clinical decisions and patient safety. The EU AI Act imposes far more rigorous requirements on medical AI, including conformity assessments and post-market monitoring.
- ✓
It is a high-risk AI system and must comply with requirements for risk management, data governance, technical documentation, and human oversight before being placed on the market.
Why this is correct
AI systems intended to be used as safety components in the management and operation of critical digital infrastructure, or in medical devices, are explicitly listed in Annex III of the EU AI Act as high-risk. The company must therefore implement a risk management system, ensure data governance, maintain technical documentation, and provide for human oversight, among other obligations.
- ✗
It is a minimal-risk AI system and can be deployed without any additional regulatory requirements beyond existing medical device regulations.
Why it's wrong here
Minimal-risk classification applies to applications like spam filters or AI-enabled video games. Medical AI systems that could impact patient health are never minimal-risk under the EU AI Act. Even if they are already regulated as medical devices, the Act adds specific AI-related obligations such as data quality and human oversight.
- ✗
It is a prohibited AI system because it uses subliminal techniques to manipulate patient behavior.
Why it's wrong here
Prohibited practices under the EU AI Act include manipulative techniques that cause harm, social scoring, and real-time remote biometric identification in public spaces. A lung cancer detection tool does not employ subliminal manipulation; it analyzes medical images. Thus, it is not prohibited, but rather high-risk due to its medical application.
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JA
Written and reviewed by Johnson Ajibi, MSc IT Security
Senior Network & Security Engineer · founder of Courseiva
Last reviewed September 2026 · checked against the official CompTIA exam blueprint
This AI0-001 practice question is part of Courseiva's free CompTIA certification practice question bank. Courseiva provides original exam-style practice questions with explanations, topic-based practice, mock exams, readiness tracking, and study analytics to help learners prepare for the AI0-001 exam.