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Where AI appears in healthcare—and what that does not prove
“AI in healthcare” covers different things: medical devices that support a defined clinical task, research models, and systems used for administrative work. These uses are not interchangeable. An administrative tool, for example, should not automatically be described as making a clinical decision.
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The U.S. Food and Drug Administration maintains a list of AI-enabled medical devices authorized for marketing in the United States. That list describes a regulated device landscape; it does not show that every clinician or appointment uses AI, nor does authorization for one intended use establish that a device is suitable for another patient or task. See the FDA’s AI-enabled medical device list.
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What transparency should tell you about a tool
FDA, Health Canada, and the UK Medicines and Healthcare products Regulatory Agency describe transparency as sharing information that can affect risks and patient outcomes with relevant audiences, including patients and health professionals. Their guidance says transparency supports patient-centered care and safe, effective device use. Read the regulators’ transparency principles.
For a medical device, useful information depends on its intended use and context. The key is not simply whether a tool is called AI, but what it is designed to do and how people use its output.
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- Purpose and population: What condition or task is it meant for, and for which patients?
- User and setting: Is it intended for a clinician, another health professional, or a patient, and in what care setting?
- Inputs and outputs: What information does it use, and does it produce a score, alert, recommendation, or something else?
- Role in the workflow: Does it inform, recommend, prioritize, or automate an action? Does a clinician review its output?
- Evidence and limits: What performance evidence applies to this exact use? What risks, data gaps, or potential biases are known?
- Monitoring: How are safety and performance checked over time, including when performance changes?
Transparency is related to explainability but is not the same thing. Explainability concerns how understandable the basis for an output is; it does not mean every AI system can give a simple account of its internal logic. The regulators’ principles emphasize communicating the information people need in context, rather than promising a particular kind of explanation.
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WHO’s 2021 guidance sets out six ethical principles for AI in health: protecting autonomy, promoting human well-being and safety, ensuring transparency, fostering responsibility and accountability, ensuring inclusiveness and equity, and promoting responsive and sustainable AI. It is an ethical framework, not a binding disclosure statute. Read WHO’s ethics and governance guidance.
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For large language models (LLMs), WHO’s 2023 statement called for clear evidence of benefit before widespread routine use in health, alongside safeguards for patient safety and protection. That caution is not proof that any specific clinician is using an LLM or hiding it. Read WHO’s statement on AI for health.
Separately, WHO’s report published July 21, 2026, addresses ethics review and oversight of AI-related health research. Its scope is research oversight, not whether clinicians disclose routine AI use to patients. Read WHO’s report on ethics and governance of AI for health research.
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How to ask about AI in your care
You can ask direct, practical questions without assuming that AI is involved or that its use is improper. For example:
- “Is an AI tool involved in this part of my care?”
- “What does it do, and what information does it use?”
- “Does it make a recommendation or a decision?”
- “How do you check its output?”
- “What are its limitations for someone like me?”
These questions reflect regulator transparency principles; they are not a claim that patients everywhere have a specific legal entitlement to disclosure in every situation. Disclosure rules depend on jurisdiction, care setting, and the particular tool. The sources here do not establish a universal legal duty to disclose each AI use.
What one survey finding can—and cannot—tell us
An FDA event-page summary of a 2026 survey concerning communication about AI/ML-enabled cardiac devices reported a 14–19% increase in patient trust and a 13–18% increase in intention to use when selected information was communicated. The information included regulatory approval, performance, provider oversight, and AI’s added value. These figures describe that survey and those devices; they are not estimates for all patients, healthcare AI, or clinician disclosure generally. See the FDA’s digital health research and events page.
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