Medical AI Compliance Glossary
Essential terms and definitions for navigating California's medical AI regulations.
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Business
Risk Management →
Evaluation and minimization of risks.
Compliance
Audit Trail →
A security-relevant chronological record providing documentary evidence of the sequence of activities that have affected a specific operation, procedure, or event.
Clinical Camouflage →
The deceptive design practice where an AI system is anthropomorphized to mimic a licensed healthcare professional (e.g., wearing white coats).
Disclosure Requirement →
The legal mandate that AI systems must inform users they are interacting with artificial intelligence at the start of every interaction.
Human-in-the-Loop (HITL) →
A system design requiring human review of AI output before it reaches the patient.
Misrepresentation →
Giving a false account of the nature of something (e.g., AI appearing human).
Persistent Disclosure →
Requirement that AI notices remain visible throughout an interaction.
Post-Nominal Letters →
Credentials like M.D. or R.N. after a name.
White Coat Rule →
Prohibition on AI avatars wearing clinical attire.
Design
UI Compliance →
Designing interfaces that meet legal standards (e.g., font size).
Ethics
Transparency →
Principle that AI should be understandable and disclosed.
Healthcare Delivery
Telehealth →
Remote delivery of healthcare.
Legal
Civil Liability →
Potential responsibility for payment of damages or other court-enforced remedies in a lawsuit.
Health Care Profession →
Any profession subject to licensure under the Healing Arts division.
Medical Licensure →
The state permit to practice medicine.
Patient Clinical Information →
Information relating to a patient's health status.
Legislation
AB 2013 →
California Assembly Bill 2013 requires developers of generative AI systems to provide high-level summaries of the datasets used to train their models. This includes information on the categories of data, whether it contains PII, and the time period it covers.
AB 3030 →
California Assembly Bill 3030 is a focused regulation targeting the use of Generative AI (GenAI) in healthcare communications. It mandates that if a GenAI tool is used to communicate clinical information to a patient, a human healthcare provider must review and approve that communication before it is sent.
AB 489 →
California Assembly Bill 489, formally known as the 'Artificial Intelligence Transparency Act for Healthcare,' is a state law enacted to prevent the deceptive use of AI in medical settings. It mandates that any automated system interacting with a patient must clearly and conspicuously disclose strictly that it is not a human.
HIPAA →
Federal law protecting sensitive patient health information (PHI).
Medical
Clinical Validation →
The process of proving that an AI model works as intended in a real-world clinical setting.
Informed Consent →
Permission obtained from a patient with full knowledge of the risks.
Patient Rights
Right to Know →
Patient's right to be informed when interacting with AI.
Privacy
PHI →
Protected Health Information under HIPAA.
Regulatory Body
Enforcement Agency →
Government bodies like the Medical Board of California empowered to uphold AI laws.
Medical Board of California →
State agency licensing physicians and enforcing medical laws.
Osteopathic Medical Board →
Regulatory body for DOs in California.
SEO
Technology
Algorithmic Bias →
Systematic and repeatable errors in a computer system that create unfair outcomes, such as privileging one arbitrary group of users over others.
Artificial Intelligence (AI) →
Any computational system that performs tasks indicative of human intelligence, broadly defined in legislation to distinguish valid tools from misleading automation.
Clinical Decision Support (CDS) →
Health IT tools providing clinical knowledge and patient-related information to enhance health care.
Data Provenance →
Documentation of the origin and history of the data used to train an AI model.
EHR Integration →
The connection between AI systems and electronic health record software.
Generative AI (GenAI) →
AI models that can create new content (text, images) rather than just analyzing data.
Hallucination →
When an AI produces confident but factually incorrect information.
Large Language Model (LLM) →
AI trained on vast text data to generate human-like language (e.g., GPT-4).
Model Training Data →
The dataset used to teach an AI model.
Patient-Facing AI →
AI interacting directly with patients (chatbots, voice assistants).
SaMD →
Software performing medical purposes without hardware.
Symptom Triage AI →
AI assessing symptoms to recommend care urgency.
Synthetic Content →
Content generated by AI mimicking human creation.
Virtual Nursing Assistant →
AI help for administrative/triage tasks.
Voice Agent →
AI interacting via spoken language.
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