A Spectrum of Possible Framings
Placeholder lead: same chatbot, different claims, different regulatory fate.
- 2: Spectrum poles (wellness vs. clinical)
- Marketing + UI claims: Framing driver (not the underlying model)
- Claim specificity: Key variable (vague to diagnostic)
- Wide: Grey zone width (placeholder metric)
Placeholder section heading
Placeholder body text, short filler sentence describing the spectrum concept briefly.
Applying the Diagnose/Treat/Cure/Mitigate Test
Placeholder lead: the classification hinges on specific claim language.
- 4: Test prongs (diagnose, treat, cure, mitigate)
- Explicit claim: Trigger type (not general capability)
- FDA (SaMD): Reviewing body (placeholder reference)
- High: Ambiguity risk (placeholder metric)
Placeholder section heading
Placeholder body text describing how the claims test is applied briefly.
No Specific Clinical Claims — General Wellness Product
Placeholder lead: staying general keeps oversight light.
- Wellness: Classification (placeholder)
- Not required: Premarket review (placeholder)
- Minimal: Oversight level (placeholder)
- "Supportive chat": Example language (placeholder)
Placeholder section heading
Placeholder body text describing minimal oversight for wellness products.
Specific Clinical Claims — Regulated as SaMD
Placeholder lead: explicit claims mean full device scrutiny.
- Medical device: Classification (placeholder)
- Required: Premarket review (placeholder)
- Full: Oversight level (placeholder)
- "Treats depression": Example language (placeholder)
Placeholder section heading
Placeholder body text describing full SaMD premarket review requirements.
A Contested and Evolving Line
Placeholder lead: even wellness chatbots draw scrutiny in crisis contexts.
- Ongoing: Debate status (placeholder)
- At-risk population: Vulnerable users (placeholder)
- Key factor: Crisis exposure (placeholder)
- Tightening: Policy trend (placeholder)
Placeholder section heading
Placeholder body text describing the contested regulatory boundary briefly.
Placeholder highlight: crisis risk keeps pressure on regulators to expand oversight.