Operating rules
Changing a label is necessary but not sufficient. A regulator reads intended purpose from what the agent does, not what we called it. These rules keep the function bounded so the label holds.
The language rules
Triage did two jobs. Keep the capture job, drop the clinical-priority job. There is no single swap, so use the right word for the right surface.
The fixed design boundaries
Two outputs only on the patient path: schedule, or connect to a human. Never do nothing, never no need to see a doctor, never a diagnosis.
Per-agent Intended Purpose statements locked to qualification and routing. This is the document a regulator reads first.
Readiness detection is behavioural, scroll depth, return visits, an explicit I want to book. Never clinical, never urgency or severity.
No interactive symptom-checker or quiz that returns a personal read. Content stays one-to-many.
Co-branding and health-content advertising rules
The With care from [Hospital] badge combined with health content can trigger therapeutic-goods and health-advertising rules: the TGA advertising code in Australia, ASCI plus the Drugs and Magic Remedies overlay in India, and health-marketing rules under the DHA and DOH in the UAE. This is advertising compliance, not device classification, but it lives on the same pages, so handle it in the same legal pass. Avoid any implied efficacy or outcome claim in co-branded copy.
Pre-pilot checklist, per market
- 1
Lock the Intended Purpose statements
One per agent, scoped to qualification and routing. No clinical verbs. This is the primary evidence of intended purpose.
- 2
Scrub the language everywhere
Patient-facing copy, agent names, contracts, investor materials, and marketing. Remove every term from the drop list.
- 3
Confirm the agent cannot free-reason on symptoms
Verify in the build that public-facing decision logic is deterministic. The function, not just the name, must stay bounded.
- 4
Set residency for the market's tier
UAE in-country. Australia, EU, UK in-region. India and US with consent and, for the US, BAAs. Choose the model per the education-versus-routing split.
- 5
Stand up the data instruments
Consent and notice flows, a processing agreement with the clinic, a DPIA where required, and breach-notification readiness.
- 6
Run the co-branding copy past the advertising rules
Check the badge and any health content against the local health-advertising code. Strip implied efficacy.
- 7
Get a local device-regulatory lawyer to sign off
Have counsel in each target market review the Intended Purpose statements and the not a medical device position paper before any pilot contract is signed.