How not to fall foul of privacy law
Staying out of device scope does not exempt us from data law. Identifiable patient conversations are personal, and in most markets health data sits in a higher-protection tier. This is a separate legal pass from SaMD, on the same pages.
| Data obligation | AU | EU | UK | US | IN | AE |
|---|---|---|---|---|---|---|
| Obligations | ||||||
| Health data treated as a higher-protection category | ✓ | ✓ | ✓ | ✓ | ⚠ | ✓ |
| Explicit consent and clear notice required | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Cross-border transfer is free of friction | ⚠ | ✕ | ✕ | ⚠ | ✓ | ✕ |
| In-country data residency effectively required for health data | ⚠ | ⚠ | ⚠ | ⚠ | ⚠ | ✕ |
| Formal data-processing agreement with the clinic needed | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Mandatory breach notification | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
By jurisdiction
Australia
OAIC
Health information is sensitive information, which raises the bar to collect and use it. APP 11 governs security, and APP 8 governs cross-border disclosure: send identifiable patient data to an overseas recipient and the entity remains accountable for how that recipient handles it, unless the patient consents or the destination is whitelisted. The 2024 reforms added a statutory tort for serious invasions of privacy, in force from June 2025, and automated-decision-making transparency obligations landing by December 2026. Australia has no EU adequacy decision, and a country-whitelist mechanism is still under development.
APP 8 is the single strongest data-residency argument we have. Routing identifiable patient data to a US model API is a cross-border disclosure. Keeping inference onshore in australia-southeast1 sidesteps APP 8 entirely. This drives the hosting decision.
European Union
GDPR
Health data is special-category data under Article 9, so processing needs both an Article 6 lawful basis and an Article 9 condition, usually explicit consent in this context. Large-scale processing of health data triggers a Data Protection Impact Assessment under Article 35. Acting for a clinic makes us a processor, requiring Article 28 terms. Transfers outside the EEA need an adequacy decision or appropriate safeguards such as Standard Contractual Clauses. Breaches are notifiable within 72 hours, and fines reach 4 percent of global turnover.
Explicit consent, a DPIA, a signed processing agreement with each clinic, and EU-region inference or SCC-backed transfer. The cleanest path is to keep processing in an EU region.
United Kingdom
ICO
Mirrors the EU framework with UK-specific machinery. Health data remains special-category, processing terms and DPIAs apply, and the Information Commissioner's Office is the regulator. International transfers use the UK addendum or the International Data Transfer Agreement. The Data (Use and Access) Act 2025 reformed some areas, including recognised legitimate interests and automated-decision rules, but the substantive protections for health data are intact.
Same posture as the EU. UK-region processing or a valid transfer mechanism, plus ICO-aligned consent and a processing agreement.
United States
HHS + states
If we act as a business associate to a clinic that is a covered entity, HIPAA applies to protected health information and a Business Associate Agreement is required, including with any subprocessor that touches that data, such as a model API. Outside HIPAA, state privacy laws fill the gap: California's CCPA and CPRA, Maryland's MODPA, and Washington's My Health My Data Act, which treats consumer health data broadly.
The rule for any US deployment is a complete BAA chain, or de-identification before any external processing. No PHI reaches a model vendor without a BAA in place.
India
Data Protection Board
The framework is now live. The DPDP Rules 2025 were notified on 13 November 2025, operationalising the 2023 Act on a phased schedule running to roughly mid-2027. The model is consent-led: clear notice, defined data-principal rights, and erasure once the purpose is served. Breaches are notifiable to the Data Protection Board, with penalties up to 200 crore per incident. Significant Data Fiduciaries face extra duties, including an annual DPIA and an independent audit. Two design-relevant points: the Act does not carve out a separate sensitive data tier the way GDPR does, treating personal data more uniformly, and cross-border transfers are permitted unless the government specifically restricts a destination, which is more flexible than the EU. Processing data of anyone under 18 needs verifiable parental consent.
Build clean consent and notice, and purpose-bound retention, in from the start. Localisation is not federally mandated, but clinic contracts and sector expectations push toward in-India hosting. Where SDF thresholds are crossed, the annual DPIA and independent audit apply.
United Arab Emirates
EDE + emirate authorities
This is the strictest residency market of the six. The federal PDPL sets general data-protection duties, but the decisive instrument is Federal Law 2 of 2019 on the use of ICT in health fields, which mandates that health data stay confidential and, in effect, requires it to be stored and processed inside the UAE, with transfer outside subject to regulator approval. The financial free zones, DIFC and ADGM, run their own GDPR-style regimes.
Health data localisation is effectively mandatory. Any identifiable patient processing must run in-country. This makes self-hosted or in-UAE managed inference a precondition, not an optimisation. See Tier 1 in Hosting.
