Part B · Data protection

    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 obligationAUEUUKUSINAE
    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✓✓✓✓✓✓
    Applies / straightforwardConditional, needs a safeguardRestricted or mandated

    By jurisdiction

    AU

    Australia

    OAIC

    Privacy Act 1988 + 13 APPsPrivacy and Other Legislation Amendment Act 2024

    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.

    For us

    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.

    EU

    European Union

    GDPR

    GDPR, Art 9 special categoryArt 28 processor termsArt 35 DPIA · Ch V transfers

    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.

    For us

    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.

    UK

    United Kingdom

    ICO

    UK GDPR + DPA 2018Data (Use and Access) Act 2025

    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.

    For us

    Same posture as the EU. UK-region processing or a valid transfer mechanism, plus ICO-aligned consent and a processing agreement.

    US

    United States

    HHS + states

    HIPAA Privacy & Security RulesState laws: CCPA/CPRA, MODPA, MHMDA

    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.

    For us

    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.

    IN

    India

    Data Protection Board

    DPDP Act 2023DPDP Rules 2025, notified 13 Nov 2025

    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.

    For us

    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.

    AE

    United Arab Emirates

    EDE + emirate authorities

    Federal Decree-Law 45 of 2021 (PDPL)Federal Law 2 of 2019 (ICT in Health)DIFC & ADGM data laws

    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.

    For us

    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.