We build the legal basis framework, privacy by design architecture, data subject rights, DPAs, and 72-hour breach response that GDPR Article 9 requires for any product handling EU health data.
Talk to our team about your EU health data processing environment. We reply within 24 hours.
Health data is a special category under GDPR Article 9 — the highest protection tier in the regulation. For digital health companies serving EU markets, compliance means legal basis documentation, data subject rights implementation, DPAs, privacy by design, and cross-border transfer mechanisms built into the architecture.
Before processing any health data of EU individuals, the legal basis under GDPR Article 9 must be identified and documented. For direct-to-consumer digital health apps, explicit consent is typically required — freely given, specific, informed, and unambiguous, with genuine ability to withdraw without detriment.
EU individuals have the right of access to all personal data held about them, the right to erasure, and the right to data portability in a machine-readable format. Applications must be designed from the start to locate, extract, and delete all data associated with a specific individual across every system and storage location.
Where a data controller engages a processor to handle EU personal data, a Data Processing Agreement — the GDPR equivalent of a HIPAA BAA — must be in place. DPAs are required with cloud providers, analytics platforms, and every sub-processor that touches EU health data.
GDPR Article 25 requires data protection to be built into system design from the earliest stage. Data minimization, purpose limitation, and access controls are architecture decisions — not afterthoughts. Only data necessary for each specific purpose is collected and retained.
GDPR restricts personal data transfers outside the EEA. For EU-to-U.S. data flows, Standard Contractual Clauses are the primary transfer mechanism — supported by a Transfer Impact Assessment evaluating whether the recipient country's legal environment adequately protects the data in practice.
Personal data breaches must be reported to the relevant supervisory authority within 72 hours of becoming aware of the breach. If the breach creates high risk to individuals, affected data subjects must also be notified without undue delay — a compressed timeline that requires incident response procedures ready before a breach occurs.
A five-step process from legal basis determination to cross-border transfer mechanisms — each step with specific deliverables that determine whether a healthcare application can lawfully operate in EU markets.
Each consequence traces to a specific gap — no documented legal basis, missing DPAs, or breach response that cannot meet the 72-hour window. Click through to see what changes when compliance is built in.
Book a GDPR Compliance ConsultationEach requirement maps to specific architecture, legal, and operational decisions — implemented across the product, not added as a compliance layer after the fact.
Health data processing is prohibited unless one of these specific bases applies and is documented.
EU individuals have enforceable rights requiring the application to locate, deliver, and delete data on request.
Required with every sub-processor handling EU health data — the GDPR counterpart to HIPAA's BAA.
GDPR Article 25 requires data protection built into the architecture from the earliest design stage.
EU personal data cannot leave the EEA without a lawful transfer mechanism in place.
72-hour supervisory authority notification and individual notification for high-risk breaches.
Data protection tooling, cloud services with EU data residency, and consent management platforms — selected to satisfy GDPR Article 25 privacy by design requirements and support data subject rights at scale.
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AWS EU Regions
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Azure EU Data Boundary
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Google Cloud EU
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AWS HealthLake EU
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Azure Health Data EU
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OneTrust
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Cookiebot
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Usercentrics
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Custom Consent Store
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Consent Audit Trail
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Auth0
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Okta
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Azure AD / Entra
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Role-Based Access
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Pseudonymization
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OneTrust DataMapping
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TrustArc
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SCCs & TIA Templates
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GDPR ROPA
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ISO 27001
Legal basis documentation, privacy by design architecture, data subject rights, DPAs, SCCs, Transfer Impact Assessments, and 72-hour breach response — we build GDPR compliance into the product from the first design decision. Book a consultation and we will tell you what compliant health data processing looks like for your EU market.
Book a GDPR Compliance Consultation
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GDPR applies to the processing of personal data of individuals who are in the EU, regardless of how frequently or occasionally that processing occurs. If a U.S.-based digital health application is accessible to and used by individuals in EU countries, GDPR applies to the processing of those individuals' personal data. The regulation does not include a de minimis exception based on the volume of EU data subjects. Companies that are uncertain about their GDPR obligations should assess whether their services are directed to EU individuals and whether they monitor the behavior of individuals in the EU — both of which trigger GDPR applicability regardless of the company's physical location.
Both documents establish the terms under which a vendor processes health or personal data on behalf of a customer organization, but they are grounded in different regulatory frameworks. A HIPAA BAA focuses on PHI and the specific requirements of the HIPAA Privacy and Security Rules. A GDPR DPA focuses on personal data processing activities and the data protection requirements of GDPR. Organizations handling data subject to both GDPR and HIPAA often need both types of agreements in place with the same vendors — the two frameworks overlap significantly in their goals but have different technical requirements for agreement content. A single comprehensive data processing agreement can be drafted to satisfy both sets of requirements.
Canada's federal private sector privacy law, PIPEDA, has been recognized by the European Commission as providing adequate protection for personal data transferred from the EU — which means EU-to-Canada personal data transfers under PIPEDA can occur without additional mechanisms such as Standard Contractual Clauses. However, this adequacy decision covers PIPEDA's federal framework and does not automatically extend to provincial health information legislation like PHIPA in Ontario, which covers health data specifically. Canadian digital health companies receiving health data from EU sources should obtain legal advice specific to their data flows and the applicable Canadian legislation in the provinces where they operate. Quebec's Law 25, in effect since 2023, adds further GDPR-like requirements that apply to health data processed in Quebec regardless of whether it originates in the EU.
