Legal Basis for Processing
Every processing activity needs an identified Article 9 legal basis. For consumer apps, explicit consent must be freely given, specific, and withdrawable.
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What GDPR Healthcare Compliance Covers
Health data is Article 9 special category — GDPR's highest tier, demanding legal basis, data subject rights, DPAs, privacy by design, and transfer mechanisms built into the architecture.
Data Subject Rights
EU individuals hold rights of access, erasure, and portability. Systems must locate, extract, and delete a person's data across every storage location.
Data Processing Agreements
A DPA — the GDPR equivalent of a HIPAA BAA — is required with every cloud provider, analytics platform, and sub-processor touching EU health data.
Privacy by Design and Default
Article 25 mandates data protection from the earliest design stage. Data minimization, purpose limitation, and access controls are architecture decisions.
Cross-Border Data Transfers
EU-to-U.S. flows require Standard Contractual Clauses backed by a Transfer Impact Assessment confirming the recipient country protects the data.
Breach Notification
Breaches must be reported to the supervisory authority within 72 hours. High-risk breaches also require notifying affected individuals — procedures must be ready in advance.
How We Build GDPR-Compliant Healthcare Products
From legal basis to cross-border transfers — five steps that determine whether a healthcare app can lawfully operate in EU markets.
Why GDPR Compliance Is a EU Market Access Requirement
Each consequence traces to a specific compliance gap.
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Maximum GDPR penalty — or 4% of global turnover, whichever is higher. Article 9 violations attract the top tier.
Article 9
Health data is special category — processing is prohibited unless a legal basis applies and is documented before collection.
72 Hours
The GDPR breach notification window — shorter than HIPAA's 60 days. The clock starts at awareness, so response workflows must be tested in advance.
DPA First
A DPA must be in place with every sub-processor before EU health data flows — EU healthcare customers require it as a contractual condition.
SCCs
The primary mechanism for lawful EU-to-U.S. data transfer — SCCs need a Transfer Impact Assessment confirming U.S. law protects the data.
Law 25
Quebec's Law 25 mirrors GDPR principles for health data. Canadian digital health companies must track both federal PIPEDA and provincial rules.
The GDPR Requirements That Apply Directly to Healthcare Software
Each requirement maps to specific architecture, legal, and operational decisions — built in, not bolted on.
Article 9 Legal Bases
A documented lawful basis for special-category health data — explicit consent, obligation, or research.
Data Subject Rights
Rights to access (within one month), erase, port, restrict, object, and rectify data on request.
Data Processing Agreements
GDPR's counterpart to HIPAA's BAA — required with every sub-processor touching EU health data.
Privacy by Design
Article 25: data protection built into the architecture — minimization, role-based access, and audit logging.
Cross-Border Transfer Mechanisms
EU data leaves the EEA only via a lawful mechanism — Standard Contractual Clauses or localization.
Breach Notification Requirements
72-hour supervisory-authority notification with classification criteria and incident response procedures.
The GDPR Compliance Stack We Build On
Data protection tooling, EU-residency cloud, and consent platforms — selected to satisfy GDPR Article 25 privacy by design and data subject rights.
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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
EU Health Data Needs the Right Legal Foundation. Let's Build That In.
Legal basis, privacy by design, DPAs, SCCs, and 72-hour breach response — built in from the first design decision, not added after.
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Frequently Asked Questions
[ 1 ]
Does GDPR apply to a U.S. company that only occasionally has EU users?
Yes. GDPR applies whenever a service is directed at or used by EU individuals — there is no volume exception. It applies regardless of where the company is based.
[ 2 ]
What is the difference between a GDPR Data Processing Agreement and a HIPAA Business Associate Agreement?
Both govern how a vendor processes health data, but under different frameworks: a BAA covers HIPAA PHI, a DPA covers GDPR obligations. Companies subject to both need both — though one well-drafted document can satisfy each.
[ 3 ]
How does GDPR interact with Canada's PIPEDA and provincial privacy legislation?
PIPEDA holds EU adequacy status, so EU-to-Canada transfers don't require SCCs federally — but that doesn't extend to provincial health laws like Ontario's PHIPA. Quebec's Law 25 adds GDPR-like requirements for health data since 2023.
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