Legal Basis for Processing
Every health data processing activity requires an identified Article 9 legal basis. For direct-to-consumer apps, explicit consent must be freely given, specific, and withdrawable without detriment.
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What GDPR Healthcare Compliance Covers
Health data is Article 9 special category — the highest GDPR protection tier. Compliance means legal basis documentation, data subject rights, DPAs, privacy by design, and cross-border transfer mechanisms baked into the architecture.
Data Subject Rights
EU individuals hold rights of access, erasure, and portability. Systems must locate, extract, and delete all data tied to a specific individual 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 that touches 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, not afterthoughts.
Cross-Border Data Transfers
EU-to-U.S. flows require Standard Contractual Clauses backed by a Transfer Impact Assessment confirming the recipient country adequately protects the data.
Breach Notification
Breaches must be reported to the supervisory authority within 72 hours. High-risk breaches also require direct notification to affected individuals — response procedures must be ready before an incident occurs.
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 gap — missing legal basis, no DPAs, or a breach response that can't meet the 72-hour window.
Book a GDPR Compliance Consultation€20M
Maximum GDPR penalty — or 4% of global turnover, whichever is higher. Article 9 health data violations attract the maximum tier.
Article 9
Health data is special category — processing is prohibited unless a specific 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 detection and response workflows must be tested before a breach occurs.
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 must be accompanied by a Transfer Impact Assessment confirming U.S. law adequately 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 evolving provincial requirements.
The GDPR Requirements That Apply Directly to Healthcare Software
Each requirement maps to specific architecture, legal, and operational decisions — built in, not bolted on. Hover a card to see what each demands.
Article 9 Legal Bases
Processing special-category health data is prohibited unless a lawful basis applies and is documented — explicit consent, healthcare professional obligation, vital interests, public health interest, or research and statistical purposes.
Data Subject Rights
Enforceable rights requiring the app to locate, deliver, and delete data on request — access within one month, erasure, portability, restriction of processing, objection, and rectification.
Data Processing Agreements
Required with every sub-processor touching EU health data — GDPR's counterpart to HIPAA's BAA. Covers subject matter, duration, nature and purpose of processing, controller obligations, and sub-processor and cloud-provider chains.
Privacy by Design
Article 25 requires data protection baked into the architecture from day one — data minimization by default, purpose limitation, retention limits by data type, role-based access, pseudonymization, and audit logging.
Cross-Border Transfer Mechanisms
EU personal data cannot leave the EEA without a lawful transfer mechanism — Standard Contractual Clauses, a Transfer Impact Assessment, adequacy decisions, Binding Corporate Rules, or data localization.
Breach Notification Requirements
72-hour supervisory authority notification, with individuals notified for high-risk breaches. Requires breach classification criteria, incident response procedures, authority contacts, and breach documentation records.
The GDPR Compliance Stack We Build On
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.
A
AWS EU Regions
A
Azure EU Data Boundary
G
Google Cloud EU
A
AWS HealthLake EU
A
Azure Health Data EU
O
OneTrust
C
Cookiebot
U
Usercentrics
C
Custom Consent Store
C
Consent Audit Trail
A
Auth0
O
Okta
A
Azure AD / Entra
R
Role-Based Access
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Pseudonymization
O
OneTrust DataMapping
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TrustArc
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SCCs & TIA Templates
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GDPR ROPA
I
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 accessible to and used by EU individuals — there is no de minimis exception based on volume. If your app is directed at EU users or monitors their behavior, GDPR 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 on a customer's behalf, but under different frameworks. A BAA covers HIPAA PHI; a DPA covers GDPR personal data processing obligations. Companies subject to both typically need both agreements with the same vendors — a single well-drafted document can satisfy both requirements.
[ 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 under the federal framework. That adequacy doesn't automatically extend to provincial health laws like Ontario's PHIPA. Quebec's Law 25 (in effect since 2023) adds GDPR-like requirements for health data processed in Quebec.
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