GDPR · Healthcare

GDPR Compliance for Healthcare and Healthtech

Article 9 health data, research bases, and patient rights

Health data is special-category data under GDPR, engaging Article 9 conditions, DPIAs, and heightened security expectations. TruePrivacy helps providers and healthtech platforms serving EU patients govern clinical and product data lawfully.

What GDPR requires of healthcare

Article 9 conditions

Healthcare provision, medical diagnosis, and public health conditions for clinical uses; explicit consent for wellness features and research without derogations.

Mandatory DPIAs

Large-scale processing of health data triggers Article 35 — assessed before processing begins, not after.

Patient DSARs

One-month deadlines across clinical records, with third-party and clinician-note redaction handled carefully.

Research and secondary use

Scientific research safeguards, pseudonymisation, and member-state derogations for consent-free research.

Processor and transfer chains

Cloud EMRs, analytics vendors, and non-EEA processing need Article 28 contracts, SCCs, and TIAs.

High-risk breach notification

Health-data breaches typically require both 72-hour authority notification and direct patient notification — with the risk assessment documented either way.

How TruePrivacy helps

01

Article 9 processing register

Every health-data activity mapped to its condition with supporting evidence — the register a supervisory authority asks for first.

02

DPIA workflow engine

Triggered assessments with risk scoring, mitigation tracking, and prior-consultation readiness.

03

Clinical DSAR automation

Assembly across EMR, imaging, and billing with redaction review and deadline tracking.

04

Research governance

Pseudonymisation tracking, safeguard documentation, and consent-or-derogation records per study.

05

Transfer compliance

SCC and TIA management for every non-EEA flow, with sub-processor chain visibility.

When our supervisory authority asked for the Article 9 basis behind every analytics pipeline, we exported the register from TruePrivacy the same afternoon. That register used to be a spreadsheet three versions out of date.

Ingrid Halvorsen
Privacy Counsel, Vitalis Digital Health

Frequently asked questions

Can we use patient data to improve our product?

Product analytics on identifiable health data is not covered by the healthcare-provision condition — it typically needs explicit consent or genuine anonymisation. TruePrivacy classifies each analytics pipeline and documents the basis or the anonymisation standard applied.

When is a DPIA mandatory for us?

Large-scale processing of special-category data — which describes most healthtech platforms — triggers Article 35. TruePrivacy's DPIA engine runs the assessment against your live data map and tracks mitigations to closure.

How do we handle DSARs that include clinician notes about third parties?

Third-party data and certain clinical opinions may need redaction or member-state-specific handling. TruePrivacy's DSAR workflow includes a redaction review step with a second reviewer for mixed-content records.

We serve EU and Indian patients. How do the regimes combine?

GDPR's Article 9 conditions govern EU patients; DPDP's consent and legitimate-use rules govern Indian data principals — with different breach models and rights sets. TruePrivacy applies each regime per patient jurisdiction from one platform.

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