EU Representative for HealthTech

HealthTech & GDPR: Highest Stakes

HealthTech and MedTech companies process the most sensitive category of personal data under GDPR — special category data under Article 9. This includes health information, biometric data, genetic data, and data concerning a person’s physical or mental condition. The GDPR imposes stricter conditions for processing special category data, and the risks of non-compliance are proportionally higher.

If you’re a non-EU HealthTech company — whether you make wearable devices, telemedicine platforms, electronic health records, AI diagnostic tools, or medical IoT devices — and you serve EU users or patients, GDPR applies to you. Article 27 requires you to designate an EU Representative.

Health Data Under GDPR Article 9

Special category data processing requires one of the following legal bases: explicit consent, vital interests, substantial public interest, or health/social care purposes. Standard consent isn’t enough — you need explicit consent. This significantly impacts how HealthTech companies design their data collection and user onboarding.

HealthTech Subsectors

Wearables & fitness trackers: Heart rate, sleep patterns, steps, location — personal and often health data. Even “wellness” trackers that measure health metrics are processing health data under GDPR interpretation.

Telemedicine platforms: Video consultations, patient records, prescriptions, lab results — extensive health data processing.

AI diagnostic tools: Medical images, patient data analysis, risk prediction models — special category data at scale.

Clinical trial software: Patient recruitment, trial monitoring, adverse event reporting — health data + clinical regulation.

Mental health apps: Therapy sessions, mood tracking, journaling, crisis data — highly sensitive special category data.

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