Privacy compliance for HealthTech companies that handle sensitive data every day

GDPR, HIPAA, health data, AI in healthcare. We handle the complexity so you can focus on patients.

If your company processes health data, you likely need a DPO, and you need one who understands the intersection of GDPR special-category requirements, HIPAA, clinical data rules, and the EU AI Act's high-risk classification for healthcare AI.

Key takeaways

  • Health data triggers stricter GDPR requirements including DPIAs and specific legal basis requirements

  • HIPAA compliance does not equal GDPR compliance (and vice versa)

  • AI in healthcare is classified as high-risk under the EU AI Act, adding another compliance layer

  • Your DPO has led privacy programs at Medtronic and AbbVie across EMEA/US/APAC

Your DPO has personally led privacy programs at 100+ organizations, including Medtronic (Global DPO across EMEA/US/APAC) and AbbVie (EU GDPR readiness across 7+ offices). We know what regulators expect and what enterprise healthcare buyers look for.

Why HealthTech privacy is different

HealthTech companies process some of the most sensitive data there is: patient records, health assessments, biometric data, genetic information. That means higher regulatory scrutiny, stricter requirements, and enterprise customers who won't sign until your privacy posture is solid.

Health data is classified as "special category data" under GDPR, which triggers additional protections: explicit consent or another specific legal basis, DPIAs where processing is likely to result in high risk (which is common with health data at scale), and a more serious risk analysis under breach notification requirements. In the US, HIPAA adds another layer entirely with its own rules for covered entities and business associates.

The intersection of these frameworks is where most HealthTech companies get stuck. Having HIPAA compliance does not mean you're GDPR compliant, and vice versa.

What we handle for HealthTech

  • DPO appointment and notification to the supervisory authority

  • Health data DPIAs (commonly required when you process health data at scale or introduce high-risk processing)

  • HIPAA compliance for US health data

  • GDPR special category data compliance

  • Clinical trial data protection

  • Health data consent frameworks

  • Vendor risk management for health data processors

  • Enterprise deal support for hospital systems, insurers, and healthcare networks

  • AI compliance for AI-powered diagnostics, triage, and health monitoring

  • Cross-border health data transfers between US and EU

Common HealthTech compliance scenarios

Telehealth platforms processing patient consultation data across EU and US need both GDPR and HIPAA compliance, plus international data transfer mechanisms.

Digital therapeutics companies using AI for treatment recommendations face high-risk AI classification under the EU AI Act, alongside GDPR DPIA requirements.

Health monitoring wearables collecting biometric data at scale can trigger the mandatory DPO requirement under GDPR, depending on the nature and purpose of the data processing.

Clinical trial platforms handling sensitive patient data across multiple countries need multi-jurisdictional compliance with country-specific clinical data requirements.

Regulations

GDPR (health data as special category), UK GDPR, HIPAA, CCPA/CPRA (including health data provisions), EU AI Act (high-risk AI in healthcare), and sector-specific health data regulations. We cover 30+ jurisdictions with local counsel support where required.

FAQ

Is a DPO required for HealthTech companies? In most cases, yes. If your core activities involve large-scale processing of health data (a special category under GDPR), you are legally required to appoint a DPO. Even outside of a legal requirement, healthcare customers and regulators will expect one.

Do you handle both GDPR and HIPAA? Yes. Many HealthTech companies need both, especially if they serve US healthcare organizations and EU patients. We cover both from a single retainer. Note that HIPAA and GDPR have different scopes and requirements. Having HIPAA compliance does not mean you're GDPR compliant, and vice versa.

Can you support clinical trial data protection? Yes. We have direct experience with clinical trials data through our work at Medtronic and AbbVie, covering both EU and UK regulatory requirements.

Does the EU AI Act affect HealthTech? Often, yes. AI used in healthcare diagnostics, triage, and health monitoring is classified as high-risk under the EU AI Act, which means additional obligations around documentation, risk management, transparency, and human oversight. We handle this alongside your GDPR compliance. See our AI Compliance page.

Does HIPAA compliance make us GDPR compliant? No. They have different scopes, different requirements, and different enforcement mechanisms. HIPAA covers protected health information (PHI) for covered entities and business associates in the US. GDPR covers all personal data of EU residents regardless of sector. You need both if you operate in both jurisdictions.

This page is general information, not legal advice. Exact obligations depend on your specific situation and jurisdictions.

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