You get a named, senior Data Protection Officer embedded in your healthtech team, ready when healthcare buyers, regulators, or investors start asking about privacy.
What you get:
- A named senior DPO on your account
- GDPR special-category data, HIPAA, and health data rules covered by one team
- DPIAs, data subject requests, and breach response handled to deadline
If your company processes health data, you likely need a Data Protection Officer (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
- Experience across 100+ companies, including prior in-house privacy roles at Medtronic and AbbVie.
- Continuity matters more in healthcare. We handle breach response in-house, with Engage’s named partner-bench model providing backfill coverage when your lead DPO is unavailable, even outside normal hours
Experience across 100+ companies, including prior in-house privacy roles at Medtronic and AbbVie. We know what regulators expect and what enterprise healthcare buyers look for. Note: outsourced DPOs are also referred to as external DPO, virtual DPO, fractional DPO, or DPaaS.
Why is healthtech privacy 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. These include 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 does a healthtech DPO handle?
- 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 and other US state privacy laws (Virginia, Colorado, Texas, and more), EU AI Act (high-risk AI in healthcare), and sector-specific health data regulations. We cover 30+ jurisdictions worldwide, including Canada, Brazil, and China, with local counsel support where required.
These rules apply wherever your company is based. If you offer health products or services to people in the EU or UK, they reach you, even with no European office. Our services are for any company serving EU or UK users, not only European companies.