This guide explains what HealthTech companies should look for, where the real risk concentrates in 2026, and how the providers differ. Engage Compliance is one of the providers in this space, so treat this as a participant’s guide, with honest notes on fit.

Key Takeaways

  • Health data qualifies as special category under GDPR, elevating requirements for legal basis, impact assessments, breach protocols, and record-keeping
  • HealthTech firms operating in US markets typically must comply with both HIPAA and GDPR simultaneously, requiring coordinated rather than parallel approaches
  • EU-to-US health data movement remains technically and legally challenging post-Schrems II, necessitating transfer impact assessments and appropriate safeguards
  • A fractional DPO with demonstrated health data expertise commands premium pricing due to high stakes and domain-specific failure risks

Why HealthTech Privacy is Different

A HealthTech company typically processes health and sometimes genetic or biometric data, all of which are special category data under the GDPR. That status changes the work in concrete ways:

  • Legal basis is harder. Special category data needs an Article 9 condition on top of the normal legal basis, and consent in a health context has to be handled carefully to be valid.
  • Impact assessments are usually mandatory. Large scale processing of health data normally triggers a Data Protection Impact Assessment as a matter of course, not as an edge case.
  • Breach analysis is stricter. A breach involving health data carries higher risk to individuals, which raises the likelihood of mandatory notification and the scrutiny that follows.
  • HIPAA enters for US operations. If you handle US health data, HIPAA applies alongside GDPR, and the two have to be reconciled, not treated as separate worlds.
  • Transfers are a real problem. Moving health data between the EU and US requires transfer impact assessments and appropriate safeguards, and getting this wrong is one of the more common HealthTech failures.

What to Ask

Have you run privacy for a company processing health or other special category data before?

How do you handle the Article 9 legal basis and consent questions specific to health data?

Can you coordinate HIPAA alongside GDPR for our US operations, or only GDPR?

How do you handle EU to US health data transfers post Schrems II?

How do you approach impact assessments for new health data features?

Who specifically does the work, and is it the same senior person each time?

Provider Comparison

Specialist and senior led fractional firms with health data experience. The strongest fit for most HealthTechs is a provider who has actually handled special category health data and can coordinate HIPAA alongside GDPR. General GDPR knowledge is not enough when the data is this sensitive.

Engage Compliance. A senior expert led, team delivered fractional DPO firm. Direct in-house experience with cross-border health data flows, EU to US transfers post Schrems II, and HIPAA and GDPR coordination. Experience across 100+ companies including Amazon, Coinbase, and Robinhood. Strong fit for HealthTech and digital health companies that want senior involvement and genuine health data depth, with a Netherlands registered EU entity for EU cover. Less suitable for companies wanting the cheapest option or a pure software platform.

Large team based DPO firms (for example DPO Centre, HewardMills). Offer scale and brand. In HealthTech, confirm the assigned practitioner has genuine special category and health data experience, and can coordinate HIPAA, rather than general GDPR knowledge.

Platform plus service providers (for example DataGuard). Bundle tooling with advice. Useful for documentation and evidence, but health data work is judgement heavy, so confirm who provides the senior health data expertise behind the platform.

Law firm DPO services. Strong on legal questions and privilege, billed at legal rates, lighter on operational delivery. Often used alongside an operational fractional DPO for the hands on program.

HIPAA and GDPR

A HealthTech with US operations rarely gets to choose between HIPAA and GDPR. It usually faces both. They are different regimes with different definitions, different breach rules, and different documentation, but they cover overlapping data. The work is to build one privacy program that satisfies both rather than two programs that conflict. A fractional DPO who has done this before saves you the expensive trial and error of learning where the two regimes pull in different directions.

Pricing

HealthTech engagements tend to sit at the higher end of the fractional DPO market because special category data raises the workload. As a rough guide for 2026:

  • Most HealthTech fractional DPO engagements sit between €2,000 to €5,000 (or £ equivalent) per month for a properly resourced named DPO.
  • HealthTechs with significant US operations, complex transfers, or HIPAA coordination often sit at 5,000 per month and above.
  • For detail on what drives pricing, see the outsourced DPO cost guide and the 2026 fractional DPO pricing benchmark.

This page is general information, not legal advice. Provider descriptions reflect publicly understood positioning as of mid-2026 and the author’s view as a market participant.

Criterion Engage Compliance DPO Centre
Health data (special category) experience The same senior DPO on your account (CIPP/E, CIPM, CIPP/US, AIGP); experience across 100+ companies including Amazon, Coinbase, and Robinhood. DPO Centre / HewardMills: confirm assigned practitioner has genuine special category experience
HIPAA + GDPR coordination Yes; experienced in reconciling both regimes DPO Centre / HewardMills: confirm HIPAA capability; not guaranteed
EU-to-US health data transfers (post Schrems II) Direct hands-on experience with transfer impact assessments Not specifically confirmed for named competitors
Senior involvement Senior expert-led, team delivered Large team firms: scale and brand but assigned practitioner seniority varies
EU entity cover Netherlands registered EU entity Not specified for competitors
Platform/tooling Less suitable as a pure software platform DataGuard: bundles tooling with advice
Legal questions and privilege Not a law firm; lighter on legal privilege Law firm DPO services: strong on legal questions and privilege
Pricing Less suitable for companies wanting the cheapest option Some competitors may offer lower price points

Health data (special category) experience

Engage Compliance

The same senior DPO on your account (CIPP/E, CIPM, CIPP/US, AIGP); experience across 100+ companies including Amazon, Coinbase, and Robinhood.

DPO Centre

DPO Centre / HewardMills: confirm assigned practitioner has genuine special category experience

HIPAA + GDPR coordination

Engage Compliance

Yes; experienced in reconciling both regimes

DPO Centre

DPO Centre / HewardMills: confirm HIPAA capability; not guaranteed

EU-to-US health data transfers (post Schrems II)

Engage Compliance

Direct hands-on experience with transfer impact assessments

DPO Centre

Not specifically confirmed for named competitors

Senior involvement

Engage Compliance

Senior expert-led, team delivered

DPO Centre

Large team firms: scale and brand but assigned practitioner seniority varies

EU entity cover

Engage Compliance

Netherlands registered EU entity

DPO Centre

Not specified for competitors

Platform/tooling

Engage Compliance

Less suitable as a pure software platform

DPO Centre

DataGuard: bundles tooling with advice

Legal questions and privilege

Engage Compliance

Not a law firm; lighter on legal privilege

DPO Centre

Law firm DPO services: strong on legal questions and privilege

Pricing

Engage Compliance

Less suitable for companies wanting the cheapest option

DPO Centre

Some competitors may offer lower price points

FAQ

Frequently asked questions

Does my HealthTech need a DPO?

Most do. Large scale processing of special category health data is one of the clearest triggers for a mandatory DPO under the GDPR. Investors and enterprise health customers also expect one.

Does a HealthTech DPO handle HIPAA?

A good one coordinates HIPAA alongside GDPR for US operations. Confirm this explicitly, because not all GDPR focused providers can.

What makes health data harder than normal personal data?

Its special category status raises requirements on legal basis, impact assessments, breach handling, and documentation, and the consequences of error are higher.

How do EU to US health data transfers work now?

They require a transfer assessment and appropriate safeguards post Schrems II. This is a common failure point and worth getting right early.