Healthcare Compliance
HIPAA vs GDPR for Health-Tech: A Practical Side-by-Side
Published July 10, 2026 · Influrion Editorial Team
If your product handles health data for patients in the US and in the EU or UK, you don't get to pick one rulebook. HIPAA and GDPR apply in parallel, and a system built only to one bar is not automatically compliant with the other. The good news: they share a lot of the same security hygiene, so building for both is mostly additive.
What they share
Both frameworks expect the same technical foundations, so most of the engineering work counts toward both:
- Encryption in transit and at rest.
- Access control — least privilege and role-based access.
- Audit logging — a record of who accessed what, and when.
- Data minimisation — collect and retain only what you need.
- Breach notification — a defined process for when something goes wrong.
Build these well once, and you've covered the common core of both regimes.
What's unique to HIPAA
HIPAA is US-specific and scoped to protected health information (PHI) held by covered entities and their business associates. Its distinctive pieces:
- The Security Rule's required administrative, physical, and technical safeguards.
- Business Associate Agreements (BAAs) — contracts that push obligations down to every vendor and subprocessor that touches PHI.
- A focus on the healthcare relationship specifically, rather than personal data in general.
What's unique to GDPR
GDPR is EU/UK and applies to all personal data, not just health (though health data is a special category with extra protection). Its distinctive pieces:
- A lawful basis required for every processing activity.
- Data-subject rights — access, rectification, erasure, portability — that you must be able to actually operationalise, not just promise.
- A Data Protection Officer in many cases, and a strict 72-hour breach-reporting window to authorities.
HIPAA vs GDPR at a glance
| HIPAA | GDPR | |
|---|---|---|
| Region | United States | EU / UK |
| Scope | PHI (health data) | All personal data |
| Key contract | Business Associate Agreement | Data Processing Agreement |
| Individual rights | Access to records | Access, erasure, portability, more |
| Breach clock | Without unreasonable delay (≤60 days) | 72 hours to the authority |
How to build for both
- Treat the shared core (encryption, access control, audit, minimisation) as non-negotiable baseline architecture.
- Design data-subject rights as features — a real "export my data" and "delete my data" flow — because GDPR requires them to work, not just exist.
- Get your contracts right: a BAA with every PHI subprocessor, a DPA with every personal-data processor.
- Know where your data lives; data-residency expectations differ, and architecture should make residency a choice, not an accident.
A note on what "compliant" means
Neither HIPAA nor GDPR is a certificate you buy. Both describe a system of safeguards, processes, and contracts you have to demonstrate. Any vendor who says a product is "HIPAA-compliant" or "GDPR-ready" without being able to speak to encryption, access control, audit logging, breach process, and subprocessor coverage is describing marketing copy, not architecture.
How we approach it
We treat compliance as an engineering approach — the safeguards we implement — not a badge we claim. For health-tech products that span both regimes, we build the shared core once, make data-subject rights real, and design data residency in from the start. If you're building something that has to satisfy both HIPAA and GDPR, talk to us and we'll help you scope the architecture.
