The essentials in 30 seconds
- A healthcare data leak is the unauthorised exit of patient information outside the scope of the organisation or its hosting provider.
- HDS certification (the French health data hosting certification) attests that a security system exists and is audited; it does not prove that an exfiltration attempt would be blocked.
- An active test with synthetic data, replayed regularly, measures what actually gets out, without touching a single patient record.
A healthcare data leak is the unauthorised exit of medical or administrative information about patients outside the scope of the organisation or its hosting provider. For a hospital, a clinic or an HDS-certified host, the real question is not “do we have controls?” but “do these controls actually stop patient data from getting out?”. Only an active test, run with synthetic data, can answer it with evidence.
Why healthcare data gets out so easily
Diagram · the legitimate flows of a hospital
Healthcare data has two particularities. It is durable (a medical history cannot be “reset” like a password) and it sells well, which makes it a classic target for double extortion ransomware operations. ANSSI and the CERT Santé of the French Digital Health Agency regularly report healthcare organisations among the recurring victims of ransomware.
The finding from the field is simple: organisations have often invested in protection components, but rarely checked that they block anything in real conditions.
The framework: GDPR, the French Public Health Code and HDS certification
What the regulation says
- GDPR, Article 9: data concerning health belongs to the special categories of data, whose processing is prohibited in principle, subject to exceptions.
- GDPR, Article 32: the controller must implement measures appropriate to the risk and a process for regularly testing, assessing and evaluating their effectiveness.
- French Public Health Code, Article L1111-8: any hosting of personal health data on behalf of a third party must be carried out by a certified host (or an approved one for paper-based hosting).
What HDS certification covers
HDS certification is run by the French Digital Health Agency (ANS). It is based on the ISO/IEC 27001 standard, supplemented by healthcare-specific requirements. A new framework was published in 2024, with a transition period for hosts already certified: check with your certification body the exact deadline that applies to your scope. This framework notably strengthens the requirements on data location and transparency towards customers.
The audit looks at processes and a sample of evidence. The exfiltration test looks at the result. The two are complementary, not interchangeable. The logic is close to that of ISO 27001 control 8.12 on data leakage prevention.
Hospital or HDS host: different leakage surfaces
| Context | Typical egress channels to test | Controls often in place |
|---|---|---|
| Healthcare organisation | Outbound email (outside the secure health messaging system), USB sticks and disc burners, printing and scanning to email, personal cloud, web upload, generative AI tools | Email DLP, device blocking, web proxy, antivirus |
| HDS host (infrastructure) | Outbound server flows, DNS, HTTPS to uncontrolled destinations, administration and support access | Firewall, segmentation, bastion, logging |
| HDS host (managed services, SaaS) | Application exports, APIs, object storage sharing, service accounts, backups | IAM, CASB, encryption, cloud-native controls |
| Vendors and remote maintenance | Remote sessions, file transfers from biomedical equipment | Dedicated VPN, contract, access review |
In a hospital, the main risk often comes from the trusted user in a hurry: the junior doctor who emails a report to a personal mailbox to finish it at home, the medical secretary who drops a file on a consumer file-sharing service. These are everyday leaks, without malice, but with the same legal consequences. At a hosting provider, the subject shifts towards the network, privileged accounts and subcontractors.
A concrete scenario: testing without touching a single patient record
Take a medium-sized hospital. The CISO has a DLP on email, a web proxy and a USB blocking policy. Management wants to know whether a patient file can get out.
- Build realistic decoys. Generate synthetic files that look like real data: fictitious names, numbers in the format of the French social security number (NIR) but invalid, template reports, CSV exports of hospital stays. No real data is used. This is the principle of synthetic data in production.
- Choose representative workstations. A shared care workstation, a medical secretary’s workstation, an administrative workstation, an application server.
- Replay the channels one by one. Sending by email to an external address, dropping on a personal cloud, copying to removable media, web upload, typing into a generative AI assistant, network egress through less monitored protocols.
- Record three outcomes per channel. Blocked, allowed but detected (alert to the SOC or the managed service provider), or passed without a trace. The third category is the one that matters.
- Prioritise. Rank the gaps by the volume exposed, the ease of exploitation and the cost of the fix.
Next step
Would a synthetic patient file get out of your organisation?
A 30-minute guided demo, on pre-built result sets: the campaign across the 8 channels covered, the report and its detail, nothing to install. The POC then replays one standard scenario with synthetic data, from a representative machine in your network, through your real egress controls. What actually gets out through your egress paths is what the pilot shows you.
What to check before running a test in a healthcare organisation
- Written approval from management, the CISO and the DPO, with a precise scope.
- The SOC or managed service provider informed, or a deliberate decision to also test detection without their knowledge.
- Explicit exclusion of critical biomedical equipment and workstations in operating theatres.
- Exclusively synthetic data, identifiable as such if discovered.
- Egress destinations controlled by the test team, purged at the end.
- Test windows compatible with care activity.
- Success criteria defined before the test: what must be blocked, what must be detected.
A one-off test is not enough
A hospital information system changes constantly: a new teleconsultation application, a DLP software update, an email migration, a new vendor. A rule that worked in January can be ineffective in June without anyone noticing. That is why regularly replaying attack scenarios is worth more than an annual audit. It produces a posture measured over time, useful for the DPO in front of the CNIL, for the CISO in front of executive management, and for the host in front of its customers and its HDS auditor. For the general method, see our page on data exfiltration testing.
Frequently asked questions
Does HDS certification protect against data leaks?
It imposes an audited security framework, based on ISO/IEC 27001 and healthcare-specific requirements. It does not guarantee that a given exfiltration channel is blocked: only a test demonstrates it.
Does a hospital have to be HDS certified?
The obligation in Article L1111-8 of the French Public Health Code targets hosting on behalf of a third party. An organisation that hosts its own data internally is in principle not concerned, but it must use a certified host if it outsources. Have your situation validated by your DPO.
Can exfiltration be tested without breaching the GDPR?
Yes, provided only synthetic data is used. No patient data is then processed by the test, which removes the risk of a real leak.
What should you do if a real leak is found?
A healthcare data breach must in principle be notified to the CNIL within 72 hours if it presents a risk, and serious security incidents must be reported through the scheme provided for healthcare organisations.

