The gap in clinical data exchange.
Dutch healthcare organizations routinely exchange patient data between systems that don't interoperate. HL7/FHIR covers in-system messaging; it doesn't cover the file that needs to travel from radiology to a referring specialist outside the hospital network. That file travels by email, by WeTransfer, by USB. Each of those channels stores a copy. NEN 7510-1 Article 14.1.1 requires confidential transmission; Article 15.1.3 requires a traceable access log. Most ad-hoc channels satisfy neither.
GDPR adds a second layer: a breach on any of those intermediate channels is a reportable incident to the AP. Healthcare organizations carry the highest-per-record breach cost of any sector precisely because the data is both sensitive and legally regulated. The exposure from a single misdirected email with a patient file is a reportable GDPR breach, a NEN 7510 non-conformance, and a reputational event.
End-to-end encryption with a compliant audit trail.
ParaShare encrypts the patient file with ML-KEM-768 + AES-256-GCM before it touches the relay. The relay holds only an opaque ciphertext. The recipient's browser decrypts locally. After pickup, the relay wipes the ciphertext from RAM. A signed receipt (ML-DSA-65, FIPS 204) records which file was delivered, to which recipient, and at which time. That receipt is the NEN 7510 Article 15.1.3 access log.
The relay runs on Hetzner DE. EU jurisdiction, no US CLOUD Act exposure, no data leaving the EEA. A pre-signed GDPR Data Processing Agreement is available on Business and Enterprise plans.
How a secure transfer works.
NEN 7510 and GDPR mapping.
| Requirement | Paramant control |
|---|---|
| NEN 7510-1 Art. 14.1.1 — Encrypted transit | ML-KEM-768 + AES-256-GCM end-to-end; relay cannot decrypt |
| NEN 7510-1 Art. 14.1.4 — Access control | Burn-on-read: one authorised download, then the ciphertext is gone |
| NEN 7510-1 Art. 15.1.3 — Audit trail | ML-DSA-65 signed receipt: file hash, recipient, timestamp, CT log entry |
| NEN 7510-2 Art. 12.3 — Data minimisation | RAM-only relay; no persistent storage of patient data |
| GDPR Art. 32 — Technical measures | FIPS 203/204 encryption, EU/DE hosting, no US CLOUD Act |
| GDPR Art. 28 — Processor agreement | Pre-signed DPA available on Business and Enterprise plans |
See also: full NEN 7510 compliance guide and Data Processing Agreement.