DPIA template for radiotherapy centres

Article 35(3) GDPR makes a DPIA mandatory when a controller processes personal data on a large scale, particularly when special-category data (health) is involved. A radiotherapy planning environment squarely falls in this category: it processes patient identity, diagnoses, doses, and imaging at volumes well above the thresholds set by national authorities.

The DPIA must demonstrate that risks have been identified, scored, and mitigated, that the processing is proportionate to its purpose, and that data subjects' rights are protected. It is also one of the first documents a supervisory authority (the Garante in Italy, ANSPDCP in Romania) asks for during an inspection.

• Description of the processing operations carried out by Veridose, broken down per module (DICOM import, constraint evaluation, report generation, audit log).
• Categories of data subjects (patients, physicists, radiation oncologists, RTTs, administrators).
• Categories of personal data (identity, contact, health/imaging, professional credentials, audit-log metadata).
• Sources of data (TPS DICOM-RT exports, the hospital's existing IAM directory).
• Lawful basis under Article 6 and exception under Article 9 GDPR for each processing purpose.
• Recipients of data and any cross-border transfers (none by default — Veridose is on-premise).
• Retention schedules, aligned with NSR-12 and Ord. 94/2004 for Romanian centres and equivalent national rules elsewhere.
• Technical and organisational measures (TLS in transit, AES-256-GCM at rest, Argon2id hashing, hash-chained audit log, role-based access, backup and DR procedures).
• Risk register: identification, likelihood × severity scoring, mitigations, residual risk.
• Consultation log with the centre's DPO, IT, and clinical leadership.
• Sign-off block for the DPO and the data controller.

• Bilingual document (English + Italian for Italian centres; English + Romanian for Romanian centres).
• Microsoft Word (.docx) for editing; PDF for archival.
• Pre-populated with Veridose's data flows. Your DPO customises the parts that are centre-specific (governance, on-call processes, local retention rules).
• Reviewed annually by Veridose and shipped with every minor release that materially changes the processing.

• Romanian regulatory mapping: NSR-12 sections on documentation and traceability; Ord. 94/2004 on radiotherapy QA records.
• Italian regulatory mapping: AGENAS clinical-risk management guidelines; Linee guida AgID on digital records.
• MDR readiness: traceability matrix that links DPIA controls to Annex I requirements, ready for a future technical-documentation submission.
• Reference standards: ISO/IEC 27001 (information security), ISO 14971 (medical-device risk management) — alignment notes included.

Email privacy@veridose.it with the name of your centre, the country, and the role of the person requesting (DPO, IT lead, medical physicist). We will get back to you.

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