Data Protection Impact Assessment (DPIA)

Conducted in accordance with GDPR Art. 35 / WP248 (rev.01) — Edition: 2026-05-26

1. Necessity and scope of the assessment

This DPIA is published by Project Line, the data processor of Intelligent Clinic Management Platform. Per Art. 35(3)(b) GDPR, processing of special-category health data on a large scale meets the mandatory-DPIA threshold. EDPB list of mandatory-DPIA operations (WP248 rev.01, criteria 1, 4 and 7) is fulfilled: special-category data + automated decisions informing services + innovative-technology (AI voice agent).

2. Description of processing

Item	Description
Nature	Hosting of clinic + patient health records, AI voice receptionist (real-time; calls not recorded), AI visit-scribe transcription, automated SMS/WhatsApp reminders.
Scope	Patients of clinics that license the Service. Volume scales with clinic count.
Context	B2B SaaS; clinic = controller, Project Line = processor.
Purposes	Appointment scheduling, electronic health records, billing, reminders, AI clinical-decision-support (non-binding).
Data categories	Name, contact, date of birth, identity document numbers, medical history, prescriptions, payment metadata (tokenised — no PAN).
Data subjects	Patients (including minors, whose data is processed only with verified parent / legal-guardian consent), clinic staff, clinic owners.
Retention	Active duration of the licence + 30 days grace + minimum statutory retention (7-30y depending on country).

3. Lawful basis

Art. 6(1)(b) — performance of the controller-processor contract.
Art. 9(2)(h) — processing necessary for medical diagnosis and care.
Art. 9(2)(a) — explicit consent for AI voice processing, captured per-patient.

4. Necessity and proportionality

Each processing operation is mapped to a specific clinical or administrative purpose. Data minimisation: only fields required for that purpose are collected. Pseudonymisation in audit logs. Granular access controls at the per-clinic boundary; cross-clinic data access is technically impossible.

5. Risks to data subjects

Risk	Likelihood	Severity	Mitigation
Unauthorised access to medical data	Low	High	Per-tenant SQL isolation, TLS 1.2+, AES-256 at rest, optional MFA (TOTP) available for clinical roles, PIN lockout, audit log with hash chain, outbound budget guard.
AI hallucination influencing clinical decision	Medium	High	Voice agent prompts present suggestions as documentation only; the treating clinician retains all clinical authority. Disclaimers in agreement.
Undisclosed AI interaction	Low	High	Mandatory AI-disclosure announcement in the patient's language at call start (EU AI Act Art. 50); per-patient AI-processing consent captured + versioned. Calls are not recorded.
Sub-processor incident	Low	Medium	Core sub-processors: Azure / OpenAI / Twilio / Meta. Optional payment + invoicing (clinic opt-in): Stripe / PayPal / Cardcom / Tranzila / PayPlus / Meshulam / GreenInvoice / iCount. Optional OAuth (clinic opt-in): Google / Microsoft. Each has binding DPA. 30-day notice on changes.
Cross-border transfer	Low	Medium	EU SCCs (EU GDPR) / UK IDTA or UK Addendum B1.0 + TRA (UK GDPR) for transfers; Azure Israel Central region by default.
Lengthy retention	Low	Medium	Termination workflow hard-deletes data after 30-day grace; statutory retention windows enforced.
Processing of minors' data	Low	High	Patients under 18 are flagged; consent is blocked server-side unless a parent / legal guardian signs (guardian name + relationship recorded, encrypted). Minors' data receives the same per-tenant isolation, AES-256 encryption and AI-disclosure as all patient data.

6. Consultation

Each clinic, as controller, is invited to review and add jurisdiction-specific risks before processing. Feedback channel: support@projectlineil.com.

7. Residual risk and conclusion

After application of the mitigations the residual risk is assessed as LOW. Consultation with the supervisory authority under Art. 36(1) is not required at present, but Project Line will reconsult should a future processing operation materially increase risk.

8. Review schedule

This DPIA is reviewed annually and whenever a sub-processor changes, a new data category is added, or applicable supervisory-authority guidance is updated.