One page for your DPO's questions.
Every document a clinical-software buyer asks us for — in one place, with a clear path to request the artefact.
Compliance artefacts you can request
Data Processing Agreement (DPA)
Our standard DPA tailored for EU and US clinic deployments. Includes SCCs where transfers apply.
Sub-processor list
Every third party that processes Faurenis data — region, data scope, contractual basis. 30 days notice on changes.
Penetration test summary
Latest annual independent pen-test. Critical findings remediated and re-tested before release.
Compliance matrix
| Framework | What it means | Faurenis | Status | Owner |
|---|---|---|---|---|
| GDPR (EU) | EU framework covering personal-data processing — lawful basis, minimisation, transfers, rights. | EU residency by default for EU tenants. DPA on request. Data-subject access export at any time. Sub-processor list published with 30 days notice on changes. | Implemented | Security & Compliance |
| HIPAA-style controls (US) | US framework for protected health information — administrative, physical, and technical safeguards. | Encryption at rest and in transit. Role-based access controls. Audit logging with 7-year retention. BAAs signed with US clinics. HIPAA does not certify products; we sign the agreements that align Faurenis with the safeguard requirements. | Implemented | Security & Compliance |
| EU AI Act | EU framework treating AI in medical contexts as high-risk — requires QMS, transparency, oversight, accuracy logging. | Designed for the Act's high-risk obligations: badged AI outputs, validation queue, accuracy logging, audit trail. Faurenis will not claim "compliant" until the certification pathway is fully formed. | Readiness pathway | Security & Compliance |
| MDR (EU) | EU medical device regulation — applies if software is classified as a medical device. | Faurenis provides AI-assisted documentation and workflow support; no AI output becomes part of the official record without clinician acceptance. Its MDR status is not self-declared: intended use and classification remain subject to qualified legal and regulatory review. | Requires legal validation | Security & Compliance |
| SOC 2 Type II | US audit framework covering security, availability, processing integrity, confidentiality, and privacy. | Type I report available on request. Type II in progress — audit window open, report expected within the year. | In progress | Security & Compliance |
| ISO/IEC 27001 | International information-security management standard. | On the readiness pathway. Gap analysis complete; certification audit scheduled. | Readiness pathway | Security & Compliance |
| NIS2 (EU) | EU directive on network and information security for essential and important entities. | NIS2 applicability to dental clinics varies by member state. Faurenis publishes the controls clinics can rely on to demonstrate their own NIS2 posture; clinic-side classification requires legal advice. | Requires legal validation | Security & Compliance |
| Croatian Personal Data Protection | National implementation of GDPR with Croatian-specific procedural requirements. | Faurenis supports Croatian-language consent forms, EU residency by default, and the procedural workflow Croatian DPOs typically require. | Implemented | Security & Compliance |
| Audit log retention | Long-tail retention for clinical and access audit events to satisfy regulatory minimums. | Audit logs retained for 7 years. Append-only storage. Per-record integrity hashes. Exportable as JSON for SOC 2 evidence. | Implemented | Engineering |
| Penetration testing | Independent security testing to identify exploitable vulnerabilities. | Annual independent penetration test. Summary report available under NDA from the Trust Centre. Critical findings are remediated and re-tested before the next release. | Implemented | Security & Compliance |
| UAE Data Protection (PDPL / DHA / DOH / MOHAP) | UAE federal Personal Data Protection Law (Federal Decree-Law No. 45 of 2021), plus emirate-level healthcare-data rules from the Dubai Health Authority, the Department of Health – Abu Dhabi, and the Ministry of Health and Prevention, and separate DIFC/ADGM free-zone data protection regimes. | Not yet supported. Faurenis is EU-hosted today, no UAE region is provisioned, and UAE-qualified legal counsel has not yet been engaged. UAE health-data residency requirements are unconfirmed. No UAE deployment or compliance claim is made until that engagement and review conclude. | Planned | Security & Compliance |
GDPR (EU)
Implemented- What it means
- EU framework covering personal-data processing — lawful basis, minimisation, transfers, rights.
- Faurenis
- EU residency by default for EU tenants. DPA on request. Data-subject access export at any time. Sub-processor list published with 30 days notice on changes.
- Owner
- Security & Compliance
HIPAA-style controls (US)
Implemented- What it means
- US framework for protected health information — administrative, physical, and technical safeguards.
- Faurenis
- Encryption at rest and in transit. Role-based access controls. Audit logging with 7-year retention. BAAs signed with US clinics. HIPAA does not certify products; we sign the agreements that align Faurenis with the safeguard requirements.
- Owner
- Security & Compliance
EU AI Act
Readiness pathway- What it means
- EU framework treating AI in medical contexts as high-risk — requires QMS, transparency, oversight, accuracy logging.
- Faurenis
- Designed for the Act's high-risk obligations: badged AI outputs, validation queue, accuracy logging, audit trail. Faurenis will not claim "compliant" until the certification pathway is fully formed.
- Owner
- Security & Compliance
MDR (EU)
Requires legal validation- What it means
- EU medical device regulation — applies if software is classified as a medical device.
- Faurenis
- Faurenis provides AI-assisted documentation and workflow support; no AI output becomes part of the official record without clinician acceptance. Its MDR status is not self-declared: intended use and classification remain subject to qualified legal and regulatory review.
- Owner
- Security & Compliance
SOC 2 Type II
In progress- What it means
- US audit framework covering security, availability, processing integrity, confidentiality, and privacy.
- Faurenis
- Type I report available on request. Type II in progress — audit window open, report expected within the year.
- Owner
- Security & Compliance
ISO/IEC 27001
Readiness pathway- What it means
- International information-security management standard.
- Faurenis
- On the readiness pathway. Gap analysis complete; certification audit scheduled.
- Owner
- Security & Compliance
NIS2 (EU)
Requires legal validation- What it means
- EU directive on network and information security for essential and important entities.
- Faurenis
- NIS2 applicability to dental clinics varies by member state. Faurenis publishes the controls clinics can rely on to demonstrate their own NIS2 posture; clinic-side classification requires legal advice.
- Owner
- Security & Compliance
Croatian Personal Data Protection
Implemented- What it means
- National implementation of GDPR with Croatian-specific procedural requirements.
- Faurenis
- Faurenis supports Croatian-language consent forms, EU residency by default, and the procedural workflow Croatian DPOs typically require.
- Owner
- Security & Compliance
Audit log retention
Implemented- What it means
- Long-tail retention for clinical and access audit events to satisfy regulatory minimums.
- Faurenis
- Audit logs retained for 7 years. Append-only storage. Per-record integrity hashes. Exportable as JSON for SOC 2 evidence.
- Owner
- Engineering
Penetration testing
Implemented- What it means
- Independent security testing to identify exploitable vulnerabilities.
- Faurenis
- Annual independent penetration test. Summary report available under NDA from the Trust Centre. Critical findings are remediated and re-tested before the next release.
- Owner
- Security & Compliance
UAE Data Protection (PDPL / DHA / DOH / MOHAP)
Planned- What it means
- UAE federal Personal Data Protection Law (Federal Decree-Law No. 45 of 2021), plus emirate-level healthcare-data rules from the Dubai Health Authority, the Department of Health – Abu Dhabi, and the Ministry of Health and Prevention, and separate DIFC/ADGM free-zone data protection regimes.
- Faurenis
- Not yet supported. Faurenis is EU-hosted today, no UAE region is provisioned, and UAE-qualified legal counsel has not yet been engaged. UAE health-data residency requirements are unconfirmed. No UAE deployment or compliance claim is made until that engagement and review conclude.
- Owner
- Security & Compliance
Faurenis is designed to support these frameworks through configurable controls, audit-ready workflows, and human-in-the-loop AI design. Certification pathways and market-specific claims require legal and regulatory validation before being relied upon. This matrix is not legal advice.
How we publish changes
Sub-processor changes get 30 days notice on the Trust Centre and via email to your admin contact. Material changes to data handling are notified 60 days in advance with an annotated changelog.
Operational changes that do not affect your data handling (engine updates, performance improvements) are notified in the monthly product update.
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