Privacy and security

Privacy and security

Therapy sessions contain some of the most sensitive data there is. Below you will find what is in place, what is in certification and which documents your CISO and DPO can request straight away.

Data flow

  • Audio

    Audio is converted to text and not stored.

  • Transcript

    The transcript is processed into a draft report.

  • Report

    After your approval the report is stored.

  • Logging

    Access and changes are logged in line with NEN 7513 and retained.

Agreements

  • Data processing agreement available as standard

  • Overview of sub-processors.

  • DPIA input for your own data protection impact assessment.

  • Your data is not used to train models.

  • Processed and stored in the Netherlands.

Information security

We have set up our policies and processes in line with NEN 7510-1:2024 and ISO/IEC 27001:2022. The certification audit has been scheduled. As soon as the certificate is issued, we will publish it here with its scope and validity.

Medical device

Notal Care's clinical modules are going through certification as a medical device under the MDR, class IIa. Expected completion: third quarter of 2027. Until then these modules are not available for clinical use. The core functions for documentation and record building do not fall under the MDR and are available now.

EU AI Act

As a certified medical device, the clinical modules fall under the requirements for high-risk AI systems. We are preparing for this in parallel with the MDR process.

Division of roles

Your organisation is the data controller; Notal Care is the processor. You decide who has access; we provide the evidence you need for NEN 7510, the Dutch Cybersecurity Act (Cyberbeveiligingswet) and your internal audits.

You can read more about the status per standard under certification and regulation.

Document pack

Data processing agreement

Based on Article 28 GDPR.

Request

List of sub-processors

Which parties process data, and where.

Request

Data flow diagram

From audio to approved report.

Request

DPIA input

For your own data protection impact assessment.

Request

Security policy and Statement of Applicability

Set up in line with NEN 7510 and ISO/IEC 27001.

Request

Audit schedule

When each audit takes place.

Request

MDR status statement

Status of the clinical modules, class IIa.

Request

Client information

What happens to the session, for your clients.

Request

Frequently asked questions

Is the session stored?

The audio is not. The transcript is.

Is Notal Care certified to NEN 7510 or ISO 27001?

We work in line with both standards.

Is Notal Care a medical device?

Partly. The core for documentation and record building is not. The clinical modules are being certified as a class IIa medical device; they will become available after CE marking, expected in the third quarter of 2027.

Your CISO and DPO at the table?

Schedule a 30-minute demo. We will answer questions about privacy, security, MDR and EHR.

Schedule a demo