Security
built
for
healthcare

We always ensure your data is handled to the highest security standards, protecting your and your patients' privacy.

Security
built
for
healthcare

We always ensure your data is handled to the highest security standards, protecting your and your patients' privacy.

Security
built
for
healthcare

We always ensure your data is handled to the highest security standards, protecting your and your patients' privacy.

MDR Class IIa certified

Tandem AI Scribe and Coding Assistant

ISO 13485

Quality management system for medical device companies

ISO 27001

Information security is systematically managed

ISO 42001

AI systems are developed and used responsibly

ISO 14001

Environmental impact is actively managed

GDPR

Patient data handled under EU privacy law

3022

CE Marked

Under EU Medical Device Regulations

UKCA

Under UK Medical Device Regulations

NEN 7510

Dutch healthcare information security standard

NHS Compliant

Meets NHS data and security requirements

UK Cyber Essentials Plus

Independently verified protection against common cyber attacks

LVV Class A1

Finnish medical device market approval

ENS Nivel Alto

Spain’s highest national cybersecurity certification

All data within the EU

MDR Class IIa certified

Tandem AI Scribe and Coding Assistant

ISO 13485

Quality management system for medical device companies

ISO 27001

Information security is systematically managed

ISO 42001

AI systems are developed and used responsibly

ISO 14001

Environmental impact is actively managed

GDPR

Patient data handled under EU privacy law

3022

CE Marked

Under EU Medical Device Regulations

UKCA

Under UK Medical Device Regulations

NEN 7510

Dutch healthcare information security standard

NHS Compliant

Meets NHS data and security requirements

UK Cyber Essentials Plus

Independently verified protection against common cyber attacks

LVV Class A1

Finnish medical device market approval

ENS Nivel Alto

Spain’s highest national cybersecurity certification

All data within the EU

MDR Class IIa certified

Tandem AI Scribe and Coding Assistant

ISO 13485

Quality management system for medical device companies

ISO 27001

Information security is systematically managed

ISO 42001

AI systems are developed and used responsibly

ISO 14001

Environmental impact is actively managed

GDPR

Patient data handled under EU privacy law

3022

CE Marked

Under EU Medical Device Regulations

UKCA

Under UK Medical Device Regulations

NEN 7510

Dutch healthcare information security standard

NHS Compliant

Meets NHS data and security requirements

UK Cyber Essentials Plus

Independently verified protection against common cyber attacks

LVV Class A1

Finnish medical device market approval

ENS Nivel Alto

Spain’s highest national cybersecurity certification

Compliance built for European healthcare

Designed to meet European healthcare regulations, with certified systems and ongoing oversight.

MDR Class IIa certified

Tandem's AI Scribe and Coding Assistant are both independently assessed and certified under EU MDR as Class IIa medical devices.

Meets national healthcare requirements

Tandem complies with NHS data security standards, including the Data Security and Protection Toolkit, and equivalent European requirements.

Continuously reviewed and improved

Our compliance and quality systems are actively maintained and strengthened to meet evolving regulatory expectations.

Certified and audited to the highest standards

Tandem is certified to ISO 27001 and ISO 13485, and fully compliant with GDPR and local patient data protection laws.

Compliance built for European healthcare

Designed to meet European healthcare regulations, with certified systems and ongoing oversight.

MDR Class IIa certified

Tandem's AI Scribe and Coding Assistant are both independently assessed and certified under EU MDR as Class IIa medical devices.

Meets national healthcare requirements

Tandem complies with NHS data security standards, including the Data Security and Protection Toolkit, and equivalent European requirements.

Continuously reviewed and improved

Our compliance and quality systems are actively maintained and strengthened to meet evolving regulatory expectations.

Certified and audited to the highest standards

Tandem is certified to ISO 27001 and ISO 13485, and fully compliant with GDPR and local patient data protection laws.

Compliance built for European healthcare

Designed to meet European healthcare regulations, with certified systems and ongoing oversight.

MDR Class IIa certified

Tandem's AI Scribe and Coding Assistant are both independently assessed and certified under EU MDR as Class IIa medical devices.

Meets national healthcare requirements

Tandem complies with NHS data security standards, including the Data Security and Protection Toolkit, and equivalent European requirements.

Continuously reviewed and improved

Our compliance and quality systems are actively maintained and strengthened to meet evolving regulatory expectations.

Certified and audited to the highest standards

Tandem is certified to ISO 27001 and ISO 13485, and fully compliant with GDPR and local patient data protection laws.

“Innovation in healthcare only works when it is designed with patient safety, clinical responsibility, and regulatory rigor at its core.”

Dr Yan Peng Zhao

MDR Compliance Lead

“Innovation in healthcare only works when it is designed with patient safety, clinical responsibility, and regulatory rigor at its core.”

Dr Yan Peng Zhao

MDR Compliance Lead

“Innovation in healthcare only works when it is designed with patient safety, clinical responsibility, and regulatory rigor at its core.”

Dr Yan Peng Zhao

MDR Compliance Lead

Data security, by design

Patient data stays private, protected, and fully under your control by default.

All patient data stays in Europe

Patient data is processed and stored exclusively in European data centres, under strict, enterprise-grade security agreements.

No audio recordings are stored

Audio is processed in real time during the consultation and deleted immediately after transcription.

Your data is never used to train AI

Tandem does not train AI models on patient or personal data, so your information always remains private and under your control.

Data security, by design

Patient data stays private, protected, and fully under your control by default.

All patient data stays in Europe

Patient data is processed and stored exclusively in European data centres, under strict, enterprise-grade security agreements.

No audio recordings are stored

Audio is processed in real time during the consultation and deleted immediately after transcription.

Your data is never used to train AI

Tandem does not train AI models on patient or personal data, so your information always remains private and under your control.

“When it comes to patient data, there's zero room for compromise. Tandem is built with security at its core and complies with the highest standards.”

Oliver Åstrand

Chief Technology Officer

“When it comes to patient data, there's zero room for compromise. Tandem is built with security at its core and complies with the highest standards.”

Oliver Åstrand

Chief Technology Officer

“When it comes to patient data, there's zero room for compromise. Tandem is built with security at its core and complies with the highest standards.”

Oliver Åstrand

Chief Technology Officer

Trusted by over 5,000 care organisations across Europe

Built on the highest security standards, ensuring safe and compliant AI-powered documentation for clinicians every day.

FAQ

Frequently asked questions about compliance and data security.

FAQ

Frequently asked questions about compliance and data security.

FAQ

Frequently asked question about our pricing and offering

Is Tandem compliant with required data standards?
Is Tandem compliant with required data standards?
Is Tandem compliant with required data standards?
Where is the data stored and processed?
Where is the data stored and processed?
Where is the data stored and processed?
Is Tandem a medical device?
Is Tandem a medical device?
Is Tandem a medical device?
Is my data used for training AI models?
Is my data used for training AI models?
Is my data used for training AI models?
Are audio recordings stored from the consultations?
Are audio recordings stored from the consultations?
Are audio recordings stored from the consultations?
Who is legally responsible for the clinical documentation?
Who is legally responsible for the clinical documentation?
Who is legally responsible for the clinical documentation?

Want more answers?

Learn more in our Trust Center or contact us directly. You can also reach our external Data Protection Office at dpo@tandemhealth.ai.

Want more answers?

Learn more in our Trust Center or contact us directly. You can also reach our external Data Protection Office at dpo@tandemhealth.ai.

Want more answers?

Learn more in our Trust Center or contact us directly. You can also reach our external Data Protection Office at dpo@tandemhealth.ai.