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

AI Scribe, Coding Assistant & Clinical Decision Support

3022

CE Marked

Under EU Medical Device Regulations

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

NHS Compliant

Meets NHS data and security requirements

UK Cyber Essentials Plus

Independently verified protection against common cyber attacks

All data within the EU

MDR Class IIa certified

AI Scribe, Coding Assistant & Clinical Decision Support

3022

CE Marked

Under EU Medical Device Regulations

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

NHS Compliant

Meets NHS data and security requirements

UK Cyber Essentials Plus

Independently verified protection against common cyber attacks

All data within the EU

MDR Class IIa certified

AI Scribe, Coding Assistant & Clinical Decision Support

3022

CE Marked

Under EU Medical Device Regulations

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

NHS Compliant

Meets NHS data and security requirements

UK Cyber Essentials Plus

Independently verified protection against common cyber attacks

All data within the EU

Compliance built for European healthcare

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

A doctor smiling with a patient, with a shield badge for MDR Class IIa certification
MDR Class IIa certified

Tandem’s AI Scribe, Coding Assistant, and Clinical Decision Support are 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.

A doctor smiling with a patient, with a shield badge for MDR Class IIa certification
MDR Class IIa certified

Tandem’s AI Scribe, Coding Assistant, and Clinical Decision Support are 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.

A doctor smiling with a patient, with a shield badge for MDR Class IIa certification
MDR Class IIa certified

Tandem’s AI Scribe, Coding Assistant, and Clinical Decision Support are 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 10,000 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?

Absolutely. Tandem meets all relevant data handling standards. You can find a full list of our certifications and our data processing agreements in our Trust Center.

Is Tandem compliant with required data standards?

Absolutely. Tandem meets all relevant data handling standards. You can find a full list of our certifications and our data processing agreements in our Trust Center.

Is Tandem compliant with required data standards?

Absolutely. Tandem meets all relevant data handling standards. You can find a full list of our certifications and our data processing agreements in our Trust Center.

Where is the data stored and processed?

All transcripts and clinical notes are stored on a database located in Europe. We never retain or store any audio recordings from your consultations.

Where is the data stored and processed?

All transcripts and clinical notes are stored on a database located in Europe. We never retain or store any audio recordings from your consultations.

Where is the data stored and processed?

All transcripts and clinical notes are stored on a database located in Europe. We never retain or store any audio recordings from your consultations.

Is Tandem a medical device?

Tandem consists of multiple modules. Tandem's AI Scribe, Coding Assistant and Clinical Decision Support are CE marked as a Class IIa medical device under the European Medical Device Regulation (EU MDR). We hold ourselves to the high standards of safety and reliability you'd expect from a medical device, no matter where we're operating. We're also actively involved in helping shape how healthcare regulations evolve for AI and large language models.

Is Tandem a medical device?

Tandem consists of multiple modules. Tandem's AI Scribe, Coding Assistant and Clinical Decision Support are CE marked as a Class IIa medical device under the European Medical Device Regulation (EU MDR). We hold ourselves to the high standards of safety and reliability you'd expect from a medical device, no matter where we're operating. We're also actively involved in helping shape how healthcare regulations evolve for AI and large language models.

Is Tandem a medical device?

Tandem consists of multiple modules. Tandem's AI Scribe, Coding Assistant and Clinical Decision Support are CE marked as a Class IIa medical device under the European Medical Device Regulation (EU MDR). We hold ourselves to the high standards of safety and reliability you'd expect from a medical device, no matter where we're operating. We're also actively involved in helping shape how healthcare regulations evolve for AI and large language models.

Is my data used for training AI models?

No, we never use your data for training AI models.

Is my data used for training AI models?

No, we never use your data for training AI models.

Is my data used for training AI models?

No, we never use your data for training AI models.

Are audio recordings stored from the consultations?

No, the audio is transcribed in real-time during the consultation and is thereafter permanently deleted.

Are audio recordings stored from the consultations?

No, the audio is transcribed in real-time during the consultation and is thereafter permanently deleted.

Are audio recordings stored from the consultations?

No, the audio is transcribed in real-time during the consultation and is thereafter permanently deleted.

Who is legally responsible for the clinical documentation?

Ultimately, you are responsible for verifying the accuracy of your notes. Like any transcription method—human or AI - errors can sometimes occur. We encourage clinicians to review Tandem’s note draft before finalising it in the medical record system.

Who is legally responsible for the clinical documentation?

Ultimately, you are responsible for verifying the accuracy of your notes. Like any transcription method—human or AI - errors can sometimes occur. We encourage clinicians to review Tandem’s note draft before finalising it in the medical record system.

Who is legally responsible for the clinical documentation?

Ultimately, you are responsible for verifying the accuracy of your notes. Like any transcription method—human or AI - errors can sometimes occur. We encourage clinicians to review Tandem’s note draft before finalising it in the medical record system.

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.