Tandem Health

AI medical scribe and coding assistant built to EU medical-device standards

by Tandem Health

Sweden🌐Processed and stored exclusively in European data centres; audio deleted immediately after transcription

TrustKit ScoreRated across 5 compliance dimensions: data residency, legal jurisdiction, data retention, certifications, and regulatory fit.Excellent

About Tandem Health

Tandem Health is a Swedish clinical-documentation company building an AI medical scribe and coding assistant for clinicians. The product listens to consultations and produces structured clinical notes across 50+ specialties, then pushes them into 100+ electronic health record systems via one-click transfer. It is purpose-built for regulated European healthcare rather than retrofitted from a general-purpose transcription tool. The company treats medical-device regulation as a baseline. Its AI scribe is CE marked under EU MDR and UKCA marked, and its coding assistant is certified MDR Class IIa — reportedly the first in Europe in its category to reach that classification. Tandem holds an unusually broad certification stack for the category: ISO 13485:2016 (medical-device QMS), ISO/IEC 27001:2022 (information security), ISO 42001:2023 (AI management), ISO 14001:2015 (environmental), and NEN 7510 (Dutch healthcare information security). It is also NHS DSPT compliant and holds UK Cyber Essentials Plus. On data sovereignty, Tandem is strong: patient data is processed and stored exclusively in European data centres, audio is processed in real time and deleted immediately after transcription (no audio storage), and the company states it does not train AI models on patient or personal data. As a Swedish entity (Tandem Health AB) with no US parent, it sits cleanly within EU/EEA jurisdiction. In January 2026 it acquired Dutch speech-recognition firm Juvoly, deepening its EU healthcare footprint. Tandem raised a $50M Series A in mid-2025 led by Kinnevik, with Northzone, Amino Collective and Visionaries Club participating, and employs roughly 170 people. Pricing is transparent: a free tier with unlimited note generation, a Pro plan at €125 per user/month (billed yearly), and custom Enterprise pricing. For EU and UK clinicians who need a documentation tool that is itself a regulated medical device with EU-only data handling, Tandem is a leading sovereignty-conscious choice.

TrustKit Score Breakdown

?100% Excellent

Data Residency

Where is your data stored and processed?

Patient data is processed and stored exclusively in European data centres, and audio is deleted immediately after transcription with no storage — an explicit EU-only posture.

5/5

Legal Jurisdiction

Which laws govern the company and your data?

Incorporated as Tandem Health AB in Sweden with no US parent, placing it fully within EU/EEA jurisdiction.

5/5

Data Retention & Training

Is your data used for model training?

States it does not train AI models on patient or personal data, deletes audio immediately after transcription, offers enterprise data agreements, and operates under an ISO 13485 medical-device QMS.

5/5

Certifications

ISO 27001, SOC 2, Cyber Essentials, etc.

Exceptional stack: ISO 27001:2022, ISO 13485:2016, ISO 42001:2023, ISO 14001, NEN 7510, plus CE/MDR Class IIa and UKCA medical-device marks, NHS DSPT and Cyber Essentials Plus. No SOC 2 published, but sector-specific medical-device certification more than compensates.

5/5

Regulatory Fit

Suitability for regulated industries and professional services

Purpose-built and CE/MDR-certified as a medical device for EU and UK clinical use, with named applicability to healthcare regulators (EMA, MHRA) and NHS frameworks.

5/5

Pricing

FreemiumFree tierFree trial

FreeFreeUnlimited note generation · Limited features · No signup cost

ProContact Sales(€125/user/mo annual)Unlimited note and document generation · 1-click transfer to 100+ EHR systems · 50+ specialties

EnterpriseContact SalesTailored per-user pricing · Custom integrations · Dedicated support · …

Full pricing details →

Quick Facts

Starting PriceFree tier; Pro €125/user/mo (billed yearly)Data HostingProcessed and stored exclusively in European data centres; audio deleted immediately after transcriptionTrains on Your DataDoes not train AI models on patient or personal dataFounded2023Employees51-200

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Frequently Asked Questions

Is Tandem Health GDPR compliant?

Tandem Health has a TrustKit compliance score of 100% (Excellent). Data Residency: Patient data is processed and stored exclusively in European data centres, and audio is deleted immediately after transcription with no storage — an explicit EU-only posture.. Legal Jurisdiction: Incorporated as Tandem Health AB in Sweden with no US parent, placing it fully within EU/EEA jurisdiction..

Where does Tandem Health store data?

Tandem Health hosts data in: Processed and stored exclusively in European data centres; audio deleted immediately after transcription. Patient data is processed and stored exclusively in European data centres, and audio is deleted immediately after transcription with no storage — an explicit EU-only posture.

Does Tandem Health train on user data?

Tandem Health: Does not train AI models on patient or personal data. States it does not train AI models on patient or personal data, deletes audio immediately after transcription, offers enterprise data agreements, and operates under an ISO 13485 medical-device QMS.

What certifications does Tandem Health hold?

Tandem Health holds: CE mark (EU MDR), MDR Class IIa, UKCA, ISO 13485:2016, ISO/IEC 27001:2022, ISO 42001:2023, ISO 14001:2015, NEN 7510, NHS DSPT, Cyber Essentials Plus, GDPR. Exceptional stack: ISO 27001:2022, ISO 13485:2016, ISO 42001:2023, ISO 14001, NEN 7510, plus CE/MDR Class IIa and UKCA medical-device marks, NHS DSPT and Cyber Essentials Plus. No SOC 2 published, but sector-specific medical-device certification more than compensates.