Tandem Health

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

Tucuvi

Autonomous clinical voice AI agents that call patients and run care workflows

Tandem Health

Excellent

25/25

Tucuvi

Excellent

23/25

Score Breakdown

DimensionTandem HealthTucuvi

Data Residency

Where is your data stored and processed?

Tandem Health: 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.

Tucuvi: EU-incorporated (Spain) and GDPR-compliant, so an EU hosting region is the reasonable expectation for EU customers, but specific data-centre locations and residency commitments are not published publicly — conservatively scored 4 pending confirmation via the Trust Center/DPA.

5/5

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.

4/5

EU-incorporated (Spain) and GDPR-compliant, so an EU hosting region is the reasonable expectation for EU customers, but specific data-centre locations and residency commitments are not published publicly — conservatively scored 4 pending confirmation via the Trust Center/DPA.

Legal Jurisdiction

Which laws govern the company and your data?

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

Tucuvi: Incorporated as Tucuvi Care S.L. in Madrid with no US parent, placing it fully within EU/EEA jurisdiction.

5/5

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

5/5

Incorporated as Tucuvi Care S.L. in Madrid with no US parent, placing it fully within EU/EEA jurisdiction.

Data Retention & Training

Is your data used for model training?

Tandem Health: 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.

Tucuvi: AI agents are trained on a proprietary manually-labelled dataset rather than on live customer data, and the QMS enforces GDPR/HIPAA data protection; however, no explicit public no-training-on-customer-data guarantee or detailed retention/DPA terms are published, so scored 4 rather than 5.

5/5

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.

4/5

AI agents are trained on a proprietary manually-labelled dataset rather than on live customer data, and the QMS enforces GDPR/HIPAA data protection; however, no explicit public no-training-on-customer-data guarantee or detailed retention/DPA terms are published, so scored 4 rather than 5.

Certifications

ISO 27001, SOC 2, Cyber Essentials, etc.

Tandem Health: 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.

Tucuvi: Strong, sector-specific stack: ISO/IEC 27001 and SOC 2 plus CE-marked Class IIb Software as a Medical Device under an ISO 13485 QMS, with EU AI Act and BS 30440 alignment. SOC 2 type (I vs II) not publicly specified.

5/5

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

Strong, sector-specific stack: ISO/IEC 27001 and SOC 2 plus CE-marked Class IIb Software as a Medical Device under an ISO 13485 QMS, with EU AI Act and BS 30440 alignment. SOC 2 type (I vs II) not publicly specified.

Regulatory Fit

Suitability for regulated industries and professional services

Tandem Health: 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.

Tucuvi: Purpose-built for regulated EU healthcare and certified as a Class IIb medical device, suitable for hospitals and health systems under EMA/AEMPS oversight and GDPR.

5/5

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

Purpose-built for regulated EU healthcare and certified as a Class IIb medical device, suitable for hospitals and health systems under EMA/AEMPS oversight and GDPR.

Total Score

25/25

23/25

Best For

Tandem Health

Best for EU-headquartered organisations needing maximum data sovereignty; organisations requiring broad certification coverage (CE mark (EU MDR), MDR Class IIa, UKCA); regulated industries (EMA, MHRA); privacy-conscious teams who need strong data retention controls; teams on a tight budget.

Tucuvi

Best for EU-headquartered organisations needing maximum data sovereignty; organisations requiring broad certification coverage (CE-marked SaMD (Class IIb), ISO 13485, ISO/IEC 27001); regulated industries (AEMPS, EMA); privacy-conscious teams who need strong data retention controls.

Detailed Comparison

Tandem Health vs Tucuvi: Trust & Compliance Comparison

Tandem Health (Tandem Health, SE) scores 25/25 overall with a Gold (Excellent) trust badge. AI medical scribe and coding assistant built to EU medical-device standards. Tucuvi (Tucuvi, ES) scores 23/25 with a Gold (Excellent) trust badge. Autonomous clinical voice AI agents that call patients and run care workflows.

Dimension-by-Dimension Breakdown

#### Data Residency

Tandem Health leads with 5/5 vs 4/5.

●Tandem Health (5/5): 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.

●Tucuvi (4/5): EU-incorporated (Spain) and GDPR-compliant, so an EU hosting region is the reasonable expectation for EU customers, but specific data-centre locations and residency commitments are not published publicly — conservatively scored 4 pending confirmation via the Trust Center/DPA.

#### Legal Jurisdiction

Both score equally at 5/5.

●Tandem Health (5/5): Incorporated as Tandem Health AB in Sweden with no US parent, placing it fully within EU/EEA jurisdiction.

●Tucuvi (5/5): Incorporated as Tucuvi Care S.L. in Madrid with no US parent, placing it fully within EU/EEA jurisdiction.

#### Data Retention & Training

Tandem Health leads with 5/5 vs 4/5.

●Tandem Health (5/5): 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.

●Tucuvi (4/5): AI agents are trained on a proprietary manually-labelled dataset rather than on live customer data, and the QMS enforces GDPR/HIPAA data protection; however, no explicit public no-training-on-customer-data guarantee or detailed retention/DPA terms are published, so scored 4 rather than 5.

#### Certifications

Both score equally at 5/5.

●Tandem Health (5/5): 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.

●Tucuvi (5/5): Strong, sector-specific stack: ISO/IEC 27001 and SOC 2 plus CE-marked Class IIb Software as a Medical Device under an ISO 13485 QMS, with EU AI Act and BS 30440 alignment. SOC 2 type (I vs II) not publicly specified.

#### Regulatory Fit

Both score equally at 5/5.

●Tandem Health (5/5): 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.

●Tucuvi (5/5): Purpose-built for regulated EU healthcare and certified as a Class IIb medical device, suitable for hospitals and health systems under EMA/AEMPS oversight and GDPR.

Certifications at a Glance

Certification	Tandem Health	Tucuvi
CE mark (EU MDR)	Yes	No
CE-marked SaMD (Class IIb)	No	Yes
Cyber Essentials Plus	Yes	No
GDPR	Yes	Yes
HIPAA	No	Yes
ISO 13485	No	Yes
ISO 13485:2016	Yes	No
ISO 14001:2015	Yes	No
ISO 42001:2023	Yes	No
ISO/IEC 27001	No	Yes
ISO/IEC 27001:2022	Yes	No
MDR Class IIa	Yes	No
NEN 7510	Yes	No
NHS DSPT	Yes	No
SOC 2	No	Yes
UKCA	Yes	No

Overall Verdict

Tandem Health has a clear trust advantage, scoring 25/25 compared to Tucuvi's 23/25. Tandem Health particularly excels in data residency, data retention & training.

Frequently Asked Questions

Which is better for EU compliance, Tandem Health or Tucuvi?

Tandem Health has a TrustKit score of 25/25 while Tucuvi scores 23/25. Tandem Health currently rates higher across data residency, legal jurisdiction, data retention, certifications, and regulatory fit.

How do Tandem Health and Tucuvi compare on data residency?

Tandem Health scores 5/5 for 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.), while Tucuvi scores 4/5 (EU-incorporated (Spain) and GDPR-compliant, so an EU hosting region is the reasonable expectation for EU customers, but specific data-centre locations and residency commitments are not published publicly — conservatively scored 4 pending confirmation via the Trust Center/DPA.).

Are Tandem Health and Tucuvi GDPR compliant?

Both tools are assessed across five compliance dimensions. Tandem Health has a regulatory fit score of 5/5 and Tucuvi scores 5/5. Check the full comparison above for a detailed breakdown.

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