Welcome to next-generation digital-first care and research

Deliver more personalised digital-first care and research with the first disease agnostic enterprise platform to achieve EU MDR Class IIb certification1.

Huma’s globally scalable platform offers clinicians new and enhanced digital capabilities to diagnose, treat and manage a wider range of more complex patients. Our platform can provide automated advice and guidance directly so patients can better manage their medical conditions from anywhere.

Huma EU MDR Class IIb Certified - Clinician happy with clinical results

Regulatory, safety and compliance

CE 0297 icon.
EU MDR 2017/745 Class IIb certified

MHRA registered Medical Device Class IIb

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21CFR820 US FDA Class II

US Food and Drug Administration Medical Device 510k # K230214

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ISO certifications

ISO 13485: 2016 certified (Medical Devices: Quality Management Systems)

ISO 27001: 2013 certified

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Data protection / infosec

Committed to GDPR compliance

NHS Registration on Data Security and Protection Toolkit

CyberEssentials / CyberEssentials Plus


Discover what Huma’s regulated platform means for the future of healthcare

Digital technology is transforming healthcare. Huma is at the forefront with the world's first digital health platform, regulated under EU MDR Class IIb, for condition agnostic use.

Download our complimentary 12-page guide and discover how Huma's platform solves some of the most pressing healthcare challenges.

Content includes:

  • Smarter patient care and optimization
  • Improving clinical outcomes
  • Improved patient engagement and adherence
  • Collecting real world evidence at scale

Download now to discover more.

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Support a wider range of more complex patients with personalised care plans

Our award-winning platform allows you to set specific thresholds and develop personalised treatment plans based on individual patient needs and user preferences to optimise health outcomes.

Enhanced decision support tools provide clinicians with treatment and diagnostic recommendations for everyone including paediatrics, patients with comorbidities and higher acuity patients across a wide range of therapeutic areas.


More predictive, more proactive patient care

Huma’s EU MDR Class IIb remote monitoring platform provides near real-time continuous data capture and reporting, delivering smarter, more personalised insights generated from a patient's medical history, symptoms, and digital biomarkers that can be used to accurately diagnose and treat even critically ill patients.

Predictive analytics with targeted treatment plans help reduce hospital readmissions and unnecessary outpatient appointments, while enhanced decision support tools and customisable RAG dashboard help clinicians triage and discharge patients safely and more efficiently.


Better insights, smarter care

Our platform’s enhanced data capture — with more frequent data points and AI-driven analysis — helps improve data accuracy, reliability and quality, helping clinicians build a more comprehensive picture of a patient’s status.

This enables a better understanding of the underlying causes of a patient’s condition and, as a result, more informed decision-making, leading to more appropriate and effective treatment, more personalised patient care, and improved health outcomes.

Huma clinician app screenshot.
Huma clinician app screenshot.
Huma clinician app screenshot.
Huma clinician app screenshot.

Real-World Evidence. Delivered.

Collect real-world, clinically meaningful data at scale across your operating markets for more accurate, more complete outcomes reporting.

Huma’s global platform captures real-world data across multiple therapeutic areas and patient registries, which can be aggregated to provide valuable insights at an individual, patient cohort, and population level.

High-trust, interoperable and compliant

Huma is redefining the digital health landscape with a single, interoperable platform certified for use across multiple therapeutic areas and patient cohorts, featuring digital biomarkers and third-party AI and device integrations, as well as third-party FDA- and MHRA-approved SDK integrations.

Our globally scalable platform is a CE marked medical device, registered in the EU, UK, US, and Saudi Arabia. We are certified under ISO13485, ISO 27001 and Cyber Essentials Plus, and are FDA 21 CFR (Part 11, 50 and 820 ff) and GxP compliant.

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EU MDR 2017/745 Class IIb certification for a disease agnostic Software as a Medical Device (SaMD) from its notified body DQS Medizinprodukte GmbH