SaMD FOR PHARMA

Real-World Evidence. Delivered

Huma’s global, Class IIb regulated 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.

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

Improve clinical outcomes

90-95%

adherence and retention rates across our care and research deployments are the result of high engagement rates1

x2

Our platform can almost double clinical capacity and reduce readmission rates by >30%2

3-4x

lower mortality amongst Huma patients compared with patients not using Huma3

88.2%

of patients highlighted as deteriorating had operation dates brought forward4

ACCURATE. TIMELY. INSIGHTFUL

Collect high-quality, real-world data at scale

Huma’s remote patient monitoring platform captures a broad range of digital biomarkers from ePRO, connected devices and wearables, ensuring higher accuracy with minimal human error. Our platform supports continuous data collection across local and global health ecosystems and patient registries, enabling the creation of aggregated datasets across multiple countries for more accurate, evidence-based conclusions.

With EU MDR Class IIb accreditation, Huma can support patients with higher acuity and risk profiles, ensuring that datasets and AI-based models are representative of the severity of illness encountered across health systems.

Huma clinician app screenshot.
Huma clinician app screenshot.
Huma clinician app screenshot.
Huma clinician app screenshot.
ACCURATE. TIMELY. INSIGHTFUL

Collect high-quality, real-world data at scale

Huma’s remote patient monitoring platform captures a broad range of digital biomarkers from ePRO, connected devices and wearables, ensuring higher accuracy with minimal human error. Our platform supports continuous data collection across local and global health ecosystems and patient registries, enabling the creation of aggregated datasets across multiple countries for more accurate, evidence-based conclusions.

With EU MDR Class IIb accreditation, Huma can support patients with higher acuity and risk profiles, ensuring that datasets and AI-based models are representative of the severity of illness encountered across health systems.
Huma clinician app screenshot.
Huma clinician app screenshot.
REACH. FLEX. EXTEND

A global, regulated platform that facilitates RWE reporting

Ready to deploy in 60+ countries, Huma enables real-world data collection and Real-World Evidence reporting from patients in your operating markets worldwide, including those in higher risk groups with multiple comorbidities.

Huma’s software as a medical device platform is certified under ISO 13485 and 27001 and Cyber Essentials Plus, is FDA 21 CFR (Part 11, 50 and 820 ff) and GxP compliant, and is registered EU MDR Class IIb with enforcement discretion for EU MDR Class IIb use cases.

Huma clinician app screenshot.
Huma clinician app screenshot.
REACH. FLEX. EXTEND

A global, regulated platform that facilitates RWE reporting

Ready to deploy in 60+ countries, Huma enables real-world data collection and Real-World Evidence reporting from patients in your operating markets worldwide, including those in higher risk groups with multiple comorbidities.

Huma’s software as a medical device platform is certified under ISO 13485 and 27001 and Cyber Essentials Plus, is FDA 21 CFR (Part 11, 50 and 820 ff) and GxP compliant, and is registered EU MDR Class IIb with enforcement discretion for EU MDR Class IIb use cases.
CLINICAL DECISIONS. SUPPORTED

Near real-time data collection across therapeutic areas and patient registries

With more than 450 unique deployments to date, our platform provides companion app solutions across diabetes, heart failure, cardiovascular disease, asthma, and many more therapeutic areas.

Capture broad datasets across health economies—including specific patient disease registries—with more complex, higher acuity patients.

Huma clinician app screenshot.
Huma clinician app screenshot.
Huma clinician app screenshot.
Huma clinician app screenshot.
CLINICAL DECISIONS. SUPPORTED

Near real-time data collection across therapeutic areas and patient registries

With more than 450 unique deployments to date, our platform provides companion app solutions across diabetes, heart failure, cardiovascular disease, asthma, and many more therapeutic areas.

Capture broad datasets across health economies—including specific patient disease registries—with more complex, higher acuity patients.

Regulatory, safety and compliance

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

MHRA registered Medical Device Class IIb

US FDA icon.
US FDA 21 CFR compliances Class I exempt and under enforcement discretion

Part 11

Part 50

Part 820 ff

ISO icon.
ISO certifications

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

ISO 27001: 2013 certified

Data protection - infosec icon.
Data protection / infosec

Committed to GDPR compliance

NHS Registration on Data Security and Protection Toolkit

CyberEssentials / CyberEssentials Plus

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