Regulatory Trust for
Better Healthcare
Decisions

EU-02

A Smarter Approach to Patient Care

Healthcare providers rely on accurate, clinically validated tools to make informed decisions. Healthentia is EU MDR-certified, ensuring that real-world data collection and remote patient monitoring meet the highest safety and compliance standards.

Any decision-making in healthcare should be supported by a certified medical device, ensuring accuracy, compliance, and trust.

 

Because every clinical decision should be based on trusted, certified data.

Why Healthentia

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SaMD for Remote Patient Monitoring

Healthentia is a Class IIa certified Software-as-medical-device that is intended to collect, visualize and compute patients’ physiological parameters to support monitoring, and decision-making under a medical treatment context. It is a software intended to be used for diagnosis, prevention, monitoring, prediction or prognosis of the disease.

Key features include:

  • Real-Time Monitoring & Decision Support
  • Integration with other IoT medical devices
  • Highlighting the evolution of physiological parameters
  • Virtual Coaching supporting patients in lifestyle change
SaMD for RPM

SaMD as Digital Therapeutics device

Digital Therapeutic (DTx) programs to support wellbeing and lifestyle management of chronic disease patients. As lifestyle is the root cause of chronic diseases, Healthentia is also leveraging virtual coaching to drive behavioral change.

Key Capabilities:

  • Personalized virtual coaching for behavioral change
  • Patient Management & Engagement
  • Real-Time Health Monitoring
  • Educational Resources
  • Teleconsultation & Virtual Visits

 

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SaMD for DTX
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Empowering Research - Decentralized Clinical Trials (DCTs)

Further to the medical device characteristics, Healthentia enables DCTs and observational studies, offering a complete digital ecosystem to enhance research efficiency, being compliant with Good Clinical Practice.

Key Research Capabilities:

  • Real-Time Data Collection (PROMs/PREMs, IoTs)
  • Comprehensive Study Portal
  • eConsent & eRecruitment
  • Study management & insights

 

ePRO for DTC

Therapeutic Areas

Healthentia supports all chronic diseases, with dedicated programs for:

 

Cardiovascular Diseases

 

COPD

 

Diabetes Type 2

 

Oncology

Beyond chronic disease management, Healthentia is a trusted platform for clinical research, enabling real-world data collection for pharmaceutical companies, life sciences organizations, and academic researchers.

For Healthcare Providers, Researchers and Patients.

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Certified MD

A Class IIa certified device per Rule 11 of Annex VIII of the Medical Device Regulation (MDR) 2017/745 as amended.

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Advanced RPM features

Real-time monitor of your patient's measurements from any device

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RWD Collection

Any Wearables & IoT device can be integrated through are RESTful API.

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BI Reports & Trends

Use of embedded Power-BI for visualization and mathematical treatment of data (trends analysis, alerts) related to the monitored chronic disease subject’s physiological parameters.

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Behavioural Coaching

Behavioural Coaching and support when you need it, through curated dialogues from clinicians backed up by science

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HL7 & FIHR compatibility

Healthentia is compatible with HL7 & FIHR for EHR integration  

More information?

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Industries

The following Industries share a common need. Healthentia let's you integrate different types of data streams, making them immediately available for research and allow close patient monitoring.

Pharma

Healthcare
Organizations

Healthcare Systems
& Payers

Homecare Facilities

Testimonials

Doctor Giuseppe Ferdinando Colloca,  Medical Director,  Fondazione Policlinico Gemelli

"In the SUPERO study, Healthentia was used to collect behavioral data and integrate it with the hospital’s clinical data into a unified dashboard. This advanced dashboard contributed to reducing the average hospital stay for interventional oncology procedures to 2.12 days for the 93 patients treated during the study, compared to 6.03 days for patients analyzed prior to the SUPERO study."

Professor Rostislav Kostadinov MD, PhD, Medical University Plovdiv

"Products like Healthentia represent the future of digital medicine. I do believe that the information collected by Healthentia is valuable and needed for the medical specialists. The data collected are important for medical assessment of the disease's development and therapeutic success/failure, as well for the patients triage and evaluation of risk. It is crucial that medical professionals are well informed and aware of these solutions and their vast potential."

Clinician

"Healthentia app offers extensive capabilities for patients and individuals striving for a healthy lifestyle by enabling them to monitor critical health parameters. I have personally recommended the app to my patients and will continue to do so in the future. It is a great way to retain the connection with the patients after leaving the hospital."

Clinician

"I believe the data collected by Healthentia is highly valuable for medical professionals. Monitoring physical activity, dietary habits, consumption of cigarettes and alcohol, sleep quality, and pain intensity is essential for evaluating disease progression and therapeutic outcomes. This data also aids in patient triage and assessing the risk of developing various conditions."

Clinician

"Using the Healthentia app for research and clinical purposes has been a positive experience. Innovation Sprint has proven to be a dependable and valuable partner. Every request I made, whether for clarifications or the inclusion of data and widgets, was addressed promptly and thoroughly. I highly recommend Innovation Sprint for future collaborations in areas where ICT and Medicine intersect."

Insights

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