Medical Device

Software as a Medical Device (SaMD)

HEALTHENTIA is a medical decision support software developed by INNOVATION SPRINT and intended to monitor, offer virtual coaching services and generate automatic alerts regarding events, based on Real World Data.

Ιntended Use: The intended use of the device is: Software intended for monitoring of non-vital parameters to support decision making and virtual coaching of patients during clinical trials or under a medical or wellbeing treatment context.

User: Principal Investigators (PI) of clinical studies and their patients, as well as patients using it as a medical or wellbeing device.

Patient: Patients taking part of clinical investigation, or those using it as a medical or wellbeing device.

Environment: Clinical trials or under a medical or wellbeing treatment context.

EUDAMED registration: Healthentia v3 (Portal, App)

Current version: v3.8 [v3(240513) - Portal: 3.08.01 / App: 3.8.0]

Medical Device

Medical modules

Healthentia App is collecting several types of RWD like physiological and psychological allowing a dense description of peoples’ lifestyle through a collection of modules. Several modules are medical software covered by the CE mark:

  • Virtual Coaching It allows the user (subject/patient) to interact with an embodied conversational coach for informative and motivational purposes.
  • eDiary: The e-Diary enables the presentation of any reported outcomes of the patient, in the form of a list, grouped by day or outcome (symptom). In this way, patients can have any time access to their electronic Diary and see the progress of their reported outcomes.
  • Physical activity: The physical activity widget gives an overview on the steps walked.
  • Sleep: The sleep widget gives an overview on the sleep duration.
  • Liquid consumption: The liquid consumption widget gives an overview on the water consumed.
  • Nutrition: The nutrition widget offers the ability to see and edit the consumption of different food categories of interest.
  • Weight: The weight widget offers the ability to add manually and through a digital scale, measure and view the weight.

Caution: The study participants also have access to visualizations, only about themselves, via the mobile app. The vital signs and lifestyle visualizations service handles the output of data of a single participant towards the mobile application. This component is excluded from the validity of Class I CE mark, as Healthentia is not intended to monitor vital parameters. For the avoidance of doubt, such parameters are highlighted in the application, so that users are informed about them. Furthermore, there is no guarantee of the reliability of the data shown and the user should always refer to the display of the measurement device (e.g. activity tracker).

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Applications & Domains

Healthentia as a medical decision support software can be used for remote patient monitoring in several therapeutic areas and for different scopes. These can be organized in 3 levels.

  • Virtual Clinic
    • Post Surgery or Discharge Monitoring
    • Covid monitoring
  • Remote Patient Support
    • Digital Care pathway monitoring with Coaching
    • Remote Outpatient Clinic
  • Self Care
    • Disease coping & prevention
    • Digital Therapeutics (DTx)

Certifications & Compliances

Having an intended use to monitor remotely patients, it is required to follow the below certifications and compliances

  • Class I Medical Device
  • 21 CFR Part 11 / 21 CFR 820 compliance 
  • GxP compliance 
  • HIPAA compliance 
  • ISO13485 Certification  
  • ISO 27001 certification & GDPR compliance 

Made for your Business

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Healthentia is a medical decision support software developed by Innovation Sprint and intended to monitor and predict outcomes, offer virtual coaching services, and generate automatic alerts regarding events, based on Real World Data.
Healthentia is also used for Decentralized Clinical Trials (DCT, leveraging best-of-breed of eClinical studies features, such as eRecruitment, eConsent, teleconsultation/ televisit, ePRO-IoT integration, and virtual coaching. Healthentia empowers patients and gives them an active role in taking trial’s actions, rather than bringing them to the trial sites; thus facilitating clinical trial optimization, accelerating trial processes, reducing drop-out and failure rates, and validating drug/intervention efficacy and effectiveness with Real World Data insights. Healthentia is used by Top5 Pharma and large hospitals and operates under the strict regulatory framework of Good Clinical Practice.

  • achieve cost savings
  • accelerate the drug approval process
  • obtain useful insights to develop drugs and interventions of higher efficacy
Healthcare Organizations

Run clinical trials smoothly, with data integrity and accuracy in data collection  and enriched Quality data setsPatient Monitoring and collection of reported Outcomes in and out of hospitalReduced patient risks after hospital release

Medical Device Companies optimize the clinical trial process for your medical device and diagnostic equipment with healthentia platform.

Insurance Companies

Insurance companies need to offer more competitive health insurance products and the only way to do so is via personalization of their products. Healthentia can help offer a tool for insurance companies to collect lifestyle data and offer reduced fees.

Read more about medical modules and device functionalities that are covered under the CE mark.

Read more about medical modules and device functionalities that are covered under the CE mark.