Healthentia

By INNOVATION SPRINT SRL

Healthentia platform, which consists of the mobile app for patients and the clinical dashboard for HCP, is a standalone software (Software as a Service) medical active device. The platform consists of a collection of medical and non-medical modules. Medical modules are intended to collect, visualize and compute patient’s physiological parameters to support the monitoring of the patient, decision making during clinical trial or under a medical treatment context. It is considered as a medical device because it is a software intended by the manufacturer to be used for human beings for diagnosis, prevention, monitoring, prediction or prognosis of disease, and does not achieve its principal intended action by pharmacological, immunological, or metabolic means. Intended purpose: https://healthentia.com/fr/dispositif-medical-v4-classe-iia-mdr/

Level 3 plus

I am a CE-certified medical device
I am safely connected
I have proven my social-economic evidence and get reimbursed by NIHDI

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Download for Android

Languages

DE EN ES FR IT NL
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General description
Additional info
Media
Financing

General description (provided by company)

Main purpose

HEALTHENTIA is a software intended for: a) the collection and transmission of physiological data including heart rate, blood pressure, oxygen saturation, and weight directly to care providers via automated electronic means in combination with validated IoT devices; b) the visualization (subjects-based dashboards) and the mathematical treatment of data (trends analysis, alerts) related to the monitored chronic disease subject’s physiological parameters; c) the transmission of patient’s outcomes and outcome scores related to patient’s health status, health-affecting factors, health-related quality of life, disease knowledge and adherence to treatment through validated questionnaires; d) the user (subject/patient) interaction with a conversational virtual coach for informative and motivational purposes, in order to support subject telemonitoring, decision making and virtual coaching.

Target audience

Patient Target Groups: Chronic disease patients taking part of clinical investigation or a medical treatment.
Intended users: Telemonitored patients and their healthcare professionals.

Approach

Healthentia platform, which consists of the mobile app for patients and the clinical dashboard for HCP, is a standalone software (Software as a Service) medical active device. The platform consists of a collection of medical and non-medical modules. Medical modules are intended to collect, visualize and compute patient’s physiological parameters to support the monitoring of the patient, decision making during clinical trial or under a medical treatment context. It is considered as a medical device because it is a software intended by the manufacturer to be used for human beings for diagnosis, prevention, monitoring, prediction or prognosis of disease, and does not achieve its principal intended action by pharmacological, immunological, or metabolic means.

Intended purpose: https://healthentia.com/medical-device-mdr/

Connectivity to sensors and platforms

Healthentia app is compatible with other devices to collect lifestyle information and vital signs. The supported devices intended for use together with Healthentia are:
• Garmin trackers & watches via Garmin API (Android & iOS): Fenix 5 pro, Fenix 6 pro, Forerunner 945, Vivoactive 4, Vivosmart 4, Venu 2S,
• Fitbit trackers & watches via Fitbit API (Android & iOS): Versa, Inspire 2
• iHealth devices via Bluetooth (Android & iOS): Connected Blood Pressure Monitor iHealth Track (KN-550BT), Smart body composition scale iHealth Fit (HS2S), Smart Pulse Oximeter - iHealth Air (POM3)
• Polar belt via Polar API (Android & iOS): H9

Financing and pricing model

The application is free-of-charge for patients, while payers, hospitals, healthcare professionals, and sponsor organizations have to pay a fee per user per month in PaaS or SaaS model.

Adoption abroad

Healthentia is made available in 12 countries in Europe.

Pathology

Cancer Chest / Lung Diabetes Gastrointestinal Healthy Living Heart / Blood Vessels Mental Health Pain Sleep Treatment adherence

Functions

Alerts & Notifications Automated Guidance Data Sharing Diagnostics Environmental Data Goal Setting & Gamification Health Tracking Personal Health Record Remote Clinical Monitoring Treatment Support

Users

Men Women Elderly Clinicians

Additional info

Compliance to M3 criteria

This application has completed levels M1 and M2 of the pyramid, and the company declares to meet the criteria for mobile medical applications that NIHDI has set within the following specific care process:

Telemonitoring and therapy guidance in chronic heart failure ( More info: EN, NL, FR )

This app temporarily, until October 1, 2024, still carries the old M2 label because the requested ICT criteria were met. For now, no reimbursement request has been submitted for this app so it would no longer fall under level M2 in the new model.

Compliance to M2 criteria

Reimbursement request

Self declaration to 6 ICT criteria

Criterion 1: GDPR app category

1 (no processing of personal data) 2 (processing of personal data) 3 (processing of sensitive personal data)

Criterion 2: Identification of the user in need of care

through his/her Social Security Identification Number (SSIN) (obliged for applications of GDPR app category 2 or 3, see above) other

Criterion 3: App user authentication

not applicable (only for app category 1) via FAS level 400 (FAS = Federal Authentication Service, More info) company own authentication system fulfilling the M2 requirements (self-declared)

Criterion 4: Verification of therapeutic relationship and informed consent

not applicable via eHealth platform user and access management system IAM (More info) via company own database fulfilling the M2 requirements (self-declared)

Criterion 5: Applied interoperability standards

KMEHR (More info) HL7 CDA (More info) HL7 FHIR (More info) SNOMED-CT (More info) Other

Criterion 6: GDPR compliance

comply with the principles of (stated in article 5 of the GDPR)
  • lawfulness, fairness and transparency
  • purpose limitation
  • data minimisation
  • accuracy
  • storage limitation
  • integrity and confidentiality
 honour the rights of the data subject (as mentioned in Chapter III of GDPR) comply with the special provision on the processing of sensitive personal data (obliged for applications of GDPR app category 3, see above) carried out a data protection impact assessment (according to articles 35 and 36 of GDPR)

Extra: Secured Messaging

not applicable via eHealth platform’s eHealth Box (More info)

Compliance to M1 criteria

CE certification

Download document Granted by KiWa Dare Assessed and certified meeting the requirements of:
Medical Device Directive: MDD 93/42/EEC (old regulation) Medical Device Regulation: MDR 2017/745 (new regulation) In Vitro Diagnostic Directive: 98/79/EC (old regulation) In Vitro Diagnostic Regulation: IVDR 2017/746 (new regulation)
Certificate granted on 17/12/2024 Certificate valid till 17/12/2029 Class type of medical device (More info): 2A
ISO Standards:
ISO 13485 Quality Management Systems for Medical Devices (on company level) ISO 14155 Clinical Investigations of Medical Devices in Human Subjects ISO 14971 Risk Management of Medical Devices ISO 27000 series: Information Security Management Systems ISO 62304 Medical Device Software Lifecycle Processes ISO 62366 Application of Usability Engineering to Medical Devices

FAMHP registration and notification

Company registration number at FAMHP: 72378 Product identification code at FAMHP: 581564

General Data Protection Regulation (More info)

Company declares explicitly to be compliant with GDPR rules Company declares that the data are stored in EU only

User instructions

https://healthentia.com/medical-device-mdr/v4-ifu-release-history/

Components of the application

Native appWeb applicationWearable / SensorMedical device

Complaints handling

Via e-mail: dpo@healthentia.comVia telephone: +3228806290

Media

Screenshot1Screenshot2Screenshot3

Financing

This application has completed levels M1 and M2 of the pyramid, and the company declares to meet the criteria for mobile medical applications that NIHDI has set within the following specific care process:

Telemonitoring and therapy guidance in chronic heart failure ( More info: EN, NL, FR )