Healthentia
Class IIa certified SaMD
Free · Designed for iPad. Not verified for macOS.
Healthentia is a Class IIa certified 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.
Your healthcare provider is responsible of the final assessment of your diagnosis and treatment.
Healthentia is providing information to support diagnostic and therapeutic decision, but the overall clinical context should be taken into consideration before taking any decision.
More information available here: https://healthentia.com/medical-device-mdr/
More information: https://healthentia.com
Ratings & Reviews
- This app has not received enough ratings or reviews to display an overview.
-Bug fixes and performance improvements
The developer, Innovation Sprint, indicated that the app’s privacy practices may include handling of data as described below. For more information, see the developer’s privacy policy .
Data Linked to You
The following data may be collected and linked to your identity:
- Health & Fitness
Accessibility
The developer has not yet indicated which accessibility features this app supports. Learn More
Information
- Size
- 97.2 MB
- Category
- Medical
- Compatibility
Requires iOS 16.4 or later.
- iPhone
Requires iOS 16.4 or later. - iPad
Requires iPadOS 16.4 or later. - Mac
Requires macOS 13.3 or later and a Mac with Apple M1 chip or later. - Apple Vision
Requires visionOS 1.0 or later.
- iPhone
- Languages
- English
- Age Rating
18+
- 18+
- Frequent
Medical Treatment Information
Contains
Health or Wellness Topics
- Provider
Innovation Sprint
- Innovation Sprint has identified itself as a trader for this app and confirmed that this product or service complies with European Union law.
- DUNS Number
400904262 - Address
Veldkapelgaarde 30 BP 1.30.30
1200 Brussel
Belgium - Phone Number
+32 477291379 - Email
contact@healthentia.com
- Medical Device
Yes
- Innovation Sprint indicated this app is a regulated medical device and complies with European Union law.
- The information below has not been verified by Apple.
- Manufacturer SRN
- BE-MF-000000879
- Address
- Veldkapelgaarde 30 BP 1.30.30
1200 Brussel
Belgium - Phone Number
- +32 477 29 13 79
- Email Address
- contact@healthentia.com
- Use Statement
- Ιntended Use: Healthentia App is part of Healthentia solution, 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.
- Safety Information
- CONTRA-INDICATIONS
Healthentia is not intended for the monitoring of patients in critical situations (operating room, emergency, intensive care).
Any physical or cognitive condition that, in clinical judgment, would prevent the patient from using Healthentia, e.g. dementia.
The device should not be used during pregnancy.
Healthentia App has not been tested with paediatric population. Therefore, Healthentia App is intended for adult use only (>18 years old) and does not cover use by children without supervision.
PATIENT INFORMATION
Please inform your patient about the following information:
Healthentia is not monitored in real-time by healthcare personnel; it is intended for non-emergency communication only. In case of an emergency, contact your care unit or the emergency number by phone.
Telemonitoring does not replace regular check-ups with your doctor. Consult your doctor in case of severe and persistent symptoms.
In some special cases, the self-care advice and instructions provided by Healthentia may not be applicable to your situation. If you have questions about your care, symptoms, and management, contact the healthcare team
WARNINGS
Healthentia is not monitored in real time by healthcare personnel, it is intended for non-emergency only. In case of an emergency, contact your care unit or the emergency number by phone.
In some special cases, the self-care advice and instructions provided by Healthentia may not be applicable to the patient's situation. If patients have questions about their care, symptoms and management, they should contact their health care team.
If you have questions about your care, symptoms and management, contact your healthcare team.
The device is not intended to replace the care of a healthcare professional, including prescription, diagnosis or treatment.
Telemonitoring does not replace regular check-ups with your doctor. Consult your doctor in case of severe and persistent symptoms.
In combination with Healthentia, use only measuring devices for which the technical performances (accuracy, precision) have been verified by your healthcare provider as it may affect the outcome of your monitoring.
Verify the consistency of your clinical data and the good transfer of them to your healthcare provider as the quality of the diagnosis and treatment is partially based on this information.
The device is not intended to replace the care of a health care professional, including prescription, diagnosis or treatment.
Consult periodically the Alerts dashboard as it may influence the follow-up of your patients. - Instructions for Use
- Visit the developer site
- Copyright
- © (c) Innovation Sprint Srl