Paper version of IFU: If you would like a paper version of the instructions for use, please contact the manufacturer at the following e-mail address: info@healthentia.com.
It will be delivered within 7 calendar days after receiving the request.

The following table presents the description of changes between software versions, including minor updates:

SW Version Healthentia SW version  SW release date Description New medical function IFUs

Patients

IFUs

Investigators

v2(200423) 2.7 23/04/2020 Class I - submitted to AFMPS (Belgium) n/a
v2(201105) 2.8  5/11/2020 Minor changes (eConsent) No Patient EN

Patient FR – NL-DE

 Inv EN
v3(210525)   3 25/05/2021 Updated submission to AFMPS (mobile app widgets) Yes Patient EN

Patient FR – NL-DE

Inv EN
v3(211018) 3.1 19/10/2021 Minor changes (software performance, new IoT devices) Yes Patient EN

Patient FR – NL-DE

Inv EN
v3(220419) 3.2  19/04/2022 Minor changes (software performance, Terms/Privacy pop-up, messaging improvements, UI fixes) No Patient EN

Patient FR – NL-DE

Inv EN
v3(221219) 3.3 19/12/2022 Minor changes (Data protection improvements, software performance) No Patient EN

Patient IT

Patient DE

Patient FR

Patient  NL

INV EN

INV IT

INV DE

INV FR

INV NL

v3(230930) 3.4 30/09/2023 Minor changes (IoT device
validation, Glucose meter, software performance)
No Patient EN

Patient IT

Patient DE

Patient FR

Patient  NL

INV EN

INV IT

INV DE

INV FR

INV NL

v3(240108) 3.5 08/01/2024 Minor changes  (registration flow refactor, medication adherence, time zone, subject notification improvements, weight goal, performance improvements) No Patient EN

Patient IT

Patient DE

Patient FR

Patient  NL

Patient FR-NL-DE

INV EN

INV IT

INV DE

INV FR

INV NL

v3(240305) 3.6 05/03/2024 Minor changes (various improvements: alerts, dynamic lists, coaching view, profile, study theming)

 

No Patient EN

Patient IT

Patient DE

Patient FR

Patient  NL

Patient FR-NL-DE

INV EN

INV IT

INV DE

INV FR

INV NL

v3(240404)

 

3.7 04/04/2024 Minor changes (subject notifications improvements, nutrition widget improvements, portal globalization, smart profiler) No Patient EN

Patient IT

Patient DE

Patient FR

Patient  NL

Patient FR-NL-DE

INV EN

INV IT

INV DE

INV FR

INV NL

v3(240513) 3.8 13/05/2024 Minor changes (diet nutrition widget refactoring, diet widget improvements, apple health sleep stages, several bug fixes) No Patient EN

Patient IT

Patient DE

Patient FR

Patient  NL

Patient FR-NL-DE

INV EN

INV IT

INV DE

INV FR

INV NL

v3(240807) 3.9 07/08/2024 Minor changes (react native/ react upgrade, redux upgrade, react navigation upgrade, biomarker feature, small UI fixes, WebView instead of renderHtml in question Title bug fix, refactor FitBit sync) No Patient EN

Patient IT

Patient DE

Patient FR

Patient  NL

Patient FR-NL-DE

INV EN

INV IT

INV DE

INV FR

INV NL

v3(241003) 3.10 03/10/2024 Minor changes (Bug fixes, optimization improvements, Notifications Translations, System Questionnaires (Qualified or Custom), Resample CHF protocol, Revoke Subject Invitation) No Patient EN

Patient IT

Patient DE

Patient FR

Patient  NL

Patient FR-NL-DE

Patient EL

Patient ES

INV EN

INV IT

INV DE

INV FR

INV NL

v3.11(241217) 3.11 03/02/2025

 

Minor changes (Library feature (lessons), Refactor Loader in homescreen, Liquids screen refactor, Sleep refactor, Notifications categories added, Homogenization of some UI elements) No Patient EN

Patient IT

Patient DE

Patient FR

Patient NL

Patient FR-NL-DE

Patient EL

Patient ES

Inv EN

Inv IT

Inv DE

Inv FR

Inv NL