Dalia Flow

The Dalia patient app supports you daily in sharing information with your healthcare team as part of your follow-up care.

With this app, you can: link your account to the connected device provided by your healthcare team, access therapeutic content, complete validated questionnaires, receive reminders, and access emergency contact information.

General Information: Dalia Flow is a Class I medical device manufactured by Dalia Care (SRN: FR-MF-000046299), located at 16 rue Eugène Varlin, 75010 Paris, France. Dalia Flow is software intended for use by healthcare professionals in their clinical setting to support planning decisions for the follow-up care of adult patients suffering from depression or at risk of depression. It is available in two configurations: Flow Configuration (adult patients with a confirmed diagnosis of depression) and Bloom Configuration (adult patients at risk of depression). The applicable configuration is determined by your healthcare professional during your registration. The patient app is a non-medical component of the device. All clinical decisions are the sole responsibility of your healthcare professional.

Not for emergency use: Dalia Flow is not intended for emergency situations or acute crisis management. Patients experiencing suicidal thoughts, severe distress, or acute psychiatric symptoms should immediately contact emergency services: 3114 (National Suicide Prevention Hotline), 15 or 112 (medical emergencies), or their local emergency number.

Use environment: Data entry requires an iOS 16.0+ smartphone with internet access, as well as a compatible wearable device provided by your healthcare team. The patient user manual is included in the application. Product version: 1.0.0 — BASIC-UDI: 0376042498DALFVE.

Warnings: Dalia Flow v1.0.0 is a planning aid. It does not generate clinical alerts, perform triage, produce diagnoses, or formulate treatment recommendations. Final decisions rest exclusively with the qualified healthcare professional. The accuracy of the suggestions depends on patient adherence (wearing the connected device at least 60% of the time, regularly completing the PHQ-9, ASEC-21, and Girerd questionnaires in Flow; and the EPDS in Bloom). The patient must open the application at least once a week to synchronize the data.