Legal recommendations for front-end-solutions
The solutions developed by Infermedica are recognized tools for supporting patients and healthcare providers in all steps of the primary care journey—from symptom to outcome.
At Infermedica, we focus on creating the highest quality solutions, which is confirmed through compliance with applicable regulations and leading certifications. This information can be used in your communication to underline the security, reliability, and quality of your implementation. Below, we present information that can be used and the limitations that must be respected.
This article is dedicated to communication for solutions implemented directly on the client's side and solutions delivered to end-users by Infermedica.
Communication of front-end solutions
The front-end solutions include Infermedica Triage (formerly known under the names Symptom Checker, and Health Form), Infermedica Intake, and Infermedica Follow-up, which is currently in the development phase. Triage and Intake are:
- CE marked Medical Devices Class I in the European Union in accordance with the Medical Device Directive (93/42/EEC) (“MDD”) and with the Council Regulation 2017/745 of April 5th, 2017 on Medical Devices (“MDR”).
- Planned change: our products will change the classification from Class I to Class IIA by May 26th, 2024, Infermedica will inform all interested parties about the exact time of change.
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Developed in compliance with HIPAA requirements.
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Developed in compliance with the GDPR regulation.
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Developed under the procedures of Quality Management System, based on the ISO
13485:2016 standards, certified by the TÜV Nord notified body.
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Developed according to information security management standard based on the ISO
27001:2017, certified by Dekra certification body.
Please note that these solutions:
- Do not replace diagnoses issued by medical doctors
- Are medical devices in European Union intended for informational and/or educational use: the software supports the health-assessment processes and provides triage recommendations but is not binding medical advice
- Its software may be used either by end-users/patients or medical professionals
Note: Please note that the checkup is for informational purposes and is not a qualified medical opinion. Infermedica’s tools cannot replace “diagnosis” as only a physician is eligible to give a proper diagnosis. Infermedica's solutions support users with suggestions that can also be called: health assessment, symptoms analysis, medical interview, and pre-visit checkup.
Information about the manufacturer
For the certified medical devices listed above you shall always communicate that Infermedica is the manufacturer responsible for CE marking of the production of the application, even when you use it under your company look and design.
Infermedica’s official nameplate is under the supervision and shall contain the following information:
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CE mark
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MD icon with the name of the application
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Version of the software
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Manufacturer icon with date of the release
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Manufacturer address
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Instruction for use icon and link to it
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UDI - Unique Device Identifier
Communication of the Infermedica brand
Alongside the communication of properties typical for solutions, you are also allowed to communicate Infermedica as the source of the used software. You can use “Powered by Infermedica”, “Infermedica 2022”, “Copyright by Infermedica” or other forms, agreed with us.