Ada Assess Instructions for Use

Manufacturer Information

Ada Health GmbH
Neue Grünstraße 17
10179 Berlin

Phone: +49 030 600 31987
E-mail: [email protected]
Website: https://ada.com

This version of the Instructions for Use applies to software versions 4.0 or later of ‘Ada Assess’.

1. What is Ada Assess? (Intended purpose)

Ada Assess is AI-based health assessment software intended to provide personal health insights and guidance. The insights and guidance provided include an overview of possible conditions, an estimated likelihood of each condition, and navigation to the appropriate level of care.

Ada Assess is not a substitute for advice from a healthcare professional and does not provide a final medical diagnosis.

2. Use Specifications

2.1. When Can I Use Ada Assess? (Specification of indications)

The device is designed to cover a wide range of medical conditions that can cause symptoms and, therefore, would not be feasible to list all specific indications for the device. Ada Assess is intended to provide a non-emergency symptom assessment to users at age 16 or above or under 16 years by their legal guardians.

2.2. Who Can Use Ada Assess? (Intended user)

Ada Assess has been designed for users above 16 years of age, and its underlying medical knowledge has been developed for all age groups. It has been designed for lay person use, no medical training is required. It is intended to be used in a home, or normal layperson user living environment, under the physical, social and technical conditions that allow the user to use standard personal computing and smartphone technologies. It can be used on any modern smartphone or computer. It can be used as a standalone tool, or linked to a healthcare provider’s information systems. The target population for the medical device is individuals above the age of 16 who are experiencing symptoms and who are seeking information about potential conditions that may be causing those symptoms. The intended population for this device includes vulnerable groups, specifically elderly people and pregnant women.

2.3. Who Should Not Use Ada Assess? (Contraindications)

Ada Assess should not be used in a medical emergency. It should not be used in a setting, where a clear understanding of the questions is not ensured (e.g. lack of knowledge in the provided languages, impaired consciousness). Age under 16 years is listed as a relative contraindication - the legal guardian of a person under 16 years of age may conduct and do an assessment on their behalf.

3. Device Overview

Ada Assess is a software application that provides users with health information relevant to medical findings they are currently experiencing (e.g. observed symptoms or other health related factors such as existing conditions or previous procedures). The user interacts with ‘Ada’ in a conversational style, similar to a chatbot.

Upon initiation of the conversational flow the user is requested to enter relevant information about themselves and the symptoms they are concerned with into the application. Once their symptoms are confirmed, the users are guided through a logical sequence of questions, intended to identify possible conditions that could be causing the symptoms specified by the user.

At the end of the health assessment the user is provided with a report (hereinafter referred to as 'assessment report') that includes a list of all present and absent findings (i.e. the information entered during the onboarding phase and the answers to all questions from the question flow), along with a list of the most likely conditions to be causing this set of findings, and advice level for each suggested condition. There are condition-specific advice levels are simplified to one of three options listed below:
Self care
Seek medical advice
Seek urgent medical advice
Seek emergency care

The assessment report can be downloaded as a PDF document. The user can also choose to share their assessment report with a healthcare provider.

Depending on the configuration of the device, Ada Assess can offer the user multiple options after presenting the assessment report. If available, the user has an opportunity to review and select relevant partner healthcare services, studies or information.

Caution! Ada Assess has a roadblock feature for certain emergency situations or conditions such as suicidal ideation and chest pain suggested of a heart attack. This means that if a user presents with one of these symptoms or confirms having one during the Question Flow, Ada Assess will immediately stop the assessment and inform the user that this is a serious condition and they need to seek medical attention right away. The user can still proceed with the assessment if they choose to.

4. User Safety

4.1. Limitations

Ada Assess should not be used as a substitute for advice from a healthcare professional and does not provide a final medical diagnosis.

4.2. Precautions

• The assessment report is produced on the basis of the information that the user provides. Ada Assess works best when the symptoms that are most worrying to the user are entered, such as the ones that have appeared most recently or most rapidly. Inaccurate or false answers can lead to the delivery of an assessment report that is not suitable for the user (i.e. inaccurate advice levels). If the user chooses to follow these inaccurate advice levels, the efficacy of the medical device is no longer ensured.
• When accessing Ada Assess in a web browser, ensure that the user is using a supported browser (see section 7) which is up to date with the latest stable release.
• When accessing Ada Assess from a mobile device, ensure that the user is using a supported operating system (see section 7) which is up to date with the latest stable release and security patches.

4.3. Safety Warnings

• Do not use Ada Assess in an emergency situation. In the case of an emergency, contact local medical emergency services.
• Do not use Ada Assess as a substitute for the advice of a healthcare professional.
• If symptoms get worse during an assessment, interrupt the assessment and consult a healthcare professional.
• Ada Assess is not a diagnostic tool. If the user is concerned about any symptoms, please consult a healthcare professional regardless of the outcome of the assessment.
• Do not wait to seek medical care, if the user is concerned about their health. Waiting may lead to delayed care and cause deterioration of the users’ health status.

4.4. Side Effects

• Use of digital health tools may be related to increased health anxiety, particularly if the conditions suggested to the user include distressing or sensitive conditions.
• Use of digital health tools may be related to increased self-surveillance and normalization of health-seeking behavior.

4.5. Residual Risk

• Ada Assess provides a list of conditions that it has identified as possible causes for the user’s symptoms. This is not an exhaustive list. The user may have a condition that is not suggested. Please consult a healthcare professional if the user is concerned about their health status. Waiting may lead to delayed care and cause deterioration of their health status.
• Ada Assess may suggest sensitive or upsetting conditions in the assessment report. Do not complete an assessment, if the user does not wish to learn information that may cause distress or anxiety.

5. Expected Clinical Benefit

Ada Assess is intended to provide timely and accurate assessment of symptoms for the layuser, aiding in appropriate care navigation based on an initial assessment of the user’s symptoms, facilitating conversation and saving time during healthcare consultations by providing a preliminary analysis of symptoms, and informing the identification of less common and rare diseases based on the user's symptoms.

6. Performance Characteristics of the Device

The performance of the device depends on the underlying performance of a software module of Ada Assess that includes, among other components, the medical reasoning engine. The performance of the module has been shown to be state of the art in testing against medical doctors and other on- market symptom assessment applications. Every update of the module is tested against a large number of clinical case scenarios to ensure that performance is always maintained within defined acceptance criteria for condition suggestion accuracy and for the proportion of relatively lenient or over-cautious advice about onward care. The results of the accuracy, leniency and over-cautiousness tests must pass certain conditions (within defined thresholds with a confidence of >95%) before a new software module is approved for release.

7. Compatibility Requirements

The Ada Assess Ada Assess application operates as a cloud-based web service accessible via standard web browsers.

Web App:

• Google Chrome
• Apple Safari
• Mozilla Firefox
• Microsoft Edge (latest 2 versions).

Mobile Web:

• iOS Safari
• Android Chrome

8. Security Guidelines

When using Ada Assess, we recommend following these security guidelines:

8.1. Lock the device when not in use: Prevent unwanted access to the users’ Ada assessments by ensuring the device is locked when they are not using it.

8.2. Keep the device updated: Regularly update the device's operating system. Updates often contain security patches that mitigate or resolve security vulnerabilities.

8.3. Use official device operating systems: Do not use Ada Assess on Apple devices that are “jailbroken” or Android devices that are “rooted”. These third-party altered operating systems should not be trusted.

8.4. Be cautious with public Wi-Fi: Avoid using public Wi-Fi networks when accessing sensitive healthcare information. Traffic sent over public networks can potentially be spied upon. If the user must use public Wi-Fi, consider using a Virtual Private Network (VPN) to encrypt the user data and protect the users’ privacy.

8.5. Be vigilant of phishing attempts: Beware of phishing emails, messages, or links that impersonate Ada Health. Avoid clicking on suspicious links or providing personal information anywhere outside of our official application.

8.6. Use caution when saving assessment reports: If the user downloads any assessment reports from Ada Assess, make sure to save them somewhere safe and not accessible by other people. If the option is available, the user should even consider adding a password for accessing their reports or the folder they saved them to. Maintain backups of this data if they need to keep it long-term.

8.7. Report suspicious activity: If the user encounters any security issues, they can always contact us.

9. Get In Touch

9.1. Report a Safety Concern

If the user would like to report a safety concern that has occurred in relation to our device, please email our Medical Safety team at [email protected].

9.2. Customer Support

If the user has questions or requires technical support, please email our Customer Service team at [email protected] or fill out the contact form on https://ada.com/contact/support/.

To request a physical copy of this manual, please email our Customer Service team at [email protected]. The physical copy of this manual will be sent to the user at no additional cost within seven calendar days after receipt of the request.