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 2.0 or later of ‘Ada Assess’, a medical device manufactured by Ada Health GmbH.

1. What is Ada Assess?

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.

After an assessment, the user can share their results with healthcare providers, who may consider this information for clinical decision-making.

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?

Ada Assess is able to consider thousands of symptoms and health findings and includes a library with thousands of conditions.

2.2. Who Can Use Ada Assess?

Ada Assess has been designed for users over the age of 16 but its underlying medical knowledge has been developed with all age groups in mind. As it has been designed for use by laypeople, no medical training is required. Ada Assess is intended for use at home or in any environment or situation where the user might use their computer or smartphone. It can be used as a standalone tool or linked to a healthcare provider’s information systems. To ensure safe use, the user should have grade 8 equivalent skills in one of the provided languages.

2.3. Who Should Not Use Ada Assess?

Ada Assess should not be used in a medical emergency. It should not be used in a situation where there is a risk to clear understanding of the questions (e.g. lack of required language skills, impaired consciousness). Users under the age of 16 must have their legal guardian conduct 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. If their healthcare provider or insurer is partnered with Ada Health GmbH, some of the user’s relevant information can be directly accessed from their provider or Electronic Health Record (EHR) via Single Sign-On (SSO).

Following this, the user is asked to enter the finding(s) that they are concerned with into the application and are guided through a logical sequence of questions, intended to identify possible conditions that could be causing the finding(s) 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 an ‘overall’ advice level based on the health assessment plus an advice level for each suggested condition. There are eight advice levels, each overall advice level has a corresponding text that is shown to the user while condition-specific advice levels are simplified to one of three options - this is outlined in the table below.

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 the ‘Connect’ module is enabled, Connect provides the user an opportunity to review and select relevant partner healthcare services, studies or information. If the ‘Handover’ module is enabled, Ada Assess can give the user the option to share their assessment report with their healthcare provider (Ada Assess will ask the user for specific consent for sharing this data with the healthcare provider).

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 you provide. Please ensure that your provided answers are true and accurate. 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 you (i.e. inaccurate advice levels). If you choose to follow these inaccurate advice levels, the efficacy of the medical device is no longer ensured.
• Ada Assess provides a list of conditions that it has identified as possible causes for your symptoms. This is not an exhaustive list. You may have a condition that is not suggested. Please consult a healthcare professional if you are concerned about your health status.
• Ada Assess may suggest sensitive or upsetting conditions in the assessment report. Do not complete an assessment, if you do not wish to learn information that may cause distress or anxiety.
• When accessing Ada Assess in a web browser, ensure you are 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 you are 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 your local medical emergency services.
• Do not use Ada Assess as a substitute for the advice of a healthcare professional.
• If your symptoms get worse during an assessment, interrupt the assessment and consult a healthcare professional.
• Ada Assess is not a diagnostic tool. If you are concerned about any symptoms, please consult a healthcare professional regardless of the outcome of the assessment.
• Do not wait to seek medical care, if you are concerned about your health. Waiting may lead to delayed care and cause deterioration of your 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 normalisation of health-seeking behaviour.

5. Expected Clinical Benefit

• Timely and accurate symptom assessment for the lay user
  Ada Assess provides timely and accurate symptom assessment for the lay user. Through an interactive dialogue interface, it enables the user to input their symptoms and it makes available an initial assessment of these symptoms, and generates a list of possible conditions (condition-suggestions).
• User peace of mind, health information access & health awareness
  This function carried out by Ada Assess is therefore similar to the assistance traditionally obtained at home through looking up a family medical encyclopaedia, and that is often obtained today through an internet search of symptoms. Ada Assess has the advantage over these alternative sources of medical information, as it provides tailored advice, which is derived from its medical knowledge base. This knowledge base is curated by expert medical doctors, and the advice provided to each user is based upon individual intelligent medical reasoning applied to their constellation of symptoms. This provides the user with access to immediate, mobile, and relevant health information 24/7 (in non-emergency situations). This health information helps users to take ownership of their physical and mental health.
• Care navigation & engaging the patient in the diagnostic journey with their healthcare provider
  Ada Assess also provides guidance about appropriate next steps in a user’s engagement with health care providers. As an example of guidance, the user is provided with an indication of whether they can manage their symptoms at home, or whether they should book a routine appointment with their primary care practitioner, or whether they should seek urgent medical care in a hospital emergency room.
• Facilitation of interaction between the user and their health care professional
  Ada Assess supports the user/patient to perform an initial self-assessment of their symptoms and provides a highly usable easily understandable symptom-level health assessment. This report can, if the patient and healthcare provider wish, be shared with the healthcare provider and can facilitate interaction - speeding up communication of symptom information, freeing up time for quality communication between the healthcare provider and patient) and/or increasing health care provision efficiency. Feedback provided by users who used Ada Assess at home and user questionnaires in clinical studies confirm user-perceived clinical benefit in better understanding their symptoms, and doctor perceived clinical benefit on the facilitation of patient-doctor conversation, rapport and inter-communication.
• Potential for appointment prioritisation
  Pre-assessment of patients (based on their presenting symptoms) can also help clinicians/practices to better identify the need of intervention and can help prioritise patient appointments.

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 is available as an SDK (software development kit) in two options:

8. Get In Touch

8.1. Report a Safety Concern

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

In addition to the notification of our Medical Safety team, serious incidents, i.e. death, serious deterioration of health or public health threats, shall be reported to the competent authority for medical devices of your country.

8.2. Customer Support

If you have questions or require 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 you at no additional cost within seven calendar days after receipt of your request.