Latest update: 2024-08-30
Table of contents:
- Intended Use
- Performance
- Regulatory Information
- Manual (HCP)
- Reporting Issues and Support Contacts
- Maintenance and Installation
Intended Use
Red Robin is a software application that is intended to automate pre-clinical triage and initial medical history taking, to support clinical decision making and patient management.
Red Robin enables the:
- remote capture of patient complaints,
- presenting potential differential diagnoses, and
- suggested urgency of the patient case.
The application utilises artificial intelligence to structure its logic, and is intended to be combined with a digital healthcare platform.
Users
Healthcare users: The healthcare users consist of healthcare professionals, such as physicians, nurses, psychologists, physiotherapists. They interact with the outcome of Red Robin through the Red Robin decision support.
Patient users: Patients engage with Red Robin exclusively through its chatbot interface, which is designed to gather initial medical history and triage information in a conversational format. These users do not get any access to output data such as suggested differential diagnosis, urgency, nor any recommendations concerning treatment options.
The intended population is human beings over 12 months of age experiencing new or recently emerged medical concerns and seeking medical consultation for their condition from healthcare providers.
Indications for use
Healthcare users: Healthcare providers or other organisations that are in need of an automated system to perform a pre-clinical assessment of the incoming patient cases, in order to prioritise their resources.
Patient users: Human beings over 12 months of age experiencing new or recently emerged medical concerns and seeking medical consultation for their condition from healthcare providers. The service can be used by an agent, a person who is seeking aid on behalf of another. The user of the device should be 13 years or older, from which age users can be considered to be capable of describing their complaints using a digital device on their own. This age limit is based on the common practice of the markets where the device is sold, and local regulations or the healthcare provider may require a higher age limit. For patients between 12 months and 13 years, an agent should operate the device on behalf of the patient.
Contraindications
- This product is primarily designed for addressing new or emergent healthcare concerns and may not be suitable for healthcare providers primarily engaged in the long-term management of chronic diseases.
- Given its focus on newly emerging health concerns, this product may not seamlessly integrate into established routine care practices that do not frequently encounter such issues.
- This product does not take into consideration medicinal information, and can not assess if the conditions described by the patient are expected side effects of any current treatment plan.
- This product is not designed to assess or manage dental conditions.
- The service should not be used in patients that are younger than 12 months of age.
- Patients who know they are pregnant should not use the service.
- The service should not be used in case of an emergency, for example if the patient has the following symptoms:
- Severe, heavy or crushing chest pain, which may move to jaw, neck, arm, or back, or be associated with sweating, shortness of breath or nausea.
- Signs of a stroke, which may include facial drooping, inability to hold both arms up, or difficulty speaking.
- Severe breathing problems.
- Suspected poisoning.
- Loss of consciousness or sudden confusion.
- Sudden difficulty moving such as following a severe injury.
- Heavy bleeding that won’t stop.
Limitations
Patients that do not consider themselves to be cisgender (people whose gender identity matches their sex at birth) may get inapplicable questions regarding their condition.
The service doesn’t have data regarding prior knowledge of the patient, such as previous or chronic health conditions or medication history.
Disclaimers
The service does not treat a patient, determine a patient's treatment, or provide a definitive diagnosis of a patient's disease or condition. The service does not replace a thorough medical history and examination. The service focuses on the presenting complaint (PC) and history of presenting complaint (HPC) and does not factor in comorbidity or prior knowledge of the patient.
The service is only intended to inform the healthcare professional about potential clinical urgency, and potential differential diagnoses that could be the cause of the combination of the patient's signs and symptoms. It is not the intent that the healthcare professional shall rely primarily on any of such suggestions to make decisions about prevention, diagnosis or treatment of a disease, nor assessing the condition for an individual patient.
- The service is primarily, but not exclusively, meant for being used by patients with newly emerged complaints.
- The service is primarily, but not exclusively, built for primary care use cases.
- The service doesn’t have data regarding prior knowledge of the patient, such as previous or chronic health conditions.
- The service must not be used outside of the region which the product version was designed for. These users should follow local or national guidelines.
Performance
Once every three (3) months a Post-Market Surveillance Update Report (PSUR) meeting is conducted. The outcome of this meeting is a report following our Post-Market Surveillance (PMS) Plan. This ensures that new information about safety and performance is proactively collected and can be used as input for risk management, clinical evaluation, and product development of our products. In addition, Post-Market Clinical Follow-up (PMCF) studies which aim to answer specific questions regarding the device's performance are carried out.
Below you'll find key performance metrics from our PMS plan and recent PMCF studies.
Clinical evaluation
Differential diagnoses - Sensitivity
The diagnostic sensitivity of Red Robin is 95%, based on the PSUR report from 2024-01-16. This metric refers to how often the diagnosis by the healthcare professional (HCP) was indicated as correct was suggested by Red Robin.
Urgency - Sensitivity
Grouping Red Robin's triage urgencies into Emergency (urgency 1-3), 24H (urgency 4-5), and Routine (urgency 6-8), the sensitivity for each group was:
- Emergency: 89%
- 24H: 77%
- Routine: 92%
The sensitivity refers to how often the urgency from Red Robin placed the patient here when the urgency indicated by the HCP placed the patient in this group. This data is based on a PMCF study from 2024-02-23.
Data security and vulnerability
Service uptime
The service uptime percentage ensures that the service is up and operational.
The service uptime was >99.9%, based on the PSUR report from 2024-01-16.
Regulatory Information
Requesting instructions for use in paper form
This instruction for use is provided in an electronic form. If you have the need for an instruction for use in paper form, please contact Visiba at support@visibacare.com. Instructions for use in paper form can be obtained within 7 calendar days without additional cost.
External services
Red Robin uses a service for dermatology analysis provided by AI Labs Group SL which is a CE-marked MDD Class I device. Images of skin-related issues uploaded to Red Robin may be sent to the module Legit.Health (https://legit.health/) for analysis.
Red Robin is available in the following regions
| Region | Representative |
| Sweden | Visiba Group AB |
| United Kingdom | Visiba UK Limited |
| Finland | Visiba Group AB |
Manufacturer
Visiba Group AB
Krokslätts Fabriker 61
431 37 Mölndal
Sweden
contact@visibacare.com
https://www.visibacare.com
Manual (HCP)
What is Red Robin?
Red Robin is an automated medical history and triage tool based on a Bayesian network (an AI model created from a combination of data and human expertise). Red Robin is continuously being tested and updated by a medical team. Healthcare organisations are connected to Red Robin in their own choice of system.
Red Robin helps to take the medical history of patients seeking medical care or patients (including children aged 12 months and above) whose representatives are seeking medical care on their behalf. In the first step, the patients can express their inquiry in their own words; Red Robin then identifies symptoms so that it can ask relevant follow-up questions about the symptoms and any risk factors. Once the patient has answered all the questions, Red Robin calculates the urgency and the likelihood of various diagnoses. Following that, depending on how the system is configured, the patient might be referred to a particular healthcare consultation setting, such as booking a video consultation, a drop-in waiting room, or an online chat.
Red Robin provides triage endpoints based on the information provided (urgency and potential differential diagnoses) presented in the Red Robin Decision Support. This includes a summary of the patient’s Red Robin chat history, as well as any images or other files the patient has uploaded. Please note, that the potential differential diagnosis suggestions are only intended to highlight diagnoses that may be related to the patient’s symptoms and it remains the responsibility of the healthcare provider to assess and diagnose the patient.
After assessing the patient, the healthcare professional can feedback on the urgency, diagnoses, and actions to be taken. This information is then used to improve Red Robin's accuracy and make the application more reliable over time.
How the AI works
Red Robin uses a Bayesian network model, which asks questions based on the patient’s previous answers. This method helps to gather relevant information efficiently. The Bayesian model uses probabilistic reasoning to evaluate the likelihood of different conditions based on the responses provided by the patient. The Bayesian network model is designed to perform consistently and accurately. Its methodical approach helps in making precise preliminary assessments, supporting healthcare professionals in their decision-making process. The performance levels can be found in the section Performance.
Triage endpoint - Urgency
The urgency given is based on the patient's medical history. This means it will be either the highest urgency indicated directly by a symptom or risk factor the patient has confirmed or the urgency exceeding its cumulative probability threshold as a result of the differential diagnoses. By considering both the symptoms themselves, as well as the diagnoses they may be caused by, a more robust urgency assessment can be made compared to only considering either factor alone. This information is intended to aid healthcare professionals in prioritization and triage of new cases, what is called “pre-clinical triage”.
The order of priority has been developed based on accepted advice and medical assessment guidelines. It ranges from priority 1 to 8, where each score can be translated to a suggested maximum waiting time to meet a healthcare professional:
| Priority | Urgency |
| 0 min | |
| 10 min | |
| 60 min | |
| 4 hours | |
| 1 day | |
| 1 week | |
| 1 month | |
| Self-care |
This triage system means that healthcare providers can get a quick summary of incoming cases and see the recommended order in which the cases should be reviewed. The patient cannot see what priority has been recommended, as that information is only visible to the healthcare practitioner.
However, any patients who, after describing their problems and answering questions in the Red Robin chat, are categorised as priority 1, 2, or 3, will see a stop sign in the application informing them that they should be aware and should promptly get in touch with a healthcare provider. Such patients can choose to continue to proceed in the app or call 111, but the app advises them to contact 999 if it is urgent.
In the case of patients classified as priority 4, the app displays a warning and the recommendation to contact healthcare services within 4 hours instead.
These stop signs increase patient safety and mean that healthcare professionals can feel more comfortable using Red Robin even at times when staffing is low and/or outside clinic reception hours.
Please note: Red Robin does not handle cases automatically, but only offers recommendations that healthcare practitioners can use as a decision-making aid. For that reason, patients will not be suggested self-treatment as an option either.
Triage endpoint - Potential differential diagnoses
The suggestions shown in the Red Robin Decision Support, under the heading Potential differential diagnoses, are intended to be used for assistance and decision-making purposes only, by highlighting diagnoses that may be related to the patient's symptoms. The suggested diagnoses are based on the outcome in Red Robin, i.e. before any clinical examination, lab tests, X-rays, etc. are performed. Red Robin is not intended to replace any healthcare practitioner’s clinical expertise and for that reason, the healthcare practitioner is always responsible for assessing and diagnosing the patient.
The differential diagnoses come with a probability, on a scale from 0% to 100%. These are presented in the Red Robin Decision Support as dots:
 |
Very likely |
 |
Likely |
 |
Quite likely |
 |
Reasonable |
 |
Not likely, but should be taken into account |
The probabilities are based on two arguments:
- Individually tailored incidence rates are based on general incidence rates in the respective country and corrected for risk factors such as age, gender, lifestyle, or underlying medical conditions.
- How well the diagnosis explains the symptoms described by the patient.
Warnings
Responsibility for prioritisation and assessment
The results from Red Robin should not be considered exhaustive or unquestionable truths. Healthcare professionals are ultimately responsible for verifying patient information and prioritising incoming patient cases.Treat Differential Diagnoses as suggestions
The differential diagnosis suggestions should only be considered to be suggestions, based on a pre-clinical assessment. The differential diagnosis list should not be treated as a comprehensive diagnostic analysis and should be approached with a critical assessment.Responsibility for recording relevant data
The information produced and presented by Red Robin may or may not need to be recorded in the patient's electronic health records. It's the healthcare professional who is responsible for recording the data that is believed to be relevant to the patient's case.Incomplete data may affect the assessment
The urgency and triage outcomes are based entirely on the answers and data the patient has shared. Patients may choose not to disclose certain information, and in such cases, Red Robin will not make any assumptions but proceed with the information provided. This also applies to the use of third-party assessment tools that Red Robin utilizes.Multiple medical complaints
The patient may be experiencing one or several medical complaints at the same time, and the answers provided may not all be related to the same medical concern.Administrative cases are not clinically assessed
Not all cases will be clinically assessed by Red Robin. The patient can choose to submit administrative cases, such as questions regarding prescription renewal and medical certificates. The patient will be warned before submitting the case that no clinical assessment will take place. These cases will receive a fixed urgency of 6 or 7. These cases might still need medical consultation!Reporting of an incident
In case Red Robin has in any way been involved in a serious situation that may or may not have resulted in a patient or user being injured or in any way harmed (including data security and protection issues), do not hesitate to report the incident to Visiba at support@visibacare.com. In some Customer Setups, there's also a reporting function in the Red Robin Decision Support.
Hardware and software requirements
Healthcare professionals setup
Final requirements are set by the customer setup, the following is a recommendation
An internet connection is required to use the service.
Recommended hardware:
- PCs (including Mac)
- iPhone and iPad
- Smartphones and tablets running Android
One of the following operating systems is recommended to use the service:
- Windows
- macOS
- iOS (latest 3 major versions)
- Android (latest 4 major versions)
One of the following software is recommended to use the service:
- Google Chrome (at least up to 1 year old)
- Mozilla Firefox (at least up to 1 year old)
- Microsoft Edge (at least up to 1 year old)
- Mobile Safari (at least up to 1 year old)
- Google Chrome for mobile (at least up to 1 year old)
- Web views inside native mobile apps (using iOS or Android native web views)
Patient interface setup
The following are requirements for the patient interface, please read the patient eIFU for more information.
An internet connection is required to use the service.
The service is supported on the following hardware:
- PCs (including Mac)
- iPhone and iPad
- Smartphones and tablets running Android
One of the following operating systems is needed to use the service:
- Windows
- macOS
- iOS (latest 3 major versions)
- Android (latest 4 major versions)
One of the following software is needed to use the service:
- Google Chrome (at least up to 1 year old)
- Mozilla Firefox (at least up to 1 year old)
- Microsoft Edge (at least up to 1 year old)
- Mobile Safari (at least up to 1 year old)
- Google Chrome for mobile (at least up to 1 year old)
- Web views inside native mobile apps (using iOS or Android native web views)
Requirements regarding external interfaces:
- Legit.Health (CE-marked medical device for skin analysis https://legit.health/) requires a minimum of 12 megapixels on the camera used to take a picture analysed by their service. Legit.Health will analyse the quality and content of the image and only return a clinical assessment for images of sufficient quality that contain skin.
Reporting Issues and Support Contacts
How to report issues, incidents, and vigilance
If you have discovered an issue with Red Robin, do not hesitate to report the issue to Visiba Group AB at support@visibacare.com. In case Red Robin has in any way been involved in a serious situation that may or may not have resulted in a patient or user being injured or in any way harmed (including data security and protection issues), please also report the incident to the competent authority in your country:
| Country | Competent Authority | Reported to |
| Sweden | Läkemedelsverket | |
| United Kingdom | Medicines and Healthcare products Regulatory Agency | |
| Finland | Fimea |
In case of a serious incident, contact your operations manager, the responsible medical doctor, patient safety officer, or equivalent.
Support for healthcare professionals
Professional users can contact Visiba, using one of the following channels:
- Email: support@visibacare.com
- Phone: +46 31 788 59 80
If the user uses the platform Visiba Care, it’s also possible to create a support ticket within the Visiba Care service. Some questions/cases are possible to help by self-help. To answer some of the most common questions, a help center is available at https://visibacare.zendesk.com/hc/en-gb/categories/14854075069724.
Support for technical integration
If the question relates to technical integration, please contact Visiba using one of the following channels:
- Email: support@visibacare.com
- Phone: +46 31 788 59 80
If needed, we will set up specific channels for the integration project as well.
Maintenance and Installation
To be able to deliver a safe, secure, and stable service, we regularly maintain our hosting environments in a controlled manner. Any updates on our hosting environments will be done in agreed-upon service windows.
Before use, Red Robin must be integrated with the Customer Setup. The following requirements are placed on the Customer Setup:
- The Customer Setup shall be able to identify each unique completed session to connect the session to a patient
- The Customer Setup shall display without obstruction or limitation, the full GUI component of the Red Robin Decision Support
-
The device shall provide access to the healthcare eIFU from the Red Robin Decision Support.
- The requirements need to be validated and explained within an Acceptance Test held by Visiba and customer representatives before commissioning.
- The customer should have Risk Controls in place to ensure continuous validity after a conducted Acceptance Test.