Babylon Regulatory

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Manufacturer:

Babylon Partners Ltd
60 Sloane Avenue
London, SW3 3DD, UK



Distributor:

TELUS Health Solutions Inc.
630 René-Lévesque Blvd. West, 22nd Floor
Montréal, Québec
H3B 1S6, Canada


App Name: Triage

Version Number: 4


21 JAN 2021



Intended Use:

Triage is a chat-based informational service that analyses the initial user input, then goes through a series of questions matched to that input (the majority of these are predetermined question flows written by clinicians; a portion is chosen using AI). After this the user is provided with some information about the location and timescale in which they might need to be treated. This is accompanied by general self-care advice, where appropriate.

Triage is intended to be used by lay people over the age of 16. The patient population includes cisgender (people whose gender identity matches their sex at birth) presenting with a common primary care condition (excluding pregnancy, and some mental health and dermatology conditions). Users must be over the age of 16. However, Triage provides health information for all age groups. This means that someone over 16 can use the product on behalf of all age groups.

Triage is not intended for use in an emergency or during pregnancy.


Warnings:

  • Do not use Triage in an emergency.
  • Triage is powered by artificial intelligence and is not a real clinician.
  • Output from Triage does not constitute medical advice, diagnosis or treatment; it provides triage advice based on the combination of symptoms that a user enters.
  • If your symptoms persist, change or worsen, or you are concerned, seek further advice.
  • Triage is only for users aged 16 and over.
  • You should read our terms and conditions for more information.
  • Where appropriate we use error messaging to guide users to improve inputs such as incorrect passwords
  • Triage is not suitable if you have the following symptoms or are at all concerned
    • 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 weakness, inability to hold both arms up, or difficulty speaking.
    • Severe breathing problems.


App Name: Healthcheck

Version Number: 2


23 APR 2020



Intended Use:

Healthcheck is intended to be used as a health self-management tool, to assess the users’ overall general health, in relation to lifestyle, mental health, current organ health and future disease risk. The software collects user information by asking a number of questions; based on the answers and information from national guidelines and standard medical practice, it provides the user with a general health assessment and general wellness advice, provided in text form and interactively on a digital human replication.

The app is designed to be used by laypersons over the age of 18 for their own use in a non-clinical environment. It is intended for use only for general wellbeing purposes or to encourage or maintain a healthy lifestyle, and is not intended to be used for any medical purpose (such as the detection, diagnosis, prevention, monitoring, management, treatment or alleviation of any medical condition, disease or injury). Any health-related information provided by this device or software should not be treated as medical advice.


Warnings:

  • Output from Healthcheck does not constitute medical advice, diagnosis or treatment and is for information purposes only.
  • You should read our terms and conditions for more information.
  • Where appropriate we use error messaging to guide users to improve inputs such as incorrect passwords.
  • Healthcheck is only for users aged 18 and over.
  • Healthcheck is not suitable for pregnant women.
  • Healthcheck is not suitable for users with long term medical conditions or disabilities that may have different needs or risks than shown


App Name: Monitor


Version Number: 2


01 MAR 2021



Intended Use:

Monitor is intended to be used as a health self-management tool, to help a user manage and feel in control of their everyday health and lifestyle. This is done by allowing users to track health metrics (such as their mood, activity and body measurements) manually and/or automatically from wearables in order to get insight into their health by discovering trends for these metrics and tracking progress. Users are also able to access content to help them understand, develop and maintain new habits to improve their health.

The app is designed to be used by laypersons over the age of 16 for their own use in a non-clinical environment. It is intended for use only for general wellbeing purposes or to encourage or maintain a healthy lifestyle, and is not intended to be used for any medical purpose (such as the detection, diagnosis, prevention, monitoring, management, treatment or alleviation of any medical condition, disease or injury). Any health-related information provided by this device or software should not be treated as medical advice.


Warnings:

  • Monitor is only for users aged 16 and over.
  • Monitor is not suitable for pregnant women.
  • Monitor is not suitable for users with serious, trauma or life-threatening emergencies.
  • Output from Monitor does not constitute medical advice, diagnosis or treatment and is for information purposes only.