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Babylon Health Regulatory

App Name:

  • PGMT
  • Checkbase
  • Healthcheck
  • Triage

Version Number:

  • PGMT: version 5
  • Checkbase: version 1
  • Healthcheck: version 1
  • Triage: version 1

PGMT: 26 APR 2019
Checkbase: 17 DEC 2018
Healthcheck: 26 JUN 2019
Triage: 11 NOV 2019

Babylon Partners Ltd
60 Sloane Avenue
London, SW3 3DD, UK
support@babylonhealth.com
+44 (0)20 7100 0762


Intended Use (PGMT and Checkbase):

The Symptom Checker encompassess two key products known as Checkbase and PGMT. Both of these products are classified as Class 1 Medical Devices. Whilst the underlying architecture varies, the final outcome for both products is very similar. The Symptom Checker is intended to provide information and, in certain instances, triage advice that will inform users of appropriate forms of assistance based on the medical symptoms they enter.

PGMT covers common primary care conditions and their associated symptoms. All assessments of symptoms in a person registered with GPathand will use the Checkbase system. All assessments of symptoms in a person below the age of 16 will use the Checkbase system. Neither system is appropriate for use during pregnancy. Only Checkbase supports the assessment of dermatology conditions and their associated symptoms.


Intended Use (Healthcheck):

Babylon’s mobile application ‘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 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.

Intended Use (Triage):

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, and may also be given some information about possible causes for what the information they entered (and their associated likelihoods). This will be accompanied with self-care advice, where appropriate. The conditions for which the service can provide information include common primary care conditions. The system is not appropriate for use during pregnancy.

Triage is intended for use by adults over the age of 16 excluding pregnant women. Triage is intended for use by lay persons.

Warnings:

  • Do not use the Symptom Checker in an emergency. Prior to entering the chat flow users are advised “if this is an emergency, please call 999”.
  • The Symptom Checker is powered by artificial intelligence and is not a real clinician.
  • Output from the Symptom Checker does not constitute medical advice, diagnosis or treatment; it provides triage advice based on the combination of symptoms that a user enters.
  • A list of possible causes that may cause these symptoms, which may be shown to a user, does not provide a personal diagnosis and is for information purposes only. The likelihood indicates the probability that a person with similar symptoms and risk factors would have this condition.
  • If your symptoms persist, change or worsen, or you are concerned, seek further advice.
  • The Symptom Checker 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
  • The Symptom Checker 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.
  • Cqc Babylonhealth
    We care about quality

    We passed our Care Quality Commission inspection with flying colours.
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  • Bsi Iso Babylonhealth
    Your data, safe in our hands

    We’re BSI certified: ISO 27001 under certificate number IS 710950.
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  • Logo Ce
    The medical app you can trust

    Our chatbot triage service is registered with the MHRA and CE marked as a Class I medical device, which means it conforms to all European regulatory standards. MHRA registration number 7139