Babylon Regulatory
21 JAN 2021
Manufacturer:
Babylon Partners Ltd
1 Knightsbridge Green
London, SW3 3DD, UK
support@babylonhealth.com
Distributor:
TELUS Health Solutions Inc.
630 René-Lévesque Blvd. West, 22nd Floor
Montréal, Québec
H3B 1S6, Canada
Intended Use:
Triage is a digital symptom assessment service. It is driven by a computer program, built with doctors. Users report symptoms and personal health information and answer related questions. The computer program suggests what level of care to get, and when to seek it. Sometimes, it also provides general self-care advice and a list of possible conditions.
Contraindications:
Triage must not be used in these situations:
- In an emergency
- For life-threatening symptoms such as (but not limited to):
- Symptoms of a heart attack, including severe chest pain, which may spread to other parts of the body. The pain may be associated with sweating, shortness of breath or nausea
- Symptoms of a stroke, including facial weakness, loss of arm movement or difficulty speaking
- Severe breathing problems
Triage must not be used by:
- Anyone under the age of 16. People over 16 can use it for children under 16
- Anyone who does not have the capacity to decide on their own actions
Triage must not be used to check symptoms for:
- People who are pregnant
- Anyone whose gender identity does not match their sex at birth
This is because pregnancy and sex at birth can impact a range of health conditions that Triage is still learning about.
Triage must not be used outside of the region which the product version was designed for. These users should follow local or national guidelines.
Your supported region is indicated in the product specifications section below.
Intended outcome limits:
Triage has the following limits to its intended outcomes:
- Triage should not be used in place of talking to a healthcare professional
- Triage does not give a medical diagnosis. Medical diagnosis usually needs a full assessment by a healthcare professional. This may include medical history, physical examination and tests
- Sometimes, Triage gives information about how conditions may be treated. This is general information, not specific to the user or their medical concerns. It is not treatment advice. Users should not do or stop doing anything (such as taking medicines) based on this information
- Healthcare professionals should not use Triage as a diagnostic or triage aid
Product specifications:
| Triage | |
| Hardware requirement (not supplied with the product) | Android / iOS device (phone; tablet) |
| Internet access required: | Yes |
| Minimum OS requirement | Android: OS version 5 (API 21) Windows macOS |
| Min. screen resolution | 640px × 1136px |
| Supported Region(s) | Canada |
| Supported Language(s) | English and French |
| Symptom coverage | Over 400 symptoms with more than 1700 key words |
| Software lifetime | 5 years of this release (from version release date indicated) |
App Name: Healthcheck
Version Number: 4
21 JAN 2021
Manufacturer:
Babylon Partners Ltd
1 Knightsbridge Green
London, SW3 3DD, UK
support@babylonhealth.com
Distributor:
TELUS Health Solutions Inc.
630 René-Lévesque Blvd. West, 22nd Floor
Montréal, Québec
H3B 1S6, Canada
Intended Use:
Babylon’s mobile application ‘Healthcheck’ is intended to be used as a health self-management tool.
Healthcheck collects information about the user by asking a series of questions. Using this information, Healthcheck provides the user with general health assessment insights and general wellness advice.
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 risks within 5 years.
It is intended to be used for general wellbeing purposes or to encourage or maintain a healthy lifestyle.
Healthcheck is intended to be used in a non-clinical environment.
Contraindications:
- Do not use Healthcheck for medical purposes such as the detection, diagnosis, prevention, monitoring, management, treatment or alleviation of any medical condition, disease or injury.
- Do not treat any health-related information provided by this device or software as medical advice.
- Healthcheck should not be used:
- by anyone below the age of 18
- by anyone whose gender identity does not match their sex assigned at birth
- by anyone with emotional or cognitive difficulties
- by anyone with serious or life-threatening emergencies,
- by anyone with trauma
- by anyone with rare conditions
- by anyone who is pregnant
- on behalf of others
Intended outcome limits:
Healthcheck has the following limits to its intended outcomes:
- The Healthcheck application does not provide medical triage advice and is not intended to provide prescriptive decision outcomes.
- Users are expected to use all reasonable decision-making capabilities to come to their own final decision.
- The Healthcheck application is not intended to be a replacement for a medical opinion.
- The Healthcheck application is not intended as a diagnostic or triage aid to healthcare professionals, nor as a replacement for healthcare professionals.
- The Healthcheck application outcomes that contain advice concerning overall health status or lifestyle is generic and not specific to a user’s particular clinical situation, and is provided as information only.
Product specifications:
| Healthcheck | |
| Hardware requirement (not supplied with the product) | Android / iOS device (phone; tablet) |
| Internet access required: | Yes |
| Minimum OS requirement | Android: OS version 5 (API 21) Windows macOS |
| Min. screen resolution | 640px × 1136px |
| Supported Language(s) | English and French |
| Therapeutic coverage | 22 diseases |
| Software lifetime | 5 years of this release (from version release date indicated) |