At Babylon, we are proud to have a strong safety culture across our engineering, product and clinical operations teams. We closely monitor all aspects of safety, so that we comply with best practice in all areas and adhere to gold safety standards globally. Our teams in the UK, Rwanda, Canada, Asia, KSA and USA are involved in the ongoing work to ensure our innovative services remain safe and compliant to local regulatory standards.
We meet all relevant regulations in every country or territory where we operate
For global consistency and as best practice, we follow the same high standard of clinical safety testing as in the United Kingdom where clinical safety standards need to meet those of a medical device. Specifically, we follow Clinical Risk Management best practice principles from ISO 14971 and NHS Safety Standards DCB 0129 and DCB 0160 on product risk assessment. Furthermore, our Quality Management System is certified to ISO 13485.
We only employ local clinicians committed to safety
Babylon's Clinical Safety Team is led by our Clinical Safety Officer who oversees all clinical safety work carried out across Asia Pacific, in close collaboration with our certified and experienced locally appointed doctors.
- For each country across Asia Pacific where Babylon’s products are live, locally registered clinicians are employed to validate our products. They have to be highly skilled at their job, but also excellent communicators. We apply rigorous testing and suitability assessments to all of our clinicians. They are all independently registered with their local professional bodies and have a professional obligation to highlight any concerns they may have about the safety of the service that they are delivering.
- Local doctors validate translation in localised languages, adapt where necessary to ensure cultural appropriateness and localise disease content. Local doctors review triage advice and adapt where necessary to ensure appropriateness and safety for the local healthcare system.
We have built a detailed governance protocol for our evolving technology
- Our Clinical Artificial Intelligence (AI) Governance merges statutory, regulatory and professional best practice to ensure our AI helps make it easier for our users to take care of themselves and their loved ones. Our approach to AI Governance consists of:
- Quality Audit – A cyclical process of improving the quality of our AI via auditing against applicable national and international standards of best practice;
- Effectiveness - Optimization of processes through application of knowledge derived from our Scientific Research team, external research, clinical experience and user studies;
- Education and Training - Continual training of our staff and AI technology to ensure the highest quality of clinical data and knowledge is used in the development of all our AI;
- Research and Development – Our Scientific Research team publishes peer-reviewed research and works with researcher from multiple universities to ensure best research practice;
- Risk Management – Our robust methodology assesses and manages risk based on applicable national and international standards of best practice, such as Clinical Risk Management best practice principles from ISO 14971 and NHS Safety Standards DCB 0129 and DCB 0160 on product risk assessment;
- Information Management – We comply with applicable data protection laws in markets where our products are available, and follow best practice in the ethical, secure and legal use of personal data in the delivery of health service;
- Openness – We engage with the global community of clinicians, our users and the wider public and welcome both feedback and compliments!
- We are working with the World Health Organisation and other health authorities to develop better ways of governing and assessing technology like ours.
We support and train our teams
All of our staff undergo initial training and are constantly updating their knowledge throughout their time with us.
Safety is the responsibility of every employee at Babylon
We have an official whistleblowing policy at Babylon, whoever you are, you can easily raise a concern without any worries.
We are transparent and welcome feedback
We work with experts from across the global community of clinical colleagues and consider feedback wherever it comes from.
Frequently Asked Questions
Question 1: What steps are taken by Babylon when safety concerns are raised by users?
We acknowledge and take all feedback seriously. All issues including those that have a safety concern go through Babylon’s Global Incident Management Process. Each issue is then risk assessed appropriately so that all concerns that are deemed to be of a high priority are assessed immediately, regardless if the issue has been raised outside of regular working hours. By providing a 24/7 365 day cover from a safety perspective, our relevant team members are always on standby to carry out the necessary safety checks, whenever a safety issue is raised. The first step would be to replicate the issue encountered by the user and verify the presence of a gap in safety. Where there is one, a multidisciplinary review involving clinicians as well as safety and regulatory officers will be convened to stratify the risk, determine the urgency of fix and identify the best measures to fill the gap. After implementation of the new measures, steps will be taken to ensure that the gap has been closed effectively with no chance of recurrence.
Question 2: How often does Babylon review its internal processes related to safety?
Our Quality Management System (QMS) meets ISO 13485 standard, which consists of requirements for a comprehensive quality management system for the design and manufacture of medical devices. Our risk management process is a part of our QMS, and is reviewed at least once a year. Additionally Babylon also has an internal audit schedule completed by external auditors to help improve any areas and incorporates any findings into improving our processes.
Question 3: How does Babylon ensure a product is safe for use before and after it has been launched in any country?
All new products as well as updated versions of existing products undergo rigorous premarket safety testing. Products are only released into the market after having satisfied internal safety standards. Postmarket surveillance of launched products will be conducted to detect and fix aftermarket safety issues after initial launch, after each major update as well as at regular intervals during sustained periods without major updates. Babylon also conducts post deployment monitoring to support safety requirements so that we have confidence that our product is safe for our users.
Question 4: What is Babylon’s overall approach to safety?
Babylon follows clinical risk management process that was created based on national and international standards, i.e. NHS Digital DCB0129 and DCB0160 on clinical risk management, ISO 14971 on medical devices risk management, and IEC 62304 on software lifecycle processes. Clinical risk is based on technical and scientific knowledge and link to the protection of end users. This process has been assured as part of our ISO 13485 certification.
Question 5: How are the safety standards Babylon abides by in the United Kingdom applicable in Asia, and what safety standards does Babylon abide by in Asia?
Babylon complies with applicable national and international safety standards. In the UK, we follow the NHS Digital safety standards on clinical risk management. On an international level, we follow best practice standards such as the ISO 14971 medical devices risk management. This is also an integral part of our Quality Management System as required by our ISO 13485 certification.
Question 6: How does Babylon ensure that the applicable possible outcomes are given to users consistently?
Within the same version of each product, the mechanisms that determine the outcomes (differential diagnoses and triage for Symptom Checker, risk assessment reports and advice for Healthcheck) will always be consistent for the same set of user inputs. Between successive versions of products, there may be improvements and upgrades in these mechanisms and hence the outcomes may differ.
Question 7: Why are Babylon’s products only intended for use by adults aged 18 years and above and not applicable for pregnant women?
Babylon’s Healthcheck and Symptom Checker products are designed for the general population as it is based on disease incidence and risk factor prevalence of adult and non-pregnant populations only.
As a result, the population level data underpinning the disease risk model is based on the general population of those aged over 18. Risks are calculated based on the assumption that all lifestyle and risk factors will remain the same for the foreseeable future. The epidemiological data used in localisation does not take specific requirements of pregnant women into account, rather that of the general population. This is because the transient changes in factors such as physical activity, alcohol intake, smoking and BMI while pregnant would inevitably impact the disease risk prediction.