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Why safety is paramount in digital health

10 March 2021 in Company

A great user experience isn’t enough when you’re designing a new digital health solution – it has to be trusted as well.

In healthcare, the only path to trust is a rigorous and expensive safety regime. That requires a bold decision for any start-up: investment in an intangible concept that can’t directly be shown to drive growth or revenue.

Healthily took the decision to invest in safety from its inception and as a result has developed world-leading processes and systems to protect our users.

Leadership

We started with leadership. One of our first senior appointments was Prof Maureen Baker, CBE, the former chair of the Royal College of General Practitioners, and the person who literally wrote the first digital safety manual for the UK’s National Health Service (NHS).

Maureen came to Healthily and immediately got to work implementing our Clinical Safety Management (CSM) system. This work underpinned our efforts to be the first self-assessment tool to achieve a Class I Medical Device certificate from the Medicines and Healthcare products Regulatory Agency.

We are in the process of applying for 2 other international standards: ISO 13485 to ratify our quality management system and ISO 14971 to confirm we understand the management of risk.

Underpinning and delivering this CSM system is our team of expert medical personnel who all have at least 5 years’ clinical experience and continue to practice as doctors or consultants. Many are PhD graduates with an interest in research and links to leading university academic departments.

Providing oversight and advice on all medical decision-making is our Clinical Advisory Board, chaired by Dr Mark Davies, the Chief Medical Officer of IBM (EMEA), IBM Watson and a former National Clinical Director for the NHS.

Healthily was the first self-assessment tool to create a clinical advisory board to independently scrutinise its clinical quality and efficacy. The board’s quality and content committees work closely with our safety team, led by Dr Rebecca Thomas.

Continuous quality improvements

Another key part of our work on safety is continuous quality improvements.

While our Clinical Safety Officer looks after day-to-day safety, the rest of the medical team focuses on the strategic and structured quality improvement of our platform. This is done by continuously looking at user feedback, examining the results of various tests based on medical stories (vignettes) and reviewing daily automated tests as well as prediction tests known as Monte Carlo simulations.

The medical team works very closely with our data scientists to constantly add more data points to the system and test how these increments make the system more precise.

The AI platform today covers more than 600 medical conditions, several hundred symptoms, multiple influencing factors and all the main red-flag scenarios. The Healthily plan is to reach more than 1,000 conditions covered in the next 18 months.

Independent validation

Finally, we have led the industry by insisting on independent appraisals of our quality controls and safety.

In 2020 we commissioned Imperial College London’s Self-Care Research Unit and the Royal College of General Practitioners to independently create a methodology that would test our ability to accurately suggest appropriate next steps to users based on their profile and symptoms.

This extensive study resulted in a finding that our triage advice is safe (or over cautious) 99% of the time. Based on this initial landmark research, we are now working with leading academics from around the world to build on this methodology and create a ‘real world’ test of our self-assessment tool.

Also, in 2020 we asked the Professional Records Standards Body (PRSB) to create a team to examine the internal processes followed by our team, which constitute our quality management system (QMS). To our knowledge, this is the first time any self-assessment tool has given free access to an organisation to scrutinise and vet every aspect of its business processes. This intense 2-month review process concluded in a public report published by the PRSB.

Most of this work is hidden behind the Healthily app and website, but we’re proud of the time we’ve taken in the areas of quality and safety. Our commitment to our users is that we will continue to strive for excellence in these fields.

Important: Our website provides useful information but is not a substitute for medical advice. You should always seek the advice of your doctor when making decisions about your health.

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