Prioritising Patient Safety in Digital Health

Introduction

Ada Health stands with the World Health Organization on World Patient Safety Day in calling for global solidarity and concerted action to improve patient safety.

In the still relatively nascent yet rapidly evolving landscape of digital health, there must be a considered, central role for safety.?

“To move fast and break things” in this arena simply does not apply when health is on the line.?

This doesn’t mean speed cannot be achieved just that it shouldn’t be prioritised above all else. Speed proportional to risk and fixing things is a more fitting approach.

Taking Safety Seriously

As a medical device manufacturer we have certain responsibilities, top of which is ensuring the safety of our users. In practice this means having systems in place both before and after a new product is released to the market or even when a seemingly innocuous software update takes place.?

Safety is baked into our entire Software Development Lifecycle.

Pre-market activities are addressed through stringent verification and validation processes overseen by our Medical Quality Team. Additionally, our Medical Knowledge Engineers, clinicians by training, oversee the curation, maintenance and validity of the medical information that underpins Ada’s medical reasoning.

Post-market activities at Ada consists of a comprehensive system of reactive and proactive monitoring for medical safety issues.?

There are 3 key factors:

1. The Human Touch: the input of our Medical Safety team experts alongside the Customer Experience and Client Success teams in analysing and interpreting data as well as responding personally to our users and clients. Our Medical Affairs team plays a parallel role in establishing trust and understanding with clinician partners through regular dialogue. (Meet our medical experts).
2. Automated & Scalable Surveilling of use across the product portfolio, geographies and user demographics.
3. Clinical Data Gathering Activities including clinical studies. (See our studies and research).

This means we have deeply data driven population level insights delivered to teams and partners, but equally the voice of the individual user shines through enabling us to monitor for bias, equity and fairness.

Safety in Principle

The utility of products such as Ada’s relies on safety and accuracy.

Ada is committed to doing the right thing through building the thing right, evidenced through our Class IIa certification under EU Medical Devices Regulation (Regulation 2017/745), ISO 13485 and ISO 27001 certification.

Safety is a key marker of performance in both our internally produced research as well as that undertaken by independent experts.

Our Medical Safety Team’s Vision:

We want to see a world where users trust Ada products because they are safe, designed to address their needs, and demonstrably improve their health outcomes.

Our Medical Safety Team’s Mission:

Safety Across the Product Life Cycle: From Ideation to Delivery

We prioritise safety from the very beginning, from brainstorming new ideas (in Principle) to the development and testing phase (in Theory) and even after deployment in the market (in Practice). Safety should be an intrinsic part of every stage - industry leading safety by design.

The Medical Safety Team's Principles

1. Nurture a Safety-First Culture
2. Proactive Safety Stance: Anticipate, Don't React
3. Innovate with Regulatory Compliance at the Core
4. Actions Rooted in Integrity

Safety in Numbers

With the above guiding principles and values in mind, here are some safety insights from a spectrum of related research featuring Ada:

• Ada’s advice safety was on par with GPs (Gilbert et al. BMJ Open, 2020)
• Ada’s recommendations were comparable to triage nurses’. (Morse et al. JMIR, 2020)
• Ada's exhibited disposition safety was 14% higher than the all-app average. (Ceney et al. PLOS ONE, 2021)
• Ada’s advice was rated equivalent to telephone triage (Cotte et al. JMIR mHealth, 2022)
• Ada provided safe and appropriate advice level triage in almost all cases (Foda et al. published poster at HIMSS Conference, 2023)

Safety in Practice

The Medical Safety team receives inputs from any number of sources ranging from social media mentions through to the triggering of automated trend monitoring dashboards. We invite and acquire insights from employees, users and client clinicians.?

By seeking, surfacing and analysing this feedback and channelling these insights into our product development process, we are able to uphold our commitment to continuous improvement.?

A core triad of complementary features exists to optimise user safety for users of Ada’s core symptom assessment and care navigation product.?

Disclaimer

All assessments provided by Ada include a clear statement from the outset that the results do not constitute an official medical diagnosis and that the user is advised to seek professional help if they are seriously concerned about their symptoms or health findings. Ada is not intended for use in critical/emergency situations and this is also made clear in our Instructions for Use.

Roadblocks

However, we appreciate that in certain situations, a user may not recognise they have symptoms suggestive of something more serious. Ada has a roadblock feature for such scenarios. If a user shares one of these symptoms, Ada will immediately stop or “short-circuit” the assessment and inform the user that this is a serious condition and they need to seek medical attention right away.?

Advice Levels

At the end of an assessment, Ada provides condition suggestions and corresponding advice levels to the user. Essentially guidance on what’s likely to be troubling them along with where and how soon they need to seek medical attention.?

This is based on clinically evaluated algorithms updated and maintained by our clinical experts and stress-tested against a bank of thousands of representative synthetic test cases.??

Meet the Team

Ada’s dedicated Medical Safety team is responsible for providing medical safety stewardship for all Ada’s products.?

Safety at Ada is not an afterthought nor a box simply to be ticked. Safety at Ada is baked into our processes and organisational thinking. In order to do so the team is embedded at all stages of the Software Development Life Cycle.?

The diverse team comprises a geographically distributed mixture of physicians, pharmacists, surveillance and vigilance experts as well as those versed in clinical evaluation. This blend of skills and backgrounds means we think about safety holistically - keeping our users safe and Ada compliant. The team works to minimise and mitigate risks which is where their mix of clinical expertise, deep familiarity with regulatory requirements and awareness of emerging trends is vital.

Conclusion

At Ada we keep the end users of our products in mind throughout the process of design, development and deployment, be they patients or clinicians. Safety and demonstrable commitment to quality are key to establishing trust. Ada has been around long enough to have witnessed the initial ‘wild west’ of AI in healthcare and has used that time to reinforce what makes us stand out as the trustable partner in the space.?

• We remain agile and responsive by assessing emerging technological trends such as LLMs and scoping the constantly evolving regulatory landscape.?
• We proactively help set the bar for what good looks like through leading the topic group of symptom checkers in ITU/WHO AI for Healthcare benchmarking.?

We believe in moving at a speed proportional to risk and fixing things rather than moving fast and breaking them instead.