In recognising the challenges faced by developers and adopters of digital health technologies, NHS England identified a key issue: the complexity of the regulatory environment particularly that related to AI technologies. To address this issue, the NHS AI Lab tasked several agencies with finding a solution. The participating agencies included:

· The National Institute for Health and Care Excellence (NICE)

· The Medicines and Healthcare products Regulatory Agency (MHRA)

· The Care Quality Commission (CQC)

· The Health Research Authority (HRA)

Collectively, their goal was to establish an online service that simplified the regulatory landscape and made it more accessible and understandable for developers and adopters of digital health solutions.

The agencies contracted the services of BJSS, challenging both to create a platform that streamlines access to regulatory information and best practices. In order to support the advancement of AI and digital technologies in healthcare, guidance within the platform also had to be clear, current, and easily navigable.

The Client

The National Institute for Health and Care Excellence (NICE) acts as the secretariat for the AI and digital regulations service (AIDRS) and was our core client for this project. Established in 1999, NICE’s core purpose is to help practitioners and commissioners get the best care to patients, fast, while ensuring value for the taxpayer.

It does this by:

· Producing useful and usable guidance for health and care practitioners

· Providing rigorous, independent assessment of complex evidence for new health technologies

· Developing recommendations that focus on what matters most and drive innovation into the hands of health and care practitioners

· Encouraging the uptake of best practice to improve outcomes for everyone

The project outlined in this case study was commissioned by NICE but overseen by other partners, including the Medicines and Healthcare products Regulatory Agency (MHRA), the Care Quality Commission (CQC), the Health Research Authority (HRA) and the National Health Service (NHS).

The Challenge

In 2019, research from the NHS identified five pain points within the AI landscape that prevent innovators from developing advanced medical technology.

1. Multiple regulators make coordination difficult

2. Regulations can be wrongly interpreted

3. Some areas of regulation may be perceived as cumbersome

4. In some cases, the remit of regulators is unclear to developers and adopters

5. Uncertainties surrounding how certain aspects of AI should be regulated

To tackle four of the five pain points (1, 2, 4 and 5 in the list above), NICE and three other regulatory partners were commissioned to deliver a service that would help developers and adopters navigate regulatory pathways.

The aim of the service was to provide developers and adopters with three offerings to help them understand and navigate the regulatory pipelines:

· Support

· Information

· Advice

NICE contracted BJSS to create this centralised service, with the challenge to compile regulations in one place and create a logical framework that developers could navigate as they advanced their technologies. BJSS needed to incorporate regulatory mandates and best practices in a way that would guide developers through the process and enhance the likelihood of new technologies being adopted by the NHS.

Another challenge was the dense legalese in which so many regulatory pieces were written, such as those outlining steps an organisation must take to get a UK Conformity Assessed (UKCA) mark for their products. BJSS had to communicate the value of simplifying content to make it easier for users to consume.

As third parties cannot influence the regulations laid down by the Medicines and Healthcare products Regulatory Agency (MHRA), the challenge was to find a way of displaying them as simply and as clearly as possible.

The Solution 

The work began by collaborating with the AIDRS partners in an alpha discovery phase, involving deep user research and iterative prototyping. It was decided that the new website would be divided into ‘adopter’ and ‘developer’ guidance so both parties could choose the paths specific to their needs.

As user trust in the reliability and currency of the website’s content was an essential feature, BJSS prioritised the use of simple, understandable language. If users doubted the regular reviews and updates or struggled to follow them, they could disengage. Meanwhile, the website design was structured in a way that enabled content managers to post and update regulatory information with ease, thereby maintaining the website's value and confidence among users.

A particularly vital decision was to separate guidance according to each product’s lifecycle. This would allow developers and adopters to navigate information relevant to each phase of a product's lifecycle, from ideation and development to testing and data requirements. Facilitating a smoother development process, this structured approach would ensure that both creators and users could access tailored, actionable advice at the appropriate times.

Regarding the distinction between required regulations and best practices, the structured approach also further helps developers to find specific information relevant to their current needs, ensuring they understand regulatory obligations and can recommended strategies for successful NHS adoption.

BJSS then added case studies, a blog section, FAQs, and an interactive glossary to the content repository, enhancing the website with real-world examples, ongoing commentary, quick answers to common questions, and simplified explanations of complex AI terms. As such, the website became more accessible and useful, helping to demystify the regulatory process.

In writing the guidance pieces, SEO best practices from a content and structural perspective were also incorporated. These SEO best practices ensure that information is relevant and useful but also easily discoverable by those searching for guidance relating to organisational digital health technology adoption.

The website's design and features were shaped by extensive user feedback, gathered through multiple rounds of testing and prototype adjustments. This user-centric approach resulted in overwhelmingly positive reactions, showcasing the effectiveness of tailoring the site to meet the real needs and preferences of its audience.

Examples of user feedback:

"Coming from a background where technology is intimidating, this website is really clear and useful."

 "NHS website is all about evidence, evidence, evidence and this (website) gives me (the info) on how to go through it and access a structure model."

"Was worried that I wouldn't understand anything on your page so it's nice that it's easy to follow."

"Language as I would expect, easy to read, suitable for all levels."

"Definitely something I would use as a resource." "I can't wait to use this."

"Definitely would use it in the future."

The finished website, available here, serves as a unified platform where developers and adopters can find regulations presented in simplified language and tailored to their specific technology, including its development or adoption stage.

Outcomes and Impact

NICE and its partners have long been aware that AI and other digital technologies will play an increasingly significant role in healthcare, reducing workloads for doctors and making patient care processes easier.

The new website enables faster uptake of digital technologies, and user research is already yielding positive feedback. More experienced practitioners report that they wish the service had been available when they began their careers. BJSS is also working on a sister project called the Innovation Service. This service will allow developers to submit digital innovation records so experts from various regulatory bodies can offer tailored support in getting new products adopted by the NHS.

Future Directions

Owed to BJSS’s excellent working relationship with NICE, the agency independently engaged the team to explore the viability of a new support service for organisations looking to integrate digital health technologies.

Over three months, BJSS conducted 18 in-depth interviews across various sectors, including Trusts, private companies, and social care. The aim was to identify their challenges and support needs from regulatory bodies, and their preferred type and format of support. The findings, along with recommendations on how to advance with the service, were compiled into a comprehensive report shared with NICE.

In Summary

The collaboration between BJSS, NICE, and its partners has addressed a critical need in the digital health technology space by centralising and simplifying complex regulations.

The initiative facilitates innovation and has far-reaching implications for patient care by streamlining the adoption of healthcare technologies. By making regulatory requirements more accessible and understandable, the project promises to accelerate the development and implementation of innovative solutions, ultimately enhancing the efficiency and effectiveness of healthcare services.