Clarity for AI regulation in healthcare.
The NHS Digital Regulations Service was built to streamline and simplify the regulatory landscape for digital health technologies, giving developers and adopters of AI and digital solutions clear, accessible guidance while still ensuring compliance. The work spanned four national regulators and demanded systems thinking, service design, and content strategy far more than interface design. As Product Design Consultant at BJSS/Sparck, I led the product design effort inside a multidisciplinary team of content designers, service designers, and developers.
NHS Digital Regulations Service, a collaboration between NICE, MHRA, HRA & CQC
At a glance
Service
NHS Digital Regulations
Phase
Alpha → Beta
Year
2022
My role
Product Design Consultant
Partner
BJSS / Sparck
Location
Lisbon · London
Project Overview & Role
A service, not a website.
The goal was to provide clear, accessible guidance to developers and adopters of AI and digital solutions in health and social care, ensuring compliance while fostering innovation rather than blocking it.
That meant working across four regulators whose remits overlap and interlock: the National Institute for Health and Care Excellence (NICE), the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA), and the Care Quality Commission (CQC). Together they provided oversight across every regulatory, evaluation, and data-governance pathway the service had to represent.
My role was to lead the product design effort within a multidisciplinary team of content designers, service designers, and developers, translating that regulatory complexity into something a startup founder could actually follow.
“The hard part wasn't the interface. It was turning four regulators' overlapping guidance into a single path a developer could follow.”
Research & Discovery
I started by mapping the maze.
I focused Discovery on the regulatory challenges digital health innovators actually face, not restating the rules, but finding where the current system failed the people trying to comply with it, and facilitating the sessions that turned that into a shared view across the team.
Stakeholder Workshops
Working sessions with representatives from NICE, MHRA, HRA, and CQC to map existing regulatory pathways and identify the gaps in accessibility and understanding between them.
User Research
Interviews with health-tech developers, clinicians, and regulatory experts to uncover the real pain points and information gaps, where people got lost, stalled, or gave up.
Content Analysis
Reviewing dense regulatory documents to restructure them into a more usable, human format, the raw material for a plainer, more navigable service.
Adopter interview synthesis and a MAAS partners workshop, run with the regulators.
Working Across the System
Four regulators, one path for the user.
The service's credibility depended on getting four national bodies to stand behind a single, shared journey. Each owns a distinct part of the regulatory picture, and the design problem was holding all four in view at once without overwhelming the user.
NICE
The National Institute for Health and Care Excellence assesses whether a technology works and represents value, the clinical and cost-effectiveness evidence a digital health product needs to demonstrate.
MHRA
The Medicines and Healthcare products Regulatory Agency regulates safety and performance, including software as a medical device, the pathway most AI products underestimate the most.
HRA
The Health Research Authority governs research ethics and approvals, when and how a product can be studied with patients and their data before it reaches wider use.
CQC
The Care Quality Commission regulates the quality and safety of care providers, the adopter side, where a technology actually lands in a clinical setting.
Design Process: Alpha & Beta
Alpha: defining the problem
Alpha focused on defining the core challenges faced by developers and adopters of AI and digital health solutions. It involved stakeholder interviews, user-needs assessments, and service blueprinting. Prototypes were created and tested to explore different ways of presenting regulatory guidance, ensuring clarity and usability. The insights from this phase shaped the foundation of the platform, the most critical pain points and the biggest opportunities.
Beta: refining the service
Beta, where I played a significant role, built on those findings to refine and expand the platform through user feedback and further collaboration with the regulators. The focus was usability, accessibility, and the clarity of regulatory pathways: a more structured information architecture, plainer content design, and iterative usability testing with developers and healthcare professionals to validate decisions.
01 · What am I developing?
02 · Does this description match?
03 · The regulations, by lifecycle stage
Alpha wireframes of the developer triage: identify the product, confirm the match, then get only the regulations that apply, stage by stage.
01
Clear navigation
Simplifying the user journey into easy-to-follow steps and guidance, so a user could always tell where they were in the regulatory path and what came next.
02
Visual aids
Using step-by-step processes and visual explanation to make complex, interlocking regulatory information legible at a glance.
03
GOV.UK & NHS standards
Building on the GOV.UK design system and the NHS digital service manual to guarantee consistency, accessibility, and usability, and to focus effort on the hard content problems, not reinventing patterns.
Designing the Service
Structure and plain language, doing the heavy lifting.
The interface is deliberately quiet. The design work lives in the information architecture and the content, a clear split between developer and adopter guidance, required versus optional steps made explicit, and dense legal language rewritten into actionable guidance without losing accuracy.
Before
After
The homepage headline, before and after: what the service does and who it is for, in plain words.
Developer guidance and structured, standards-based content pages.
Challenges
Where the difficulty actually lived.
The hardest problems came from the complexity of the regulatory frameworks and the diversity of the people who had to use them.
Navigating complex regulatory frameworks
Healthcare regulation is intricate, with multiple governing bodies and different requirements. Synthesising guidance from NICE, MHRA, HRA, and CQC into a clear, structured format users could act on was the central challenge.
Simplifying technical and legal language
Guidance is often written in highly technical or legalistic language, hard for innovators, especially startups, to interpret. We worked with content designers and regulatory experts to translate it into accessible, actionable steps without compromising accuracy.
Ensuring accessibility and usability
Users ranged from large healthcare organisations to individual developers with varying expertise. The platform had to be both highly functional and easy to navigate, which took continuous testing and iteration to keep key information discoverable and digestible.
Aligning stakeholder expectations
Regulators focused on compliance and risk mitigation; users prioritised speed and clarity. Balancing those required close collaboration, iterative feedback loops, and careful decision-making to hold regulatory rigour and a user-centred approach together.
The content governance flow: how guidance from four organisations moved from request to publication, with a named role at every gate. Click to open.
Solutions & Impact
Clarity, made measurable in behaviour.
While still in Beta, the service already changed how people engage with regulation for digital health, a step toward removing the uncertainty that slows safe adoption.
Enhanced clarity
Users get a streamlined way to understand compliance requirements without sifting through dense regulatory documents.
Time savings
By structuring guidance into digestible steps, the platform reduces the time needed to assess regulatory obligations.
Increased adoption
By removing regulatory uncertainty, the service helps accelerate the safe development and deployment of AI and digital technologies in healthcare.
Reflections & Next Steps
Rigour and usability aren't opposites.
The Beta phase reinforced how much this kind of work depends on balancing regulatory rigour with user-friendly design. In a high-stakes, heavily governed domain, the instinct is to add more caveats and more content. The opposite is what helps: clarity, structure, and plain language are what actually let people comply.
The path forward is continued refinement based on user feedback, stronger decision-support tools to give more tailored guidance, and expanding the service to support emerging digital health innovations as the sector evolves.
It's the same lesson that runs through my work at British Airways, adidas, and TitanBay: the most valuable design decisions are made upstream, in how a problem is framed, structured, and aligned across stakeholders, long before anyone opens a design tool.
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