Independent review and advisory support for digital health and AI-enabled tools
We help organisations develop, adopt, and use digital health and AI-enabled products safely, ethically, and with appropriate governance in place, providing practical, independent review and clear recommendations.
Digital health and AI tools can create significant benefits, but also serious risks around safety, fairness, privacy, transparency, and accountability. We help teams identify and address those risks before they become problems, and build the governance practices that partners, buyers, and funders expect to see.
What we offer
Pre-Launch Risk Review
An independent review of a digital health or AI-enabled product, feature, or service before pilot or launch.
- Safety & harm
- Fairness & inclusion
- Privacy & data
- Transparency
- AI oversight
Pre-Launch Risk Review
- •Safety and harm risk identification
- •Fairness and inclusion
- •Privacy and data handling
- •Transparency and accountability
- •AI oversight and escalation
- •Governance gaps
- •Prioritised recommendations
- •An independent risk review report
- •A prioritised list of safety, fairness, and governance risks
- •Clear, actionable mitigations
- •A pre-launch readiness summary for your team or board
Ethical, Social & Legal Impact Assessment
An in-depth assessment of the ethical, social, and legal implications of an AI-enabled or data-driven health tool or system.
- HInequitable accessInclusive design review
- MDataset biasDiversify training data
- MLimited user understandingPlain-language explainers
Ethical, Social & Legal Impact Assessment
- •Algorithmic impact assessment
- •Ethical, social and legal impact review
- •Fairness and bias risks
- •Effects on vulnerable users
- •Human oversight and accountability
- •Unintended harms
- •Mitigation recommendations
- •A structured ethical, social and legal impact report
- •Identified bias, fairness, and harm risks
- •Human oversight and accountability recommendations
- •A defensible record of responsible AI assessment
Data, Privacy & Trust Review
A focused review of privacy, data governance, and trust-related risks associated with a digital health product or service.
Data, Privacy & Trust Review
- •Data collection, use, storage and sharing
- •Consent and transparency
- •Privacy risk identification
- •Governance and accountability gaps
- •DPIA-informed assessment
- •Practical recommendations
- •A privacy and data governance review report
- •Identified risks across the data lifecycle
- •DPIA-informed findings
- •Practical recommendations to strengthen trust
Claims & Evidence Review
An independent review of the claims made about a digital health or AI-enabled product to ensure they are accurate, proportionate, and evidentially sound.
- “Clinically validated” Aligned
- “AI diagnoses accurately” Overstated
- “Improves outcomes” Aligned
Claims & Evidence Review
- •Product and impact claims
- •AI capability statements
- •Health benefit messaging
- •Evidence alignment
- •Identification of overstatement
- •Clearer and more credible wording recommendations
- •A review of marketing, product, and impact claims
- •An evidence-to-claim alignment summary
- •Flagged overstatements and risk areas
- •Suggested clearer, more defensible wording
Market & Investor Readiness
Structured support for organisations preparing for procurement, partnership, due diligence, or funding conversations.
- Governance position
- Risk & safety record
- Evidence & trust pack
- Diligence Q&A prep
Market & Investor Readiness
- •Governance and risk position review
- •Key diligence questions
- •Evidence and trust summary
- •Accountability and oversight documentation
- •Concise materials for partners, buyers, or funders
- •A governance and risk readiness summary
- •Anticipated due diligence questions and prepared responses
- •A concise evidence and trust pack
- •Materials ready for buyers, partners, or investors
Regulatory & Compliance Support
Orientation and guidance through the complex landscape of digital health and healthcare AI regulations and standards.
Regulatory & Compliance Support
- •Regulatory pathway orientation (MHRA, FDA, EU AI Act)
- •Standard alignment support (DTAC, DCB0129, DCB0160, ISO/IEC 42001)
- •Equality, accessibility & data protection review (Equality Act 2010, ICO AI guidance)
- •Compliance roadmap development
- •Evidence gap analysis for regulatory requirements
- •Support preparing documentation for health system buyers
- •A clear view of your relevant regulatory pathway
- •A gap analysis against key standards
- •A practical compliance roadmap
- •Documentation ready for health system buyers
Who this is for
Our Responsible Digital Health & AI services are used by digital health startups, small businesses building or adopting AI-enabled health tools, health organisations selecting digital vendors, and teams preparing for NHS procurement, enterprise sales, or investor due diligence.
Common questions we help clients answer
"Is our product safe and fair for the people who will use it?"
"Could our AI tool create harms we haven't anticipated?"
"What do we need in place before launching into a clinical or health setting?"
"How do we handle sensitive health data responsibly?"
"Are the claims we make about our product accurate and defensible?"
"What will a potential buyer, funder or investor ask us about our governance?"