Impact assessment and governance support for digital health and AI projects

Digital health and AI tools can raise important questions about privacy, fairness, accountability, trust and their wider effects on individuals, communities and services. We conduct impact assessments to identify and address potential risks and review compliance with relevant regulations and frameworks. Our findings provide project teams with clear, practical recommendations to strengthen responsible development, adoption and use.

Drawing on our work across Horizon Europe consortia and other funded programmes, we conduct structured impact assessments across ethical, legal, social, privacy, equity and governance dimensions, and review alignment with applicable regulations and frameworks — so project teams can identify and address risks early and build the governance that partners, funders and adopters expect to see.

Responsible Digital Health Services

Ethical, Legal & Social Impact Assessment

A structured assessment of the potential implications of a digital health or AI-enabled tool, system or project.

Risk Assessment
High (H) Medium (M) Low (L)
  • H
    Inequitable access
    Inclusive design review
  • M
    Dataset bias
    Diversify training data
  • M
    Limited user understanding
    Plain-language explainers

Privacy & Data Governance Assessment

Assessment of privacy risks, data handling practices and governance arrangements across the data lifecycle.

Data lifecycle reviewed
Collect
Use
Store
Share
Delete
DPIA-informedGDPR-alignedConsent & transparency

Bias, Fairness & Equity Review

Assessment of whether a tool, system or process could create unequal effects across individuals or groups.

Claim ↔ evidence alignment
  • “Clinically validated” Aligned
  • “AI diagnoses accurately” Overstated
  • “Improves outcomes” Aligned

Trust, Adoption & Compliance Review

Assessment of the factors that may affect trust, acceptability, adoption and compliance.

Relevant regulation, standards and guidance
MHRAFDAEU AI ActUK GDPRDTACISO/IEC 42001

Who this is for

We support digital health and AI project teams, startups and SMEs, universities and research consortia, health organisations developing or adopting digital tools, and teams preparing for funding, procurement or implementation.

Common questions we help clients answer

"What ethical, legal or social risks does our tool raise?"

"Are our privacy and data governance arrangements robust?"

"Could our tool create unequal or exclusionary effects?"

"How well aligned are we with the frameworks that matter for adoption?"

Scope of our assessments. Our assessments provide independent research, impact and governance advice. They do not replace formal legal advice, clinical safety assessment, regulatory approval or technical certification.
Fixed scope services

Prefer a defined package?

Fixed timelines and fees for focused pieces of work.

View fixed scope services

Discuss a digital health or AI review

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