Healthcare & Life Sciences
Documentation, evidence, and operations automation under MDR, GDPR, and the AI Act.
Clinical and pharma organisations need AI that reduces administrative load without compromising safety, privacy, or evidence standards.
Use cases
Where AI pays off in Healthcare.
Regulatory notes
What the rules require.
Software as a medical device falls under MDR/IVDR and, where AI-based, is high-risk under the AI Act. Health data processing requires a lawful basis under GDPR Article 9 and typically a DPIA. We keep clinical decision support out of scope unless the client owns the regulatory pathway.
Services
How we help.
Industry lead
Dr Amara Okafor
Partner, Run
Amara leads Governance, Risk & Operations. She holds a PhD in machine learning robustness, advised the drafting of sector guidance under the EU AI Act, and runs our AI red-teaming programme.
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