Disclaimer: Medical AI law is an emerging field in Nigeria. The services described on this page are based on current Nigerian and international legal frameworks, including the Nigeria Data Protection Act 2023, NAFDAC’s evolving Software as a Medical Device posture, and NITDA’s digital governance initiatives. Nothing here constitutes legal advice or guarantees any particular regulatory outcome. Prospective clients should seek direct counsel tailored to their specific technology and clinical context.
Overview
Medical AI is not a future possibility. It is a present reality — and a present legal risk.
Hospitals are deploying algorithms to prioritize emergency patients. Diagnostic laboratories are using machine learning to interpret pathology slides. Health tech startups are building AI tools that claim to detect tuberculosis, diabetic retinopathy, or breast cancer from a smartphone image.
Each of these applications raises the same fundamental legal questions:
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Is this AI system a regulated medical device?
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Who is liable when the algorithm is wrong?
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Where does the patient data go — and who governs it?
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Can patients challenge a machine’s clinical decision?
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How does a hospital or startup innovate without violating laws written for human doctors?
At The Sanu Attorneys, we help institutions and innovators answer these questions before the regulator — or the courtroom — asks them.
Our approach is grounded in the PhD research of Principal Olatunde Sanu:
“Governing Artificial Intelligence in Nigerian Healthcare: Integrated Legal Frameworks for Data Sovereignty, Clinical Accountability, and Innovation under the NDPA 2023 and Emerging Regulatory Frameworks.”
Led by a PhD researcher in Digital Health Law, The Sanu Attorneys combines academic depth with over three decades of real-world legal experience across healthcare, finance, and infrastructure.
Services
Service 1: AI Regulatory Classification & Pathway Advisory
Assessment of your AI product against FDA SaMD frameworks, IMDRF guidelines, and NAFDAC’s emerging classification criteria. Where Nigerian law is silent, we rely on internationally recognised frameworks (FDA, EU MDR, IMDRF) to build compliance readiness that will translate to local rules once enacted. Determination of registration, clinical validation, or post-market surveillance requirements. Regulatory engagement strategy with NAFDAC, NITDA, and state health ministries.
Service 2: Clinical Accountability & Liability Architecture
Liability allocation in contracts between AI developers, hospitals, and clinical users. Professional indemnity gap analysis for AI-assisted care. Human oversight protocol design. Medical malpractice defence preparation for algorithm-related incidents.
Service 3: Health Data Sovereignty & AI Governance
NDPA-compliant data governance for AI training datasets and live processing. Data Processing Agreements with cloud and AI vendors. Federated learning structures for collaborative development without centralized patient data. Breach response protocols for AI-specific risks (model inversion, re-identification). Algorithmic bias audit documentation for regulatory and litigation defence.
Service 4: AI Innovation & Regulatory Sandbox Advisory
Eligibility assessment for NITDA and NAFDAC innovation frameworks and sandboxes. Sandbox application drafting, including pilot design, patient safeguards, and risk mitigation. Regulatory meeting representation and policy consultation. Position papers for legislative and rule-making processes.
Service 5: Medical AI Governance & Board Advisory
AI procurement policies and vendor due diligence checklists for hospital and health tech boards. Human-in-the-loop protocol design. Board training on AI legal, regulatory, and reputational risks. Governance documentation satisfying fiduciary duty standards.
Real-World Scenarios
Scenario 1 – Radiology AI startup.
You have a pilot agreement with a Lagos teaching hospital for TB detection from chest X rays. We advise on NAFDAC medical device classification, structure your hospital liability agreement, and ensure your training data complies with the NDPA.
Scenario 2 – Hospital CEO deploying AI triage
We draft your patient notification protocol, design your human override procedures, and review your professional indemnity coverage for AI-related incidents.
Scenario 3 – Multi jurisdictional AI diagnostic app.
You are building an AI tool for diabetic retinopathy using smartphone cameras, serving Nigeria, Kenya, and Ghana. We map regulatory requirements across jurisdictions, structure cross border data governance, advise on clinical validation strategy, and coordinate with local counsel where needed.
Scenario 4 – Private equity acquiring a diagnostic lab with AI pathology.
We conduct regulatory due diligence on AI vendor contracts, assess liability exposure, verify data governance compliance, and flag enforcement risks affecting valuation.
Why The Sanu Attorneys For Medical AI?
- Because our Principal is actively researching this field. Olatunde Sanu is a PhD candidate in Digital Health Law at the University of Medical Sciences, Ondo, with a research focus precisely on governing artificial intelligence in Nigerian healthcare.
- Because we understand both the algorithm and the administrative law. We engage with NAFDAC, NITDA, and the NDPC not as outsiders, but as researchers and advisors who help shape the frameworks our clients must navigate.
- Because we combine AI governance with our core health law practice. Innovation without patient safety is reckless. Compliance without innovation is stagnant. We hold both in balance.
- Because we have done this across sectors. Thirty-three years of experience in healthcare, banking, construction, and corporate governance means we see the full board — regulatory, commercial, structural, and human.