Enabling Healthcare Innovation Through Legal Intelligence

Our research group LIDER-Lab (https://www.lider-lab.it/en/home-page-english/) at the renowned Sant’Anna School of Advanced Studies (Pisa, IT) specializes in AI governance, health data use and reuse, medical device regulation, cybersecurity, risk management and insurance law.

We bring clarity and legal certainty to medical R&I activities within complex and evolving frameworks, combining theoretical insight with empirical expertise.

With longstanding experience in interdisciplinary projects, we translate requirements into compliant, safe, and legally sound practices. Our proven track record includes supporting technological and biomedical R&I in projects such as:

• Biorobotic Research & Innovation Engineering Facilities: https://biorob-hub.eu/

• Fit 4 Medical Robotics: https://www.fit4medrob.it/

• SoBigData: https://plusplus.sobigdata.eu/

• Legality Attentive Data Scientists: https://www.legalityattentivedatascientists.eu/

• Post Quantum Cryptography Framework for Energy Aware Contexts: https://pqreact.eu/

We deliver the SSH component required in many Horizon calls, for example by :

• Mapping the legal requirements for innovative health solutions:

  • Regulatory compliance analysis: Mapping EU and national regulations (e.g., MDR, AI Act, GDPR, EHDS, Product Safety Reg., CRA, etc.) to specific technologies like AI-driven diagnostics, robotics, and telemedicine.

  • Risk assessment frameworks: Identifying legal risks in data sharing, algorithmic transparency, and medical device liability.

  • Gap analysis & readiness checks: Helping partners understand where their innovation stands in relation to compliance requirements and what steps are needed.

• Drafting best practices for researchers and practitioners:

  • Hands-on guidelines for data use: Ensuring lawful secondary use of health data for AI training and clinical research.

  • Design-for-compliance principles: Embedding legal considerations early in the development process (privacy-by-design, safety-by-design).

  • Interdisciplinary training: Workshops for engineers, clinicians, and data scientists on regulatory implications of their activities.

  • Support for certification & CE marking: Helping partners through conformity assessment for medical devices.

• Developing policy recommendations that create impact in health innovation:

  • Evidence-based input for policymakers: Translating research findings into actionable recommendations for EU health and AI strategies.

  • Impact assessments: Evaluating legal implications of emerging technologies to inform policy.

  • Stakeholder engagement: Acting as a bridge between researchers, industry, and regulators.

The LIDER-Lab (International and Comparative Law Research Laboratory) has a long tradition in theoretical and empirical legal research, training, and consulting. The LIDER-Lab collaborates with partners across the social sciences and humanities, the physical sciences and engineering, and the life sciences.

It employs a comparative, interdisciplinary methodological approach that spans private law and regulation at the national, transnational, and international levels. Its main expertise relates to fundamental rights protection, personal data protection, contracts, risk management insurance and liabilities, AI, intellectual property, and private law of new technologies.