Our program will delve into key issues at the intersection of AI, software, and medical devices, providing valuable insights into both current challenges and future opportunities.
Topics include:
Regulatory Frameworks & Compliance
- Global AI & Digital Health Regulations – Comparing FDA, EMA, MHRA, and other regulatory approaches
- The EU AI Act and Its Impact on Digital Health
- FDA’s Approach to AI/ML-Based Software as a Medical Device (SaMD)
- Regulatory Sandboxes for AI in Healthcare: Case Studies and Lessons Learned
- Post-Market Surveillance and AI in Digital Health: Regulatory Obligations
- Ethical AI and Compliance: Meeting GDPR, HIPAA, and Data Protection Laws
Clinical Evidence & Investigations
- Clinical Evidence Requirements for AI/ML-Based Medical Devices
- Best Practices in Conducting Clinical Trials for AI-Powered Digital Health Solutions
- Adaptive AI in Healthcare: How to Generate and Maintain Real-World Evidence (RWE)
- Bias, Fairness, and Generalizability in AI Clinical Validation
- Digital Twins & Virtual Clinical Trials: The Future of AI Evidence Generation
- Regulatory Expectations for AI-Based Clinical Decision Support (CDS) Tools
Legal & Liability Considerations
- Legal Risks in AI-Based Diagnostics and Treatment Recommendations
- Product Liability and AI in Healthcare: Who Is Responsible for Errors?
- Patentability of AI-Driven Medical Innovations
- Intellectual Property Challenges in AI and Digital Health
- The Role of Informed Consent in AI-Driven Medical Interventions
- Data Ownership & AI: Who Controls Patient-Generated Data?
AI Governance & Ethical Considerations
- Explainability & Transparency in AI: Regulatory and Ethical Perspectives
- Algorithmic Accountability: Legal and Regulatory Implications
- AI and Medical Malpractice: Emerging Case Law and Precedents
- Regulating AI for Mental Health and Behavioral Digital Therapeutics
- Interoperability and AI Regulation: Navigating Compliance Across Systems
- Ensuring Equity and Inclusion in AI-Drive
