AI & EUROPEAN HEALTH SYSTEMS
Mapping AI, IP, and Human Rights in European Health Systems
This analysis synthesizes 53 laws and treaties to illustrate the IP landscape for AI in health systems across Europe and examines their intersections with health-focused human rights.
Executive Impact & Key Metrics
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Deep Analysis & Enterprise Applications
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IP Landscape for AI
AI technologies, including datasets, software, and hardware, are subject to various IP protections like patents, copyrights, trade secrets, and database rights.
The legal framework protects a wide variety of AI components. Datasets can be protected by copyright, trade secrets, and sui generis database rights. AI models and software can be patented or copyrighted as computer programs, while underlying algorithms may be trade secrets.
AI IP Protection Pathways
| IP Right | AI Technologies Covered | Key Provisions |
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| Patent |
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| Copyright |
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| Trade Secret |
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Human Rights Intersections
Tensions exist between promoting innovation (IP) and ensuring accessibility, quality, and equity in health systems (human rights).
Health-focused human rights include the right to enjoy scientific progress, access to medical services, information about treatment, and freedom from non-consensual experimentation. These rights often conflict with the exclusive nature of IP, especially concerning AI in health.
Case Study: Data Biases and IP
The study highlights how IP protection for datasets can contribute to biases. For example, patents on genetic testing led to extensive data aggregation for certain populations, leaving minority data scattered and low-quality. This exemplifies the tension between IP-driven aggregation and the human right to equitable health outcomes. The AI Act attempts to mitigate this through transparency requirements, but challenges remain.
Regulatory Challenges & Future
Existing legislation like the AI Act introduces transparency but leaves much to court interpretation, highlighting the need for clearer definitions of 'public interest' and 'legitimate interest'.
The regulatory landscape is complex, with the AI Act, Medical Devices Regulation, and Data Governance Act all playing roles. 'Black box' characteristics of AI, combined with IP protections, make transparency challenging. Future research should focus on reconciling conflicting objectives and fostering solidarity.
AI Act Regulatory Compliance Flow
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AI Implementation Roadmap
A high-level roadmap for integrating AI, navigating IP, and ensuring human rights compliance.
Phase 1: Assessment & Strategy
Identify AI use cases, assess data availability, and conduct initial IP and human rights impact assessments. Define clear ethical guidelines and legal compliance strategies.
Phase 2: Development & IP Protection
Develop or acquire AI solutions, ensuring appropriate IP protection for models, software, and data. Implement robust data governance and transparency mechanisms.
Phase 3: Deployment & Monitoring
Integrate AI into health systems, continuously monitor for biases, performance, and compliance with human rights and IP regulations. Establish feedback loops for continuous improvement.
Phase 4: Governance & Scaling
Refine internal policies, train staff, and scale AI solutions across the organization while maintaining vigilance on legal and ethical obligations. Engage with regulatory bodies for guidance.
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