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Enterprise AI Analysis: Artificial intelligence, intellectual property, and human rights: mapping the legal landscape in European health systems

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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0 Laws & Treaties Analyzed
0 European Countries Covered
0 Key IP Mechanisms Identified

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

Datasets
AI Model Architecture
Software/Code
Hardware
Generated Output
70,761 Documents Identified in Policy Repositories (Initial)

IP Rights Overview for AI in Health

IP Right AI Technologies Covered Key Provisions
Patent
  • Hardware
  • computer-implemented inventions (if technical effect)
  • Requires disclosure
  • Time-limited exclusive right
  • Cannot patent mathematical models 'as such'
Copyright
  • Software (source code)
  • preparatory design materials
  • output (in certain cases)
  • Protects expression, not ideas
  • Time-limited
  • Exceptions for research/education
Trade Secret
  • AI model weights
  • training decisions
  • development pipeline info
  • datasets
  • Indefinite protection as long as secret maintained
  • No public disclosure
  • Must have commercial value

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.

35% Estimated AI Efficiency Gain in Healthcare (Hypothetical)

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

AI System Development
Risk Classification
Compliance Assessment
Market Deployment

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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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