EU and US Regulatory Challenges Facing AI Health Care Innovator Firms


Publish Date:
April 4, 2024
Publication Title:
Harvard Law School, Petrie-Flom Center Bill of Health
Op-Ed or Opinion Piece
  • Suzan Slijpen, Mauritz Kop & I. Glenn Cohen, EU and US Regulatory Challenges Facing AI Health Care Innovator Firms, Harvard Law School, Petrie-Flom Center Bill of Health, Apr. 4, 2024.
Related Organization(s):


The article discusses the complex regulatory challenges that AI healthcare innovator firms face in the EU and the US. It highlights the fragmented nature of the emerging regulatory landscape, including the need for compliance with a multitude of sector-specific and cross-sectoral laws and guidelines, such as the EU’s Medical Device Regulation, GDPR, the EU AI Act, the US’s Health Insurance Portability and Accountability Act (HIPAA), and the FDA regulatory categories. The articles advocates for a balanced regulatory approach that combines the benefits of both the EU’s precautionary and US’s permissionless innovation models to foster both patient safety and technological advancement.

Introduction: A Fragmented AI in Healthcare Regulatory Landscape

The surge in AI research and diagnostics in the medical field, particularly in radiology for disease detection and prediction, has led to a proliferation of guidelines and regulations. However, this regulatory environment is fragmented, making it difficult for companies to navigate, especially those aiming to enter the European market.

Cross-sectoral EU Laws

In the EU, AI healthcare products must comply with a complex web of regulations including the Medical Device Regulation (MDR), the GDPR, and forthcoming specific requirements for ‘high risk’ AI technology under the EU AI Act. This creates an overlapping and often confusing regulatory scope that healthcare innovator firms must traverse.

Sectoral US Laws

The US approach to AI regulation is more sectoral, focusing on specific areas like health privacy (HIPAA) and FDA regulation of medical devices, including AI. This approach has both advantages and disadvantages, particularly in adjusting to new technologies like foundational generative AI models and adaptive algorithms.

Additional Challenges for AI Healthcare Innovator Firms

Firms also face challenges related to the materials used in physical devices -especially in the quantum/AI space- like export and import controls, fragile supply chains, potential dual use, intellectual property protection, and adapting to the rapid pace of technological innovation, such as generative AI systems.

Best of Both Worlds: A Mixed Horizontal-Vertical Approach

The article suggests that a mixed approach to regulation, combining the EU’s precautionary principles with the US’s permissionless, ad libitum innovation model, would be most effective. This middle ground position would focus on patient safety, practical implementation, and be tailored to the unique needs of AI & quantum driven innovation in healthcare. In parallel, regulators must make an effort to truly understand these disruptive technologies, to avoid rules lagging behind the increased tempo of innovation.

Concludingly, the article highlights the complexity of navigating AI healthcare regulation at both sides of the transatlantic spectrum, suggesting that a balanced, mixed regulatory approach could better support innovation. A best of both worlds model would increase the chances of creating EU- and US-origin health care innovator unicorn firms, while ensuring patient safety and legal compliance.