#1 – Brian Anderson, President and CEO at Coalition for Health AI (CHAI) & Randi E Seigel, Healthcare Regulatory Lawyer at Manatt Phelps and Phillips

Introduction: The Intersection of Healthcare and AI 

In a rapidly evolving technological landscape, healthcare AI stands at a pivotal crossroads of innovation and regulation. On the latest episode of Healthcare AI for Dummies, host Missy Krasner sits down with experts Brian Anderson, co-founder of the Coalition for Health AI (CHAI), and Randi E. Seigel, a seasoned healthcare regulatory lawyer from Manatt Phelps & Phillips. Together, they delve into the challenges and opportunities of navigating healthcare AI from both a private and policy perspective.

Understanding CHAI’s Mission and Structure 

Brian Anderson shares how CHAI, a coalition of over 3,000 members, is working to define what responsible AI looks like across healthcare. “We’re building a consensus on good AI practices,” Anderson explains. CHAI’s aim is to create a framework of best practices that includes detailed metrics and certification processes for quality assurance labs. These labs will evaluate AI models for safety, bias, and effectiveness, ensuring that AI tools in healthcare meet high standards of accountability and transparency. Anderson emphasizes the importance of geographically diverse labs to address the unique health needs of different regions.

Regulatory Landscape: Federal and State Activity 

Randi E. Seigel provides an in-depth look at the complex landscape of AI regulation in the U.S. The federal scene, influenced by President Biden’s executive order, is focused on promoting safety, privacy, and equity in AI use. However, much of the activity remains at the discussion stage, with agencies like the FDA issuing non-binding guidance on AI in medical devices. “There’s been a flurry of federal guidance, but comprehensive action is still lacking,” Seigel notes.

Seigel also highlights the challenges of a patchwork of state regulations. States like California and Colorado have introduced AI transparency laws, each with different requirements for companies and providers. She warns of the difficulty for multi-state providers and startups in navigating these varying rules, which could potentially stifle innovation and favor larger players with more resources.

The Role and Challenges of AI in Healthcare 

Both experts emphasize the promise and risks of AI in healthcare. Anderson describes the Coalition’s focus on ensuring that AI tools are inclusive and unbiased. “AI is trained on our histories,” Anderson explains, noting that any underlying biases in training data can lead to discriminatory outcomes. Seigel concurs, adding that while AI can greatly enhance healthcare through better identification and data analysis, it also brings concerns around privacy, transparency, and ethical use.

The conversation touches on specific examples, such as AI’s role in radiology and prenatal care, where AI has shown promise in improving accuracy and access. Yet, the risks of data bias and inaccuracies remain a crucial area of focus for both policymakers and industry leaders.

Looking Ahead: A Vision for the Future 

Anderson envisions a future where AI in healthcare is governed by a network of certified assurance labs. These labs would evaluate models for regional relevance, ensuring that AI tools perform effectively across diverse communities. “In five years, I see AI labs helping to ensure that models align with human values and support human flourishing,” he says.

Seigel adds that a unified federal framework would be ideal, creating consistent transparency standards that help developers and healthcare providers comply across states. She expresses hope for bipartisan cooperation in Congress to address these challenges.

Conclusion: Bridging Innovation and Regulation 

As AI continues to transform healthcare, balancing innovation with effective regulation remains a critical challenge. Both Anderson and Seigel highlight the need for collaboration between the private sector and policymakers to create a future where AI tools are safe, transparent, and beneficial for all. Their discussion serves as a roadmap for stakeholders navigating the intersection of healthcare and AI policy.

Stay Tuned: Live from the Health Conference 

Don’t miss the next episode, where Healthcare AI for Dummies will broadcast live from the Health Conference in Las Vegas, featuring interviews with key players in the AI pavilion. Tune in from October 20th to 23rd to hear the latest insights on healthcare AI.