PNCDNC Perspective on Regulating AI in Health Care

Artificial intelligence (AI) has the potential to revolutionize healthcare, offering breakthroughs in diagnostics, treatment planning, and patient care. However, the mounting calls for strict regulation of AI in healthcare may inadvertently stifle its promise. Here’s why the current trajectory of regulation might be setting us up for failure.

1. Regulations Are Reactive, Not Proactive

Regulatory frameworks often lag behind the pace of innovation. By the time policies are enacted, AI technologies have evolved, rendering the regulations obsolete or misaligned. This reactive approach creates a perpetual game of catch-up, where regulators address yesterday’s problems while today’s challenges go unchecked. In a field as dynamic as AI, this delay could cost lives by slowing the adoption of life-saving advancements.

2. Overregulation Will Choke Innovation

Healthcare is already burdened by bureaucratic inertia. Adding layers of AI-specific regulation risks discouraging innovation. Startups and smaller companies, which often drive the most groundbreaking advancements, may find themselves priced out of the market due to compliance costs. This consolidates power in the hands of a few large players, stifling competition and diversity in AI solutions.

3. One-Size-Fits-All Approaches Don’t Work

AI applications in healthcare vary widely, from administrative tools to surgical robotics and personalized medicine. A single regulatory framework cannot address these diverse use cases effectively. Imposing uniform standards risks either overregulating simple tools or underregulating complex, high-risk systems. Both scenarios can lead to harm—whether through inefficiency or unaddressed risks.

4. Ethical Concerns Are Complex and Context-Dependent

AI systems in healthcare operate within a web of ethical dilemmas: bias in training data, patient privacy, and the delegation of life-and-death decisions to machines. These issues require nuanced, context-sensitive responses, not blanket rules. Misguided regulations might address one ethical concern while exacerbating another, leaving patients worse off.

5. Global Disparities in Regulation

AI development and deployment are global endeavors, but regulatory environments vary widely. Overregulation in one country may push innovation to less regulated regions, creating a fragmented global landscape. This not only undermines the intent of regulation but also risks creating disparities in healthcare quality and access.

6. Regulators Lack Technical Expertise

Regulating AI effectively requires deep technical understanding, yet most regulatory bodies lack the expertise to evaluate complex AI systems. This knowledge gap can lead to poorly designed policies that hinder innovation without meaningfully improving safety or efficacy. Worse, it opens the door to regulatory capture, where industry influences rules to its advantage.

7. The Stakes Are Too High for Paralysis

Healthcare already struggles with access, affordability, and disparities. AI has the potential to address many of these issues by democratizing access to expertise, streamlining workflows, and reducing costs. Overregulation risks delaying these benefits, perpetuating avoidable suffering and inequality.

A Way Forward

Rather than imposing rigid regulations, we need a dynamic, adaptive framework for AI in healthcare. Here are some guiding principles:

- Collaborative Governance: Involve diverse stakeholders, including technologists, healthcare providers, patients, and ethicists, in shaping policies.

- Agile Regulation: Create mechanisms for continuous updates to policies as technology evolves.

- Risk-Based Oversight: Tailor regulatory intensity to the specific risks posed by each AI application.

- Foster Innovation Sandboxes: Allow developers to test and refine AI systems in controlled environments before widespread deployment.

- Global Harmonization: Work toward international standards that ensure safety and fairness without stifling cross-border innovation.

AI in healthcare holds transformative potential, but only if we get the regulatory balance right. Striking this balance requires recognizing that innovation and safety are not opposing forces but complementary goals. Let’s ensure our regulatory ambitions don’t inadvertently undermine the very progress we seek to achieve.