Key Considerations for Developers Under New Health AI Regulations

[Podcast] Five Things Developers Should Remember About New State AI Laws in Health Care

In the evolving landscape of health care, the introduction of state laws regulating artificial intelligence (AI) has become increasingly significant. This article outlines the five essential considerations for developers in the health care sector regarding compliance with these new regulations.

Understanding the Health AI Atlas

The Health AI Atlas serves as an online resource aimed at helping health care stakeholders navigate the complex patchwork of state laws concerning AI. It is particularly vital for developers, health care providers, investors, and health IT developers who need to grasp how these laws may apply to their operations.

1. Scope of Applicability

The first challenge developers face is determining whether the AI systems they are creating fall under any state regulations. Different states have varying requirements; for instance, states like California and Texas impose regulations on all developers of generative AI, while others, like Colorado, focus only on “high-risk” AI applications impacting health care and insurance decisions. Developers must closely examine which laws apply directly and indirectly based on their target end-users.

2. Implementing a Compliance Program

Before launching any AI product, developers must establish a compliance program. The laws dictate various elements that must be included, such as:

  • Conducting a comprehensive inventory of AI offerings and their intended uses.
  • Developing policies and contracts to address issues like discrimination and transparency.
  • Adopting a risk management framework, such as the NIST AI Risk Management Framework.

Moreover, states like California require developers to publish documentation regarding training data on their websites before launch.

3. Ongoing Risk Monitoring

Compliance is not a one-time effort; developers must actively monitor their AI systems for risks throughout their lifecycle. States like Colorado and Texas mandate continuous monitoring for accuracy and safety post-deployment. Documentation regarding system capabilities and limitations must be kept up to date, and some states require annual reviews of compliance programs.

4. Regulatory Reporting Obligations

Developers must also be prepared for disclosures and submissions to regulatory agencies. If a compliance issue arises, such as an AI system causing discrimination, developers are obligated to report these incidents. Each state has its own definitions and triggers for reporting, necessitating the implementation of incident response procedures tailored to state-specific regulations.

5. Potential Penalties for Non-Compliance

Non-compliance can lead to significant financial penalties. For example:

  • Texas imposes fines of up to $200,000 per incident.
  • New York allows penalties of up to $10 million.

With enforcement expected to increase, developers should remain vigilant about meeting these requirements.

Broader Legal Considerations

Beyond AI-specific laws, developers must also be aware of broader privacy statutes that govern automated decision-making and profiling. States like Maryland and Virginia have laws that require explicit consent and transparency for automated processing, which can apply even if AI is not explicitly mentioned.

Final Advice

Developers are urged to stay informed and proactive in navigating this complex regulatory landscape. Regularly reviewing compliance measures, updating documentation, and ensuring team training on new obligations are critical steps in treating compliance as an integral part of the development process.

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