Generative AI is converging with every sector – and health care is no exception. With it, companies should keep up with the array of laws and regulations – existing and envisioned – that govern its use. Read on for highlights from a conversation Orrick hosted recently with the Women’s General Counsel Network. Speakers included:
- Jennee DeVore, General Counsel at Simple HealthKit
- Thora Johnson, Partner at Orrick
- Jasmine Singh, General Counsel at Binti
Here are five key takeaways from their conversation:
1. The 1,000 mark is coming: The FDA has approved 950 AI/machine-learning enabled medical devices as of August 2024.
- Three main types of applications: Generative AI promises to drive research, reduce administrative tasks and advance precision medicine.
- This builds on a legacy of researchers and providers using AI for years to do things such as analyze X-rays, MRIs and CT scans.
2. Compliance check: Special considerations apply to AI in health care.
- Generative AI leverages large and highly sensitive data sets, making data security critical.
- Companies must use health data in compliance with laws and regulations such as the HIPAA Privacy Rule, FTC Act and state laws.
- Health care providers who accept federal funds will need to follow nondiscrimination standards to comply with Section 1557 of the Affordable Care Act.
3. Take it from the regulators and legislators: Transparency is key.
- The FTC has reminded companies it may be unfair or deceptive to train AI on consumer data without proper disclosure.
- Utah requires providers to inform their patients when their care includes generative AI.
4. Proactive planning: Most health care companies are developing risk assessment processes before deploying AI.
5. What’s next? We expect continued fairness, transparency, safety, accountability and human oversight in laws and best practices governing AI in health care.
