Bytes: Week in Review — Investments flow into health tech, FDA approves modifying AI medical devices, and California’s AI insurance claim law
Dec 13, 2024
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Christina Farr, managing director with Manatt Health, dives into the transformative role of AI in healthcare. She discusses a surge in investments for AI-driven health tech startups, showcasing a rebound after 2023's slump. The FDA's new guidelines enabling software updates post-approval are explored as a pivotal step in tech innovation. Farr also highlights California’s groundbreaking law mandating human oversight for AI in healthcare, raising critical conversations about transparency and the ethical implications of automated decision-making.
Health tech startups, particularly those leveraging AI, are seeing a resurgence in investments despite a general funding slowdown post-pandemic.
The FDA's new guidance allows AI medical device makers to update algorithms post-approval, enhancing functionality while addressing regulatory concerns.
Deep dives
The Rise of AI in Health Tech Startups
Health tech startups have experienced a resurgence in investment, particularly those integrating artificial intelligence into their solutions. The pandemic initially inflated funding levels as virtual care gained popularity, but this trend has since plateaued with more patients returning to in-person visits. Despite a more subdued atmosphere for funding compared to pandemic highs, AI remains the focal point for investment, with many investors explicitly seeking AI integration in proposals. However, while AI technology shows promise, the majority of revenue in healthcare continues to flow from traditional services involving patient care interactions.
FDA's Guidance on AI-Enabled Medical Devices
The FDA has recently released important guidance concerning the modification of algorithms in AI-enabled medical devices, allowing software updates post-approval. This change acknowledges that software, including AI systems, must be adaptable to improve functionality over time rather than remaining static. Such updates are critical as they can enhance the detection and treatment of conditions like atrial fibrillation, where AI has proven to outperform even seasoned medical professionals. This shift represents a collaborative effort between regulators and technology developers to promote innovation while ensuring patient safety.
AI in Health Insurance and Prior Authorization Scrutiny
The use of AI in the claims approval process within health insurance has come under increasing scrutiny, particularly concerning its impact on patient care decisions. Legal challenges have arisen against companies like UnitedHealthcare for allegedly using algorithms that may deny necessary treatments without adequate human oversight. As transparency around healthcare costs becomes more critical, there is concern that automated systems could exacerbate inequities and biases in care approvals. Efforts are underway to ensure that decision-making processes involve human judgment, addressing the complex dynamics of prior authorization in healthcare.
There’s been a lot of discussion about health insurance over the last week. And one practice could be seeing more oversight: the use of artificial intelligence in coverage decisions. Plus, the FDA issues final guidance for makers of AI-enabled medical devices so they can now update their software after approval. And it was a good year for health tech startups — after a not-so-good year in 2023 — especially for those with the letters “AI” attached to their business. Our regular contributor Christina Farr, managing director with Manatt Health, joins Marketplace’s Meghan McCarty Carino to discuss the news.
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