Artificial Intelligence in Healthcare: A Regulatory Overhaul – Medriva

Artificial Intelligence in Healthcare: A Regulatory Overhaul

In 2024, the U.S. government is expected to reshape the regulations surrounding the use of artificial intelligence (AI) in healthcare, a significant move that holds the potential to impact the future of healthcare services and patient care. This move has been triggered by President Joe Bidens crackdown on AI by federal health agencies and a promise from Congress members to increase oversight and pass new legislation. This regulatory transformation is driven by the urgent need for standards for AI in healthcare, motivated by the rapid advancements of generative AI tools.

Manufacturers of predictive models may soon be required to explain how their systems were developed and tested, and to demonstrate that they are safe, reliable, and fair. This significant step towards transparency and accountability in AI application will ensure that these technologies are held to high standards, thus safeguarding patients health and personal information.

The U.S. government and Congress have increased their focus on AI and its implications for healthcare and life sciences. The Senate and House have held hearings and forums to explore AIs impact on healthcare, and to establish strong governance over the potential dual-use risks of AI in biosecurity.

The Department of Health and Human Services (HHS) has advanced its initiatives to implement President Bidens AI executive order. These include developing a strategic plan for responsible deployment of AI, finalizing rules for algorithm transparency and information sharing, and outlining specific objectives to establish policies, advance quality and safety, leverage funding, and deploy AI capabilities across HHS.

Building on the momentum from 2023, the U.S. government is expected to continue implementing AI regulations in 2024. This includes increased transparency and new standards, focusing on best practices and a nuanced approach to regulating different sectors of the economy. The National Institute of Standards and Technology has proposed a framework for grading types and uses of AI by risk; a strategy similar to the EUs AI Act.

These changes are expected to influence the global conversation on AI regulation, with the upcoming U.S. presidential election playing a significant role. Companies developing high-risk AI systems will need to adhere to the law, thus encouraging more thoughtful system development and requiring detailed documentation for auditing purposes.

Decisions made in 2024 could potentially reshape the landscape of healthcare, particularly in areas like telehealth and remote prescribing. Flexibilities in reimbursement for telehealth services, a result of the COVID-19 pandemic, are set to expire, and the fate of these policies hangs in the balance. Regulations that could alter everything from AI and telehealth reimbursement to remote prescribing are under consideration.

However, its worth noting that major legislation regulating AI in healthcare is not expected to become law in 2024. Industry insiders deem the current regulatory framework adequate, suggesting that changes will be more about refining existing regulations rather than implementing entirely new ones. Despite this, the conversation and actions surrounding AI in healthcare in the coming year will undoubtedly set the stage for the future of the industry.

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Artificial Intelligence in Healthcare: A Regulatory Overhaul - Medriva

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