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The White House has released an executive order that contains what it hails as “the most sweeping actions ever taken to protect Americans from the potential risks of AI systems.” Relevant to drug development, a fact sheet on the order describes its aim to help further “the responsible use of AI in healthcare and the development of affordable and life-saving drugs.” The order also is designed to protect against the risks of using AI to synthesize new chemicals and biological materials, and will require government agencies funding life science projects to follow these standards as a prerequisite.
Other provisions of the order that could affect drug developers include its potential to affect AI-assisted clinical trials. The order could require drug developers to ensure that their algorithms do not exacerbate discrimination in clinical trials or patient interactions. Drug developers processing patient data or other sensitive information will need to prioritize privacy-preserving techniques in their AI systems.
In addition, the executive order directs the Department of Health and Human Services to create a program to evaluate potentially harmful AI-related health care practices. This provision could potentially involve drug developers using AI.
Measures that could codify responsible AI
The presidential directive also has a provision intended to gauge the labor market impact of AI systems, which could impact pharma companies with aggressive plans to integrate AI systems into their drug development processes.
Biden has repeatedly called for America to help drive “responsible AI innovation.” To help support the burgeoning AI industry in the U.S., the executive order also aims to promote innovation and competition in the AI ecosystem, offering access to grants for AI research in health care and other areas. Other countries, most notably China, have made significant investments in the development of AI systems in recent years.
The executive order calls for a whole-of-government approach to regulating AI, aiming to set standards and rules around the technology. In that vein, the presidential directive aims to foster collaboration with international stakeholders to refine AI standards. The potential standards from this request could impact drug developers operating in global markets.
In addition, the executive order asks each federal agency to create the position of a chief AI officer.
The move follows voluntary commitments Biden has secured from prominent AI companies.
Mixed assessments of the AI executive order
Initial assessments of the executive order have been mixed. The online trade association referred to the order as “a red tape AI” wishlist, arguing that it puts “the future of American innovation and global technological dominance at risk.” Texas Senator Ted Cruz said the new rules would stymie innovation. Conversely, IBM noted in a statement that the directive ensures that “AI used by the United States government will be responsible AI.”
It remains to be seen how well federal authorities can enforce the executive order’s provisions, as its ability to do so will hinge on the willingness of Congress to provide the necessary funding for it.
Earlier this year, Biden sought to reboot the Cancer Moonshot project.
Although the pharma industry has tended to prefer BIden’s handling of the pandemic to Trump’s, the industry has resisted the Inflation Reduction Act, signed into law in August 2022. The law called for substantial changes in the U.S. pharmaceuticals market, including measures to prevent increases in drug prices from surpassing inflation and the introduction of price negotiations for certain prescription Medicare drugs.