Regulation
The overall picture balances innovation and intuition
The global artificial intelligence (AI) landscape is undergoing significant changes as regulators grapple with the technology’s rapid advances.
As the United States and Europe consider tightening regulations on artificial intelligence, Argentine President Javier Milei is positioning his country as a potential haven for tech investments. Meanwhile, the US legal system is proceeding cautiously, with federal appeals courts hesitant to adopt AI-related rules.
Several industry leaders are also urging the United States Food and drug administration (FDA) to find balance in its approach to regulating AI in the pharmaceutical and medical device industries.
Regulatory changes could push investment in artificial intelligence in Argentina
After six months in office, President Milei is leveraging global regulatory changes to position Argentina as the world’s fourth AI hub. Milei’s economic advisor, Demian Reidelhighlighted Argentina’s potential as a strategic destination for technology investments, given growing regulatory pressures in the United States and Europe, according to a report from Financial Times.
Reidel, who orchestrated Milei’s recent meetings with tech giants like OpenAI, Google, Apple AND Halfsaid restrictive regulations in other regions are making Argentina an attractive alternative.
“Extremely restrictive” rules have “killed artificial intelligence in Europe,” Reidel said. He added that discussions in the United States, particularly California, indicated that American lawmakers may follow a similar path, further pushing companies to seek more favorable environments.
In May, Milei and Reidel held private meetings in California with key industry figures, including Sam Altman of OpenAI and Apple Tim Cook. They also hosted a summit with AI investors and thinkers, such as venture capitalists Marc Andreessen and sociologist Larry Diamond. Additionally, Milei met with the CEO of Tesla Elon Musk twice.
Court case? Better to bring a human
In a move that could have set a digital precedent, the 5th U.S. Circuit Court of Appeals in New Orleans has decided to keep its courtrooms strictly human for now. The court decided not to adopt what would have been the first national rule to regulate the use of generative artificial intelligence by lawyers, Reuters reported Tuesday (June 11).
The proposed rule, introduced last November, sought to require that lawyers using AI-generated documents – courtesy of tools like OpenAI’s ChatGPT – certify that the documents had been thoroughly reviewed for accuracy. Missteps in compliance could have led to fines or the deletion of incorrect documents from court records.
The court’s decision came after an influx of public comments, mostly from skeptical lawyers. The legal community has expressed concern about the reliability of AI, citing incidents where AI “hallucinations” have led to fictitious case citations.
If the 5th Circuit had moved forward, it would have been the only court among the 13 federal appeals courts with such a rule. Other federal appeals courts are also toying with the idea of AI regulations, echoing the 5th Circuit’s concerns.
Across the pond, a recent survey by Thomson Reuters showed that British lawyers are divided on the regulation of AI: 44% of in-house lawyers want government oversight, while 50% prefer self-regulation. Law firms echo this divide, with 36% favoring regulation and 48% opting for a laissez-faire approach, leaving regulators in a bind.
Experts urge FDA to find balance in regulating AI
Industry leader at RAPS Regulatory Intelligence Conference stressed the need for a balanced approach in future FDA AI regulations, advocating flexibility and collaboration over rigid rules, Regulatory News reported Monday (June 10).
Moderated by Chris Whalley, PfizerDirector of Regulatory Intelligence, the panel included Atty Bradley Thompson of the law firm Epstein, Becker and Green; Vice President of Pharmaceutical Sector Sam Kay of an AI-powered health data company Basil Systems; Director of Global Regulatory Strategy Gopal Match of a pharmaceutical company Bayer; and head of U.S. global science and regulatory policy at Merck Group Elizabeth Rosenkrands Lange of a scientific and technological company EMD Serono/Merck. Collectively they warned that overly prescriptive regulations could hinder innovation.
The panel highlighted the importance of clearly defining the goals of AI in the pharmaceutical and medical device sectors. Bayer’s use of AI has been highlighted as an example of integrating AI into medical devices and regulatory intelligence. Merck’s AI tools and pilot projects were also considered, with an emphasis on the need for supplier partnerships due to current technological limitations.
The potential for AI to analyze large amounts of data points to untapped data that could streamline regulatory processes, Thompson noted.
Opinions on AI readiness varied among speakers.
Some have expressed skepticism about AI’s current capabilities and advised against large investments without clear goals, pointing out that companies often fail within a matter of months due to inadequate planning. However, others were more optimistic, highlighting AI’s ability to accelerate product development, but cautioned that this is only the first step and requires further refinement.
The panel concluded with a consensus that precise goals and strategic investments are crucial to unlocking the full potential of AI in the pharmaceutical and medical device industries, while effectively navigating the regulatory landscape.
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