Artificial Intelligence

AI Executive Order, the Full Breakdown

White House

The White House’s long-awaited executive order on “Safe, Secure, and Trustworthy” artificial intelligence is finally here, and it left little room to miss its underlying message: the laissez-faire era of AI regulation is over.

Among the 100+ pages of actions guiding the direction of responsible AI development, President Biden laid out several initiatives poised to make an immediate impact within healthcare, including…

  • Calling on HHS to create an AI task force within six months to assess new models before they go to market and oversee their performance once they do
  • Requiring that task force to build a regulatory structure that can “maintain appropriate levels of quality” in AI used for care delivery, research, and drug development
  • That structure will require healthcare AI developers to share their safety testing outcomes with the government
  • Balancing the added regulation by ramping up grantmaking for AI development in areas such as personalized immune-response treatments, burnout, and improving data quality
  • Standing up to serve as the go-to resource for federal AI standards and hiring, a decent signal that there’ll be actual follow-through to cultivate public sector AI talent

The FDA has already approved upwards of 520 AI algorithms, and has done well with predictive models that take in data and propose probable outcomes. 

  • However, generative AI products that respond to human queries require “a vastly different paradigm” to regulate, and FDA Digital Health Director Troy Tazbaz believes any new structure will involve ongoing audits to ensure continuous safety.

There’s already been tons of great post-game analysis on these developments, with the general consensus looking like a cautious optimism. 

  • While some appreciate the order’s whole-of-government approach to AI, others worry that “excessive preemptive regulation” could slow AI’s progress and delay its benefits.
  • Others are skeptical that the directives will be carried out at all, given the difficulty of hiring enough AI experts in government and passing the needed legislation.

The Takeaway

President Biden’s executive order aims to thread the needle between providing protection and encouraging innovation, but time will tell whether it’ll deliver on some much-needed guardrails. Although AI is a lightning-quick industry that doesn’t exactly lend itself to the type of centralized long-term planning envisioned in the executive order, more structure should be an improvement over regulatory uncertainty.

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