EU releases AI regulatory proposal

Given the anticipated growth of AI in healthcare and other sectors, say observers, developers and providers need to stay abreast of emerging regulatory guidelines.
Jeff Rowe

With new technology comes risk, and with risk comes regulation.

That may be a bit overly simplistic, but enthusiasts for AI in healthcare would do well to keep an eye on emerging regulatory proposals from policymakers both for how it will impact the broader healthcare landscape and, ideally, how it could make the introduction of AI more consistent and productive.

Writing recently at Forbes, for example, writer Sai Balasubramanian points to the EU’s recently unveiled “Proposal for a Regulation on a European approach for Artificial Intelligence,” which intends to “the first ever legal framework on AI,” while also setting the stage for Europe to take the lead for AI growth around the globe.

According to Balasubramanian, EU policymakers recognize that “the same elements and techniques that power the socio-economic benefits of AI can also bring about new risks or negative consequences for individuals or the society,” so they aim to ensure, via appropriate regulation, “that people can trust that the technology is used in a way that is safe and compliant with the law, including the respect of fundamental rights.”

The problem, he says, is that “the wider arc of (AI) does not lend itself to easily drawn boundaries, simply due to the nature of the technology. Hence, in the coming months and years, legal scholars, regulatory authorities, scientists, and AI innovators will have to scrupulously navigate what exactly the real-world effects of this new proposal will entail.”

Specifically, he points to, among other references, sections of the proposal that identify “prohibited AI practices,” which include “practices that have a significant potential to manipulate persons through subliminal techniques beyond their consciousness,” and “transparency obligations for certain AI systems,” meaning if people are interacting with AI they need to know it’s AI.

“Though regulators and innovators may not exactly know yet how this proposal will impact healthcare in real terms,” notes Balasubramanian,  it will likely create some sort of precedent and framework moving forward, depending on how well it is received in the coming months.”

The bottom line, he says, is that regulatory frameworks regarding AI are bound to keep emerging and evolving, and while “some amount of regulation is indeed necessary, in order to ultimately prioritize patient safety, health, and privacy, . . . the key will be to find the perfect middle ground with this aspect in mind—carefully focused on the highest standards of patient safety, while also ensuring progress in innovation.”