Regulatory readiness will decide who wins in the NHS AI revolution, says Visiba

London, July 22, 2026 – As the NHS accelerates AI adoption, healthcare leaders are being urged to ask a more fundamental question: which AI platforms are positioning themselves as long-term partners for public health systems, and which are not.

Following the UK Government's announcement that AI-powered clinical triage will be rolled out nationwide through the NHS App by April 2028 as part of its £10 billion NHS technology modernisation programme, Hannah Gibson, Chief Commercial Officer at Visiba, commented:

“While this announcement is a significant milestone for AI in healthcare, it also marks the start of a new market phase in which regulatory strength and investment, rather than technical capability alone, will determine provider success.”

Noting that the debate around AI in healthcare is changing, Gibson added that “the question is no longer whether AI should be used in public health systems, but whether it has been developed, validated, and governed to the standards patients, clinicians and regulators should expect."

As adoption accelerates, Gibson believes the market is increasingly dividing between companies meeting today's minimum regulatory requirements and those investing proactively in higher levels of clinical assurance.

In Europe, a small group of AI-powered triage and Ambient Voice Technology (AVT) providers have been voluntarily seeking independently audited Class IIA certification, a significant investment of time and money, which is often excessive to market requirements. Providers such as Visiba, Infermedica, Healthily and Ada are amongst those taking this approach.

For Visiba, this strategy reflects the belief that regulation will continue to evolve as AI becomes integrated into frontline healthcare.

"Healthcare has always demanded a higher standard of evidence than other industries," Gibson explained. "The organisations investing in stronger regulatory foundations today are preparing for tomorrow's healthcare system, where the introduction of AI makes transparency, clinical evidence and independent validation increasingly important."

Visiba's approach has already received independent recognition. In 2024, the company won the Nordic Health App Award after ORCHA independently assessed its AI technology for safety, quality, and clinical effectiveness. Past experience suggests this shift may accelerate.

When the European Union introduced the Medical Device Regulation (MDR) in 2021, many manufacturers struggled to meet the significantly higher evidentiary requirements, with industry estimates suggesting that around 30 percent of smaller medical device manufacturers exited the market rather than undertake the necessary investment.

Gibson advises healthcare organisations procuring AI solutions to learn from this experience.

"As AI becomes critical national healthcare infrastructure, procurement decisions cannot be based solely on functionality or cost," she said. "Healthcare leaders should be asking whether providers have invested in being a long-term partner, and prioritised the regulatory standards that future healthcare systems will require, not simply what is acceptable today."

As AI transitions from isolated pilots to core NHS infrastructure, Gibson argues that regulatory maturity will increasingly be a competitive advantage rather than merely a compliance requirement.

"The winners in healthcare AI won't necessarily be those who move fastest," she concluded. "They'll be those who build technologies that clinicians trust, regulators support, and patients can rely on for years to come."

For more information, please contact Hannah Gibson, Chief Commercial Officer, at hannah.gibson@visibagroup.com or call +44 7725 723 438 (visit the Visiba online website here)

About Visiba

Visiba UK has been awarded two separate NIHR Research Grants in the last three years, designed to advance the evidence base for AI in NHS patient navigation, and was also shortlisted for an HSJ award in 2024 for its work on the first-ever AI model deployed into NHS 111 to triage patients.

Visiba is a member of Sweden’s purpose-driven investment portfolio, Blue AB, launched in 2016 by Swedish ecopreneur Bengt Rittri, founder of companies including the indoor air purification leader Blueair (divested to Unilever in 2016) and the sustainable water purification and beverage company Bluewater.