The EU AI Act: What this means for healthcare providers and investors

Since starting my role at HBI back in February, it has been a steep learning curve as I previously had limited experience in both the healthcare and investing industries.

Nevertheless, I have been enjoying unlocking new understandings of the healthcare-investing ecosystem. I’ve been using materials such as HBI’s event session videos and Special Reports to aid me in my journey, along with external readings.

After all, my role as the Events Marketing Executive demands a depth of knowledge of the current market. It also requires me to stay up to date with recent events and to understand the partnerships that CEOs and investors in the industry are aiming to achieve.

Recently, I’ve explored the many roles AI is playing in creating value for healthcare providers, their investors, and, most importantly, their patients. Alongside this, I’ve been learning about the new regulations the EU is introducing: its first attempt to establish clear standards for how AI is integrated within businesses.

Here’s what I have found out:

The second stage of the European Union’s Artificial Intelligence act comes into effect this week and with it, a number of considerations for investors and healthcare firms.

As AI remains a promising value creation ’wonder-drug’ to tackle mounting cost, resource and efficiency challenges, what does this next stage of the Act mean in practical terms?

From Saturday, organisations deploying General Purpose AI (GPAI) models, such as Large Language Models (LLMs) used for documentation automation, virtual assistants, and patient triage, must meet new legal requirements specifically around transparency, documentation, and risk mitigation. In Healthcare, that final point is particularly significant as most AI deployments are classified as ‘high risk’. 

AI is becoming ubiquitous with any discussion in 2025, but is particularly prevalent in our conversations with CEOs and investors keen to share their results and placing it high on the value creation agenda. 

Optegra, the UK’s second-largest for-profit ophthalmology provider by revenue, has implemented an AI virtual assistant called Iris into its patient pathway. This has resulted in annual savings of over £1 million and improved efficiency by 20%.

Pan-European Diagnostics company Unilabs has deployed AI in its breast cancer screening programme, which led to a 29% increase in accurate diagnosis including earlier diagnosis of severe cases. The use of AI in radiology has also enabled Swiss diagnostics company Unilabs to increase efficiency through the use of a radiologist plus AI versus two radiologists. 

Italy’s second largest for-profit hospital group by revenue, Humanitas, has invested heavily to build an entire centre for AI that has developed multiple tools and spin-out AI businesses from triage, to scheduling to diagnostics accuracy. 

These are just a few examples raised during the recent HBI 2025 session, What is AI’s Equity Story?, which you can watch in full here.

What does this mean for healthcare providers?

In short, it introduces complexity, regulatory uncertainty, and a potential administrative burden. Some may feel this places limits on innovation, whether developing solutions in-house or purchasing them externally. Of course, this isn’t necessarily a bad thing if it helps safeguard patient safety, both physical and data-related.

However, it does mean that products and roll-out plans need to be adapted and recalibrated, adding a few speed bumps along the way.

What does this mean for investors?

AI-enabled companies attract investors because, when deployed effectively, AI reduces costs and eases workload pressures, as demonstrated by Optegra. This creates clear potential for scalable growth.

It also signals that the company is proactively innovating and aligning with the direction of the industry. This scalability can drive higher margins for investors.

In addition, buyers are actively seeking AI-enabled assets to enhance their portfolios, which provides investors with attractive exit opportunities.

However, the EU AI Act introduces a new layer of scrutiny. Now, companies deploying AI systems must comply with stricter regulations around transparency, data governance, and oversight.

For investors, this means compliance-readiness will become a key part of due diligence. Companies that are proactive in aligning with these standards are likely to be more attractive to buyers and command stronger valuations. Conversely, non-compliance could introduce legal risk, reputational damage, or scaling limitations across the EU, factors that may directly impact investment returns.

For investments directly into AI companies who are mostly at the start-up phase, their compliance to this regulation could change how high or how low they are valued. How do you think this will affect companies looking to enable themselves with AI? Do you think it will stunt the sharp trend of progress we have seen over recent years? 

Let me know if you have any additional thoughts on this, I would be very open to hearing your predictions. Email me at harvie@healthcarebusinessinternational.com or call 0207 183 3779.

With AI regulations and technologies evolving rapidly, HBI 2026 offers a unique opportunity to benchmark your progress against peers, discover new real-world AI use cases, and explore where the next wave of value will come from. Book your tickets here to get up to 29% off.

For our Intelligence members, you can read more about the EU AI Act, and other upcoming technology regulations, in our Special Report - European Healthcare Technology Regulations - available here.