What Exactly Is High-Risk AI and Does It Apply to You?

thesocialimpactnl
Sep 12, 2025
3 min read

The European AI Act is now in effect, introducing a new reality for businesses using AI. Especially if your applications directly impact people’s lives. In that case, you may fall under the category of high-risk AI. But what does that actually mean? And when does it apply to you?

In this blog, we’ll explain clearly what high-risk AI is, share practical examples, and help you understand what’s expected of you as a business owner to remain compliant and future-ready.

What is high-risk AI?

High-risk AI refers to systems used in areas where mistakes can have serious consequences for people. Think decisions about someone’s health, job, credit, or even their freedom.

The European Union has created a list of scenarios where AI use is considered high-risk. The reason is simple: when AI fails in these contexts, it can have immediate, sometimes severe, consequences for real people.

Examples of high-risk AI

You fall under the high-risk AI category if you use AI in areas such as:

Recruitment: AI that screens job applicants or ranks candidates
Healthcare: AI that provides diagnoses or treatment recommendations
Financial services: AI that assesses creditworthiness
Education: AI that influences access to exams or learning programs
Law enforcement or surveillance: AI that assesses behavior or predicts risks
Public services: AI that determines eligibility for benefits or permits

Even if you develop, sell, or integrate such systems as part of your business, the regulations

still apply to you.

Not sure if it applies? Ask yourself these 5 questions:

Does my AI system make decisions that affect people? For example: who gets access to a product, service, or opportunity?
Are people being assessed or scored? Think of job screenings, loan applications, or behavioral analysis.
Does my AI impact health, safety, or human rights? Especially in healthcare, legal processes, public services, or education.
Is my AI used in a regulated industry? Such as government, justice, finance, or healthcare.
Am I a provider or integrator of an AI system in one of these areas? If so, you may still be held responsible under the law.

If you answered ‘yes’ to one or more of these questions, your AI solution may fall under high-risk obligations.

What are your obligations?

If your AI is classified as high-risk, you must meet a series of legal requirements, including:

Transparency: explaining what your AI does and why
Human oversight: ensuring a human is always in control
Data governance: managing the quality and integrity of training data
Risk management: analyzing and minimizing potential harm
Documentation: maintaining detailed technical records
Monitoring: continuously supervising your AI system’s performance

This might sound heavy, but the purpose is clear: to ensure safety, fairness, and trust.

What does this mean for small businesses?

Even smaller businesses can fall under these rules. For example, if you use AI in recruiting or offer AI-based tools to healthcare providers, the same standards apply to you as they do to large corporations.

The law doesn’t focus on company size. It focuses on the impact your AI has.

How to stay compliant and avoid problems

Map your AI applications: Know where and how AI is used in your business
Check if you fall under high-risk AI: Use the 5 questions above
Seek expert guidance: A specialist can help assess your risks
Choose pre-compliant solutions: Like the AI Employees from Autopilots

Playing smart with strict rules

The AI Act isn’t here to slow your business down, but to ensure AI is used safely and responsibly. Think of it as an opportunity to professionalize your systems, build customer trust, and get ahead of competitors who are not yet prepared.

At Autopilots, we design AI Employees that meet the latest legal standards, including transparency, auditability, and privacy-by-design. That means you stay safely within the lines while leading the way forward.