Navigating Uncertainty in AI Development

The AI Act gives us clear boundaries to innovate responsibly. It is a framework that ensures our tools are safe, reliable, and accessible for all. Anders Kofod-Petersen, Co-founder and CEO

At OptikosPrime, we are an AI-driven organization. Our mission is to make eye health accessible to everyone with a smartphone, using tools like VisionCheck. But AI’s rapid growth across industries has brought uncertainty. Without clear rules, companies face questions: What’s allowed? What’s off-limits? How do we balance innovation with responsibility?

Some companies prioritized speed over safety, risking user trust, while others, like us, adhered to strict standards, such as those for medical devices under EU and FDA regulations. We needed a framework that clarified expectations and ensured fairness for all.

The AI Act Sets a Clear Path for Responsible AI

The EU’s AI Act, effective since February 1, 2025, is the world’s first comprehensive attempt to regulate AI applications. It is about guiding the use of AI responsibly and setting forth a solid framework for building in the space. We at OptikosPrime see it as a great fit for our values. Here’s why the AI Act works for us:

Flexible Framework: The Act doesn’t define AI rigidly, avoiding outdated restrictions. It instead focuses on what AI does and why, leaving the “how” to be defined with use and time. This lets us innovate freely while meeting clear standards.

Risk-Based Regulation: The Act scales requirements based on risk. Higher stakes mean stricter rules, ensuring user safety without burdening low-risk applications. This approach aligns with our commitment to precision in tools like VisionCheck.

Level Playing Field: By setting universal standards, the Act ensures all companies follow the same rules. It is only fair.

OptikosPrime has also contributed to CEN/CENELEC standards that support the Act, helping shape practical guidelines that balance innovation and safety. This ensures our products meet global expectations while influencing sensible regulations.

Stronger Products Through Responsible Practices

The AI Act reinforces our commitment to building trustworthy AI tools thar are widely used. We’ve chosen to treat our products as high-risk systems, even though they may not be classified as such, because the Act’s requirements align with our existing practices. These include:

• Robust Risk Management: Continuous risk assessment throughout our product lifecycle
• Data Governance: Using representative, error-free datasets for reliable results‍
• Transparency: Detailed logs and documentation for accountability

By embracing these standards, we ensure our tools are accurate, secure, and user-friendly. For example, VisionCheck benefits from rigorous data governance, ensuring tests are reliable across diverse populations. Our quality management system captures company knowledge, making our processes repeatable and scalable. 

The AI Act levels the playing field, holding all companies to the same high standards we already follow. This supports our mission to deliver effective, affordable, and accessible eye health solutions globally.

What’s Next?

We’re excited to keep aligning our work with the AI Act, refining our tools to meet its standards and continuing to contribute to global AI regulations. This helps strengthen our products and builds trust with opticians, retailers, and users worldwide.

Want to learn more about how our responsible AI approach can benefit your business? Reach out to explore partnerships or discover how VisionCheck can enhance your operations.