Navigating the Future of AI in Healthcare under the EU AI Act!

September 17, 2024, Copenhagen – At gMendel^®, we are committed to pushing the boundaries of AI-powered healthcare solutions, and we’re excited to announce a major milestone in our journey toward compliance with the evolving regulatory landscape in the European Union.

Our CTO and co-founder, Zoran Velkoski, said, “With the recent introduction of the EU AI Act, which sets out stringent guidelines for high-risk AI systems, we’ve taken proactive steps to ensure our gMendel®Test meets the highest standards of safety, transparency, and effectiveness.”

As a pioneer in genetic testing, compliance is key, not only with the In Vitro Diagnostic Regulation (IVDR) but also under this new AI regulation.

Here’s how we’re refining our operations to align with the EU AI Act:

AI Policy & Governance – establishing a robust AI policy to ensure data transparency and security in every phase of our processes.
Data Provenance & Tracing – implementing state-of-the-art techniques to ensure accuracy, traceability, and robustness in our machine learning models.
Bias & Cybersecurity – addressing bias in our models and strengthening cybersecurity protocols to protect patient data and maintain trust.
Feature Engineering & AI Impact Assessments – ensuring our AI-driven genetic testing remains effective, ethical, and aligned with patient care standards.

We are already ISO 13485 certified and IVDR compliant, and we’re expanding our scope to adhere to the ISO 42001:2023 AI Management System as well.

As we continue refining our processes, we remain dedicated to delivering safer, smarter AI-driven healthcare solutions that comply with the most stringent global standards.