AI Act

Artificial intelligence unveils vast prospects in the realm of healthcare, offering advancements ranging from decision support systems to intelligent prosthetics, as well as facilitating robot-assisted remote surgery. To address these developments, regulatory bodies, including institutions of the European Union, are beginning to formulate relevant regulations. The European Commission, a pivotal Member State institution, has introduced a proposed regulatory framework known as the "Artificial Intelligence Act" (AI Act). This prospective legislation is crafted to ensure the safe deployment of AI technologies while upholding fundamental rights.

The scope of the AI Act, initiated by the European Commission, is broad and its influence extends across multiple sectors, with life sciences standing as a prime example. Iliomad is positioned to guide companies through the intricacies of these evolving regulatory landscapes. By factoring in both existing and prospective privacy regulations stipulated by the European Union, iliomad assists organizations in crafting privacy-compliant AI models, thereby aligning with the stringent standards set by Member States under the guidance of the European Commission and other institutions of the European Union.

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Why become compliant with the AI act ?

For life sciences companies, compliance with the AI Act is essential to ensure that AI applications, which are increasingly integral in research, diagnostics, and patient care, are developed and deployed in a manner that prioritizes patient safety, data privacy, and ethical considerations. Complying with the AI Act enables life sciences companies to maintain access to the European market, build trust with healthcare providers and patients, and proactively mitigate legal and reputational risks associated with AI technologies, thus fostering responsible innovation and competitiveness in a rapidly evolving industry

Risk Classification

The AI Act classifies AI systems based on their risk to fundamental rights. Those deemed high-risk will be subject to stricter regulations. In life sciences, many AI applications, such as those used for critical healthcare decisions or drug discovery, could be classified as high-risk.


The AI Act emphasizes transparency in AI systems. For life sciences, this means companies would need to ensure that AI models, especially in diagnostic or treatment recommendation tools, are explainable and that patients are informed when AI is used in their care.

Data Quality

The AI Act underscores the importance of training AI models with high-quality datasets. For life sciences, this emphasizes the need for robust, diverse, and representative data, especially when developing medical AI tools that can impact patient health.

Conformity Assessment

High-risk AI applications in life sciences may require third-party conformity assessments before deployment to ensure they meet the AI Act's requirements.

Record-Keeping, Traceability, and Accountability

The act would require robust documentation for high-risk AI systems. This can affect life science companies by obligating them to maintain detailed records of AI system training, testing, and deployment.

Post-market Monitoring

For AI tools used in life sciences, continuous monitoring after they're deployed would be essential to ensure ongoing compliance and safety.

How can iliomad Health Data help you ?

iliomad has assisted healthcare companies in crafting AI models for various purposes, such as diagnosis, monitoring, and imaging. The experts at Iliomad can guide you in pinpointing the kind of AI model you're creating, evaluating potential risks, determining responsibilities, and formulating a strategy to develop and launch your models in a compliant manner.

Assess risks
Determine responsibilities
Data governance and data strategy
Carry out risk analysis