The early diagnosis of rare diseases (RDs) is crucial for timely intervention and effective management. The Screen4Care project seeks to accelerate this process by combining newborn screening with artificial intelligence (AI) and machine-learning (ML) tools. The Screen4Care interdisciplinary approach aims to reduce the lengthy diagnostic journey for individuals with RDs and improve their quality of life. A Code of Ethical Practice (CoEP) was developed to ensure the ethical handling of personal data in AI/ML-based screening. This CoEP outlines standards for how Screen4Care partner organizations can share and access patient data while minimizing the risk of misuse. Developed through the combined efforts of expert groups, European teams, advisory bodies, and patient organizations, the CoEP ensures a secure framework for data handling. This establishes a robust set of ethical principles, ensuring that data collection and sharing are conducted in a safe and responsible manner. This framework supports innovative AI/ML solutions, optimizing the diagnosis, treatment, and management of RDs, while safeguarding the interests of individuals and their families.