Course overview
This programme provides innovators, entrepreneurs, and healthcare professionals with the knowledge and practical frameworks needed to navigate European Health Data Space (EHDS) standards and quality labelling requirements for health and wellness apps. Through an exploration of ISO 82304-2 requirements, regulatory principles, and quality assessment approaches, participants will gain the skills to evaluate, improve, and align digital health solutions with European quality frameworks that support safer, more trusted, and effective healthcare innovation.
What you will learn:
- Understanding EHDS regulations and ISO 82304-2 quality labelling standards for health and wellness apps.
- Applying quality and compliance criteria to assess digital health app performance, safety, and reliability.
- Identifying key regulatory requirements related to data protection, interoperability, and digital health standards.
- Using practical tools and frameworks to improve app quality and alignment with European requirements.
- Recognising how quality labelling can strengthen user trust, transparency, and market credibility.
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