This piece critiques the exclusion of healthcare practitioners (HCPs) from the digital health innovation process. Drawing on “Sync fast and solve things—best practices for responsible digital health” by Landers et al., the editorial argues for the importance of inclusive co-creation, in which clinicians play an active role in developing digital health solutions. It emphasizes that without the meaningful involvement of HCPs, digital health tools risk being clinically irrelevant.

The newly adopted EU AI Act represents a pivotal milestone that heralds a new era of AI regulation across industries. With its broad territorial scope and applicability, this comprehensive legislation establishes stringent requirements for AI systems. In this article, we analyze the AI Act’s impact on digital medical products, such as medical devices: How does the AI Act apply to AI/ML-enabled medical devices? How are they classified? What are the compliance requirements? And, what are the obligations of ‘providers’ of these AI systems? After addressing these foundational questions, we discuss the AI Act’s broader implications for the future of regulated digital medical products.