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

Healthcare AI faces an ethical dilemma between selective and equitable deployment, exacerbated by flawed performance metrics. These metrics inadequately capture real-world complexities and biases, leading to premature assertions of effectiveness. Improved evaluation practices, including continuous monitoring and silent evaluation periods, are crucial. To address these fundamental shortcomings, a paradigm

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

There is a need for digital health innovation focused on bettering the health of marginalized populations. These communities, often insured by Medicaid and Medicare, face complex healthcare barriers that technology can address—emphasizing the role of the Center for Medicaid and Medicare Services (CMS) in fostering innovation. Dasari et al. identify four areas of CMS collaboration with startups: enhancing

A highly ambitious FDA initiative will explore, through a hub and ideas lab, how equitable healthcare at home can be delivered, recognizing that this is unlikely to come about without intervention. Market forces, as shaped by current regulations, are leading to digital health tools developed and operating in islands rather than enabling integrated digital care. Can the initiative, which adopts system-level

EU-US data transfers for health research remain a particularly thorny issue in view of the stringent rules of the EU General Data Protection Regulation (GDPR) and the challenges related to US mass surveillance programs, particularly the manner in which US law enforcement and national security agencies can access personal data originating from the EU. Since the entry into force of the GDPR, evidence

Decentralized clinical trials have gained in popularity over the last years due to their advantages related to broadening recruitment strategies and resource saving possibilities. As more clinical trials adopt decentralized strategies, it is essential to share the knowledge about both successful and unsuccessful efforts in the research community. In the present commentary, we explore potential reasons

Digital health technologies (DHT) offer the ability to deliver personalized care, lower barriers to access, and positively impact health outcomes. However, DHT utilization is impacted by insufficient market access pathways. A policy “full-stack”—including regulatory authorization, product value assessment, pricing and reimbursement, and patient access infrastructure—offers a framework for DHT integration

Diabetic eye disease (DED) is a leading cause of blindness in the world. Annual DED testing is recommended for adults with diabetes, but adherence to this guideline has historically been low. In 2020, Johns Hopkins Medicine (JHM) began deploying autonomous AI for DED testing. In this study, we aimed to determine whether autonomous AI implementation was associated with increased adherence to annual

Increasing evidence supports reduced accuracy of noninvasive assessment tools, such as pulse oximetry, temperature probes, and AI skin diagnosis benchmarks, in patients with darker skin tones. The FDA is exploring potential strategies for device regulation to improve performance across diverse skin tones by including skin tone criteria. However, there is no consensus about how prospective studies should