Consideration of Cybersecurity Risks in the Benefit-Risk Analysis of Medical Devices: Scoping Review.

Background: The integration of connected medical devices (MDs) into health care brings benefits but also introduces new, often challenging-to-assess risks related to cybersecurity, which have the potential to harm patients. Current regulations in the European Union and the United States mandate the consideration of these risks in the benefit-risk analysis (BRA) required for MD approval. This important step in the approval process weighs all the defined benefits of a device with its anticipated risks to ensure that the product provides a positive argument for use.

The regulatory status of health apps that employ gamification.

Smartphone applications are one of the main delivery modalities in digital health. Many of these mHealth apps use gamification to engage users, improve user experience, and achieve better health outcomes. Yet, it remains unclear whether gamified approaches help to deliver effective, safe, and clinically beneficial products to users.

A future role for health applications of large language models depends on regulators enforcing safety standards.

Among the rapid integration of artificial intelligence in clinical settings, large language models (LLMs), such as Generative Pre-trained Transformer-4, have emerged as multifaceted tools that have potential for health-care delivery, diagnosis, and patient care. However, deployment of LLMs raises substantial regulatory and safety concerns. Due to their high output variability, poor inherent explainability, and the risk of so-called AI hallucinations, LLM-based health-care applications that serve a medical purpose face regulatory challenges for approval as medical devices under US and EU laws, including the recently passed EU Artificial Intelligence Act.

Bridging between hype and implementation in medical extended reality.

The path to market and to a meaningful impact on care delivery for medical extended reality (MXR) is challenging, due to limitations with current display technologies and as the MXR approach is far away from the traditional practice of medicine and the daily experience of most patients or healthcare providers. Focused conferences, which bring together all stakeholders for free communication and the brainstorming of optimal approaches to design, validation, and regulatory approval are important and are being organized by the clinician-enthusiast and developer community. These conferences and the community spirit they inspire are models for other digital health subdomains.