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The need to better balance the promotion of scientific and technological innovation with risk management for consumer protection has inspired several recent reforms attempting to make regulations more flexible and adaptive. The pharmaceutical sector has a long, established regulatory tradition, as well as a long history of controversies around how to balance incentives for needed therapeutic innovations and protecting patient safety. The emergence of disruptive biotechnologies has provided the occasion for regulatory innovation in this sector. This article investigates the regulation of advanced biotherapeutics in the European Union and shows that it presents several defining features of an adaptive regulation regime, notably institutionalized processes of planned adaptation that allow regulators to gather, generate, and mobilize new scientific and risk evidence about innovative products. However, our in‐depth case analysis highlights that more attention needs to be paid to the consequences of the introduction of adaptive regulations, especially for critical stakeholders involved in this new regulatory ecosystem, the capacity and resource requirements placed on them to adapt, and the new tradeoffs they face. In addition, our analysis highlights a deficit in how we currently evaluate the performance and public value proposition of adaptive regulations vis‐à‐vis their stated goals and objectives. [ABSTRACT FROM AUTHOR]

The Internet of Things (IoT) is a disruptive innovation known for its socio‐economic potential, but also for generating unprecedented vulnerabilities and threats. As a dynamic sociotechnical system, the IoT comprises well‐known cybersecurity risks and endemic uncertainties that arise as IoT adoption increases and the system evolves. We highlight the impact of these challenges by analyzing how insecure IoT devices pose threats to both consumer protection and the Internet's infrastructure. While recent regulatory responses are starting to target IoT security risks, crucial deficiencies – especially related to the feedback necessary to keep pace with emerging risks and uncertainties – must be addressed. We propose a model of adaptive regulatory governance that integrates the benefits of centralized risk regulatory frameworks with the operational knowledge and mitigation mechanisms developed by epistemic communities that manage day‐to‐day Internet security. Rather than focusing on the choice of regulatory instruments, this model builds on the "planned adaptive regulation" literature to highlight the need to systematically plan for a knowledge‐sharing interface in regulatory governance design for disruptive technologies, facilitating the feedback necessary to address evolving IoT security risks. [ABSTRACT FROM AUTHOR]

Background: Health care professionals receive little training on the digital technologies that their patients rely on. Consequently, practitioners may face significant barriers when providing care to patients experiencing digitally mediated harms (eg, medical device failures and cybersecurity exploits). Here, we explore the impact of technological failures in clinical terms., Objective: Our study explored the key challenges faced by frontline health care workers during digital events, identified gaps in clinical training and guidance, and proposes a set of recommendations for improving digital clinical practice., Methods: A qualitative study involving a 1-day workshop of 52 participants, internationally attended, with multistakeholder participation. Participants engaged in table-top exercises and group discussions focused on medical scenarios complicated by technology (eg, malfunctioning ventilators and malicious hacks on health care apps). Extensive notes from 5 scribes were retrospectively analyzed and a thematic analysis was performed to extract and synthesize data., Results: Clinicians reported novel forms of harm related to technology (eg, geofencing in domestic violence and errors related to interconnected fetal monitoring systems) and barriers impeding adverse event reporting (eg, time constraints and postmortem device disposal). Challenges to providing effective patient care included a lack of clinical suspicion of device failures, unfamiliarity with equipment, and an absence of digitally tailored clinical protocols. Participants agreed that cyberattacks should be classified as major incidents, with the repurposing of existing crisis resources. Treatment of patients was determined by the role technology played in clinical management, such that those reliant on potentially compromised laboratory or radiological facilities were prioritized., Conclusions: Here, we have framed digital events through a clinical lens, described in terms of their end-point impact on the patient. In doing so, we have developed a series of recommendations for ensuring responses to digital events are tailored to clinical needs and center patient care., (©Isabel Straw, Irina Brass, Andrew Mkwashi, Inika Charles, Amelie Soares, Caroline Steer. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 11.07.2024.)