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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]

Ongoing efforts by state actors to collaborate on addressing the challenges of global cybersecurity have been slow to yield results. Technical expert communities such as Computer Security and Incident Response Teams (CSIRTs) have played a fundamental role in maintaining the Internet's functional structure through transnational collaboration. Responsible for security incident management and located in diverse constituencies, these coordination centres engage in joint responses and solve day‐to‐day cybersecurity problems through diverse national, regional and international networks. This article argues that CSIRTs form an epistemic community that engages in science diplomacy, at times navigating geopolitical tensions in a way that political actors are not able to. Through interviews with CSIRT representatives, we explain how their collaborative actions, rooted in shared technical knowledge, norms and best practices, contribute to the advancement of international cooperation on cybersecurity. Collaborating around a clearly defined technical need, CSIRTs' issue‐based actions can feed into and support other non‐state and state actors' endeavours to solve global collective action on cybersecurity. Their practices neither replace nor overshadow other diplomatic mechanisms–including those carried out by state actors – but they help us to identify and understand the subtle instances of science diplomacy that might otherwise be overlooked. [ABSTRACT FROM AUTHOR]