Global Perspectives on Regulatory Landscape for Low-Dimensional Biosensors

The swift progress of low-dimensional biosensors has revolutionized fields like healthcare and environmental monitoring, prompting increased interest in their regulatory framework. This chapter offers a comprehensive overview of global perspectives on regulating low-dimensional biosensors, focusing on standardized testing, privacy concerns, and safety measures. It highlights the need for a delicate balance between innovation and regulation to ensure user and public safety, emphasizing the challenges in developing adaptable universal standards. Ongoing efforts by global regulatory bodies to harmonize testing protocols are discussed. Privacy concerns regarding sensitive personal data are explored, referencing emerging regulations like the General Data Protection Regulation and addressing the challenges of cross-border implementation. Safety implications of deploying low-dimensional biosensors, including biocompatibility and toxicity, are examined, stressing the importance of continuous risk assessment. The chapter proposes best practices and recommendations, advocating for international collaborations to establish harmonized standards, integrating ethics into the regulatory process, and adopting a risk-based approach for safety evaluations.