Regulatory Sandboxes and the Public Health

Sherkow, Jacob S.

doi:10.2139/ssrn.3792217

Cited by 4 publications

(4 citation statements)

References 31 publications

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“…Regulatory sandboxes remain appealing to the financial sector within and beyond the United Kingdom. In the meanwhile, they have been embraced in other regulated sectors, including data protection, energy, health care, and telecommunications (Leckenby et al, 2021;Sherkow, 2021;Veseli et al, 2021).…”

Section: Experimental Legal Regimesmentioning

confidence: 99%

Experimental Regulations and Regulatory Sandboxes – Law Without Order?

Ranchordás¹

2021

Law and Method

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This article discusses the key methodological shortcomings of experimental regulations and regulatory sandboxes. I argue that the poor design and implementation of these experimental legal regimes have both methodological and legal implications. The deficient design of experimental regulations and regulatory sandboxes can have three adverse effects: First, the internal validity of experimental legal regimes is limited because it is unclear whether the verified results are the direct result of the experimental intervention or other circumstances. The limited external validity of experimental legal regimes impedes the generalizability of the experiment. Second, experimental legal regimes that are not scientifically sound make a limited contribution to the advancement of evidence-based lawmaking and the rationalization of regulation. Third, methodological deficiencies may result in the violation of legal principles which require that experimental regulations follow objective, transparent, and predictable standards. I contribute to existing comparative public law and law and methods literature with an interdisciplinary framework which can help improve the design of experimental regulations and regulatory sandboxes. I draw on social science literature on the methods of field experiments to offer novel methodological insights for a more transparent and objective design of experimental regulations and regulatory sandboxes.

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Section: Experimental Legal Regimesmentioning

confidence: 99%

Experimental Regulations and Regulatory Sandboxes – Law Without Order?

Ranchordás¹

2021

Law and Method

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“…Regulatory sandboxes disrupt traditional approval paradigms and allow private actors to conduct limited tests of their innovations with fewer regulatory constraints but with real individuals (Sherkow 2021). This "safe space" for trial-and-error offers opportunities for the promotion of innovation in the development of AI but it also has some risks.…”

Section: Regulatory Sandboxes and The Eu Ai Regulation Proposal: A Reflectionmentioning

confidence: 99%

Experimental Regulations for AI: Sandboxes for Morals and Mores

Ranchordás¹

2021

Morals & Machines

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Recent EU legislative and policy initiatives aim to offer flexible, innovation-friendly, and future-proof regulatory frameworks. Key examples are the EU Coordinated Plan on AI and the recently published EU AI Regulation Proposal which refer to the importance of experimenting with regulatory sandboxes so as to balance innovation in AI against its potential risks. Originally developed in the Fintech sector, regulatory sandboxes create a test bed for a selected number of innovative projects, by waiving otherwise applicable rules, guiding compliance, or customizing enforcement. Despite the burgeoning literature on regulatory sandboxes and the regulation of AI, the legal, methodological, and ethical challenges of these anticipatory or, at times, adaptive regulatory frameworks have remained understudied. This exploratory article delves into the some of the benefits and intricacies of allowing for experimental instruments in the context of the regulation of AI. This article’s contribution is twofold: first, it contextualizes the adoption of regulatory sandboxes in the broader discussion on experimental approaches to regulation; second, it offers a reflection on the steps ahead for the design and implementation of AI regulatory sandboxes.

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“…More than 50 countries, including Indonesia, have adopted this framework [ 1 ]. The COVID-19 pandemic has further underscored the importance of regulatory sandboxes, as evidenced by the use of emergency authorization for COVID-19 vaccines [ 2 , 3 ]. Although regulatory sandboxes have been used in a number of health sectors in high-income countries [ 4 , 5 ], their adoption remains very limited in low- and middle-income countries, including Indonesia.…”

Section: Introductionmentioning

confidence: 99%

“…Regulatory sandboxes in the health sector strike a balance between disruptive innovation and public health [ 2 ]. They created a safe testing ground in which new regulatory processes and technologies can be evaluated in real-world settings.…”

Section: Introductionmentioning

confidence: 99%

Introducing a Regulatory Sandbox Into the Indonesian Health System Using e-Malaria as a Use Case: Participatory Action Study

Fuad,

Tiara,

Kusumasari

et al. 2023

J Med Internet Res

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Background Regulatory sandboxes offer an alternative solution to address regulatory challenges in adopting disruptive technologies. Although regulatory sandboxes have been widely implemented in the financial sector across more than 50 countries, their application to the health sector remains limited. Objective This study aims to explore stakeholders’ perspectives on introducing a regulatory sandbox into the Indonesian health system using e-malaria as a use case. Methods Using a participatory action research approach, this study conducted qualitative research, including desk reviews, focus group discussions, and in-depth interviews with stakeholders. This study sought to understand stakeholders’ concerns and interests regarding the regulatory sandbox and to collaboratively develop a regulatory sandbox model to support the malaria program. Results The study revealed that most stakeholders had limited awareness of the regulatory sandbox concept. Concerns have been raised regarding the time required to establish regulations, knowledge gaps among stakeholders, data protection issues, and limited digital infrastructure in malaria endemic areas. Existing regulations have been found to be inadequate to accommodate disruptive healthtech for malaria. Nevertheless, through a collaborative process, stakeholders successfully developed a regulatory sandbox model specifically for e-malaria, with the crucial support of the Ministry of Health. Conclusions The regulatory sandbox holds the potential for adoption in the Indonesian health system to address the limited legal framework and to facilitate the rapid and safe adoption of disruptive healthtech in support of the malaria elimination program. Through stakeholder involvement, guidelines for implementing the regulatory sandbox were developed and innovators were successfully invited to participate in the first-ever trial of a health regulatory sandbox for e-malaria in Indonesia. Future studies should provide further insights into the challenges encountered during the e-malaria regulatory sandbox pilot study, offering a detailed account of the implementation process.

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Regulatory Sandboxes and the Public Health

Cited by 4 publications

References 31 publications

Experimental Regulations and Regulatory Sandboxes – Law Without Order?

Experimental Regulations and Regulatory Sandboxes – Law Without Order?

Experimental Regulations for AI: Sandboxes for Morals and Mores

Introducing a Regulatory Sandbox Into the Indonesian Health System Using e-Malaria as a Use Case: Participatory Action Study

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Regulatory Sandboxes and the Public Health

Cited by 4 publications

References 31 publications

Experimental Regulations and Regulatory ­Sandboxes – Law Without Order?

Experimental Regulations and Regulatory ­Sandboxes – Law Without Order?

Experimental Regulations for AI: Sandboxes for Morals and Mores

Introducing a Regulatory Sandbox Into the Indonesian Health System Using e-Malaria as a Use Case: Participatory Action Study

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Product

Resources

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Experimental Regulations and Regulatory Sandboxes – Law Without Order?

Experimental Regulations and Regulatory Sandboxes – Law Without Order?