AI-Based Medical Devices and Regulations: A Cross-Country Perspective

The development and commercialisation of products in the market is subject to regulation. New technologies are also impacted by existing regulation. Regulatory changes also happen due to the development of many different types of technologies. Regulation of technology includes compliance with technical requirements/specification, standardisation, taxes, information disclosure and market regulation. On the one hand, regulation can incentivise innovation, and on the other hand, it may create an entry barrier. The evolution of regulatory processes is governed by political, economic and social imperatives (Weiner in Technol Soc 26:483–500, 2004). There are different standpoints in understanding regulatory design. Regulatory assessments are key for policy and implementation. Diffusion of new technologies is affected by regulation. Governments develop regulations as a reactive response to the introduction of new technology-based products by the industry. Hence, initially it is the industry which develops compliance procedures that are reviewed by the regulators. Companies tend to be in an advantageous position with respect to market in cases where there is no or very little regulation of new technology products. This is in contrast to companies that introduce products when there is not only a full-fledged legislation but also has been implemented for years. So, the flexibility or stringency of a regulation depends on these considerations as well. Regulation is also jurisdiction specific and has several components. It is not static and is dynamic and is influenced by the growth of social regulation. The development of the risk regulatory framework involves the study of the impact of new technologies on the health, safety and environment. Prof. Alfed Kahn in his seminal work on the economics of regulation noted that it is the responsibility of legislatures and regulatory commissions to find ‘the best possible mix of inevitably imperfect regulation and inevitably imperfect competition’ (Khan in The economics of regulation: principles and institutions, 1988) The economics of regulation: principles and institutions). Technological developments that are disruptive are widely utilised on the global front. Emerging technologies present a huge challenge to regulatory authorities. Further, the implementation of technologies on the digital medium has brought several challenges. Just as in the case of other technologies, digital healthcare has necessitated a relook at whether or not the traditional regulatory system is effective. While digital medium helps in decentralising and providing greater flexibility and public convenience, there are adequate concerns on monitoring and assessment of safety of the digital technologies. Building soft-law approaches has been observed to be an alternative to enhance regulatory governance. The introduction of industry guidance, best practice recommendations, white paper reports and advisory circulars help in stakeholder engagement as well as drive public policy mandates. These build flexibilities yet ensure that industry is accountable. Regulatory authorities, unlike in earlier times, engage in multi-stakeholder discussions to identify and adopt consensus-based standards (Hagemann et al. in Columbia Technol Law J 17:37–130, 2018).