The FDA’s standard-making process for medical digital health technologies: co-producing technological and organizational innovation

Abstract

As digital health technologies (DHT) have been embraced as a ‘panacea’ for health care systems, they have evolved from a buzzword into a high priority objective for health policy across the globe. In the realm of quality and safety standards for medical devices, the US Food and Drug Administration (FDA) has been a frontrunner in adapting its regulatory framework to DHT. However, despite the utmost relevance of quality and safety standards and their role for sustaining the innovation pathway of DHT, their actual making has not yet been subjected to in-depth social-science scrutiny. Drawing on the conceptual repertoires of Science and Technology Studies (STS), this article investigates how digital health evolved from a buzzword into an ‘object of government’, or gained material meaning and transformed into a regulatable object, by charting the standard-making process of FDA’s medical digital health policy between 2008 and 2018. From this, we reflect on the mutually sustaining dynamics between technological and organizational innovation, as the FDA’s attempts to standardize medical DHT not only shaped the lifestyle/medical boundary for DHT. It also led to significant reconfigurations within the FDA itself, while fostering a broader shift toward the uptake of alternative forms of evidence in regulatory science.

Learning From Experience and Finding the Right Balance in the Governance of Artificial Intelligence and Digital Health Technologies

“…Considering the “tightness” of regulation in the AIeMD and DHT sectors, it is also important to consider the internationally divergent approaches, as outlined in depth below. In the last decade, the United States has adopted a more flexible approach than the United Kingdom and the European Union [ 11 , 12 ]. There are well-argued concerns about increasing “red tape” limiting the ability of innovation in AIeMDs and DHT to deliver functional and helpful technologies to health care providers and systems [ 13 ].…”

“…The Food and Drug Administration (FDA) approach to the introduction of AI-based DHTs regulation is markedly different to that of the European Union [ 4 , 45 ]. Comparison of the United States and European Union positions on the regulation of DHT and AIeMD needs to acknowledge the expressed will of recent US executives to promote digital health innovation, act in a manner that promotes growth, and take a relatively less stringent approach in its regulation, particularly of digital health innovations deemed to be of lower risk [ 11 ]. The FDA addresses the tensions and potential challenges by adopting a temporary hands-off enforcement discretion approach for large groups of use cases, when justified on an assessment of the risks.…”

Digital health: A sociomaterial approach

“…Furthermore, the FDA started a pre-certification pilot to assess the culture of quality of the applying companies instead of going through each individual product's risk assessment. Lievevrouw et al (2021) stress that this innovation-friendly and rapid pre-market approval system does require a novel and extensive post-market monitoring framework in order to ensure patient safety and quality.…”

“…Alex Faulkner has outlined how regulatory practices enact and determine the ‘medical deviceness’ of technologies and thus transform them into the subject of governance (Faulkner, 2008 ). More recently, Lievevrouw and colleagues have charted the standard‐making process of the US Food and Drug Administration’s (FDA) digital health policy and outlined its challenges and tensions to elaborate the ‘world’s first attempt to demarcate the boundary between lifestyle and medical digital health technologies’ (Lievevrouw et al., 2021 ).…”

“…Lievevrouw et al. ( 2021 ) stress that this innovation‐friendly and rapid pre‐market approval system does require a novel and extensive post‐market monitoring framework in order to ensure patient safety and quality.…”