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.

随着数字健康技术 (DHT) 被视为医疗保健系统的“灵丹妙药”，它们已从流行语演变为全球卫生政策的高度优先目标。在医疗器械的质量和安全标准领域，美国食品和药物管理局 (FDA) 在调整其监管框架以适应 DHT 方面一直处于领先地位。然而，尽管质量和安全标准具有最大的相关性以及它们在维持 DHT 创新路径中的作用，但它们的实际制定尚未受到深入的社会科学审查。本文借鉴科学技术研究 (STS) 的概念库，研究数字健康如何从流行语演变为“政府对象”，或获得物质意义并转变为可监管对象，通过绘制 2008 年至 2018 年间 FDA 医疗数字健康政策的标准制定过程。由此，我们反思技术和组织创新之间相互支持的动态，因为 FDA 对医疗 DHT 标准化的尝试不仅塑造了生活方式/医疗边界对于 DHT。它还导致了 FDA 内部的重大重组，同时促进了更广泛的转变，即在监管科学中采用替代形​​式的证据。