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Openness in donor conception families 捐赠受孕家庭的开放性
IF 1.6 4区 医学 Q4 SOCIAL SCIENCES, BIOMEDICAL Pub Date : 2022-04-04 DOI: 10.1057/s41292-021-00265-1
Caitlin M. Macmillan
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引用次数: 1
Dynamic pharmaceuticals: how stimulant compounds changed the ADHD profile 动态药物:兴奋剂化合物如何改变ADHD的特征
IF 1.6 4区 医学 Q4 SOCIAL SCIENCES, BIOMEDICAL Pub Date : 2022-04-04 DOI: 10.1057/s41292-022-00275-7
Jonathan Ruiz
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引用次数: 0
Analysing bio-art’s epistemic landscape: from metaphoric to post-metaphoric structure 生物艺术的认知景观分析:从隐喻到后隐喻结构
IF 1.6 4区 医学 Q4 SOCIAL SCIENCES, BIOMEDICAL Pub Date : 2022-03-26 DOI: 10.1057/s41292-022-00270-y
D. Ahmedien
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引用次数: 1
Sexual health as surplus: the marketization of PrEP in Taiwan 性健康过剩:台湾PrEP的市场化
IF 1.6 4区 医学 Q4 SOCIAL SCIENCES, BIOMEDICAL Pub Date : 2022-03-11 DOI: 10.1057/s41292-022-00273-9
Poyao Huang
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引用次数: 1
The other face of medical globalization? Pharmaceutical data, prescribing trends, and the social localization of psychostimulants 医疗全球化的另一面?药物数据、处方趋势和精神刺激药物的社会定位
IF 1.6 4区 医学 Q4 SOCIAL SCIENCES, BIOMEDICAL Pub Date : 2022-03-08 DOI: 10.1057/s41292-022-00271-x
A. Filipe
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引用次数: 1
‘Healthy’ for whom? ‘Healthy’ food’s effectivities, avocados, and the production of differentiated bodies 对谁来说“健康”?“健康”食品的功效,牛油果,以及分化体的产生
IF 1.6 4区 医学 Q4 SOCIAL SCIENCES, BIOMEDICAL Pub Date : 2022-03-08 DOI: 10.1057/s41292-022-00274-8
Myriam Durocher
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引用次数: 0
Making epistemic goods compatible: knowledge-making practices in a lifestyle intervention RCT on mindfulness and compassion meditation 使认知商品兼容:生活方式干预中的知识制造实践正念和同情冥想的随机对照试验
IF 1.6 4区 医学 Q4 SOCIAL SCIENCES, BIOMEDICAL Pub Date : 2022-03-08 DOI: 10.1057/s41292-022-00272-w
M. Smolka
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引用次数: 1
Making it happen: data practices and the power of diplomacy among Danish organ transplant coordinators 实现这一目标:丹麦器官移植协调员的数据实践和外交力量
IF 1.6 4区 医学 Q4 SOCIAL SCIENCES, BIOMEDICAL Pub Date : 2022-01-25 DOI: 10.1057/s41292-021-00267-z
Anja M B Jensen
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引用次数: 1
It’s all about kids, kids, kids! Negotiating reproductive citizenship and patient-centred care in ‘factory IVF’ 都是关于孩子,孩子,孩子!在“工厂试管婴儿”中协商生殖公民身份和以患者为中心的护理
IF 1.6 4区 医学 Q4 SOCIAL SCIENCES, BIOMEDICAL Pub Date : 2022-01-25 DOI: 10.1057/s41292-021-00268-y
B. Kvernflaten, P. Fedorcsak, K. Solbrække
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引用次数: 1
The FDA's standard-making process for medical digital health technologies: co-producing technological and organizational innovation. FDA的医疗数字健康技术标准制定过程:共同生产技术和组织创新。
IF 1.6 4区 医学 Q4 SOCIAL SCIENCES, BIOMEDICAL Pub Date : 2022-01-01 Epub Date: 2021-05-13 DOI: 10.1057/s41292-021-00232-w
Elisa Lievevrouw, Luca Marelli, Ine Van Hoyweghen

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.

随着数字卫生技术(DHT)被视为卫生保健系统的“万灵药”,它们已从一个流行语演变为全球卫生政策的一个高度优先目标。在医疗器械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及其对维持DHT创新途径的作用具有极大的相关性,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,通过绘制2008年至2018年FDA医疗数字健康政策的标准制定过程,研究了数字健康如何从一个流行语演变为“政府对象”,或获得物质意义并转变为可监管对象。由此,我们反思了技术和组织创新之间相互维持的动态,因为FDA标准化医疗DHT的尝试不仅塑造了DHT的生活方式/医疗边界。它也导致了FDA内部的重大重组,同时促进了监管科学中更广泛地转向采用替代形式的证据。
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引用次数: 4
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