从概念到市场：识别并解决数字健康产品开发生命周期中的伦理和监管考量因素。
From an idea to the marketplace: Identifying and addressing ethical and regulatory considerations across the digital health product-development lifecycle.
作者信息
Largent Emily A, Karlawish Jason, Wexler Anna
机构信息
Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
Department of Medicine, Department of Medical Ethics and Health Policy, Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
出版信息
BMC Digit Health. 2024;2(1). doi: 10.1186/s44247-024-00098-5. Epub 2024 Jul 25.
Abstract
Widespread adoption of digital health tools has the potential to improve health and health care for individuals and their communities, but realizing this potential requires anticipating and addressing numerous ethical and regulatory challenges. Here, we help digital health tool developers identify ethical and regulatory considerations - and opportunities to advance desirable outcomes - by organizing them within a general product-development lifecycle that spans generation of ideas to commercialization of a product.
摘要
广泛采用数字健康工具有可能改善个人及其社区的健康状况和医疗保健水平，但要实现这一潜力，需要预见并应对众多伦理和监管挑战。在此，我们通过将伦理和监管考量——以及推进理想成果的机会——组织在一个涵盖从创意产生到产品商业化的一般产品开发生命周期内，来帮助数字健康工具开发者识别这些考量和机会。
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1
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2
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PLOS Digit Health. 2023 Jul 6;2(7):e0000270. doi: 10.1371/journal.pdig.0000270. eCollection 2023 Jul.
3
Considering tomorrow's patients in today's drug approvals.
BMJ. 2023 Jun 8;381:e075000. doi: 10.1136/bmj-2023-075000.
4
Ethical considerations for researchers developing and testing minimal-risk devices.
Nat Commun. 2023 Apr 22;14(1):2325. doi: 10.1038/s41467-023-38068-6.
5
European reclassification of non-invasive brain stimulation as class III medical devices: A call to action.
Brain Stimul. 2023 Mar-Apr;16(2):564-566. doi: 10.1016/j.brs.2023.02.012. Epub 2023 Mar 2.
6
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7
Wearable devices-addressing bias and inequity.
Lancet Digit Health. 2022 Dec;4(12):e856-e857. doi: 10.1016/S2589-7500(22)00194-7. Epub 2022 Nov 2.
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