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

Author:

Lievevrouw ElisaORCID,Marelli LucaORCID,Van Hoyweghen IneORCID

Funder

Fonds Wetenschappelijk Onderzoek

H2020 Marie Skłodowska-Curie Actions

Publisher

Springer Science and Business Media LLC

Subject

Health Policy,Health(social science)

Reference110 articles.

1. Abraham, J. 1995. Science, Politics, and the Pharmaceutical Industry: Controversy and Bias in Drug Regulation. London: UCL Press.

2. Abraham, J., and C. Davis. 2007. Deficits, expectations and paradigms in British and American Drug Safety Assessments: prising open the Black Box of Regulatory Science. Science, Technology, & Human Values 32 (4): 399–431.

3. Allen, A. 2014. Health Apps boom while regs lag. Politico, 3 June. https://www.politico.com/story/2014/06/health-apps-boom-while-regs-lag-107345_Page2.html

4. AppleVideoArchive. 2011. Apple WWDC 2008. Youtube.com, 31 December. https://www.youtube.com/watch?reload=9&v=AHolDv1plk0

5. Australian Digital Health Agency. 2018. Australia’s National Digital Health Strategy. Safe, seamless and secure: evolving health and care to meet the needs of modern Australia. https://conversation.digitalhealth.gov.au/sites/default/files/adha-strategy-doc-2ndaug_0_1.pdf

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