Researchers from University of Leuven (KU Leuven) Provide Details of New Studies and Findings in the Area of Managed Care (The Fda’s Standard-making Process for Medical Digital Health Technologies: Co-producing Technological and Organizational …): Managed Care

2023 JUN 16 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- New research on Managed Care is the subject of a report. According to news reporting originating from Leuven, Belgium, by NewsRx correspondents, research stated, “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.”

Funders for this research include FWO, Odysseus Project ‘Postgenomic Solidarity. European Life Insurance in the Era of Personalised Medicine’, Horizon 2020.

Our news editors obtained a quote from the research from the University of Leuven (KU Leuven), “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.”

According to the news editors, the research concluded: “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.”

This research has been peer-reviewed.

For more information on this research see: The Fda’s Standard-making Process for Medical Digital Health Technologies: Co-producing Technological and Organizational Innovation. BioSocieties, 2022;17(3):549-576. BioSocieties can be contacted at: Palgrave Macmillan Ltd, Brunel Rd Bldg, Houndmills, Basingstoke RG21 6XS, Hants, England. (Cambridge University Press - www.cambridge.org; BioSocieties - http://journals.cambridge.org/action/displayJournal?jid=BIO)

The news editors report that additional information may be obtained by contacting Elisa Lievevrouw, University of Leuven (KU Leuven), Ctr Sociol Res CeSO, Life Sci & Soc Lab, Pk Str 45, B-3000 Leuven, Belgium. Additional authors for this research include Luca Marelli and Ine Van Hoyweghen.

The direct object identifier (DOI) for that additional information is: https://doi.org/10.1057/s41292-021-00232-w. This DOI is a link to an online electronic document that is either free or for purchase, and can be your direct source for a journal article and its citation.

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