Legal and Regulatory Barriers to Reverse Innovation

<p>Background</p><p>Reverse innovation, or the importation of new, affordable, and efficacious models to high-income countries from the developing world, has emerged as a way to improve the health care system in the United States. Reverse innovation has been identified as a key eme...

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Autores principales:	Virginia Rowthorn, Alexander J. Plum, John Zervos
Formato:	article
Lenguaje:	EN
Publicado:	Ubiquity Press 2017
Materias:	innovation legal healthcare health system barriers regulation Infectious and parasitic diseases RC109-216 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/1c236a17a4b846038494a2dd737ff87c
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spelling	oai:doaj.org-article:1c236a17a4b846038494a2dd737ff87c2021-12-02T06:44:11ZLegal and Regulatory Barriers to Reverse Innovation2214-999610.1016/j.aogh.2016.10.013https://doaj.org/article/1c236a17a4b846038494a2dd737ff87c2017-03-01T00:00:00Zhttps://annalsofglobalhealth.org/articles/216https://doaj.org/toc/2214-9996<p>Background</p><p>Reverse innovation, or the importation of new, affordable, and efficacious models to high-income countries from the developing world, has emerged as a way to improve the health care system in the United States. Reverse innovation has been identified as a key emerging trend in global health systems in part because low-resourced settings are particularly good laboratories for low-cost/high-impact innovations that are developed out of necessity. A difficult question receiving scant attention is that of legal and regulatory barriers.</p><p>Objectives</p><p>The objective of this paper is to understand and elucidate the legal barriers faced by innovators bringing health interventions to the United States.</p><p>Methods</p><p>Semistructured qualitative interviews were conducted with 9 key informants who have directly participated in the introduction of global health care approaches to the United States health system. A purposive sampling scheme was employed to identify participants. Phone interviews were conducted over one week in July 2016 with each participant and lasted an average of 35 minutes each.</p><p>Findings</p><p>Purely legal barriers included questions surrounding tort liability, standard of care, and concerns around patient-administered self-care. Regulatory burdens included issues of international medical licensure, reimbursement, and task shifting and scope of work challenges among nonprofessionals (e.g. community health workers). Finally, perceived (i.e. not realized or experienced) legal and regulatory barriers to innovative modalities served as disincentives to bringing products or services developed outside of the United States to the United States market.</p><p>Conclusions</p>Conflicting interests within the health care system, safety concerns, and little value placed on low-cost interventions inhibit innovation. Legal and regulatory barriers rank among, and contribute to, an anti-innovation atmosphere in healthcare for domestic and reverse innovators alike. Reverse innovation should be fostered through the thoughtful development of legal and regulatory standards that encourage the introduction and scalable adoption of successful health care innovations developed outside of the US, particularly innovations that support public health goals and do not have the benefit of a large corporate sponsor to facilitate introduction to the market.Virginia RowthornAlexander J. PlumJohn ZervosUbiquity Pressarticleinnovationlegalhealthcarehealth systembarriersregulationInfectious and parasitic diseasesRC109-216Public aspects of medicineRA1-1270ENAnnals of Global Health, Vol 82, Iss 6, Pp 991-1000 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	innovation legal healthcare health system barriers regulation Infectious and parasitic diseases RC109-216 Public aspects of medicine RA1-1270
spellingShingle	innovation legal healthcare health system barriers regulation Infectious and parasitic diseases RC109-216 Public aspects of medicine RA1-1270 Virginia Rowthorn Alexander J. Plum John Zervos Legal and Regulatory Barriers to Reverse Innovation
description	<p>Background</p><p>Reverse innovation, or the importation of new, affordable, and efficacious models to high-income countries from the developing world, has emerged as a way to improve the health care system in the United States. Reverse innovation has been identified as a key emerging trend in global health systems in part because low-resourced settings are particularly good laboratories for low-cost/high-impact innovations that are developed out of necessity. A difficult question receiving scant attention is that of legal and regulatory barriers.</p><p>Objectives</p><p>The objective of this paper is to understand and elucidate the legal barriers faced by innovators bringing health interventions to the United States.</p><p>Methods</p><p>Semistructured qualitative interviews were conducted with 9 key informants who have directly participated in the introduction of global health care approaches to the United States health system. A purposive sampling scheme was employed to identify participants. Phone interviews were conducted over one week in July 2016 with each participant and lasted an average of 35 minutes each.</p><p>Findings</p><p>Purely legal barriers included questions surrounding tort liability, standard of care, and concerns around patient-administered self-care. Regulatory burdens included issues of international medical licensure, reimbursement, and task shifting and scope of work challenges among nonprofessionals (e.g. community health workers). Finally, perceived (i.e. not realized or experienced) legal and regulatory barriers to innovative modalities served as disincentives to bringing products or services developed outside of the United States to the United States market.</p><p>Conclusions</p>Conflicting interests within the health care system, safety concerns, and little value placed on low-cost interventions inhibit innovation. Legal and regulatory barriers rank among, and contribute to, an anti-innovation atmosphere in healthcare for domestic and reverse innovators alike. Reverse innovation should be fostered through the thoughtful development of legal and regulatory standards that encourage the introduction and scalable adoption of successful health care innovations developed outside of the US, particularly innovations that support public health goals and do not have the benefit of a large corporate sponsor to facilitate introduction to the market.
format	article
author	Virginia Rowthorn Alexander J. Plum John Zervos
author_facet	Virginia Rowthorn Alexander J. Plum John Zervos
author_sort	Virginia Rowthorn
title	Legal and Regulatory Barriers to Reverse Innovation
title_short	Legal and Regulatory Barriers to Reverse Innovation
title_full	Legal and Regulatory Barriers to Reverse Innovation
title_fullStr	Legal and Regulatory Barriers to Reverse Innovation
title_full_unstemmed	Legal and Regulatory Barriers to Reverse Innovation
title_sort	legal and regulatory barriers to reverse innovation
publisher	Ubiquity Press
publishDate	2017
url	https://doaj.org/article/1c236a17a4b846038494a2dd737ff87c
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Legal and Regulatory Barriers to Reverse Innovation

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