Francis King Carey School of Law, University of Maryland, Baltimore, MD; Global Health Initiative, Henry Ford Health System, Detroit, MI.
Francis King Carey School of Law, University of Maryland, Baltimore, MD; Global Health Initiative, Henry Ford Health System, Detroit, MI.
Ann Glob Health. 2016 Nov-Dec;82(6):991-1000. doi: 10.1016/j.aogh.2016.10.013.
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.
The objective of this paper is to understand and elucidate the legal barriers faced by innovators bringing health interventions to the United States.
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.
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.
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.
逆向创新，即将新的、负担得起的、有效的模式从发展中国家引入高收入国家，已成为改善美国医疗保健系统的一种方式。逆向创新被认为是全球卫生系统的一个关键新兴趋势，部分原因是资源匮乏的环境特别适合开发出于必要而产生的低成本、高影响力的创新。一个很少受到关注的难题是法律和监管障碍。
本文旨在了解和阐明将医疗干预措施引入美国的创新者所面临的法律障碍。
对 9 名关键知情者进行了半结构式定性访谈，他们直接参与了将全球医疗保健方法引入美国医疗系统的工作。采用目的性抽样方案来确定参与者。2016 年 7 月的一周内对每位参与者进行了电话访谈，平均每次访谈持续 35 分钟。
纯粹的法律障碍包括围绕侵权责任、护理标准以及对患者自行护理的担忧等问题。监管负担包括国际医疗执照、报销以及非专业人员（如社区卫生工作者）的任务转移和工作范围挑战等问题。最后，对创新模式的感知（即尚未实现或经历）法律和监管障碍成为将在美国境外开发的产品或服务引入美国市场的抑制因素。
医疗保健系统内的利益冲突、安全问题以及对低成本干预措施的重视不足，抑制了创新。法律和监管障碍是医疗保健领域反创新氛围的一部分，并促成了这种氛围，无论是对国内创新者还是逆向创新者都是如此。应该通过深思熟虑地制定法律和监管标准来促进逆向创新，鼓励引入和可扩展地采用在美国境外开发的成功医疗保健创新，特别是那些支持公共卫生目标且没有大型企业赞助商来促进其推向市场的创新。
