The modern health care landscape is increasingly hard to capture in regulation and difficult to control by supervision agencies since, due to technological innovation and societal developments, new products and new health risks often emerge that extant regulation does not cover adequately. To counteract potentially harmful conduct, supervision agencies may frequently apply pressure on regulatees through regulatory conversations or negative publicity, even if their conduct may be legal. In this paper we provide context for such interventions beyond the law, outline the broad range of such interventions and discuss their efficacy and legitimacy. We recommend that relevant stakeholders engage in a dialogue that may result in institutional guidelines for supervision agencies on informal supervision practices and interventions beyond the law.

中文翻译：

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面对新出现的健康风险进行监管：市场动态如何迫使执法人员延长任务期限

由于技术创新和社会发展，新的产品和新的健康风险经常出现，现有的监管不能充分覆盖，因此现代医疗保健环境越来越难以被监管机构所控制，监管机构也难以对其进行控制。为了消除潜在的有害行为，监管机构可能会经常通过监管对话或负面宣传对监管施加压力，即使其行为可能是合法的。在本文中，我们为法律之外的此类干预措施提供了背景信息，概述了此类干预措施的广泛范围，并讨论了其有效性和合法性。我们建议相关的利益相关者进行对话，这可能会为监管机构制定有关法律以外的非正式监管做法和干预措施的机构指南。