Building A Regulatory And Payment Framework Flexible Enough To Withstand Technological Progress
Building A Regulatory And Payment Framework Flexible Enough To Withstand Technological Progress
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DOI：
10.1377/hlthaff.2018.05151
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发表时间：
2018-12-01
期刊：
影响因子：
9.7
通讯作者：
Jarrin, Robert
中科院分区：
文献类型：
--
作者：
Flannery, David;Jarrin, Robert
数字医疗的发展受到联邦法规和政策的限制。无论是考虑什么是或不是医疗设备，数字医疗技术的报销，还是医疗保险或医疗补助下与远程患者监测或远程医疗相关的医生服务，管理数字健康的规则和政策都不容易区分。面对快速的创新，很难将这些产品和服务纳入美国食品和药物管理局以及医疗保险和医疗补助服务中心的现有法规，特别是当这些框架从未考虑到通信技术今天可以做什么时。相反，规则被滥用，在某些情况下，它们阻碍了这些技术的使用，抑制了相关服务的扩散。然而，法规已经开始改变。我们讨论了已经开始演变的政策和监管变化，以及它们应该继续发展的方向。
The evolution of digital health is entwined with federal regulation and policy. Whether considering what is or is not a medical device, the reimbursement for digital medical technologies, or physician services under Medicare or Medicaid related to remote patient monitoring or telehealth, the rules and policies governing digital health have not been easy to distinguish. In the face of rapid innovation, it has been difficult to fit these products and services into existing regulations of the Food and Drug Administration and the Centers for Medicare and Medicaid Services, particularly when these frameworks never contemplated what communications technologies can do today. Instead, rules have been misapplied, and in some cases, they have hampered the use of these technologies, depressing the proliferation of associated services. However, regulations have begun to change. We discuss the policy and regulatory changes that have begun to evolve and where they should continue to head.