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Health Aff (Millwood). 2018 Dec;37(12):2052-2059. doi: 10.1377/hlthaff.2018.05151.

Building A Regulatory And Payment Framework Flexible Enough To Withstand Technological Progress.

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David Flannery ( ) is director of telegenetics and digital genetics at the Genomic Medicine Institute, Cleveland Clinic, in Ohio. Flannery and Jarrin share credit as co-first authors.
Robert Jarrin ( ) is senior director of wireless health public policy at Qualcomm Incorporated, in Washington, D.C. Jarrin and Flannery share credit as co-first authors.


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.


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