Table 2

Timeline of selected COVID-19 related regulatory guidance and policy changes encouraging the use of telehealth and remote monitoring in the USA

DatePolicy/event nameDescription
11 March 2020WHO declares COVID-19 a pandemic16
16 March 2020Emergency declarations issued in every US state17Acting under emergency orders, many state governors enact stay-at-home orders requiring individuals to remain in their residence, shutting down non-essential in-person commerce and requiring postponement of elective medical procedures.
17 March 2020 (revised 30 April, 25 June)COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers18CMS issues temporary emergency order to expand Medicare coverage of telehealth services provided by licensed providers, including doctors, nurse practitioners and physician assistants.
20 March 2020 (revised 5 June)Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the COVID-19 Public Health Emergency19FDA releases first guidance for industry and FDA staff encouraging the use of certain non-invasive remote monitoring devices to support patient monitoring during COVID-19 by suggesting the agency will not object to limited modifications to the indications, claims, functionality, or hardware or software.
27 March 2020 (revised 2 July, 21 September)FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency20FDA releases first guidance for industry, investigators, and institutional review boards on conduct of clinical trials, suggesting trial sponsors consider using telephone and video consultation in clinical trials to replace in-person site visits and collect clinical outcome assessments remotely using validated technology when appropriate.
30 April–15 May 2020‘Stay at home’ orders lifted for most US states21Majority of states lift their ‘stay at home’ orders but encourage individuals to limit unnecessary trips outside the home. Phased reopening begins and varies by state.
  • Sources: (a) Timeline: WHO16 (b) Kaiser Family Foundation17 (c) Centers for Medicare & Medicaid Services18 (d) FDA.gov19 (e) FDA.gov20 (f) Moreland A et al.21