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Note From the Editors
The pace of impact through digital health in 2021 is off to a rapid start be it the number of transactions, the numerous legislative proposals and actions, or the focused attention of enforcement bodies. Given the accelerated pace of tech-enabled methods, such as telehealth or product development through streamlined digital tools and decentralized clinical trials, not to mention AI and big data s impact on diagnostic and research capacity, the policy and regulatory spotlight on digital health will no doubt be bright throughout this year. In the Industry Insights contribution for this issue, several of our digital health experts briefly summarize the focused attention of U.S. enforcement agencies on telehealth given significantly increased reimbursement trends in the area.
[co-authors: Michelle Fong, and Adrienne Peng]
New Federal Developments
Activity
On April 15th, the U.S. Department of Health & Human Services (HHS) announced the renewal of the Public Health Emergency (PHE).
The COVID-19 PHE will be renewed for another 90 days, beginning on April 21 (the date the PHE was previously scheduled to expire) and extending through July 21, 2021.
This update enumerates the key regulatory flexibilities and funding sources that are linked to the PHE, as well as key emergency measures with independent timelines that are not directly affected by the PHE renewal.
On April 15th the Federal Communications Commission (FCC) announced the second round of the COVID-19 Telehealth funding will open April 29th.