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Covington Digital Health Blog

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OCR Seeks Comments Related to Recognized Security Practices and Distribution of Civil Monetary Penalties under the HITECH Act

USA - April 14 2022 On April 6, 2022, the Office for Civil Rights (“OCR”) at the Department of Health and Human Services (“HHS”) published a request for information…

OIG Issues Advisory Opinion on Digital Program for the Treatment of Substance Use Disorders

USA - March 23 2022 On March 2, 2022, the Office of Inspector General (“OIG”) for the Department of Health and Human Services (“HHS”) posted an advisory opinion…

3 Takeaways Digital Health Innovators Should Be Watching in the PREVENT Pandemics Act

USA - February 23 2022 On January 25, 2022, Senators Patty Murray and Richard Burr (Chair and Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP)…

FDA Webinar Provides New Insights on Use of Digital Health Technologies in Clinical Trials

USA - February 18 2022 Spurred by the realities of the COVID-19 pandemic, FDA has taken a number of regulatory actions to advance the use of digital health technologies…

FTC Releases New Health Breach Notification Rule Guidance, Targets Health Apps and Connected Devices

USA - January 28 2022 On January 21, the Federal Trade Commission (“FTC”) announced new resources to help companies determine their obligations under the Health Breach…

5 Digital Health Issues to Watch at FDA in 2022

USA - January 5 2022 As we kick off 2022, several recent developments from FDA suggest that this year could be pivotal for the Agency’s digital health priorities. From…

CMS Proposal Would Impact Coverage of Innovative Digital Health Technologies

USA - September 30 2021 On September 15, 2021, CMS published a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and…

Consultation on the Future Regulation of Medical Devices in the UK, including Work Programme for Software and AI Medical Devices

United Kingdom - September 20 2021 The Medicines & Healthcare products Regulatory Agency (“MHRA”) has published a “Consultation on the future regulation of medical devices in the United…

FTC Adopts Policy Statement on Privacy Breaches by Health Apps and Connected Devices

USA - September 17 2021 On September 15, the Federal Trade Commission (“FTC”) adopted, on a 3-2 party-line vote, a policy statement that takes a broad view of which health…

UK Government Publishes Report on Harnessing Technology For Benefit of the UK Healthcare System

United Kingdom - August 31 2021 On August 23, 2021 the UK Government published its report entitled “Harnessing technology for the long-term sustainability of the UK’s healthcare…