COVID-19

Yesterday, the Federal Communications Commission (“FCC”) granted GE Healthcare (“GEHC”) a waiver of its equipment authorization rules to allow for the importation, marketing, and operation of certain medical devices that have yet to receive authorization under applicable FCC requirements. The GEHC devices at issue include bedside and wearable patient monitors;…
Continue Reading FCC Waives Equipment Authorization Rules for GE Healthcare to Address COVID-19 Supply Chain and Testing Challenges

Senate Commerce Committee Chairman Roger Wicker is working on draft legislation that would regulate the collection and use of health and location information in connection with efforts to track and limit the spread of COVID-19.   Some key highlights of the tentatively titled “COVID-19 Consumer Data Protection Act” include:

  • For the

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Continue Reading Republicans Poised To Introduce COVID-19 Privacy Bill

On April 9, 2020, U.S. Department of Health and Human Services (“HHS”) issued a Notification of Enforcement Discretion (the “Notification”) regarding certain covered entities and business associates who choose to participate in the operation of a Community-Based Testing Site (“CBTS”) during the COVID-19 nationwide public health emergency. The Notification relaxes…
Continue Reading HHS Relaxes HIPAA Enforcement for Certain Covered Entities and Business Associates Regarding Their Participation in COVID-19 Community-Based Testing Sites

On April 3, 2020, the Department of Health and Human Services Office for Civil Rights (“OCR”) released an alert warning covered entities and business associates of an individual posing as an OCR Investigator to obtain protected health information. According to the alert, “[t]he individual identifies themselves as an OCR Investigator…
Continue Reading OCR Alert Warns Covered Entities and Business Associates of Potential PHI Scam

In light of the COVID-19 pandemic, Congress and the Federal Communications Commission (FCC) have ramped up efforts to subsidize the provision of the telecommunications and broadband services necessary to deliver telehealth solutions. This includes steps to make it easier for eligible health care providers to secure funding under the FCC’s…
Continue Reading FCC Embarks on New Rural Health Initiatives with CARES Act Funding

The rapid spread of COVID-19, along with the effectiveness of existing public health response plans and the impacts of social distancing on the economy, have raised the question of how new technology can be used to address and manage the pandemic. On April 1, 2020, the Stanford Institute for Human-Centered Artificial Intelligence hosted “COVID-19 and AI: A Virtual Conference” to explore the potential applications of artificial intelligence (“AI”) in diagnostics and treatment, epidemiological tracking and forecasting of the spread of COVID-19, and the pandemic’s impacts on the economy, culture, and human behavior.
Continue Reading AI Update: Using Artificial Intelligence to Combat COVID-19

Digital health companies are playing an important role in the global response to the COVID-19 public health emergency.  For example, the White House Office of Science and Technology Policy issued a Call to Action to the tech community requesting help in answering urgent scientific questions about COVID-19.  As readers of …
Continue Reading COVID-19: FDA Regulatory Considerations for Digital Health Solutions

This month, the U.S. Department of Health and Human Services (“HHS”) issued guidance waiving enforcement of certain provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) in response to the COVID-19 nationwide public health emergency.

Covered Health Care Providers

On March 17, 2020, the Department of Health and Human…
Continue Reading HHS Relaxes Enforcement of Certain HIPAA Provisions Amidst COVID-19 Nationwide Public Health Emergency

To assist companies that are developing technology solutions to help predict, mitigate or contain the spread of COVID-19, our cross-practice digital health team has put together a checklist of considerations to keep in mind (available here).

For additional guidance, please visit our COVID-19 Legal and Business Toolkit (available here
Continue Reading Covington Publishes Coronavirus/COVID-19 Checklist for Technology Solutions