Archives: COVID-19

Subscribe to COVID-19 RSS Feed

Recent AI Developments in the Fight Against COVID-19

Artificial Intelligence (AI) has played an important role in battling COVID-19 since the initial outbreak: HealthMap – an AI tool from Boston Children’s Hospital that scans news reports, social media, and other data for signs of disease outbreaks – first sounded the international alarm after picking up reports of an emerging virus in Wuhan, China. … Continue Reading

Client Alert: FDA Issues Temporary Guidance on New CARES Act Provision Requiring Certain Device Notifications to CDRH

The following guidance could be relevant to manufacturers of software as a medical device (SaMD).  The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of an interruption or permanent discontinuance … Continue Reading

FCC Waives Equipment Authorization Rules for GE Healthcare to Address COVID-19 Supply Chain and Testing Challenges

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; telemetry transmitters; antenna infrastructure; wireless … Continue Reading

HHS Announces Enforcement Discretion Over the Implementation of Interoperability Final Rules Due to COVID-19 Public Health Emergency

On April 21, 2020, the Department of Health and Human Services (“HHS”) announced that, as a response to the COVID-19 public health emergency, it will exercise enforcement discretion to “permit compliance flexibilities” regarding the implementation of the interoperability final rules issued on March 9th, 2020.  This joint announcement was made by the Office of the … Continue Reading

Republicans Poised To Introduce COVID-19 Privacy Bill

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 duration of the public health … 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 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 HHS’s enforcement of certain provisions … Continue Reading

OCR Alert Warns Covered Entities and Business Associates of Potential PHI Scam

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 on the telephone, but does … Continue Reading

FDA Issues COVID-19 Policy for Certain Digital Health Solutions

On April 14, 2020, FDA issued a direct-to-final guidance outlining its “Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”  The guidance intends to “expand the availability of digital health therapeutic devices” – possibly the first time FDA has used such term in its written … Continue Reading

State Medical Licensing Changes to Combat COVID-19

The rapid spread of COVID-19 has transitioned the telehealth debate from a matter of access, convenience, and cost-saving to a matter of absolute necessity on a large scale. A variety of barriers have traditionally stood in the way of broader adoption of telehealth including a lack of reimbursement by both state and private insurance, restrictions … Continue Reading

AI Update: FTC Provides Guidance on Use of AI and Algorithms

On April 8, 2020, the Federal Trade Commission (“FTC”) released a blog post about the use of artificial intelligence (“AI”) and algorithms in automated decisionmaking. The blog highlighted the potentially great benefits and risks presented by increasingly sophisticated technologies, particularly in the “Health AI” space. However, it also emphasized that automated decisionmaking is not a new phenomenon—and … Continue Reading

FCC Embarks on New Rural Health Initiatives with CARES Act Funding

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 existing Rural Healthcare (RHC) program, … Continue Reading

The Potential Benefits of Digital Health Technology in Managing COVID-19

The COVID-19 crisis is demonstrating the potential of digital health technology to manage some of our greatest public health challenges.  The White House Office of Science and Technology Policy has issued a call to action for technology companies to help the science community answer high-priority scientific questions related to COVID-19.  The Centers for Disease Control … Continue Reading

Digital Health Alert: Product Liability Considerations for COVID-19-Related Solutions

Product liability considerations are not likely the first concerns that spring to mind for the many companies working to develop digital health countermeasures and other products related to COVID-19.  Yet even while putting together solutions on an accelerated timeline, there are some straightforward actions that companies can take that may reduce litigation risk down the … Continue Reading

COVID-19: FDA Regulatory Considerations for Digital Health Solutions

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 this blog are aware, some … Continue Reading

HHS Relaxes Enforcement of Certain HIPAA Provisions Amidst COVID-19 Nationwide Public Health Emergency

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 Services Office for Civil Rights … Continue Reading

Covington Publishes Coronavirus/COVID-19 Checklist for Technology Solutions

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
LexBlog