On May 28, the White House Office of Science and Technology Policy (OSTP) hosted a meeting of the G7 Science & Technology (S&T) Ministers to collaborate on COVID-19 response and recovery.  The G7 S&T Ministers emerged from the meeting with a declaration, in which they expressed their intent to:

  • Enhance cooperation on shared 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.

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

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

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

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

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

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

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 policies – to facilitate consumer and patient use and reduce potential exposure to COVID-19.  The guidance applies to two groups of products: (1) computerized behavioral therapy devices and other digital health devices for psychiatric disorders; and (2) low-risk wellness and digital health products for mental health or psychiatric conditions. Like FDA’s many other COVID-19 enforcement policies, the policy will remain in effect “only for the duration of the public health emergency related to COVID-19.”
Continue Reading FDA Issues COVID-19 Policy for Certain Digital Health Solutions

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