When the academic year ended in the spring of 2020, many US university students assumed that a return to campus would be straightforward this fall. However, it is now clear—at least in the near term—that a return to the old...more
8/27/2020
/ CLIA ,
Consent Agreements ,
Contact Tracing ,
Educational Institutions ,
Emergency Use Authorization (EUA) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Mobile Apps ,
Quarantine ,
Re-Opening Guidelines ,
Remote Learning ,
Research and Development ,
Sanctions ,
Screening Procedures ,
Universities ,
Virus Testing ,
Waivers
The US Food and Drug Administration (FDA) announced several initiatives to increase access to ventilators and other respiratory devices during the Coronavirus (COVID-19) pandemic, as well as relaxed enforcement of certain...more
On March 20, 2020, the US Food and Drug Administration announced updates to its enforcement policy on the use of non-invasive remote monitoring devices, specifically for uses designed to support patient monitoring during the...more
Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more
1/29/2020
/ Anti-Kickback Statute ,
Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Regulatory Standards ,
Stark Law ,
Telemedicine
The U.S. Food and Drug Administration (FDA), in conjunction with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), recently issued a draft report...more