The use of digital health to deliver healthcare has seen unprecedented growth over the past few years, with significant acceleration due to the COVID-19 Public Health Emergency (PHE). As patients seek ways to empower...more
n December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from...more
1/7/2022
/ Clinical Trials ,
Comment Period ,
Coronavirus/COVID-19 ,
Data Collection ,
Data Privacy ,
Digital Health ,
Food and Drug Administration (FDA) ,
Investigations ,
Medical Devices ,
New Guidance ,
Technology Sector
California’s governor recently signed SB 41 into law. The bill enacts the Genetic Information Privacy Act (GIPA). The governor rejected a similar bill last year over concerns about COVID-19 public health efforts. To address...more
10/13/2021
/ California ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Data Privacy ,
Data Security ,
Digital Health ,
Digital Privacy Act ,
Governor Newsom ,
Healthcare ,
New Legislation ,
Privacy Laws ,
State Privacy Laws
At the beginning of February, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) appointed Professor Kevin Fu as the first ever Acting Director of Medical Device Cybersecurity. Fu’s...more
On July 10, 2020, Commissioner Hahn of the U.S. Food and Drug Administration (FDA) issued a statement announcing that the agency is planning to resume on-site inspections of domestic facilities during the week of July 20. The...more
FDA issued new guidance on June 19, 2020, advising manufacturers of drugs, biologics, and active pharmaceutical ingredients (APIs) on manufacturing controls to prevent contamination of drugs with SARS-CoV-2, including...more
On May 4, 2020, the US Food and Drug Administration (FDA) updated its enforcement policy on antibody tests for COVID-19. The revised policy requires developers of commercial antibody tests to submit a request for emergency...more
During COVID-19, in certain areas of the law, we have seen significant flexibility from regulators and government agencies in how they are addressing typical approval processes and/or compliance requirements. In the context...more
A number of private and government entities have released apps and software development kits (SDKs) relying on location tracking data to help tackle the COVID-19 pandemic. While the use of such technologies are being hotly...more
Following its 20th plenary session on April 7, the European Data Protection Board (EDPB) selected geolocation and health data to focus on in its upcoming COVID-19 guidance. This follows in response to the EDPB’s earlier broad...more
As reported earlier... FDA is taking steps to increase the availability of Personal Protective Equipment (PPE) and COVID-19 diagnostic tests, support the development of therapeutics, and facilitate remote patient access to...more
FDA is taking action every day to increase the availability of Personal Protective Equipment (PPE) and COVID-19 diagnostic tests, to support the development of therapeutics, and to facilitate remote patient access to...more