On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid Check COVID-19/Flu A&B Antigen Test. Although other at‑home combination tests...more
In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...more
- As the COVID-19 pandemic continues, the clamor for liability protections for the nation’s health care providers continues.
- Although there are serious political divisions, the COVID Phase 4 relief legislation may...more
8/7/2020
/ Coronavirus/COVID-19 ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Immunity ,
Legislative Agendas ,
Liability ,
Long Term Care Facilities ,
Nursing Homes ,
Physicians ,
Proposed Legislation
While the United States now leads the world with the number of reported cases of COVID-19, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) takes major, though perhaps still incomplete, steps...more
4/1/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Financial Stimulus ,
Health Care Providers ,
Hospitals ,
Medical Devices ,
Medical Supplies ,
Medical Testing ,
Over The Counter Drugs (OTC) ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Relief Measures
As COVID-19 continues to spread, health care providers, health plans and employers are facing difficult privacy questions as they attempt to balance privacy concerns against the need to protect patients, employees and...more
3/27/2020
/ Coronavirus/COVID-19 ,
Data Privacy ,
Employee Privacy Rights ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Infectious Diseases ,
Patient Privacy Rights ,
PHI ,
Privacy Laws ,
Privacy Policy ,
Public Health