As developments regarding COVID-19 continue to unfold, Verrill’s Health Care & Life Sciences Group will be updating this page with additional valuable resources to help our clients and friends navigate this unprecedented time.
Advisories distributed by Verrill’s Health Care & Life Sciences Group:
News Flash: HHS Issues Statement Removing Premarket Review Requirements for Laboratory Developed Tests (“LDTs”), Including COVID-19 LDTs (Published August 27, 2020)
FDA Issues Guidance on IRB Review of Non-Emergency Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products to Treat COVID-19 (Published June 18, 2020)
FDA Announces New Updates to its Guidance on Conducting Clinical Trials During COVID-19 and Notes Availability of its COVID MyStudies App (Published June 12, 2020)
FDA Updates its Guidance on Conducting Clinical Trials During COVID-19 Public Health Emergency (Published April 23, 2020)
OHRP Issues Guidance on the Conduct of Research During COVID-19 Public Health Emergency (Published April 23, 2020)
Updated FDA COVID-19 Guidance for Conduct of Clinical Trials (Published April 1, 2020)
Due to COVID-19, Federal Agencies Relax Requirements Regarding the Provision of Telehealth Services (Published March 20, 2020)
COVID-19: FDA Clinical Trial Guidance (Published March 20, 2020)
COVID-19 Expanded Access Template (Published March 19, 2020)
Responsible Research During the COVID-19 Pandemic (Published March 17, 2020)
Additional Resources:
- American Medical Association – COVID-19 (2019 novel coronavirus) resource center for physicians
- Centers for Medicare & Medicaid Services
- Council on Governmental Regulations – Institutional and Agency Responses to COVID-19 and Additional Resources
- Federal Bureau of Investigation – Guidance released on video-teleconferencing hijacking and what has been referred to as "Zoom-bombing"
- Federal Bureau of Investigation Internet Crime Compliant Center – Public Service Announcement highlights increase in fraud schemes related to COVID-19
- Federation of State Medical Boards - U.S. States and Territories Modifying Requirements for Telehealth in Response to COVID-19
- National Alliance of State Pharmacy Associations – COVID-19: Information from the States
- National Institute of Health – Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding
- U.S. Department of Health & Human Services
- U.S. Department of Health & Human Services Office for Civil Rights:
- COVID-19 and HIPAA: Disclosures to law enforcement, paramedics, other first responders and public health authorities
- COVID-19 and HIPAA Enforcement: DHHS Office for Civil Rights releases notification of enforcement discretion under HIPAA during COVID-19 (access guidance online here)
- U.S. Department of Justice Drug Enforcement Administration – COVID-19 Information Page
- U.S. Food & Drug Administration – Coronavirus Disease 2019 (COVID-19)
- Wheel – Up-to-Date COVID-19 Emergency Licensing Database for Telehealth Clinicians
Verrill's attorneys from across the firm have been hard at work developing pertinent legal information for employers regarding COVID-19. Click here to access a full list of alerts published by the firm.
