In light of the COVID-19 pandemic, our 9th McDermott International Seminar Series will be held as a virtual series, with eight sessions taking place between January 21 – February 4, 2021. Though we cannot see you in person,...more
1/7/2021
/ Acquisitions ,
Biden Administration ,
Compliance ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Cybersecurity ,
Data Privacy ,
Enforcement Actions ,
FRAND ,
Global Market ,
Intellectual Property Protection ,
International Data Transfers ,
Investors ,
Japan ,
Mergers ,
Patent Portfolios ,
US Trade Policies ,
Webinars ,
White Collar Crimes
Introduction -
Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more
1/10/2018
/ 21st Century Cures Act ,
Artificial Intelligence ,
Biometric Information ,
Consumer Protection Act ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Health Insurance ,
Life Sciences ,
OIG ,
Privacy Policy ,
Research and Development ,
TCPA ,
Telehealth
The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more
2/10/2017
/ 510(k) RTA ,
Biologics ,
Clinical Trials ,
Cybersecurity ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
Laboratories ,
Medical Devices ,
Pharmacies ,
REMS ,
Software
On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more