US Food and Drug Administration Archives - Page 2 of 3

Agencies Issue Helpful FAQs on COVID-19 Testing Coverage

by Jacob Mattinson | Jul 7, 2020 | Employee Benefits, Employment, Health and Welfare Plans

The US Departments of Labor, Health and Human Services, and Treasury issued a second set of answers to frequently asked questions. The tri-agency FAQs (Part 43) clarify important health and welfare provisions under the Families First Coronavirus Response Act (FFCRA), which became law on March 18, 2020, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, enacted on March 27, 2020. Both laws addressed Coronavirus (COVID-19) testing and prevention coverage, as well as expansion of telehealth service availability.

Access the full article.

Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018

by Jiayan Chen, Lisa Schmitz Mazur, Michael Ryan, Ryan Marcus, Scott Weinstein, Sarah T. Hogan, Vernessa T. Pollard, McDermott Will & Emery, Bernadette M. Broccolo, Dale C. Van Demark and Jennifer S. Geetter | Feb 8, 2018 | Health and Welfare Plans, Privacy and Data Security

Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment as well as product research, development and commercialization for both long-standing and new stakeholders. At the same time, lawmakers and regulators made meaningful progress toward modernizing the existing legal framework in a way that will both adequately protect patients and consumers and support and encourage continued innovation, but their efforts have not kept pace with what has become the light speed of innovation. As a result, some obstacles, misalignment and ambiguity remain.

We are pleased to bring you this review of key developments that shaped digital health in 2017, along with planning considerations and predictions for the digital health frontier in the year ahead.

Digital Health Governance: Management and Strategy for the 21st Century Digital Economy

by Dale C. Van Demark and Jennifer S. Geetter | Aug 15, 2017 | Employee Benefits, Health and Welfare Plans, Privacy and Data Security

Jennifer Geetter and Dale Van Demark wrote this bylined article on how companies must manage and govern their use of digital healthcare information assets. “Organizations will need to design and implement digital governance structures that … include additional components and organizational stakeholders, in order to meet the business and strategic demands of the digital health revolution,” the authors wrote.