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FDA Loosens the Reins on Informed Consent Requirements for Certain Clinical Studies

USA - November 20 2018 Following up on its July 2017 guidance on the same topic (discussed in a previous blog post), FDA issued a proposed rule on November 15, 2018 to…

Response to RFIs: EBG Submits Comments to CMS on Stark Law Reforms and Is Preparing Comments to OIG on Anti-Kickback Statute and Beneficiary Inducement CMP Modifications

USA - August 29 2018 As addressed in a previous Epstein Becker Green ("EBG") Client Alert, earlier this summer, the Centers for Medicare & Medicaid Services ("CMS")…

David E. Matyas, Jason E. Christ, Anjali N.C. Downs, Leonard Lipsky, Victoria Vaskov Sheridan, Carrie Valiant

FDA Makes Moves to Advance Digital Health

USA - August 17 2017 At the end of July, FDA released a tangible plan for promoting innovation in the development of digital health products. In this Digital Health…

Kim Tyrrell-Knott

New Federal and State Initiatives Seek to Combat Antimicrobial Resistance

USA - January 9 2017 Recent federal and state legislative efforts signal an increased focus on a significant and largely underappreciated public health threat -…

Wearables in the Workplace: Promise and Pitfalls

USA - August 10 2016 In recent years, the use of wearable devices, such as smartwatches and Fitbits, has gained popularity not only with the general public and consumers…

Ian Carleton Schaefer