FDA Publishes Digital Health Technology Framework

Last month, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The publication of this digital health technology (DHT) framework fulfills an FDA commitment under the seventh iteration of the Prescription Drug User Fee Act reauthorization (PDUFA VII).

What Are DHTs?

In […]

By | April 3rd, 2023 ||

Holland & Knight Health Law Update

The U.S. House of Representatives and U.S. Senate are both in session this week, following House Republicans’ policy retreat in Orlando, Florida. The Senate Committee on Homeland Security and Governmental Affairs will be conducting a hearing entitled “Drug Shortage Health and National Security Risks: Underlying Causes and Needed Reforms” on March 22, 2023, and the House Committee on Ways and Means will conduct a hearing entitled “Why Healthcare is Unaffordable: The Fallout of Democrats’ […]

By | April 1st, 2023 ||

DOJ’s Evolving ‘Carrot And Stick’ Approach To Increasing Health Care Fraud Corporate Compliance

The carrot or the stick … which motivates compliance conduct more? Consider it a rhetorical question for now, but it’s once again a tactic being deployed by the U.S. Department of Justice to motivate or cajole corporate compliance. In separate announcements over the past several weeks, DOJ dangled two new “carrots” in front of companies involved in fraud investigations and criminal cases. Prior to that, the Department also reminded the public about the significant […]

By | March 24th, 2023 ||