R&W Insurance Coverage For Healthcare Services Transactions

After being squeezed out of the R&W insurance market in 2021, deals in the healthcare services sector have regained interest from insurers and are seeing lower rates and greater competition. Healthcare has been a bright spot for deal activity over the past year (see chart). As the number of private deals involving healthcare services rose, demand for representations and warranties (R&W) insurance in the space also increased. Despite turning away from this sector in […]

By | Jun 02, 2023 ||

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 | May 31, 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 | May 29, 2023 ||