On March 14, 2025, the U.S. Department of Health and Human Services (HHS) issued a revised Statement of Organization for the Office of the General Counsel (HHS-OGC).1 Changes include a return to an […]
On January 17, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a proposed guidance document on study protocols that use real-world data (RWD). The proposed guidance focuses on studies with […]
On December 10, 2024, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule with technical changes for the Medicare Advantage (MA) Program and the Medicare Prescription Drug […]
The Biden administration’s executive order issued on October 30, 2023, includes a number of initiatives relating to the development and use of artificial intelligence (AI), including in healthcare. As AI becomes a […]
Healthcare providers, health plans, and technology companies that use mobile health apps to access, collect, share, use, or maintain information related to an individual’s health should take note of the […]
In 2022, many if not most pharmaceutical, medical device, and other life sciences companies established strategies to innovate digital health technology complementary to their existing strategic focus. The digital transformation […]
Digital health companies should take note of new data privacy and security developments under the Health Insurance Portability and Accountability Act (HIPAA) that can affect product planning and customer negotiations. […]