The U.S. Department of Health and Human Services (HHS), through its Office of the National Coordinator for Health Information Technology (ONC), recently finalized its “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” (HTI-1) Rule.  The …

HHS “HTI-1” Final Rule Addresses Artificial Intelligence & Information Sharing Read more »

The U.S. Food and Drug Administration (FDA) recently published a final rule amending “its regulations concerning direct-to-consumer (DTC) advertisements for human prescription drugs presented in television or radio format and stating the name of the drug and its conditions of …

FDA Final Rule on Direct-to-Consumer Prescription Drug Advertisements Read more »

The U.S. Centers for Disease Control and Prevention (CDC) recently reported that newborn syphilis cases increased over 10 times from 2012 to 2022.  “The increase in newborn syphilis follows rising syphilis cases among women of reproductive age combined with social …

CDC Sounds Alarm about Skyrocketing Newborn Syphilis Cases Read more »

The U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services and Office of the National Coordinator for Health Information Technology have proposed a rule that “would implement the provision of the 21st Century Cures Act specifying …

Proposed Federal Rule on Disincentives for Health Care Providers Blocking Information Read more »

The U.S. Food and Drug Administration (FDA) recently created a Digital Health Advisory Committee to provide relevant expertise and perspective to improve the FDA’s understanding of the benefits, risks, and clinical outcomes associated with use of Digital Health Technologies (DHTs),” …

FDA Digital Health Advisory Committee Read more »