As the use of artificial intelligence (AI) becomes increasingly commonplace, some have raised concerns about its use in medicine, particularly when AI assumes a role that is traditionally held by a physician or other licensed...more
On November 15, 2024, the US Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) jointly issued a temporary rule, which extends the current flexibilities relating to prescribing controlled...more
On July 8, 2024, the Food and Drug Administration (FDA) released updated draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” that replaces similar guidance from...more
Facing novel, swiftly evolving technologies in the digital health space, the US Food and Drug Administration has been trying to balance fostering innovation with providing reasonable assurance of safety and effectiveness...more