On October 30, 2023, President Biden issued an executive order (EO) to guide federal agencies on the development and use of artificial intelligence (AI). The administration views AI as holding numerous benefits but at the...more
10/31/2023
/ Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Pharmaceutical Industry ,
Prescription Drugs ,
Technology Sector ,
Telemedicine
On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more
10/25/2023
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Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Labeling ,
Medical Devices ,
Medical Software ,
Pharmaceutical Industry ,
Policies and Procedures ,
Regulatory Requirements ,
Regulatory Standards
FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more