FDA recently announced that it will host a public workshop on August 6, 2024 focused on “Artificial Intelligence (AI) in Drug & Biological Product Development.” Aimed at bringing drug sponsors and AI experts together, the workshop, hosted in collaboration with the Clinical Trials Transformation Initiative, will feature presentations and a
Continue Reading FDA Announces Workshop on AI Used In Drug & Biological Product DevelopmentInternet of Things (IoT)
FDA Medical Product Centers Continue Focus on AI
On March 15, 2024, FDA’s medical product centers – CBER, CDER, and CDRH – along with the Office of Combination Products (OCP) published a paper outlining their key areas of focus for the development and use of artificial intelligence (AI) across the medical product life cycle. The paper, entitled “…
Continue Reading FDA Medical Product Centers Continue Focus on AIBiden Administration Announces Artificial Intelligence Executive Order
Earlier today, the White House issued a Fact Sheet summarizing its Executive Order on a comprehensive strategy to support the development of safe and secure artificial intelligence (“AI”). The Executive Order follows a number of actions by the Biden Administration on AI, including its Blueprint for an AI Bill of…
Continue Reading Biden Administration Announces Artificial Intelligence Executive OrderFramework for the Future of AI: Senator Cassidy Issues White Paper, Seeks Public Feedback
On September 6, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, issued a white paper about the oversight and legislative role of Congress related to the deployment of artificial intelligence (AI) in areas under the HELP Committee’s jurisdiction, including health…
Continue Reading Framework for the Future of AI: Senator Cassidy Issues White Paper, Seeks Public FeedbackCMS Proposes Changes to Medicare Telehealth Policies, Including Increased Payment Rates
On Thursday, July 13, 2023, the Centers for Medicaid & Medicaid Services (CMS) released the Calendar Year (CY) 2024 Physician Fee Schedule (PFS) Proposed Rule (CY 2024 PFS Proposed Rule), which proposes policy changes to the PFS and other Medicare Part B issues, effective on or after January 1, 2024. …
Continue Reading CMS Proposes Changes to Medicare Telehealth Policies, Including Increased Payment RatesFDA Releases Discussion Paper on AI in the Drug and Biological Product Development Process
Last week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) issued a second discussion paper on the use of artificial intelligence (“AI”) and machine learning (“ML”) with respect to drug and biological products, this time focusing on the use of AI/ML in the drug and biologic development process,…
Continue Reading FDA Releases Discussion Paper on AI in the Drug and Biological Product Development Process

FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development
On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT Framework”). This DHT Framework is on the heels of a Discussion Paper the Agency released earlier this month on the use of artificial intelligence (AI) in drug…
Continue Reading FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development5 Reasons Digital Solutions for Women+ Health Will Grow in 2023
Innovative digital solutions intended to address health issues typically experienced by women have been an area of increased focus. Ranging from reproductive-related mobile applications to AI-enabled breast cancer screening devices, digital solutions for women+ health show promise to serve an enormous market with medical needs that have often failed to…
Continue Reading 5 Reasons Digital Solutions for Women+ Health Will Grow in 2023California AG Probes for Potential Bias in Healthcare Algorithms, Federal Attention Continues
Digital health technologies, including algorithms for use in health care, are being developed to aid healthcare providers and serve patients, from use with administrative tasks and workflow to diagnostic and decision support. The use of artificial intelligence (“AI”) and machine learning algorithms in health care holds great promise, with the…
Continue Reading California AG Probes for Potential Bias in Healthcare Algorithms, Federal Attention Continues3 Takeaways Digital Health Innovators Should Be Watching in the PREVENT Pandemics Act
On January 25, 2022, Senators Patty Murray and Richard Burr (Chair and Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, respectively) released a “discussion draft” of bipartisan legislation—the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (“PREVENT Pandemics Act”)—which contains notable…
Continue Reading 3 Takeaways Digital Health Innovators Should Be Watching in the PREVENT Pandemics Act