Covington Digital Health

Latest from Covington Digital Health

On September 27, 2023, Governor Newsom signed AB 254 and AB 352, which both amend the California Confidentiality of Medical Information Act (“CMIA”).  Specifically, AB 254 expands the scope of the CMIA to expressly cover reproductive or sexual health services that are delivered through digital health solutions and the associated health information generated from

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 and life sciences.  In the

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.  As explained in our article,

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, “Using Artificial Intelligence &

On March 15, 2023, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (2023 Draft Guidance). The 2023 Draft Guidance revises the draft guidance for industry the Agency issued in June 2017 entitled Use of Electronic

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 manufacturing to seek public input

To avoid a real and imminent risk of shortages of devices on the EU market, the European Commission recently adopted Regulation (EU) 2023/607, extending the transitional provisions in Regulation (EU) 2017/745 (the “MDR”) and removing the sell-off period in the MDR and Regulation (EU) 2017/746 (the “IVDR”).  The Commission has published a Q&A on the

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 get the level of attention

On December 19, 2022, the U.S. Department of Health and Human Services (“HHS”) through the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule to adopt standards for certain electronic health transactions.  Specifically, the proposed rule would adopt standards for health care attachment transactions (e.g., medical charts, x-rays, provider notes) and electronic signatures