On December 29, 2025, the U.S. Department of Health and Human Services (“HHS”), through the Assistant Secretary for Technology Policy (“ASTP”)/Office of the National Coordinator for Health Information Technology (“ONC”) (collectively, “ASTP/ONC”), issued a proposed rule to update its Health Data, Technology, and Interoperability (“HTI”) regulations, as well as a notice to withdraw prior proposals
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5 Developments Digital Health Innovators Should Watch in 2026
With 2026 underway, signs point to another year focused on enhancing health IT and digital health innovation. From new payment models to deregulatory efforts, these developments show that digital health continues to be increasingly central to the healthcare and life sciences sectors. Below are five key developments to watch unfold in the year ahead.
FDA Requests Public Comment on Real-World Evaluation of AI-Enabled Medical Devices
On September 30, 2025, the U.S. Food and Drug Administration (FDA) issued a Request for Public Comment seeking input on “practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real-world,” including strategies for detecting, assessing, and mitigating performance changes over time (the “Request”).
The Request acknowledges the opportunities for AI,
FDA to Convene Advisory Committee Meeting on GenAI Mental Health Devices
The Food and Drug Administration (FDA) has announced that its Digital Health Advisory Committee (DHAC) will meet on November 6, 2025, to discuss and make recommendations on the topic of genAI-enabled digital mental health medical devices. The DHAC will discuss potential “benefits, risks to health, and risk mitigations” for such devices, “including premarket evidence and
What Life Sciences and Digital Health Companies Need to Know About CMS’s New Health Technology Ecosystem Initiative
On July 30, 2025, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) announced a new Health Technology Ecosystem Initiative—a collaborative effort between government and industry to unlock innovation by modernizing healthcare data flows among patients, providers, payers, and technology platforms. The new initiative does not contemplate any
Could FDA Model Master Files Facilitate Use of Third-Party AI Models in the Drug Life Cycle?
As the Covington team discussed in a recent article, use of AI models in biopharma is on the rise, with use cases spanning the life cycle of drugs and biologics, including product development, manufacturing, and pharmacovigilance. Recently, FDA announced its own intentions to aggressively scale the use of AI in regulatory review and launched
CMS & HHS Health IT Office Issue Request for Information on Digital Health Products and Health Technology Infrastructure
On May 13, 2025, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services’ Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) announced a request for information seeking stakeholder input on the market of digital health products for Medicare beneficiaries,
FDA Requests Comments on Substantial Proposed Changes to Data Standards
FDA has issued two Federal Register notices in under two weeks that seek comments on updates to FDA data standards.
FDA Announces Workshop on AI Used In Drug & Biological Product Development
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 panel discussion around guiding principles
EHDS Series – 4: The European Health Data Space’s Implications for “Wellness Applications” and Medical Devices
In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS). For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted. This article focuses on the implications for “wellness applications” and medical devices; for an overview of the EHDS