On March 24, 2026, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule establishing a Health Insurance Portability and Accountability Act (“HIPAA”) standard for electronic signatures in connection with health care claims attachments transactions, as well as standards governing the electronic exchange of claims attachments more generally. The rule adopts the first-ever
FDA Seeks Input on Use of Digital Health Technologies in Clinical Investigations of Drugs & Biologics
On Tuesday, March 31, FDA published a Request for Information seeking input on the use of digital health technologies (“DHTs”) in clinical investigations for drugs and biological products (the “RFI”). Building on commitments under PDUFA VII and prior Agency publications – including a March 2023 Discussion Paper and December 2023 Guidance – FDA’s Centers for
HHS Proposes Changes to the Health IT Certification Program and Information Blocking Regulations in HTI-5 Proposed Rule
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
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.