digital health

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

Continue Reading 5 Developments Digital Health Innovators Should Watch in 2026

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

Continue Reading FDA Requests Public Comment on Real-World Evaluation of AI-Enabled Medical 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

Continue Reading FDA to Convene Advisory Committee Meeting on GenAI Mental Health Devices

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 new regulations; instead, it is a CMS-led effort intended to empower and accelerate innovation by the private sector through (i) the development of public digital infrastructure and data standards and (ii) voluntary commitments from industry to deliver new technology solutions based on a common data-sharing framework.

It is too early to predict how successful the Health Technology Ecosystem will be—the stubborn prevalence of data silos, lack of interoperability between systems, and challenges with using data for secondary purposes have long been a hurdle to innovation—yet, with 60 organizations, including leading tech firms, already pledging support for the new initiative, the broader industry may see this as an occasion for renewed focus and expanded efforts to bring health technology solutions to market at scale. For life sciences and digital health companies, this new initiative may present a strategic opportunity to better serve patients, empower providers, improve real-world evidence generation, and support innovation leading to better healthcare outcomes. Continue Reading What Life Sciences and Digital Health Companies Need to Know About CMS’s New Health Technology Ecosystem Initiative

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

Continue Reading Could FDA Model Master Files Facilitate Use of Third-Party AI Models in the Drug Life Cycle?

This blog was prepared in collaboration with, and was originally published by, the UK BioIndustry Association, here. We are grateful to the UK BioIndustry Association for collaborating on this blog, and for the opportunity to post it here.

What are the UK’s plans to reform data protection law?

After

Continue Reading The UK’s new Data Legislation – What does it mean for the Life Science sector?

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

Continue Reading CMS & HHS Health IT Office Issue Request for Information on Digital Health Products and Health Technology Infrastructure

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 Development

On Friday, April 26, 2024, the Federal Trade Commission (“FTC”) voted 3-2 to issue a final rule (the “final rule”) that expands the scope of the Health Breach Notification Rule (“HBNR”) to apply to health apps and similar technologies and broadens what constitutes a breach of security, among other updates.  We previously covered the proposed rule, which was issued on May 18, 2023.Continue Reading FTC Issues Final Rule to Expand Scope of the Health Breach Notification Rule

On April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence (“AI”).  The Approach is a response to the UK Government’s white paper: a pro-innovation approach to AI regulation and subsequent Secretary of State letter of 1 February 2024, and is the culmination of 12 months’ work by the MHRA to ensure the risks of AI are appropriately balanced with the potential transformative impact of AI in healthcare.

AI in Healthcare

AI has the potential to revolutionize the healthcare sector and improve health outcomes at every stage of healthcare provision – from preventative care through to diagnosis and treatment.  AI can help in research and development by strengthening outcomes of clinical trials, as well as being used to improve the clinical care of patients by personalizing care, improving diagnosis and treatment, enhancing the delivery of care and health system efficiency, and supplementing healthcare professionals’ knowledge, skills and competencies. Continue Reading MHRA Outlines New Strategic Approach to Artificial Intelligence