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 DevicesThe 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 DevicesOn 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.
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 InfrastructureFDA has issued two Federal Register notices in under two weeks that seek comments on updates to FDA data standards.
Continue Reading FDA Requests Comments on Substantial Proposed Changes to Data Standards
On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog
Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices
This update focuses on how growing quantum sector investment in the UK and US is leading to the development and commercialization of quantum computing technologies with the potential to revolutionize and disrupt key sectors. This is a fast-growing area that is seeing significant levels of public and private investment activity. We take a look at how approaches differ in the UK and US, and discuss how a concerted, international effort is needed both to realize the full potential of quantum technologies and to mitigate new risks that may arise as the technology matures.
Quantum Computing
Quantum computing uses quantum mechanics principles to solve certain complex mathematical problems faster than classical computers. Whilst classical computers use binary “bits” to perform calculations, quantum computers use quantum bits (“qubits”). The value of a bit can only be zero or one, whereas a qubit can exist as zero, one, or a combination of both states (a phenomenon known as superposition) allowing quantum computers to solve certain problems exponentially faster than classical computers.
The applications of quantum technologies are wide-ranging and quantum computing has the potential to revolutionize many sectors, including life-sciences, climate and weather modelling, financial portfolio management and artificial intelligence (“AI”). However, advances in quantum computing may also lead to some risks, the most significant being to data protection. Hackers could exploit the ability of quantum computing to solve complex mathematical problems at high speeds to break currently used cryptography methods and access personal and sensitive data.
This is a rapidly developing area that governments are only just turning their attention to. Governments are focusing not just on “quantum-readiness” and countering the emerging threats that quantum computing will present in the hands of bad actors (the US, for instance, is planning the migration of sensitive data to post-quantum encryption), but also on ramping up investment and growth in quantum technologies. Continue Reading Quantum Computing: Developments in the UK and US
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