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 DevicesWhat 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 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
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
Continue Reading Could FDA Model Master Files Facilitate Use of Third-Party AI Models in the Drug Life Cycle?
The UK’s new Data Legislation – What does it mean for the Life Science sector?
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?
Quantum Computing and its Impact on the Life Science Industry
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 potential applications of quantum computing are wide-ranging and industry-agnostic. For instance, they could be used to enhance the analysis of large, complex data sets, optimize supply-chain processes, and enhance artificial intelligence (“AI”) technologies and improve machine learning algorithms.
Given the potential applications, quantum computing could have a significant impact on companies in the life sciences sector, and more specifically could be used to improve:Continue Reading Quantum Computing and its Impact on the Life Science Industry
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
Continue Reading CMS & HHS Health IT Office Issue Request for Information on Digital Health Products and Health Technology InfrastructureFDA 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.
Continue Reading FDA Requests Comments on Substantial Proposed Changes to Data Standards
European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers
On 15 January 2025, the European Commission published an action plan on the cybersecurity of hospitals and healthcare providers (the “Action Plan”). The Action Plan sets out a series of EU-level actions that are intended to better protect the healthcare sector from cyber threats. The publication of the Action Plan follows a number of high-profile incidents in recent years where healthcare providers across the European Union have been the target of cyber attacks.Continue Reading European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers
Biden Administration Rulemakings at Risk for Congressional Review Act Cancellation in New Congress
In a new post on the Inside Privacy blog, our colleagues discuss the potential risk for Congressional Review Act (CRA) cancellation of Biden Administration rulemakings under the newly assembled 119th Congress.
Continue Reading Biden Administration Rulemakings at Risk for Congressional Review Act Cancellation in New CongressHHS Issues Notice of Proposed Rulemaking to Update the HIPAA Security Rule
On January 6, 2025, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) issued a notice of proposed rulemaking (the “proposed rule”), which proposes a number of significant updates to the HIPAA Security Rule. According to OCR’s announcement, the proposed rule seeks to “improve cybersecurity and better protect the U.S. health care system from a growing number of cyberattacks” and “better align the Security Rule with modern best practices in cybersecurity.” The preamble states that the proposed rule seeks to address common areas of non-compliance with the Security Rule identified by OCR in its recent investigations, as well as build on recommendations from the National Committee on Vital Health Statistics and guidelines and best practices recommended by other parts of the government, such as the Cybersecurity and Infrastructure Security Agency (CISA) and the National Institute of Standards and Technology (NIST).
Below, we provide a brief summary of the proposed changes. The proposed rule is open for comment until March 7, 2025.Continue Reading HHS Issues Notice of Proposed Rulemaking to Update the HIPAA Security Rule