Recent weeks have proved of great interest to the UK medical device industry, with various key developments emerging.  Foremost among these, on 10 September 2026, the National Commission into the Regulation of AI in Healthcare (“National Commission”) published its report on recommendations for a future regulatory framework (“Report”).  The Report contains 44 recommendations, including several of particular relevance to developers of AI health technologies.  The Government subsequently responded on 6 October 2026, confirming that it intends to implement all the National Commission’s recommendations.

In addition, several amendments to the UK Government’s proposed Health Bill were announced in September.  These included an amendment tabled by the Secretary of State for Health and Social Care that would create a new legal basis for regulating medical devices in Great Britain through a licensing framework.

Most recently, on 21 October 2026, the UK Government confirmed it will continue to recognize CE marked medical devices and in vitro diagnostic devices placed on the Great Britain market indefinitely.

We discuss these developments and their potential impact on the UK regulatory landscape below.

Continue Reading UK Medical Device Update: Developments in AI, Proposed GB Licensing Framework and Indefinite CE Mark Recognition

On 29 July 2026, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (the regulatory authority with responsibility for enforcing UK medical device rules) published new guidance on ambient voice technology-enabled products (“AVTs,” also known as ambient scribing tools) (“AVT Guidance”).  The AVT Guidance is intended to clarify (and essentially…

Continue Reading New UK Guidance Clarifies Medical Device Status of AI Scribes

The Office of Management and Budget (“OMB”) has released its 2026 Unified Agenda, which identifies regulatory actions that federal agencies expect to propose or finalize during the remainder of the year. Below, we highlight several notable health privacy, interoperability, and data exchange rules that the Department of Health and Human…

Continue Reading OMB Publishes 2026 Unified Agenda Signaling Upcoming Health Privacy and Interoperability Updates from HHS

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 standards for health care claims attachments under HIPAA. CMS explains that the standards are intended to eliminate reliance on manual processes, such as faxing and mailing, which the agency believes will lead to cost and time savings, faster care delivery, enhanced security, and improved efficiency.

Continue Reading CMS Finalizes HIPAA Standard for Electronic Signatures in Health Care Claims Attachments Transactions

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…

Continue Reading FDA Seeks Input on Use of Digital Health Technologies in Clinical Investigations of Drugs & Biologics

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 issued as part of the HTI-2 proposed rule.   

Continue Reading HHS Proposes Changes to the Health IT Certification Program and Information Blocking Regulations in HTI-5 Proposed Rule

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 December 16, 2025, the EU Commission unveiled its proposal for the Biotech Act.  The proposal, which is only the first part of a bigger initiative for regulating biotechnologies, focuses primarily on the health sector.  The Commission took the opportunity to broadly revise the Clinical Trial Regulation (“CTR”) –…

Continue Reading EU Biotech Act Suggests Clarifying Data Protection Rules For Clinical Trials

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