HTA’s approach to horizon scanning in 2026/27
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Overview of HTA's approach to horizon scanning
Horizon scanning is, at its core, about asking what is coming that could affect the sectors we regulate, and considering how we should respond. The HTA regulates the storage and use of human tissue across a range of settings, from transplantation and research to post-mortem examination and public display. The science, technology, and policy landscape in which we operate continues to evolve, and the horizon scanning function supports us to anticipate change and respond proportionately.
Our horizon scanning function helps us to consider how emerging developments may affect the sectors we regulate, and how we can prepare. In March, we published our 2026 Horizon Scanning Report, Annual horizon scanning report | Human Tissue Authority and I wanted to share what the process involves and what this year's report covers.
The process is embedded in our 2024 to 2027 strategy and reflects our commitment to being a proportionate, forward-looking regulator. Each year, we identify and assess a range of topics that could influence our work, scoring them for likely impact and likelihood of occurrence. The resulting report is presented to our Board and then published on our website.
The 2026 report identifies five high-priority topics, two of which are new this year.
Assessment and Recovery Centres (ARCs) featured again this year. ARCs are specialist regional hubs that could improve deceased donor organ transplantation by giving surgeons more time to assess organ function before surgery. The HTA has no direct licencing role at this stage, but we will consider any longer-term implications for licencing as developments emerge.
Future models of regulation is a new topic that draws together several connected threads, including learning from the Independent Inquiry into the issues raised by the David Fuller case, broader Government initiatives such as the AI Opportunities Action Plan, and the Life Sciences Sector Plan which aims to make the UK Europe's leading life sciences economy by 2030. This topic considers what effective, proportionate regulation may look like in the coming years, and how the HTA can usefully contribute.
AI and digitalisation in healthcare continues to be an area of focus. AI is developing quickly and has potential implications for diagnostics, drug discovery, and patient care. Our aim is to build and maintain a sound organisational understanding of this landscape and to keep pace with wider developments, including those being considered by other regulators such as the MHRA.
Sale and auction of human remains is a topic we are monitoring. The Human Tissue Act 2004 prohibits commercial dealings in human material for transplantation but does not extend to the sale of human remains as artefacts. This has attracted parliamentary attention and media interest over the past year, and we will be considering our existing policy on the sale of human bodies, body parts, and tissue.
Advances in the use of tissue in life sciences is the second new topic for 2026. A number of developments in this area, including acellular products such as exosomes, stem cell-based embryo models, manufactured products from human tissues and cells, and xenotransplantation sit at or beyond the current boundaries of our regulatory remit. These areas may have implications for our legislative framework in future, and we are monitoring them as part of both the horizon scanning function and our legislative log review.
Our log review is closely connected to this work. It is a record of areas where our legislation may benefit from updating given how practice has changed over the past 20 years. Two areas have been identified as priorities for potential legislative consideration: living organ donation panel cases, alignment of inspection frequency with the new Substance of Human Origin Regulation in Northern Ireland.
Publishing the report is the start of a longer process. During 2026/27, we intend to explore these areas further and seek views on these and other topics, before updating a report in March 2027.
If you have views to share or are aware of emerging issues you think we should be considering, please do get in touch. Contact us | Human Tissue Authority
Jonathan Spencer, Head of Policy and Communications