Annual horizon scanning report
Horizon scanning helps the HTA identify and monitor emerging developments within and adjacent to its remit, assessing their potential impact on the organisation and those it regulates. This work helps the HTA address risks and opportunities, support innovation, and maintain public confidence in the ethical and safe use of human tissues.
Topics are identified through published literature, parliamentary discussions, media, conferences, inspection findings and stakeholder engagement, and recorded on a register. An annual report summarising shortlisted topics is presented to the HTA Board.
This page covers the topics identified as high priority for 2025 and 2026, representing emerging issues within the HTA's regulatory remit and those of potential professional interest.
Horizon scanning report 2026
Assessment and Recovery Centres
Background
The development of ARCs was identified as a priority issue in 2024/25. The rationale for this was that it would be a novel development potentially enabling significant improvements to deceased donor organ utilisation rates. It would do so by introducing specialist geographical/regional perfusion hubs to re‑perfuse and assess the function of organs before they are sent to the recipient hospital for transplantation (where appropriate). This would extend the time available to transplantation, allowing for better assessment of function and planning of surgery.
Work to date
Our understanding is that NHS Blood and Transplant (NHSBT) will be commencing a pilot in February 2026. The pilot will use selected existing transplant centres to trial, rather than develop, standalone perfusion hubs. Even though there is currently no direct role for the HTA in this process, it was considered important for ARCs to remain a horizon‑scanning topic for 2026. This is because a pilot phase began in early 2026 and could constitute a meaningful change to the sector, with the potential for longer‑term considerations in relation to licensing.
Engagement in 2026/27
Continue to engage with NHSBT on this topic and keep abreast of the pilot. If significant developments are made, the HTA could consider what the impact might be on licensing in the future.
Future models of regulation
Background
This new area has been identified throughout the Horizon scanning work in 2025/26. This has been driven by broader questions around regulation posed by the Independent Inquiry into the issues raised by the David Fuller case, but also for the HTA to continue to be aligned with Government initiatives. This would include:
a) Government considerations around regulation – including learning from the Regulatory Innovation Office, potential regulation of funeral directors, and learnings from the SoHO project;
b) Government initiatives in AI – including the AI Opportunities Action Plan and additional AI tools currently being rolled out across the Civil Service; and
c) Life Sciences Sector Plan – published in July 2025, the plan aims to make the UK Europe’s leading life sciences economy by 2030. There is a focus on innovation in science and healthcare and supporting the Government’s growth agenda.
Work to date
This is a new topic which aims to consider broader Government initiatives and how these could relate to the role of the HTA, or where the HTA could make a meaningful contribution.
The horizon scanning work on future regulatory models has been complemented by a parallel review of the HTA's legislative log. This review identified three priority areas for potential legislative consideration, two of which have been shared with Ministers and the Department. A further seven areas will be assessed for potential policy development during 2026/27.
Engagement in 2026/27
Maintain our understanding of the broader Government direction of travel and the core question of what effective and proportionate regulation considerations could look like for the HTA. This will likely span across several sectors and areas and could inform and contribute to our Government returns, and the HTA’s ongoing legislative log review considering the impact of legislative change.
Sale and auction of human remains
Background
The Human Tissue Act 2004 prohibits commercial dealings in human material for transplantation. However, the Act does not cover the sale or auction of human remains as artefacts.
In 2025 the HTA received four media enquires relating to the sale of human remains. It indicates that there continues to be an interest in this issue. At Prime Minister's Questions on 20 November 2024, Bell Ribeiro-Addy MP raised concerns about the sale of human remains and asked the Government to take action to end the practice. This was followed up on 1 December 2025 with a similar written question on banning the sale and public display in UK institutions of African ancestral remains. Bell Ribeiro-Addy MP will seek to introduce a Human Remains (Prohibition of Sale, Purchase and Advertising) Bill on 4 February 2026 under the Ten Minute Rule. The rule allows MPs to give a ten-minute speech in favour of a Bill before seeking the House’s permission to introduce it. The Bill would end the practice of selling human remains in auction houses and on social media under the guise of being modified items or replicas.
Work to date
In the Board paper on 6 March 2025, it was agreed that the HTA will develop a position statement on the sale and auction of human remains, acknowledging that this practice currently falls outside our statutory remit. The HTA has not developed a specific statement on this, however, it is sufficiently outlined in the published HTA policy on the Sale of human bodies, body parts and tissue. If additional work is considered across Government the HTA will re‑assess this issue, and how we can contribute. This would include any overlap with the review of the Public Display Code of Practice.
Engagement in 2026/27
The HTA will continue to monitor the developments in this area, and if there will be wider Government interest in reviewing these issues. The HTA will review the current policy on the Sale of human bodies, body parts and tissue. If appropriate, the HTA could further explore issues around tissue as property. This would intersect with other areas of the HTA’s remit, including Human Application.
Artificial Intelligence (AI) and digitalisation in healthcare
Background
AI is a fast-developing technology with potential to radically change the healthcare and regulatory landscape. AI has been applied in healthcare to enhance drug discovery, diagnostics, and patient care, supporting personalised treatment plans. We are aware that other regulators, such as the Medicines and Healthcare Products Regulatory Agency (MHRA), are exploring the role of AI in patient treatment.
Work to date
In 2025 there were no specific corporate performance indictors linked to this Horizon scanning topic. The purpose was to keep a watching brief as it is an area of wider interest across the healthcare landscape. The overall ambition was to maintain a good organisational understanding and keep abreast of broader developments.
Next steps for 2025/26
The scope has been narrowed to focus on AI and broader healthcare developments, with the robotics section removed. The purpose is to build an organisational awareness in this area, even where topics do not directly link to current regulatory functions. Simultaneously, the HTA will keep abreast of wider Government ambitions in this area and continue to engage with other organisations as appropriate, including the MHRA.
Advances in use of tissue in life sciences
Background
This topic focus on important areas relating to the use of tissue in life sciences, adjacent to the HTA’s current regulatory remit, and which could impact on the organisation or its regulated sectors in the future. This horizon scanning topic has a strong correlation with the legislative log review and issues identified throughout that process. Specific areas identified as important are:
a) Acellular products (e.g. exosomes). Regulatory uncertainty for products derived from human cells that do not contain cells. Legal advice indicates these products fall outside of the HTAs remit, and it’s unclear who should license procurement of source material in the future;
b) Manufactured products from human tissues/cells. Current regulations are not explicit about regulating products manufactured from human tissues and cells, creating a potential regulatory gap. The introduction of ATMP and Medical Device legislation has added complexity, creating uncertainty about how products that do not fit these definitions should be regulated;
c) Novel tissue and cell products and clinical efficacy. It is an important area as The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (‘Q&S regs’) lack requirements for clinical trials to establish efficacy or safety of novel tissue and cell products, presenting patient safety and public health risks;
d) Stem cell-based embryo models (SCBEM). SCBEMs are embryo-like structures created in a laboratory in vitro using human stem cells. These models mimic the processes that occur in early human embryo development. These models are often developed to research early stages of human embryo development, however, it is a rapidly expanding area and the HTA will continue to monitor and consider regulatory implications; and
e) Xenotransplantation. A potential alternative to human organ donation, however, likely a longer-term Horizon scanning issue. Recent developments include the Food and Drug Administration in the United States approving a clinical trial of the transplantation of a non-human animal organ (a genetically modified pig kidney) to a human.
Work to date
The HTA is currently monitoring these areas as part of its Horizon Scanning activity. These areas are also considered as part of the legislative log review – including implications on the HTA’s current legislative framework.
Engagement in 2026/27
To keep abreast of broader developments across the sector, and potential regulatory implications.
This will be informed in part by work being undertaken to review a number of issues identified on the legislative log to better understand the benefits and risks associated with potential legislative change in these areas and possible alternative approaches. The HTA will consider how future development would interplay with our current regulatory remit, and the potential impact and scope of future legislative changes.
Horizon scanning report 2025
Assessment and Recovery Centres (ARCs)
Background
In the UK, like many countries, there is a shortfall in organs available for transplantation, leading to significant patient waiting times. Many donated organs are deemed unsuitable for transplantation due to concerns about their viability and function. However, some organs could be viable if sufficiently assessed and repaired before transplantation.
In 2023, the Organ Utilisation Group’s (OUG’s) report ‘Honouring the gift of donation: utilising organs for transplant’ made several recommendations to maximise the potential for organ transplantation from living and deceased donors. The report recommended establishing national Assessment and Recovery Centres (ARCs). ARCs aim to bring techniques, including machine perfusion, into widespread clinical practice as soon as possible. This would support maximising the number and quality of organs available for transplant and associated logistics. The report also recommended creating a national oversight system of innovation in organ assessment, perfusion, and preservation.
The Department of Health and Social Care (DHSC) created the Implementation Steering Group for Organ Utilisation (ISOU) to implement these recommendations. In their November 2024 implementation plan, the ISOU outlined its intention to progress the establishment of ARCs and innovation oversight during the 2025/26 business year, led by NHS Blood and Transplant (NHSBT). The plan indicates that if a business case is approved in quarter two of 2025/26, procurement could begin in quarter four of 2025/26.
Work to date
The HTA has already undertaken work to address the introduction of ARCs. In November 2022, the HTA updated ‘The Quality and Safety of Organs Intended for Transplantation: A Documentary Framework’ to include new directions related to ARCs. Specifically, when an organ is sent to an establishment for assessment or recovery using machine perfusion, the establishment must record and store any organ characterisation and traceability data generated during this process for 30 years.
Dignity of the deceased; Body stores; Regulation of funeral directors
Background
In January 2022, the Independent Inquiry into the issues raised by the David Fuller case in the mortuaries at Maidstone and Tunbridge Wells NHS Trust was established. The Inquiry also considers whether the procedures and practices in other hospital and non-hospital settings where deceased individuals are placed safeguard their security and dignity.
The first phase of this Inquiry concluded in November 2023 with the publication of the phase one report. The Inquiry is now in its second phase, with an interim report focused on the funeral sector published in October 2024. The phase two report is planned for publication in 2025.
Work to date
The HTA has supported the Inquiry since it was established in 2022. Most recently, the HTA Chief Executive spoke at a seminar in November 2024 on the regulatory and oversight measures in place to safeguard the dignity and security of the deceased.
We have also taken steps to increase protections for the dignity of the deceased, as outlined in the paper presented to the Board in September 2024. This includes delivering mandatory webinars on security standards for designated individuals (DIs) in the PM sector.
We have also published revised guidance on HTA Reportable Incidents (HTARI) and developed a trial programme of unannounced inspections in the PM sector, commending mid-September 2024. The September Board paper also outlines a pilot with the Welsh Government and Health Boards to deliver advisory inspections of unlicensed hospital body stores.
Sale and auction of human remains
Background
There have previously been reports about the auction of human and ancestral remains, including human bones, shrunken heads and skulls. The British Association for Biological Anthropology and Osteoarchaeology (BABAO) has raised concerns about this practice, stating that it is unethical. In response, they have established the Trading and Sale of Human Remains Task Force. This group aims to educate the public about the ethical, legal, and social ramifications of the private commercial trade in human remains.
At Prime Minister's Questions on 20 November 2024, Bell Ribeiro-Addy MP raised concerns about the sale of human remains after discussions with BABAO. She asked the government to take action to end the practice. In response, the Deputy Prime Minister, Angela Rayner, acknowledged the HTA’s regulation of the public display of human remains but that this did not cover sales or purchases. She confirmed that a meeting would occur with the appropriate Minister to discuss the issue.
Work to date
To support this discussion of the sale and auction of human remains, the HTA has engaged with and supported DHSC and the Department for Digital, Culture, Media and Sport (DCMS), including providing relevant information to inform discussions and briefings.
Artificial intelligence, digitisation and robotics in healthcare
Background
Artificial Intelligence (AI) is a fast-developing technology with increasing numbers of everyday applications. AI has been applied in healthcare to enhance drug discovery, diagnostics, and patient care, supporting personalised treatment plans. It also has the potential to streamline operational activities and support administrative tasks such as creating staff rotas and resource allocation.
Many businesses are investing heavily in AI to reduce manual processing and improve the productivity of their workforce. The use of AI to enhance patient care and operational efficiency continues to be a priority of the current government. One of the UK Government’s missions under the plan for change is ‘an NHS fit for the future’. The NHS 10-Year Health Plan for England is being developed to aid in delivering this mission. One of the three reform shifts under this plan is titled ‘analogue to digital’. This focuses on combining new technologies and digital approaches to modernise the NHS. In October 2024, the Regulatory Innovation Office (RIO) was also formed to increase the speed of innovative technology, including AI in healthcare, to market by reducing regulatory burdens.
AI poses unique regulatory considerations. As defined in the Government’s 2023 white paper ‘AI regulation: a pro-innovation approach,’ the technology’s characteristics of ‘adaptivity’ and ‘autonomy’ create the need for bespoke regulatory responses. For example, adaptability and the potential for ongoing ‘training’ can make explaining the intent or logic of the system’s outcomes challenging. Autonomy makes it difficult to assign responsibility for outcomes. To produce reliable outputs, AI requires large quantities of high-quality data. If not, there is a risk of algorithmic outcomes perpetuating historical biases and discrimination. Consideration is also needed for data security, particularly for sensitive medical information.
Of note, this horizon topic does not consider the HTA's use of AI in our work or regulatory activities. The HTA's use of AI is included as a separate topic on the HTA’s horizon scanning register. This is because of the distinct risks and opportunities related to the HTA’s use of AI compared to the use and regulation of AI in our licensed establishments.
In February 2025 the HTA responded to a Parliamentary Question (PQ) on our use of AI. In response the HTA commented that we currently use the Government Communication Service (GCS) Assist tool. The tool is designed to support communications professionals in a number of areas including: the production of first draft communications products; stakeholder management; research and media handling.
Work to date
The HTA has engaged with stakeholders to establish where and how licensed establishments are using, or planning to use, AI. At the HTA’s stakeholder event in September 2024, roundtable discussions explored the use of AI across our six sectors.
A recent stakeholder survey indicated that around a quarter of our licensed establishments currently use or plan to use AI in their work in areas such as text generation, image analysis, data processing, and predictive modelling.