Annual horizon scanning report

The HTA regulates all mortuaries where post-mortem examinations occur in England, Wales, and Northern Ireland. Through our work with mortuaries, we help ensure that the bodies of the deceased are treated with respect in a safe and secure environment, maintaining their dignity at all times. However, it is not within the HTA’s statutory remit to regulate funeral services or unlicensed body stores.  

The Inquiry is, therefore, reviewing areas of practice that are both directly and indirectly associated with the HTA’s statutory remit. This makes the potential impact of the Inquiry's findings on the organisation high. 
 

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.
 

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.
 

The HTA oversees compliance with laws ensuring the quality and safety of the UK's organs, tissues, and cells for transplantation. This includes licensing and inspecting hospitals where activities associated with deceased and living organ donations occur and approving living donation cases. Therefore, ARCs would be within the HTA’s statutory remit, meaning we would be responsible for reviewing whether Assessment and Recovery Centres (ARCs) comply with quality and safety standards. 

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.
 

The Human Tissue Act 2004 (The Act) prevents commercial dealing in human tissue for organ donation. It also requires those holding human remains less than 100 years old for a scheduled purpose to obtain a licence from the HTA.

This includes an exhibition or display where the public can view a body or relevant material from a body. However, the Act does not cover the sale or auction of human remains as artefacts. 

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 (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. 

The HTA ensures that human tissues, cells and organs are handled with dignity, used with consent and stored safely. Across all six of the HTA’s sectors, we aim to maintain public trust and confidence in the safe handling of human tissues. This includes where AI is used in a way that would fall under or impact the HTA's statutory remit. It is therefore important for the HTA to monitor the current or future application of AI in our sectors to determine the role of the HTA in AI's regulation, or providing guidance and support to licensed establishments. 

As AI's application expands, it increasingly affects areas of practice within or adjacent to the HTA’s statutory remit. AI has the potential to aid in organ and tissue donor-recipient matching, determine organ viability and predict treatment outcomes. AI can also be used in medical education and public display to simulate human anatomy or artefacts. This could reduce the need for interaction with human cadavers, prosections or specimens. AI-assisted virtual post-mortems could assist pathologists in determining the cause and time of death, reducing the need for invasive physical post-mortem procedures.

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.