We are an effective regulator that maintains public confidence through our licensing, inspection and authorisation processes and by being open and transparent. We believe that patients and families should be confident that their tissue will be used in line with their wishes and handled with care.
Our approach to regulation involves being attuned to the risks, taking a targeted – yet proportionate – approach, and using the necessary regulatory tools to achieve compliance and improvement
We require establishments in several sectors to report serious incidents that occur in areas covered by their licence. This is to ensure we are sighted on incidents and can ensure they are carefully investigated.
Once an incident is reported to us, we check that it meets our requirements of a reportable incident. We subsequently seek to understand what immediate actions have been taken and work with establishments to reduce the likelihood of the incident being repeated.
When we inspect an establishment, we assess the premises, review their records, operational policies and procedures, and observe practices. We also conduct interviews and roundtable discussions with a range of staff. By assessing establishments in this way, we can identify whether they are compliant with our standards and – where they are not met – assess the criticality of any shortfalls.
HTA publishes a review of achievements for 2023/24.
As well as providing regulatory oversight and guidance to our sectors, we take an active role in supporting our establishments to ensure they deliver to a high standard and are equipped to overcome challenges.
We work to ensure the safe and trusted use of human tissue in our regulated sectors by improving compliance, supporting innovation and developing a strong reputation as an expert regulator.
When carrying out our activities, we take a pragmatic and constructive approach to regulation.
As a result, our impact as a regulator is largely achieved through our core functions of licensing, inspection and providing guidance.
The Human Tissue Authority (HTA) regulates six key areas:
We are the statutory regulator for ensuring that the removal, storage and use of human tissue is undertaken safely, ethically and with proper consent across a variety of settings.
This includes when they are used for medical treatment, education, research, public display, and are subjected to post-mortem examination.
We also approve all organ donations from living people in the UK.