What Human Tissue Authority does

The Human Tissue Authority (HTA) is a statutory non-departmental public body of the UK Department of Health and Social Care, established under the Human Tissue Act 2004 to regulate organisations that collect, store, and use human tissue for research, teaching, training, patient treatment, organ transplantation, post-mortem examination, and public exhibitions. It operates across England, Wales, and Northern Ireland, and additionally assesses living organ donation cases in Scotland on behalf of Scottish Ministers under the Human Tissue (Scotland) Act 2006. HTA licenses more than 800 establishments spanning six regulated sectors: Post-Mortem, Anatomy, Public Display, Research, Human Application (quality and safety for patient treatment), and Organ Donation and Transplantation. Its core product set comprises sector-specific licensing, seven Codes of Practice (A-G), inspection and regulatory assessment services (on-site, virtual, and desk-based), the HTA Portal for licensing and incident reporting (HTARIs and SAEARs), and the Independent Assessor programme for living organ donation interviews. HTA's technology stack centres on a secure web portal with FIPS 140-2, Common Criteria EAL2+, and AES-NI encryption, supplemented by AI-assisted advertising compliance monitoring that raised UK fertility clinic ad compliance from 81.9% in September 2024 to 96.7% by October 2025.

HTA is funded primarily through parliamentary supply from the Department of Health and Social Care, with supplementary revenue from annual licensing fees set and published via HTA Legal Directions. It has no external shareholders and operates under an 11-member Board appointed by the Secretary of State for Health and Social Care. Leadership comprises Chief Executive Dr Colin Sullivan (appointed January 2022, ex-Food Standards Agency COO), three operational Directors (Regulation; Data, Technology & Development; Resources), and a Deputy Director for Performance and Corporate Governance. Recent strategic moves include the April 2024 enforcement of transplant offence reporting regulations, a December 2024 Director of Resources appointment, a high-profile Nottingham NHS Trust mortuary inspection, and the deployment of AI-assisted advertising compliance monitoring that flagged 2,380 unique ads from 60+ fertility clinics. Distribution to regulated establishments is delivered directly via the HTA Portal, site visits, and published guidance and inspection reports.

Name

Human Tissue Authority

Legal name

Human Tissue Authority

Website

https://hta.gov.uk

Company type

Public

Founded year

2004

Operating status

Operating

Headcount range

101–250 employees

Short description

The Human Tissue Authority is a UK non-departmental public body that licenses and inspects more than 800 establishments across post-mortem, anatomy, research, human application, public display, and organ donation sectors in England, Wales, and Northern Ireland.

Ownership category

akta.pro rank

Headquarters

HQ city

London

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure, Others

Revenue model

1. Licensing fees from regulated establishments: The HTA generates revenue through annual licensing fees charged to establishments it regulates. The HTA licenses more than 800 establishments that store and use human tissue for purposes such as patient treatment, organ transplantation, post mortem examination, research, teaching, and public exhibitions. Fees are set annually and published through Legal Directions.
2. Government funding: As a non-departmental public body of the Department of Health and Social Care, the HTA receives government funding for its regulatory operations.

Pricing tiers

Distribution channels3 records

Marketing channels6 records

Core offering

The Human Tissue Authority (HTA) is a UK statutory regulator that licenses and inspects establishments in England, Wales, and Northern Ireland which remove, store, use, or dispose of human tissue and organs. Operating under the Human Tissue Act 2004, it oversees six regulated sectors (post-mortem, anatomy, public display, research, human application, and organ donation) to ensure public confidence and safety in the use of human tissue.

Product overview

The Human Tissue Authority (HTA) is the UK regulator of human tissue and organs, operating as a non-departmental public body of the Department of Health and Social Care. The HTA does not offer a single product but rather provides a comprehensive regulatory framework with six licensing sectors covering Post-Mortem, Anatomy, Public Display, Research, Human Application (Quality and Safety), and Organ Donation and Transplantation. The HTA's regulatory portfolio includes licensing of establishments, Codes of Practice (A-G), inspection and assessment services, the HTA Portal for incident reporting, Independent Assessor training and accreditation, and incident reporting systems. The HTA licenses over 800 establishments that store and use human tissue for purposes including patient treatment, organ transplantation, post mortem examination, research, teaching, and public exhibitions.

Differentiator

Problem solved

Functional benefit

Products and services

• Establishment Licensing Statutory licensing of establishments that remove, store, use, or dispose of human tissue and organs, required for organisations across six regulated sectors in England, Wales and Northern Ireland.
• Codes of Practice Statutory codes of practice (A through G) providing guidance to professionals on the proper handling, storage, use, and disposal of human tissue and organs under the Human Tissue Act 2004.
• Inspection and Regulatory Assessment On-site inspections and regulatory assessments of licensed establishments to verify compliance with statutory standards, identify non-conformities, and enforce corrective action where required.
• Independent Assessor Services Statutory service providing independent assessment for consent decisions under the Human Tissue Act 2004, for example where a deceased person's wishes regarding organ or tissue donation need verification outside of the family.

Quantifiable outcome

• 96.7% fertility clinic advertising compliance rate achieved through enforcement
• +1 more outcomes

Segments6 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Health Research Authority (HRA): UK NDPB that oversees health and social care research, including research tissue banks — directly overlapping with HTA's Research sector. Comparable governance structure (NHS-linked NDPB), small headcount, and a regulatory remit spanning ethics review, research approval, and tissue governance that intersects HTA's Research sector.
• Human Fertilisation & Embryology Authority (HFEA): UK statutory regulator of fertility treatment and embryo research under the Human Fertilisation and Embryology Act 1990. Closely comparable in mandate (health-related statutory regulation of sensitive biological activities), scale (small NDPB with ~70 staff), funding model (parliamentary grant + licence fees), and licensing/inspection approach.

Broad incumbents

• Care Quality Commission (CQC): England's independent regulator of health and adult social care. Directly comparable as a UK health and social care regulator with licensing, inspection, and ratings functions; significantly larger in scope and headcount. HTA's Director of Data, Technology & Development previously held senior roles at CQC for seven years.
• Medicines and Healthcare products Regulatory Agency (MHRA): Executive agency of DHSC regulating medicines, medical devices, and blood components for transfusion. Operates in adjacent UK health regulatory space, with comparable licensing/inspection powers over biological products that may be used in combination with HTA-regulated tissues and cells.
• National Institute for Health and Care Excellence (NICE): UK NDPB that provides evidence-based guidance and health technology assessment (HTA — the alternative meaning of the HTA acronym). Comparable as a UK health NDPB funded via DHSC, and conceptually adjacent to HTA's regulatory remit by sharing the 'HTA' acronym but operating in clinical/economic evaluation rather than tissue regulation.

Others

• General Medical Council (GMC): UK statutory regulator maintaining the official register of medical practitioners. Operates in the same UK health professional regulatory ecosystem as HTA, with comparable governance, complaints handling, and fitness-to-practise processes, though focused on individuals rather than establishments.
• NHS Blood and Transplant (NHSBT): Statutory body within the NHS that manages blood, plasma, and organ transplantation services. NHSBT operates within HTA's Human Application and Organ Donation & Transplantation sectors as a major licensed establishment, making it both a regulated entity and a key operational partner.
• Advertising Standards Authority (ASA): UK advertising self-regulator that partners with HTA on fertility clinic advertising compliance. HTA's AI-powered monitoring programme is used to feed ASA enforcement actions, making ASA an enforcement counterpart rather than a direct competitor.
• Food Standards Agency (FSA): UK non-ministerial department regulating food safety and standards. HTA's CEO (Dr Colin Sullivan) was previously Chief Operating Officer at FSA, and the Director of Regulation previously headed Regulatory Delivery at FSA — making it a closely related UK regulator in terms of operating model, inspection methodology, and leadership pipeline.

Regional players

• Scottish Housing Regulator: Statutory regulator covering social landlords in Scotland. Comparable as a UK NDPB-style statutory regulator with a single-country remit, analogous to how HTA operates in England/Wales/Northern Ireland while having limited delegated reach into Scotland.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/hta_uk
• Facebookfacebook.com/humantissueauthority
• LinkedInlinkedin.com/company/human-tissue-authority

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Human Tissue Authority