Compliance and Retention: What the Law Expects in Healthcare

Understand UK healthcare record retention laws. Learn what GxP archiving involves and how to stay compliant with document storage.

In healthcare, how you manage your records is just as important as the care you deliver. Whether it’s a patient file, a clinical trial record or a diagnostic image, UK law sets clear expectations for how long medical documents must be kept, how they should be stored and how quickly they should be accessible.

If your records aren’t compliant, the risks range from regulatory fines to compromised patient safety. This guide outlines the legal requirements for healthcare record retention in the UK, explains GxP archiving and offers practical steps to help you stay compliant.

What UK Law Says About Record Retention in Healthcare

Healthcare providers in the UK must follow guidance from a few key sources:

  • NHS Records Management Code of Practice 2021 – This is the main retention schedule for NHS and independent providers in England. It outlines specific timeframes for different types of medical and corporate records.
  • UK GDPR and the Data Protection Act 2018 – These laws require personal data (including medical records) to be stored securely and retained only as long as necessary.
  • MHRA (Medicines and Healthcare products Regulatory Agency) – Enforces GxP compliance for organisations involved in pharmaceutical and clinical research.

     

Together, these frameworks shape how healthcare providers store, access and destroy records in a way that protects patient data and meets regulatory expectations.

Standard Retention Periods for UK Healthcare Records

Retention periods differ depending on the type of record and the patient involved. Key examples from the NHS Code of Practice include:

  • Adult health records – Retain for 8 years after the conclusion of treatment or death.
  • Children’s records – Keep until the patient’s 25th birthday, or 8 years after death if the child dies before turning 18.
  • Mental health records – Store for 20 years after last treatment or 8 years after death, whichever is longer.
  • GP records – Keep for 10 years after a patient’s death.
  • Clinical trial documentation – Must be retained for a minimum of 15 years post-trial, or longer depending on the study’s scope and MHRA guidance.
  • Adult dental records: Retain for 11 years after the last entry or until the patient’s 25th birthday, whichever is longer.
  • Children’s dental records: Keep until the patient’s 25th birthday or 11 years after the last entry, whichever is longer.

These retention rules apply to both paper and digital formats and are enforceable by law.

What Is GxP Archiving and Why It Matters

GxP refers to various “Good Practice” guidelines, including:

  • GCP (Good Clinical Practice)
  • GMP (Good Manufacturing Practice)
  • GLP (Good Laboratory Practice)

In the UK, organisations regulated by the MHRA must follow GxP when managing records related to pharmaceuticals, clinical trials and other life sciences data.

GxP-compliant archiving must ensure:

  • Data is complete, accurate, secure and traceable
  • An audit trail exists for all access, edits or movements of records
  • Long-term data integrity through validated systems and secure storage
  • Controlled access to prevent unauthorised changes or deletions

These expectations are essential for any healthcare organisation involved in research or regulated by the MHRA.

Where UK Healthcare Record Compliance Goes Wrong

Common issues include:

  • Relying on paper-based records that are hard to track and vulnerable to loss
  • Storing documents in non-compliant environments (e.g. damp basements, unsecured drives)
  • Failing to implement clear retention policies
  • No structured process for audits, retrieval or secure destruction

These missteps can put patient data at risk and lead to MHRA inspections or ICO (Information Commissioner’s Office) investigations.

How to Stay Compliant in the UK Healthcare Sector

To meet retention and compliance standards, healthcare providers should:

  • Digitise records to improve accessibility and reduce physical storage needs
  • Use document management systems with UK GDPR-compliant access controls
  • Automate retention tracking and destruction dates using a trusted provider
  • Ensure GxP archiving protocols are in place for research and pharmaceutical documents

Working with a specialist partner can remove much of the burden and help ensure your organisation is always inspection-ready.

How Ardington Archives Can Help

At Ardington Archives, we work with UK healthcare providers to deliver secure, compliant document storage and scanning services.

  • Our systems are built for GxP archiving, with full traceability and audit support
  • We ensure secure digitisation of records in line with NHS Code of Practice guidelines
  • Our off-site storage facilities meet UK standards for healthcare document protection

Whether you’re digitising patient records, archiving trial data or updating your retention policy, we’re here to help you stay compliant with less stress and better peace of mind.