Outcomes and Registries Directions 2024

The purpose of these Directions (the Purpose) is to require NHS England to establish and operate an information system to collect and analyse information from relevant health and social care bodies  and other organisations, including private healthcare providers, in England for the purposes of improving clinical safety and patient outcomes, reducing variation in clinical practice and to support the NHS and government response to the recommendations of the Independent Medicines and Medical Devices Safety Review  and the Paterson Inquiry report . 

The purpose includes setting up new registries and consolidating a range of existing outcome registries, patient reported outcome datasets and audits over time, into a shared delivery model.  The Outcomes and Registries datasets within scope of these Directions are published on Outcomes and Registries List  and will be updated regularly in line with the Requirements Specifications.

Sections 254(1) (2)(b), 254(5), 260(2)(d) and 304(9 to (12)  of the 2012 Health and Social Care Act (the 2012 Act), section 13ZC of the National Health Service Act 20062 (the 2006 Act)

This Direction came into force on 14 March 2024.

Revocation

The Surgical Devices and Implants Directions 2020 are revoked.