According to the legislation (Statutory Instrument 256 of 2018), HIQA must justify:

  • any new practices that involve exposing patients to ionising radiation before they are generally adopted*
  • existing practices that involve exposing patients to ionising radiation, if new and significant information becomes available about the efficacy or safety of the practice itself or about any alternative practice that could replace it

*generally adopted means the practice is used for broad categories of patients, rather than individual patients. The process whereby HIQA approves a practice for a broad category of patients is also known as ‘generic justification’.

To apply for the generic justification please see information below

HIQA has commenced its generic justification function. This means that hospitals and service providers in the public and private sectors who wish to provide a new type or class of practice involving ionising radiation in Ireland must apply to HIQA for generic justification before they can use the practice on a routine basis.

To apply for the generic justification of a new type or class of practice which involves a medical exposure to ionising radiation please click to see the application form and a methods document, which outlines how HIQA will carry out generic justification.

If you have any queries about generic justification, please email radiationjustification@hiqa.ie or phone (021) 240 9300.

See information on HIQA's EAG which advises on its medical exposure to ionising radiation functions

HIQA has an Expert Advisory Group (EAG) to advise on its medical exposure to ionising radiation functions. This standing EAG includes representatives from patient organisations, regulators and key professional bodies. The EAG is responsible for reviewing the available evidence about practices and making a recommendation to HIQA about whether the practices should be generically justified. Please click here to see the current members of the Expert Advisory Group and terms of reference for this group.

See list of applications for generic justification currently in progress:

Published reports on the justification of practices involving medical exposure to ionising radiation

Following consideration of the evidence and the recommendation of its Medical Exposure to Ionising Radiation Expert Advisory Group, HIQA has issued decisions with respect to the following types and classes of practice:

Practice

Decision

Date Effective

Underpinning evidence

¹⁷⁷Lu oxodotreotide for the treatment of metastatic or inoperable gastroenteropancreatic neuroendocrine tumours (GEP-NETs

Generically justified

20 April 2023

Report

Infographic

A slot-scanning, biplanar, digital X-ray imaging system for the evaluation and monitoring of orthopaedic conditions

Generically justified

10 July 2023

Report

Infographic

Ultra-hypofractionated adjuvant radiotherapy for breast cancer

Generically justified 

16 November 2023

Report

Infographic

¹⁸F-prostate-specific membrane antigen (PSMA) PET/CT imaging for the staging of high-risk or recurrent prostate cancer

Generically justified 

15 December 2023

Report

Infographic

¹⁷⁷Lutetium PSMA radioligand therapy for the treatment of metastatic castrate-resistant prostate cancer

Generically justified 

18 April 2024

Report

Infographic

See below details of information events held by HIQA

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You can download the presentation slides which accompany this webinar.

  • Generic Justification Application Form

    Download

  • Methods for Generic Justification

    Download