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 here 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 01 828 6700.
See information on HIQA's EAG which advises on medical exposure to ionising radiation functions
HIQA has convened an new Expert Advisory Group (EAG) to advise on medical exposure to ionising radiation functions. This EAG includes representatives from patient organisations, regulators and key professional bodies. The EAG will be 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. The dates for the EAG meetings in 2023 are:
- Thursday, 23rd February at 2pm
- Thursday, 1st June at 2pm
- Thursday, 19th October at 2pm
See list of applications for generic justification currently in progress:
• ¹⁸F-prostate-specific membrane antigen (PSMA) PET/CT imaging for the staging of high-risk or recurrent prostate cancer.
• ¹⁷⁷Lu-prostate-specific membrane antigen (PSMA) therapy for the treatment of metastatic, castrate-resistant prostate cancer.
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 |
A slot-scanning, biplanar, digital X-ray imaging system for the evaluation and monitoring of orthopaedic conditions
|
Generically justified |
10 July 2023 |
See below details of information events held by HIQA
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You can download the presentation slides which accompany this webinar.
Contact us by email: radiationjustification@hiqa.ie