View Justification of practices 

The Health Information and Quality Authority (HIQA) is now taking applications for the generic justification of new practices involving medical exposure to ionising radiation. Generic justification considers the overall potential for benefit, as well as the potential for harm of a new practice (for example, a new X-ray technology).

HIQA will compare the new practice with existing options, taking into account the amount of ionising radiation to which patients will be exposed.

Generic justification is important for patient safety as it aims to safeguard the use of radiation across the healthcare sector. It does this by considering the evidence on the safety and effectiveness of a new type or class of practice before that practice can be generally adopted or used on a day-to-day basis for patients. 

From today, hospitals and service providers in the public and private sectors who wish to offer a new practice using ionising radiation in Ireland must apply to HIQA for generic justification before they can offer the practice on a routine basis.

Dr Patricia Harrington, Deputy Director of Health Technology Assessment, said: “The commencement of HIQA’s role in generic justification is a key part of safeguarding patients undergoing medical exposures to ionising radiation. HIQA’s decisions will be guided by the evidence about the safety and effectiveness of practices compared with the available alternatives.  

Dr Harrington continues: “HIQA will also evaluate existing practices if new and important information becomes available about the effectiveness or the safety of that practice or about alternative practices that could replace it.”

HIQA will be supported in its role by its Medical Exposure to Ionising Radiation Expert Advisory Group (EAG). This group is composed of experts in ionising radiation from key professional bodies in Ireland, independent experts as well as representatives of patient organisations, and regulatory authorities and key professional bodies. The EAG has an independent chairperson, Professor Mary Coffey. 

If you would like to apply for generic justification or you have any queries please see www.hiqa.ie for further information.

Ends.

For further information please contact:

Marty Whelan, Head of Communications & Stakeholder Engagement
01 814 7480/085 805 5202, mwhelan@hiqa.ie 

Notes to editor:

• Regulations are in place which transposed the EU Council Basic Safety Standards (BSS) Directive of 2013 into Irish law. Under the law, HIQA is the competent authority for patient protection in relation to medical exposure to ionising radiation in Ireland and has responsibility for the generic justification of new practices involving medical exposure in advance of these being generally adopted. 
• Ionising radiation is commonly used in medical treatment and diagnosis, such as when X-rays are used to diagnose broken bones or when radiation is used to treat cancer. The safe use of ionising radiation in medicine in Ireland has been regulated by HIQA since January 2019. HIQA is responsible for the regulation of all medical and dental providers of ionising radiation, in both the public and private sector. 
• Please see our Methods Document for further information.