S.L. 585.1 Art. 65Justification.

(1) Medical exposure shall show a sufficient net benefit, weighing the total potential diagnostic or therapeutic benefits it produces, including the direct benefits to health of an individual and the benefits to society, against the individual detriment that the exposure might cause, taking into account the efficacy, benefits and risks of available alternative techniques having the same objective but involving no or less exposure to ionising radiation.

(2) Undertakings shall apply the justification principle defined in sub-regulation (1) is applied and in particular that:

(a) It is ensured that both the referrer and the practitioner shall make reference to referral guidelines.

(b) Undertakings inform and supply supporting justification documentation to the Commission in advance of that undertaking adopting any new types of practices involving medical exposure.

(c) All individual medical exposures are to be justified in advance by a practitioner taking into account the specific objectives of the exposure and the characteristics of the individual involved. where appropriate, in special circumstances, to be evaluated by a practitioner on a case-by-case basis and documented for practices involving medical exposure that are not justified in general.

(e) The referrer and the practitioner, shall seek, to obtain previous diagnostic information or medical records relevant to the planned exposure and consider these data to avoid unnecessary exposure. Repeat of medical exposure is not justified if the diagnostic information is already available.

(f) For the justification of any medical exposure for medical or biomedical research undertakings shall obtain clearance from the Commission. Prior to the Commission issuing clearance for any medical exposure for medical or biomedical research the undertakings shall provide confirmation that they have obtained clearance from the ethics committee.

(g) Undertakings shall obtain clearance from the Commission before any type of health screening is performed. The Commission shall seek advice from any appropriate medical scientific societies and health regulatory bodies and shall make reference to any available internationally accepted justification norms for screening.

(h) The exposure of carers and comforters shall show a sufficient net benefit, taking into account the direct health benefits to a patient, the possible benefits to the carer / comforter and the detriment that the exposure might cause.

(i) Medical radiological procedure for the early detection of disease on an asymptomatic individual can only be performed if it is:

(i) part of a health screening programme, or

(ii) requires specific documented justification for that individual by the practitioner, in consultation with the referrer, following guidelines from relevant medical scientific societies and the Commission.

Special attention shall be given to the provision of information to the individual subject to medical exposure, as required by paragraph

(e) of regulation 68.

(3) Referrers shall as part of the justification process:

(a) ensure and document that the medical exposure of the patient is warranted based on the medical indications;

(b) make reference to referral criteria; clinical details;

(d) state on each individual referral the clinical question to be answered;

(e) where practical, seek, to obtain previous diagnostic information or medical records relevant to the planned exposure and consider this data to avoid unnecessary exposure; and

(f) seek the outcome of the exposure and act on the result.