conditions and (NBA, Hospital) forecast and secure indications. sufficient product supply. (NBA, Hospital, Authoriser,) NBA - 3 Indication Indication The indication Providing transparency The linkage of specific Risk to assessing Use Transparent to – for which of the specific indication and incorrect dose and some users of system treatment is indication relating to condition to clinical infusion plan at (see security matrix). being requested the condition requiring outcome data and authorisation resulting No disclosure other treatment is a critical prescribed treatment in potential ineffective than at level of element needed for is essential for clinical outcome, aggregated reports accurate Authorisation building the evidence inappropriate product for clinical of proposed patient base and determining and dose/schedule of governance and Ig treatment (dose, the efficacy of Ig treatment, determining governance purposes. frequency and treatment. efficacy of treatment treatment schedule). and inability to demand (NBA, Hospital) This is different for forecast and secure different conditions sufficient product and indications. supply. (NBA, Hospital, Authoriser,) NBA - 3
conditions and indications. (NBA, Hospital, Authoriser,) NBA - 3 (NBA, Hospital) forecast and secure sufficient product supply. Indication Indication The indication for which treatment is being requested Providing transparency of the specific indication relating to the condition requiring treatment is a critical element needed for accurate Authorisation of proposed patient treatment (dose, frequency and treatment schedule). This is different for different conditions and indications. (NBA, Hospital, Authoriser,) NBA - 3 The linkage of specific indication and condition to clinical outcome data and prescribed treatment is essential for building the evidence base and determining the efficacy of Ig treatment. (NBA, Hospital) Risk to assessing incorrect dose and infusion plan at authorisation resulting in potential ineffective clinical outcome, inappropriate product and dose/schedule of treatment, determining efficacy of treatment and inability to demand forecast and secure sufficient product supply. Use – Transparent to some users of system (see security matrix). No disclosure other than at level of aggregated reports for clinical governance and Ig governance purposes.
ig-gov-and-system-privacy-impact-assesmt-rprt.DOCX