Patient Patient The patient for Mandatory Provides transparency Transparency Risk to patient safety if Use Transparent to – which regarding the patient supports confirmation incorrect patient some users of system treatment is relevant to the request. that correct patient record has been (see security matrix). being record has been accessed and/or (NBA, Hospital, Disclosure - No requested. accessed for data inability to support Authoriser) disclosure other than entry and review of verbal conversation at level of authorisation when required to aggregated request. confirm qualifying/ reports. review criteria, NBA - 3 (Authoriser, NBA) regarding details of clinical condition/response, dose or product with prescriber. Collection of A list of Provides transparency Transparency also Reduced rigor and Use Transparent to – Previous previous of previous treatments supports validation of quality of both some users of system Treatments treatments that that are relevant to future product authorisation requests (see security matrix). the medical ongoing patient selections and and authorisation Disclosure - No officer deems management. Data reduces likelihood of outcome. disclosure other than important (or supports planning of duplicate treatments Increased risk of at level of may be future authorisation being requested or duplicate authorisation aggregated required) to requests, clinical authorised from requests for same reports. disclose in the review of current and different patient being authorisation future treatments, prescribers/hospitals. authorised request. assessment of clinical (Hospital, Authoriser, concurrently. outcome, timing of NBA) cessations of therapy
Patient Patient The patient for which treatment is being requested. Mandatory Provides transparency regarding the patient relevant to the request. (NBA, Hospital, Authoriser) NBA - 3 Transparency supports confirmation that correct patient record has been accessed for data entry and review of authorisation request. (Authoriser, NBA) Risk to patient safety if incorrect patient record has been accessed and/or inability to support verbal conversation when required to confirm qualifying/ review criteria, regarding details of clinical condition/response, dose or product with prescriber. Use – Transparent to some users of system (see security matrix). Disclosure - No disclosure other than at level of aggregated reports. Collection of Previous Treatments A list of previous treatments that the medical officer deems important (or may be required) to disclose in the authorisation request. Provides transparency of previous treatments that are relevant to ongoing patient management. Data supports planning of future authorisation requests, clinical review of current and future treatments, assessment of clinical outcome, timing of cessations of therapy Transparency also supports validation of future product selections and reduces likelihood of duplicate treatments being requested or authorised from different prescribers/hospitals. (Hospital, Authoriser, NBA) Reduced rigor and quality of both authorisation requests and authorisation outcome. Increased risk of duplicate authorisation requests for same patient being authorised concurrently. Use – Transparent to some users of system (see security matrix). Disclosure - No disclosure other than at level of aggregated reports.