Remarks A high response to in this question indicates that respondents do not have any ‘No’ concerns with the assumptions. Of the responders, 27 provided comments which indicate they were seeking ‘Yes’ further clarification on the assumptions including the definitions on facility types and therefore do not indicate significant concern with the assumptions. Further comments raise concern around the logistics of gaining consent and registering to access the Ig System in order to prescribe. For the purposes of this survey the for the patient is made up 4 System record” “Ig of identifying information including: name, sex and date of birth; past and present IVIg/SCIg authorisation requests; previous treatments relevant to an authorisation; treatment duration and review; treating medical specialist details; medical condition and indication; patient characteristics (weight); dosage, product and reason for product choice as well as do not prescribe advisories. It may also include: particular infusions and reactions to those infusions. Additionally, the outcomes of Immunoglobulin Therapy will be captured at each review for the purpose of assessing efficacy and continuing access to Immunoglobulin Therapy. IMPORTANT NOTE: the Ig System record is not a copy of the patient’s medical record nor is it a clinical registry. It is therefore important to understand that in many scenarios the Ig System is unlikely contain more detailed information about the patient than the patient record at the hospital/facility at which they're receiving treatment. Do you have any comments to make on the proposed make-up of the 'Ig System record'?
Remarks A high response to ‘No’ in this question indicates that respondents do not have any concerns with the assumptions. Of the ‘Yes’ responders, 27 provided comments which indicate they were seeking further clarification on the assumptions including the definitions on facility types and therefore do not indicate significant concern with the assumptions. Further comments raise concern around the logistics of gaining consent and registering to access the Ig System in order to prescribe. 4 For the purposes of this survey the “Ig System record” for the patient is made up of identifying information including: name, sex and date of birth; past and present IVIg/SCIg authorisation requests; previous treatments relevant to an authorisation; treatment duration and review; treating medical specialist details; medical condition and indication; patient characteristics (weight); dosage, product and reason for product choice as well as do not prescribe advisories. It may also include: particular infusions and reactions to those infusions. Additionally, the outcomes of Immunoglobulin Therapy will be captured at each review for the purpose of assessing efficacy and continuing access to Immunoglobulin Therapy. IMPORTANT NOTE: the Ig System record is not a copy of the patient’s medical record nor is it a clinical registry. It is therefore important to understand that in many scenarios the Ig System is unlikely contain more detailed information about the patient than the patient record at the hospital/facility at which they're receiving treatment. Do you have any comments to make on the proposed make-up of the 'Ig System record'?
ig-gov-and-system-privacy-impact-assesmt-rprt.DOCX