The Fundraiser's Transfer of Personal Data from the European Union to the United States in Context of Crowdfunding Activities

European start-up companies must overcome more ‘transfer hurdles’ when personal data is transferred from the European Union to the US (United States of America) as part of crowdfunding campaign activities. Transfer of personal data is commonly not associated with (small scale) crowdfunding activities. However, the strict rules of the EU GDPR (European General Data Protection Regulation) on safeguarding personal data apply to all companies when data is transferred from the EU to the US - regardless the size of the business. This article identifies exchange of personal data that takes place between primarily fundraiser and crowdfunding service provider in different steps of fundraising campaigns. The framework for rewardbased crowdfunding for goods production that is provided by the US based Indiegogo platform is used as example and context. The article highlights by way of example the obligations that must be met by European fundraisers as "data controllers" when personal data is transferred to Indiegogo. No easy solutions are provided by either European Union or national data protection authorities on how to establish an adequate level of personal data protection. Paradigms on how to secure transfer of personal data to third countries are available in form of so-called standard contractual clauses, but still conditions for transfer of personal data from Europe to the US are hard to comply with. Apart from entering into an inter partes agreement on use of standard contractual clauses with the crowdfunding platform provider, a European fundraiser must furthermore make a so-called "transfer impact assessment" to ensure that third party access to personal data is avoided. In the case of transfer of personal data from the EU to the US the fundraiser must consider using encryption of data as a "supplementary measure" to block third party access. Encryption of data is however not suitable for exchange of data in a dynamic crowdfunding campaign so other means for protection of data must be found and applied. The reason and explanation for making data transfers from the EU to the US that hard for e.g., fundraisers are thus to be found at interstate level in the relation between the EU and the US. According to EU law, more specifically the GDPR and several of the provision of the Charter of Fundamental Rights of the European Union, US security legislation authorises a disproportionate access for US intelligence services to citizens' personal data. A solution on manageable transfer of personal data from the EU to the US may be found before the end of 2022, since a new TADP (Trans-Atlantic Data Privacy Framework) is currently being negotiated between EU and US at top politician level. However, the implementation of the TADP may take som time since the EU legislative framework needs adjustments to make the new transfer possibilities operational

Thresholds for Oxford Knee Score after total knee replacement surgery:a novel approach to post-operative evaluation

Abstract Background In a prospective cohort study, we wanted to detect thresholds distinguishing between patients with a satisfactory and an unsatisfactory outcome after total knee replacement (TKR) based on Patient-Reported Outcome Measures (PROMs), namely the Oxford Knee Score (OKS), using patient satisfaction and patient-perceived function as global transition items. Methods Seventy-three TKR patients completed the OKS questionnaire before surgery and were invited to complete the same questionnaire again 6 (4 to 9) months after surgery. Correlations between outcome measures and anchors were calculated using Pearson’s correlation coefficient. Thresholds were established by receiver operating characteristics (ROC) analysis, using multiple anchor-based approaches. Results Patients showed a mean increase of 16.5 (SD 9.5) in OKS following TKR. Significant positive correlations were found between outcome measures and anchors. Six different thresholds were determined for outcome measures coupled with satisfaction, patient-perceived function and a combination thereof using a cut-off of 50 and 70. Conclusions This study has established a set of clinically meaningful thresholds for Oxford Knee scores that may help to detect TKR patients who might be in need of post-operative evaluation

Thresholds for the Oxford Hip Score after total hip replacement surgery:a novel approach to postoperative evaluation

Abstract Background This is a prospective cohort study to define the thresholds to distinguish patients with a satisfactory or unsatisfactory outcome after total hip replacement (THR) based on patient-reported outcome measures (PROMs) including the Oxford Hip Score (OHS), and using patient satisfaction and patient-perceived function as global transition items. The thresholds are intended to be used as a tool in the process of determining which patients are in need of postoperative outpatient evaluation. Methods One hundred and three THR patients who had completed a preoperative questionnaire containing the OHS questionnaire were invited to complete the same questionnaire and supplementary questions at a mean of 6 (4–9) months after surgery. Correlations between outcome measures and anchors were calculated using Pearson’s correlation coefficient. Thresholds were established by receiver operating characteristic (ROC) analysis, using multiple anchors. Results Significant correlations were found between outcome measures and anchors. Thresholds were determined for outcome measures coupled with satisfaction, patient-perceived function and a combination thereof using a cut-off of 50 and 70. Conclusions We have established a set of thresholds for Oxford scores that may help determine which THR patients are in need of postoperative evaluation. These thresholds can be implemented in clinical practice. Level of evidence Level 3