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Regulatory Considerations When Deploying your Software in a Clinical Environment
Published in Johan Helmenkamp, Robert Bujila, Gavin Poludniowski, Diagnostic Radiology Physics with MATLAB®, 2020
Philip S. Cosgriff, Johan Åtting
Pseudonymization is the separation of data from direct identifiers so that linkage to an identity is not possible without additional information that is held separately (a key). For example, if radiology images are sent for external review to another healthcare facility, that receiving healthcare facility might not need to know the identity of the patients. In that case, data elements that could identify the individual can be removed (unless they are needed for the review), and instead a reference number can be assigned that can only be linked to a patient identity by the sending healthcare facility. Using pseudonymization reduces the risk of a confidentiality breach but will not make the data anonymized. The regulations still apply to pseudonymized data sets, but it is a good protection mechanism.
Medical research
Published in Marc Stauch, Kay Wheat, Text, Cases and Materials on Medical Law and Ethics, 2018
Elsewhere the Regulation distinguishes between anonymisation and pseudonymisation of personal data. Whereas anonymous data – which is not reasonably linkable back to the data subject – falls outside the scope of the Regulation, pseudonymous data remains personal. However, pseudonymisation means that it is stored in a way that subjects can no longer be identified without the use of additional information, and that information is stored separately (and the organisation has taken technical and organisational measures to ensure this separation) (Article 4(3b)). According to the ‘data-minimisation’ principle (Article 5(1)(c)) the personal data processing must be ‘limited’ (ie not excessive) by reference to the processing purpose. This requires that the purpose aimed at cannot be achieved by processing less personal data: in this regard, the onus will be on the researcher to show (if it be the case) that achieving the research purpose requires use of identifying rather than pseudonymised (or, better still, anonymous), data.
Informatics and The Law
Published in Alexander Peck, Clark’s Essential PACS, RIS and Imaging Informatics, 2017
4 Anonymous. To make information anonymous, it must be unidentifiable and detached from the source and this is achieved at different levels: Anonymisation converts the information into a form where it is difficult to identify the source individual; within radiology this is typically done by removing demographic information from DICOM files.Pseudonymisation leaves information traceable to source but only by those holding the contextual data – widely used for clinical trials.Deidentification is the highest level of detachment; deidentification removes both visible and non-visible clues as to the origin; this may for radiology imaging include selective depth blurring or pixilation of distinctive anatomical features, such as the face on CT head studies – preventing high-resolution CT scans from ‘giving away’ otherwise anonymised data sets.
Treatment Exit Options for Non-infectious Uveitis (TOFU): Study Protocol for a Prospective Clinical Registry
Published in Ophthalmic Epidemiology, 2022
Jeany Q. Li, Carsten Heinz, Jennifer Dell, Matthias Schmid, Robert P. Finger
The TOFU registry is led by a steering committee and advised by a scientific advisory board. The registry is physically hosted on the servers of the clinical site Bonn (Studienzentrum Bonn, SZB). The majority of participating sites are member of the European Vision Clinical Research Network (EVICR.net). Standard operating procedures (SOP) are implemented at all participating sites. Registry specific procedures such as data entry are outlined in additional TOFU SOPs and a TOFU registry manual. Data are entered at study sites through a web-based interface into electronic case report forms (eCRF) implemented in RedCap (Version 9, Vanderbilt University, USA). The eCRF was developed by the coordinating sites in collaboration with the participating sites and in alignment with the uveitis dataset by the Royal College of Ophthalmologist’s (RCOpht).25 Entered data are pseudonymous with the pseudonymisation key remaining at the respective study site. All sites are initiated and trained prior to patient enrolment.
Purchase of prophylactic topical corticosteroids is associated with improved survival in NSCLCs treated with EGFR TKI: real-world cohort study
Published in Acta Oncologica, 2021
Virve Alanen, Sanna Iivanainen, Martti Arffman, Jussi P. Koivunen
We collected all the patients who had received entitlement to special reimbursement for EGFR TKIs (gefitinib, erlotinib, and afatinib) in the Special Reimbursement Register of the Social Insurance Institution (SII) of Finland in 2011–16 (n = 1541). In Finland, reimbursement for gefitinib and afatinib is based on the advanced disease and the presence of activating tumor EGFR mutations. On the other hand, the reimbursement for erlotinib is available for patients in an advanced disease setting with either 1) progression on first-line chemotherapy or 2) tumors with the EGFR-activating mutations. With erlotinib, the patients are registered under the same reimbursement number and cannot be separated by the mutational status. Furthermore, the registries do not include information on the treatment line. Drug purchases (date of purchase, strength, and number of purchased units) from the prescription database of SII, cancer data from the Finnish Cancer Registry (FCR), and dates of death from Statistics Finland were linked using personal identity codes. Pseudonymization was carried out before the data analysis. Finally, patients having purchases for EGFR TKIs and data available at FCR (n = 1271) were included in the study. Due to the adjustments, the cohort had only missing information for some of the patients for the primary stage (21.2%). The formation of the cohort is described in more detail in our previous publication [20].
The role of physical activity promotion in typical exercise therapy concepts: a latent class analysis based on a national survey in German rehabilitation settings
Published in Disability and Rehabilitation, 2020
Gorden Sudeck, Wolfgang Geidl, Judith Deprins, Klaus Pfeifer
Furthermore, potential selection effects with regard to the recruited departments are difficult to assess. Overall, the response rate was satisfactory at over 50%. It is important to note that we have used strict pseudonymization, so that respondents did not have to fear that their information would be available to the cost provider, for example. However, the selection effect is more likely to lead to an overestimation of the dissemination of theoretically sound, evidence-based concepts for the promotion of physical activity. For this reason, the percentages given for the frequency of the typical exercise therapy concepts should be viewed with caution. Finally, classification approaches do not definitively answer the question of how many subgroups exist. The number of classes depends on the number of variables chosen [38]. We therefore applied EFA in advance of the latent class analysis to reduce the complexity of the information on the content and methods of exercise therapy. This should facilitate an understanding of general patterns within the conceptual orientations of exercise therapy departments.