Document is current

Article History

Received: 17 May 2022

Accepted: 30 March 2023

First Online: 15 May 2023

Declarations

:

: This was a retrospective analysis of anonymised medical claims data and electronic health records collected during routine clinical practice. The Decision Resources Group Real-World Evidence Data Repository US database (Clarivate) is a commercially available database. Clarivate has a robust user access management program which governs the process of administering access to individual users within a system so that they have appropriate access at the right time. This process utilises many standards and practices that have administrative safeguards implemented, including but not limited to, encryption, requiring resources to complete training modules regarding handling de-identified data before provisioning access to such data, applying a minimum necessary standard to those who have access, implementing access controls and multiple approval workflows that authorise access to our de-identified data. Our systems are designed to comply with applicable international laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA) in the US. According to the US HIPAA Privacy Rule, there are no restrictions on the use or disclosure of de-identified health information by covered entities. Claims and her data were linked by a HIPAA-compliant encrypted participant key generated by a third party. Ethics committee/institutional review board approval and informed consent were therefore not sought for this analysis due to the use of de-identified data. All methods were performed in accordance with the relevant guidelines.

: Not applicable.

: Not applicable.