Data Sharing Agreements#
A Data Sharing Agreement (DSA) is a document between two institutions before sharing medical data, for ensuring legal compliance, protecting patient privacy and data security, and clearly defining the terms and conditions of the data sharing arrangement, which are particularly critical when handling sensitive medical data.
Templates of Data Sharing Agreements#
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Privacy and Confidentiality: Medical data often contains sensitive personal information. A data sharing agreement ensures that both parties adhere to strict confidentiality protocols to protect patient privacy in compliance with laws like HIPAA (Health Insurance Portability and Accountability Act) in the United States, GDPR (General Data Protection Regulation) in the European Union, and other local data protection regulations.
Legal Compliance: The agreement ensures that both institutions comply with relevant laws and regulations regarding the handling, storage, and transmission of medical data. This includes adherence to patient consent requirements and other legal obligations.
Data Security: The agreement outlines measures to secure data against unauthorized access, breaches, and other security risks. It specifies the responsibilities of each party in maintaining data security.
Data Use and Limitations: The agreement clearly defines how the shared data can be used, including the scope of research or analysis and any limitations on data usage. This prevents misuse of data and ensures that it is used only for agreed-upon purposes.
Data Integrity and Quality: Ensuring the accuracy and quality of the shared data is essential. The agreement can include provisions about the standards and procedures for data collection, processing, and storage to maintain data integrity.
Intellectual Property Rights: The agreement addresses the ownership of any intellectual property that may arise from the data analysis or research, protecting the interests of both parties.
Responsibility and Accountability: Clearly defining the roles and responsibilities of each institution in managing and utilizing the data helps in maintaining accountability. This includes provisions for handling data errors, omissions, and corrections.
Dispute Resolution: In case of disagreements or breaches of the agreement, it outlines the mechanisms for resolution, ensuring a structured approach to handling disputes.
Termination and Data Disposal: The agreement should specify the conditions under which the data sharing can be terminated and outline the procedures for safe and compliant disposal or return of the data.
Transparency and Trust: Establishing a formal agreement fosters a transparent and trusting relationship between the institutions, facilitating smoother collaboration and data sharing.
The data sharing agreement ought to undergo scrutiny by the legal departments of both institutions involved. It is important that the agreement be formally endorsed by the legal representatives of the respective institutions, rather than at the individual researcher level.
Schulthess Klinik, Zürich, Switzerland
The Data Sharing Agreement of the Schulthess Klinik can be downloaded here.