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SOPs-omics-data-exchange.md

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Standard Operating Procedures for omics data exchange

  • GDPR rules: Ensure data security through encryption, access controls, and anonymization to safeguard individual privacy in all data exchanges, including image data. Maintain detailed documentation to guarantee compliance with GDPR regulations and protect privacy throughout all activities related to data handling.
  • Notification protocols to inform about any access or exchange: Define clear procedures to notify relevant participants in case of data access or exchange, ensuring everyone is informed and follows the correct procedures.
  • Consent Management: Development of procedures for obtaining patient consent for the exchange of diverse health data types. Establishing consent preferences for different data modalities, ensuring compliance with patient choices.
  • Data Governance and Oversight: Establishment of governance structures to oversee the exchange process, ensuring compliance with regulations and organizational policies. Defined roles and responsibilities for entities involved in managing diverse health data.
  • Data Integrity and Validation: Implement robust protocols for ensuring the accuracy and completeness of data before and after exchanges, including checks for data integrity and error-free transfers.
  • Regular Cybersecurity Training: Conduct routine cybersecurity awareness training for all personnel involved in data exchange, ensuring adherence to best practices for data protection and minimizing human error.
  • Cybersecurity Risk Assessments: Regularly perform risk assessments to identify potential cybersecurity threats and vulnerabilities within the data exchange process, ensuring proactive protection measures.
  • Rename files so that any patient data are concealed: Prioritize data confidentiality by implementing a systematic and secure approach to file renaming, ensuring compliance with privacy standards and safeguarding patient information.
  • GA4GH standards: Data exchange standards and frameworks for omics data, provide essential guidelines for secure and interoperable data sharing.
  • Long-Term Data Storage and Retention Policies: Define policies for the long-term storage, retention, and disposal of data, ensuring compliance with relevant legal and ethical guidelines.
  • Data Format Standardization: Establish a standard for omic file formats (e.g., FASTQ, SAM/BAM/CRAM, and VCF) to ensure compatibility and consistency across different systems while maintaining data integrity during exchange.