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Data Disclosure Agreement
"I need a Data Disclosure Agreement under German law for sharing clinical trial data with a research institution in Munich, with specific provisions for handling sensitive medical data and compliance with healthcare regulations, to be effective from March 2025."
1. Parties: Identification of the data discloser and recipient, including full legal names, registration details, and addresses
2. Background: Context of the agreement, purpose of data disclosure, and relationship between the parties
3. Definitions: Detailed definitions of key terms including 'Confidential Information', 'Personal Data', 'Processing', 'Technical Data' and other relevant terms
4. Scope and Purpose of Data Disclosure: Detailed description of what data will be disclosed and the specific permitted purposes for its use
5. Data Protection Obligations: GDPR and BDSG compliance requirements, including legal basis for processing, data subject rights, and security measures
6. Confidentiality Obligations: Obligations regarding data confidentiality, permitted uses, and protection requirements
7. Technical and Organizational Measures: Required security measures for data protection, including specific GDPR Article 32 requirements
8. Data Transfer and Processing: Rules for data handling, including any international transfers and sub-processor requirements
9. Breach Notification: Procedures and timelines for reporting data breaches or security incidents
10. Term and Termination: Duration of the agreement and conditions for termination
11. Return or Destruction of Data: Obligations regarding data handling upon termination
12. Liability and Indemnification: Allocation of risks and responsibilities between parties
13. Governing Law and Jurisdiction: Specification of German law application and jurisdiction for disputes
1. Audit Rights: Optional section for when regular auditing of data handling practices is required, particularly relevant for sensitive data or regulated industries
2. Insurance Requirements: Optional section specifying required insurance coverage, relevant for high-risk data processing activities
3. Data Transfer to Third Countries: Required when data may be transferred outside the EU/EEA, including Standard Contractual Clauses
4. Specific Industry Compliance: Additional requirements for specific industries (e.g., healthcare, financial services)
5. Sub-processor Management: Detailed procedures for appointing and managing sub-processors, relevant when sub-processing is anticipated
6. Joint Controller Provisions: Required when parties act as joint controllers under GDPR Article 26
7. Service Levels: Optional section defining performance metrics and standards for data handling
1. Schedule 1: Description of Data Processing: Detailed description of data categories, processing purposes, and data subjects
2. Schedule 2: Technical and Organizational Measures: Detailed specification of security measures and controls
3. Schedule 3: Authorized Sub-processors: List of approved sub-processors and their roles, if applicable
4. Schedule 4: Transfer Mechanisms: Details of mechanisms for international data transfers, including SCCs if needed
5. Schedule 5: Contact Points: List of key contacts for operational, technical, and legal matters
6. Appendix A: Data Fields and Categories: Specific listing of data fields and categories to be disclosed
7. Appendix B: Standard Contractual Clauses: EU SCCs if required for international transfers
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Data Protection Officer
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