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Data Disclosure Agreement
I need a Data Disclosure Agreement for sharing clinical trial data between our Danish pharmaceutical company and a research institution in Copenhagen, with strict GDPR compliance and specific provisions for handling sensitive health data, to be implemented by March 2025.
1. Parties: Identification of the data discloser and recipient, including registered addresses and company registration numbers
2. Background: Context of the data sharing relationship and purpose of the agreement
3. Definitions: Key terms used throughout the agreement, including specific data types, processing activities, and technical terminology
4. Scope and Purpose: Detailed description of the data to be disclosed and permitted purposes for its use
5. Data Protection Obligations: GDPR and Danish law compliance requirements, including lawful basis for processing and data protection principles
6. Security Measures: Technical and organizational measures required to protect the disclosed data
7. Confidentiality: Obligations regarding maintaining confidentiality of the disclosed data
8. Data Subject Rights: Procedures for handling data subject requests and ensuring data subject rights
9. Breach Notification: Procedures and timeframes for reporting data breaches
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 Danish law application and jurisdiction for disputes
1. International Data Transfers: Required when data will be transferred outside the EU/EEA, including transfer mechanisms and safeguards
2. Sub-processors: Include when the recipient may engage third parties to process the disclosed data
3. Audit Rights: Include when regular audits of data handling practices are required
4. Insurance Requirements: Include when specific insurance coverage for data protection is required
5. Data Protection Impact Assessment: Include when processing activities require DPIA under GDPR
6. Special Categories of Data: Include when sensitive personal data or criminal records are involved
7. Intellectual Property Rights: Include when the disclosed data includes or may generate intellectual property
8. Competition Law Compliance: Include when shared data might have competition law implications
1. Schedule 1 - Categories of Data: Detailed list of data types, formats, and categories being disclosed
2. Schedule 2 - Technical and Security Requirements: Specific security measures, protocols, and standards to be implemented
3. Schedule 3 - Transfer Mechanisms: Details of data transfer methods and related security measures
4. Schedule 4 - Contact Points: List of key contacts for operational, technical, and legal matters
5. Schedule 5 - Processing Activities: Detailed description of all processing activities to be performed
6. Appendix A - Data Processing Agreement: Standard DPA terms if required under GDPR
7. Appendix B - Standard Contractual Clauses: EU SCCs if required for international transfers
8. Appendix C - Security Breach Response Plan: Detailed procedures for handling and reporting data breaches
Authors
Financial Services
Healthcare
Technology
Research and Development
Manufacturing
Professional Services
Public Sector
Education
Telecommunications
Biotechnology
Energy
Retail
Insurance
Pharmaceuticals
Consulting
Legal
Compliance
Information Security
Data Protection
IT
Risk Management
Operations
Research & Development
Business Development
Information Governance
Privacy
Regulatory Affairs
Corporate Governance
Technology
Data Protection Officer
Chief Privacy Officer
Legal Counsel
Compliance Manager
Information Security Manager
Chief Information Security Officer
Risk Manager
IT Director
Chief Technology Officer
Research Director
Project Manager
Business Development Manager
Operations Manager
Chief Legal Officer
Data Protection Manager
Privacy Analyst
Information Governance Manager
Regulatory Compliance Officer
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