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1. Parties: Identification of the disclosing party (medical institution/professional) and receiving party, including registration details and addresses
2. Background: Context of the agreement, nature of medical information to be shared, and purpose of disclosure
3. Definitions: Definitions of key terms including 'Confidential Information', 'Medical Data', 'Personal Data', 'Processing', 'Security Breach', and other relevant terms
4. Scope of Confidential Information: Detailed description of what constitutes confidential medical information, including patient data, research data, and derived information
5. Obligations of Confidentiality: Core confidentiality obligations, including handling, storage, and protection of medical information
6. Data Protection and GDPR Compliance: Specific provisions relating to GDPR and Dutch medical data protection requirements
7. Permitted Disclosures: Circumstances under which confidential information may be disclosed (e.g., legal requirements, regulatory obligations)
8. Security Measures: Required technical and organizational security measures for protecting medical information
9. Return or Destruction of Information: Obligations regarding the return or destruction of confidential information upon agreement termination
10. Term and Termination: Duration of the agreement and termination provisions
11. Breach and Consequences: Consequences of breaching the agreement, including notification requirements for data breaches
12. General Provisions: Standard clauses including governing law, jurisdiction, and entire agreement
1. Research Data Provisions: Additional provisions specifically for medical research data, used when the NDA covers research activities
2. International Transfer Provisions: Specific provisions for cross-border data transfers, required when medical data may be transferred outside the Netherlands
3. Audit Rights: Provisions allowing the disclosing party to audit the receiving party's compliance, recommended for high-sensitivity medical data
4. Insurance Requirements: Obligations to maintain specific insurance coverage, relevant for high-risk medical information
5. Sub-processor Provisions: Requirements for engaging sub-processors, needed when the receiving party may need to share data with third parties
6. Patient Consent Procedures: Specific procedures for handling patient consent, relevant when direct patient care is involved
7. Intellectual Property Rights: Provisions regarding IP rights in derived data or research findings, relevant for research contexts
1. Schedule 1 - Security Requirements: Detailed technical and organizational security measures required for protecting the medical information
2. Schedule 2 - Approved Sub-processors: List of pre-approved sub-processors and their specific roles (if applicable)
3. Schedule 3 - Data Processing Activities: Detailed description of permitted data processing activities and purposes
4. Schedule 4 - Contact Points: List of key contacts for security incidents, audits, and general communication
5. Appendix A - Data Categories: Detailed categorization of types of medical data covered by the agreement
6. Appendix B - Standard Operating Procedures: Procedures for handling specific types of medical information and security incidents
Healthcare
Pharmaceuticals
Biotechnology
Medical Devices
Healthcare Technology
Clinical Research
Healthcare Insurance
Medical Laboratory Services
Healthcare Consulting
Medical Education
Digital Health
Healthcare Data Analytics
Medical Waste Management
Healthcare Compliance
Legal
Compliance
Medical Affairs
Research and Development
Data Protection
Information Security
Clinical Operations
Quality Assurance
Regulatory Affairs
Healthcare Operations
Information Technology
Risk Management
Ethics Committee
Medical Records
Privacy Office
Medical Director
Chief Medical Officer
Healthcare Privacy Officer
Data Protection Officer
Clinical Research Coordinator
Medical Research Director
Healthcare Compliance Manager
Medical Information Officer
Healthcare IT Manager
Clinical Trial Manager
Medical Records Administrator
Healthcare Operations Manager
Medical Device Specialist
Healthcare Quality Manager
Medical Ethics Officer
Healthcare Legal Counsel
Medical Software Developer
Healthcare Security Officer
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