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1. Parties: Identification of the disclosing party (medical facility/professional) and receiving party, including their legal status and contact details
2. Background: Context of the agreement, relationship between parties, and purpose of sharing medical information
3. Definitions: Detailed definitions including 'Confidential Information', 'Medical Data', 'Personal Data', 'Processing', 'Security Breach', and other relevant terms
4. Scope of Confidential Information: Specific description of what constitutes confidential medical information under the agreement
5. Confidentiality Obligations: Core obligations regarding non-disclosure, permitted uses, and security measures
6. Data Protection Compliance: GDPR and BDSG compliance requirements, including legal basis for processing and data subject rights
7. Security Measures: Required technical and organizational measures for protecting confidential medical information
8. Permitted Disclosures: Circumstances under which disclosure is permitted (legal requirements, court orders, etc.)
9. Breach Notification: Procedures and timeframes for reporting any breaches or unauthorized disclosures
10. Return or Destruction of Information: Requirements for handling confidential information upon termination
11. Term and Termination: Duration of the agreement and termination provisions
12. Remedies: Legal consequences of breach, including injunctive relief and damages
13. General Provisions: Standard clauses including governing law, jurisdiction, and entire agreement
1. Transfer to Third Countries: Required when confidential information may be transferred outside the EU/EEA
2. Subcontractor Provisions: Needed when the receiving party may engage subcontractors to process confidential information
3. Insurance Requirements: Optional section specifying required insurance coverage for data protection incidents
4. Audit Rights: Optional provisions allowing the disclosing party to audit compliance
5. Special Categories of Data: Required when dealing with specific types of sensitive medical data (genetic, biometric data)
6. Research Use Provisions: Required when confidential information may be used for research purposes
7. Professional Standards Compliance: Required when involving specific medical professional groups with additional regulatory requirements
1. Schedule 1 - Security Measures: Detailed technical and organizational security measures required for protecting the confidential information
2. Schedule 2 - Authorized Personnel: List of authorized personnel who may access the confidential information
3. Schedule 3 - Data Processing Agreement: GDPR-compliant data processing terms when applicable
4. Schedule 4 - Information Classification Guide: Guidelines for categorizing different types of medical information and their handling requirements
5. Schedule 5 - Breach Response Protocol: Detailed procedures for responding to and reporting security breaches
6. Appendix A - Contact Details: Contact information for key personnel responsible for data protection and breach notification
Healthcare
Medical Technology
Pharmaceuticals
Biotechnology
Medical Research
Health Insurance
Medical Devices
Healthcare IT
Clinical Research
Medical Education
Telemedicine
Digital Health
Laboratory Services
Legal
Compliance
Data Protection
Medical Records
Research & Development
Information Technology
Clinical Operations
Quality Assurance
Medical Affairs
Information Security
Healthcare Operations
Risk Management
Ethics Committee
Clinical Research
Medical Director
Data Protection Officer
Clinical Research Coordinator
Healthcare Compliance Manager
Medical Information Officer
Chief Medical Officer
Healthcare IT Manager
Medical Research Director
Clinical Trial Manager
Medical Records Administrator
Healthcare Privacy Officer
Medical Software Developer
Healthcare Project Manager
Medical Device Specialist
Clinical Data Manager
Medical Quality Assurance Manager
Healthcare Operations Director
Medical Ethics Officer
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