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Medical Non Disclosure Agreement
"I need a Medical Non-Disclosure Agreement under Irish law for a clinical research collaboration between our hospital and a pharmaceutical company, with specific provisions for handling patient data and research findings from our upcoming clinical trial starting in March 2025."
1. Parties: Identification of the disclosing party (typically healthcare provider, medical research organization, or medical device company) and receiving party, including full legal names and addresses
2. Background: Context of the agreement, explaining the medical nature of the relationship and why confidential information needs to be shared
3. Definitions: Key terms including 'Confidential Information' (specifically defining medical data, patient information, research data, etc.), 'Permitted Purpose', 'Representatives', and other relevant terms
4. Scope of Confidential Information: Detailed description of what constitutes confidential medical information, including patient data, medical records, research findings, clinical trial data, etc.
5. Obligations of Confidentiality: Core confidentiality obligations, including GDPR and Irish medical data protection requirements
6. Permitted Uses and Disclosures: Specific circumstances under which the confidential medical information may be used or disclosed
7. Security Measures: Required security protocols for handling medical data, including digital security measures and physical safeguards
8. Return or Destruction of Confidential Information: Procedures for returning or destroying confidential medical information upon agreement termination
9. Term and Termination: Duration of the agreement and circumstances for termination
10. Breach and Remedies: Consequences of breach, including specific provisions for medical data breaches and mandatory reporting
11. General Provisions: Standard clauses including governing law (Irish law), jurisdiction, entire agreement, etc.
1. Data Processing Agreement Provisions: Required when the receiving party will be processing personal health data as a data processor under GDPR
2. Research Protocol Compliance: Required when the NDA relates to medical research activities
3. Third Party Access: Include when other parties (such as regulatory authorities or ethics committees) may need access to the information
4. International Transfer Provisions: Required when medical data may be transferred outside the EEA
5. Insurance Requirements: Include when handling particularly sensitive medical data or high-risk information
6. Subcontractor Provisions: Include when the receiving party may need to engage subcontractors to handle the medical information
1. Schedule 1 - Specified Confidential Information: Detailed list of types of medical information covered by the agreement
2. Schedule 2 - Security Requirements: Specific technical and organizational measures required for data protection
3. Schedule 3 - Authorized Representatives: List of individuals authorized to access the confidential medical information
4. Appendix A - Data Processing Terms: GDPR-compliant data processing terms if applicable
5. Appendix B - Information Security Standards: Detailed security protocols and standards for handling medical data
Authors
Healthcare
Pharmaceuticals
Medical Devices
Biotechnology
Health Technology
Medical Research
Clinical Trials
Healthcare Insurance
Medical Diagnostics
Digital Health
Life Sciences
Legal
Compliance
Medical Affairs
Research and Development
Clinical Operations
Data Protection
Information Security
Healthcare Operations
Quality Assurance
Regulatory Affairs
Medical Information
Clinical Data Management
Medical Director
Clinical Research Manager
Healthcare Data Protection Officer
Medical Research Coordinator
Chief Medical Officer
Healthcare Compliance Officer
Clinical Trial Administrator
Medical Technology Officer
Healthcare Legal Counsel
Medical Information Manager
Healthcare Project Manager
Medical Device Development Manager
Healthcare Operations Director
Clinical Data Manager
Medical Affairs Director
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