Internal ERP Privacy Policy for Medical Imaging Research Equipment Manufacturing

Executive Summary

This Privacy Policy governs the collection, use, storage, and protection of personal data within our internal Enterprise Resource Planning (ERP) systems and related business operations. As a manufacturer of medical imaging research equipment, we are committed to protecting personal information while maintaining compliance with applicable privacy regulations and industry standards. Important Note: Our company and our equipment do not store, process, or handle patient data or protected health information (PHI).

1. Purpose and Scope

Policy Objectives

This policy establishes comprehensive data protection standards for all personal information processed within our internal systems, including employee data, vendor information, customer contacts, and operational data. The policy ensures compliance with applicable privacy laws while supporting our business operations as a medical device manufacturer.

Scope of Application

Internal Systems: All ERP modules, databases, and integrated business applications
Data Types: Employee personal information, vendor/supplier data, customer business contacts, operational data, and research datasets
Geographic Coverage: All company locations and cross-border data transfers
Personnel: All employees, contractors, vendors, and authorized system users

Explicit Exclusions: This policy does not apply to patient data or protected health information, as our company and equipment do not collect, store, or process such information.

2. Regulatory Framework and Compliance Requirements

Medical Device Manufacturing Compliance

As a medical imaging equipment manufacturer, we comply with:

FDA Section 524B Requirements: Cybersecurity plans and post-market vulnerability management
ISO 13485:2016: Quality management system requirements including document control and risk management
Export Control Regulations: EAR and ITAR compliance for technology and data transfers
Medical Device Reporting: Regulatory reporting requirements while maintaining data privacy

Privacy Law Compliance

California Consumer Privacy Act (CCPA/CPRA): Employee and business contact data protection
General Data Protection Regulation (GDPR): For EU employee data and international operations
State Privacy Laws: Virginia CDPA, Colorado CPA, Connecticut CTPA, and Utah UCPA
Federal Trade Commission Act: Section 5 unfair and deceptive practices prevention

Industry Standards Integration

ISO 27001/27002: Information security management systems
ISO 27701: Privacy information management system (PIMS)
NIST Privacy Framework: Structured approach to privacy risk management
DICOM Security Standards: For medical imaging data handling procedures

3. Data Classification and Handling

Personal Data Categories

Employee Data:

Identification information (name, address, social security number, employee ID)
Contact information (phone, email, emergency contacts)
Employment records (salary, benefits, performance evaluations, disciplinary actions)
Time and attendance records, payroll information
Training records and certifications
Health and safety information (occupational health records, workplace injury reports)

Business Contact Data:

Customer and vendor contact information
Marketing and sales data
Business relationship records
Communication logs and correspondence

Operational Data:

Manufacturing and production data
Quality control records
Supply chain information
Financial records and transactions
Intellectual property and proprietary information

Research and Development Data:

Non-patient research datasets
Algorithm development data
Product testing and validation information
Clinical trial administrative data (non-patient)

Data Processing Principles

Lawfulness: All processing based on legitimate legal grounds
Purpose Limitation: Data used only for specified, explicit, and legitimate purposes
Data Minimization: Collection limited to what is necessary and relevant
Accuracy: Data kept accurate and up-to-date with correction procedures
Storage Limitation: Retention only as long as necessary for stated purposes
Integrity and Confidentiality: Appropriate security measures implemented
Accountability: Demonstrated compliance with all privacy principles

4. Employee Rights and Procedures

Fundamental Employee Rights

Employees have the following rights regarding their personal information:

Right to Information: Employees receive clear notice about data collection, use, and sharing practices through this policy and supplementary notices.

Right of Access: Employees may request access to their personal data held in company systems. Requests must be submitted to [email protected] and will be fulfilled within 30 days.

Right to Rectification: Employees may request correction of inaccurate or incomplete personal information by contacting their manager or HR department.

Right to Erasure: In limited circumstances, employees may request deletion of personal data when it is no longer necessary for employment purposes and no legal retention requirements apply.

Right to Data Portability: Upon termination, employees may request their personal data in a portable format for transfer to new employers, subject to legal and practical limitations.

Right to Object: Employees may object to certain data processing activities, particularly for purposes beyond core employment obligations (e.g., optional benefit programs, non-essential monitoring).

Request Procedures

Submission Process:

Submit written requests to [email protected] or HR department
Include specific details about the request and data in question
Provide identity verification as required
Allow 30 days for processing (45 days for complex requests)

Response Framework:

Acknowledgment within 3 business days
Identity verification if required
Comprehensive response including requested information or explanation of denial
Appeal process for denied requests through Legal department

5. Access Controls and Security Measures

Role-Based Access Control (RBAC)

Access Management:

Principle of Least Privilege: Users granted minimum necessary access for job functions
Role-Based Permissions: Access rights aligned with job responsibilities and organizational hierarchy
Regular Access Reviews: Quarterly reviews of user permissions and access rights
Automated Deprovisioning: Immediate access removal upon role changes or termination

ERP-Specific Controls:

Module-Level Access: Granular permissions for different ERP modules (HR, Finance, Manufacturing, etc.)
Field-Level Security: Sensitive data fields restricted based on job requirements
Transaction Controls: Approval workflows and segregation of duties for critical transactions
Data Masking: Dynamic masking of sensitive information for non-authorized users

Technical Security Measures

Authentication and Authorization:

Multi-factor authentication (MFA) required for all ERP system access
Strong password policies with regular updates (90-day rotation)
Single sign-on (SSO) integration where technically feasible
Session management with automatic timeout after 30 minutes of inactivity

Encryption and Data Protection:

AES-256 encryption for data at rest
TLS 1.3 for data in transit
Database-level encryption for sensitive employee information
Secure backup procedures with encryption and offsite storage

Monitoring and Logging:

Comprehensive audit trails for all system access and data modifications
Real-time monitoring for suspicious activities and unauthorized access attempts
Automated security alerts and incident response procedures
Regular security assessments and penetration testing (annually)

Physical Security Controls

Secured server rooms with restricted access and environmental monitoring
Clean desk policy for workstations handling sensitive data
Secure disposal procedures for electronic media and printed materials
Facility access controls and visitor management procedures

6. Data Retention and Disposal

Retention Schedule

Employee Data:

Personnel files: 7 years after termination
I-9 forms: 3 years after hire date or 1 year after termination (whichever is longer)
Payroll records: 4 years from date of payment
Benefits records: 6 years for ERISA-covered plans
OSHA records: 5 years for workplace safety documentation
Medical records: 30 years for occupational health information
Performance evaluations: 4 years after separation
Disciplinary records: 4 years after separation

Business Data:

Customer contracts and correspondence: 7 years after contract termination
Vendor agreements: 7 years after relationship ends
Financial records: 7 years per tax and accounting requirements
Quality records: Per ISO 13485 requirements (minimum 5 years)
Regulatory submissions: Per FDA requirements (device lifetime + 2-10 years)

Research and Development Data:

Product development records: Life of product plus 7 years
Clinical trial data: 25 years or 2 years after device discontinuation
Intellectual property documentation: Life of IP protection plus 7 years
Regulatory correspondence: Per applicable regulations

Secure Disposal Procedures

Electronic Data:

DOD 5220.22-M standard wiping for hard drives
Cryptographic erasure for encrypted storage systems
Certificate of destruction for all disposal activities
Quarterly purge reviews and disposal execution

Physical Records:

Cross-cut shredding for all paper documents containing personal information
Witnessed destruction for highly sensitive materials
Incineration for special category documents
Chain of custody documentation for all disposal activities

Retention Compliance Monitoring

Automated retention rules in ERP systems where technically feasible
Manual review processes for complex retention requirements
Legal hold procedures to suspend disposal for litigation or investigations
Regular audits of retention compliance and disposal documentation

7. Data Sharing and Third-Party Management

Internal Data Sharing

Legitimate Business Purposes:

Employee data shared only with personnel having legitimate business need
Cross-departmental sharing governed by access controls and business justification
Management reporting limited to aggregate or anonymized data where possible
Clear documentation of data sharing purposes and recipients

External Data Sharing

Vendor and Service Provider Management:

Due diligence assessments for all service providers handling personal data
Data processing agreements (DPAs) with contractual privacy protections
Regular vendor security assessments and compliance monitoring
Business associate agreements (BAAs) when required for healthcare-related services

Regulatory and Legal Disclosures:

Compliance with lawful government requests and subpoenas
Regulatory reporting requirements balanced with privacy protection
Court order compliance with appropriate legal review
Employee notification when legally permissible

International Data Transfers

Cross-Border Transfer Safeguards:

Standard contractual clauses (SCCs) for GDPR compliance
Adequacy determinations or appropriate safeguards for all transfers
Data localization requirements compliance where applicable
Export control compliance for technical data and IP

8. Employee Training and Awareness

Comprehensive Training Program

All Employees:

Annual privacy awareness training covering company policies and legal requirements
Role-specific training based on data handling responsibilities
New employee onboarding with privacy policy acknowledgment
Regular updates on privacy law changes and policy modifications

Specialized Training:

HR Personnel: Advanced privacy law training, DSAR processing, vendor management
IT Staff: Technical privacy controls, incident response, security implementation
Management: Privacy impact of business decisions, accountability frameworks
Research Staff: Research data handling, collaboration agreements, IP protection

Training Documentation and Compliance

Training completion tracking with annual certification requirements
Assessment testing to verify comprehension and competency
Training records maintained for compliance auditing
Recognition programs for privacy compliance excellence

9. Incident Response and Breach Management

Incident Classification

Privacy Incidents:

Unauthorized access to personal data
Accidental disclosure or misdirected communications
Data processing outside policy parameters
System vulnerabilities affecting personal data

Security Breaches:

Confirmed unauthorized access by external parties
Malware or ransomware affecting personal data systems
Physical theft of devices containing personal data
Any incident posing risk of harm to data subjects

Response Procedures

Immediate Response (0-24 hours):

Incident containment and system isolation
Initial assessment of scope and potential impact
Notification to incident response team and senior management
Documentation of all response activities

Investigation and Assessment (1-72 hours):

Forensic investigation to determine root cause and scope
Risk assessment for affected individuals
Legal analysis of notification requirements
Preparation of regulatory notifications as required

Notification and Remediation:

Regulatory notifications within required timeframes (72 hours for GDPR)
Individual notifications when required by law or high risk determination
Credit monitoring or other remedial services as appropriate
System remediation and security improvements

Continuous Improvement

Post-incident reviews and lessons learned documentation
Policy and procedure updates based on incident findings
Staff training updates incorporating incident prevention measures
Regular testing of incident response procedures

10. Governance and Accountability

Privacy Governance Structure

Privacy Officer: Designated senior manager responsible for privacy program oversight, policy development, and regulatory compliance.

Privacy Committee: Cross-functional team including representatives from Legal, HR, IT, Quality, and Operations meeting quarterly to review privacy matters.

Management Oversight: Executive leadership commitment with regular reporting to senior management and board-level oversight.

Compliance Monitoring

Regular Audits:

Annual comprehensive privacy compliance audits
Quarterly access control reviews and user permission audits
Monthly review of data retention and disposal activities
Ongoing monitoring of vendor compliance and performance

Key Performance Indicators:

Privacy training completion rates (target: 100% annually)
Incident response times and resolution effectiveness
Data subject request response times (target: 95% within 30 days)
Vendor compliance assessment scores
Audit finding resolution timeframes

Policy Maintenance

Regular Reviews:

Annual policy review and update process
Quarterly legal and regulatory update assessments
Continuous monitoring of privacy law developments
Stakeholder feedback integration and policy improvements

Change Management:

Formal change control procedures for policy modifications
Impact assessment for all proposed changes
Employee communication and training for policy updates
Version control and historical documentation maintenance

11. Contact Information and Resources

Privacy Contacts

Privacy Officer: [email protected] | (555) 123-4567
HR Department: [email protected] | (555) 123-4568
Legal Department: [email protected] | (555) 123-4569
IT Security: [email protected] | (555) 123-4570

Employee Resources

Privacy Policy Questions: [email protected]
Data Subject Rights Requests: [email protected]
Privacy Incident Reporting: [email protected]
Training Materials: Available on company intranet

External Resources

Regulatory Authorities: State Attorney General offices, FTC, relevant data protection authorities
Industry Organizations: Medical Device Manufacturers Association, Healthcare Information Management Association
Legal Counsel: [Company Legal Counsel Contact Information]

12. Policy Effective Date and Acknowledgment

Effective Date: [Insert Date] Version: 1.0 Next Scheduled Review: [Insert Date + 1 Year]

Employee Acknowledgment: All employees must acknowledge receipt and understanding of this privacy policy annually. Acknowledgment constitutes agreement to comply with all policy requirements and procedures.

This privacy policy is designed to be a living document that evolves with changing regulations, business needs, and industry best practices. Regular review and updates ensure continued effectiveness and compliance.