Biomedical Imaging and Instrumentation

11.

Regulatory and Ethical Considerations

11.1.

Medical Device Regulation

11.1.1.

Regulatory Bodies

11.1.1.1.

11.1.1.1.1.

Device Classification

11.1.1.1.2.

Approval Pathways

11.1.1.1.2.1.

510(k) Clearance

11.1.1.1.2.2.

Premarket Approval

11.1.1.1.2.3.

De Novo Classification

11.1.1.2.

11.1.1.2.1.

11.1.1.2.2.

Medical Device Regulation

11.1.1.2.3.

Notified Bodies

11.1.1.3.

Other International Bodies

11.1.1.3.1.

11.1.1.3.2.

11.1.1.3.3.

11.1.2.

Quality Management Systems

11.1.2.1.

11.1.2.2.

Design Controls

11.1.2.3.

Risk Management

11.1.2.3.1.

11.1.2.3.2.

11.1.2.3.3.

11.1.3.

Clinical Evaluation

11.1.3.1.

Clinical Trials

11.1.3.2.

Post-Market Surveillance

11.1.3.3.

Adverse Event Reporting

11.2.

Quality Assurance and Quality Control

11.2.1.

Equipment Performance

11.2.1.1.

Acceptance Testing

11.2.1.2.

11.2.1.3.

Performance Specifications

11.2.2.

Routine Quality Control

11.2.2.1.

11.2.2.2.

Periodic Testing

11.2.2.3.

Preventive Maintenance

11.2.3.

Calibration Procedures

11.2.3.1.

Calibration Standards

11.2.3.2.

11.2.3.3.

Calibration Intervals

11.2.4.

Documentation and Record Keeping

11.2.4.1.

Standard Operating Procedures

11.2.4.2.

Quality Control Records

11.2.4.3.

11.3.

Radiation Safety and Protection

11.3.1.

Radiation Protection Principles

11.3.1.1.

ALARA Principle

11.3.1.2.

11.3.1.3.

11.3.2.

11.3.2.1.

Personal Dosimeters

11.3.2.1.1.

11.3.2.1.2.

11.3.2.1.3.

Electronic Dosimeters

11.3.2.2.

Area Monitoring

11.3.2.2.1.

11.3.2.2.2.

11.3.3.

Shielding and Protection

11.3.3.1.

Structural Shielding

11.3.3.2.

Personal Protective Equipment

11.3.3.3.

Administrative Controls

11.3.4.

Regulatory Compliance

11.3.4.1.

Radiation Safety Programs

11.3.4.2.

License Requirements

11.3.4.3.

Inspection and Enforcement

11.4.

Patient Safety and Privacy

11.4.1.

11.4.1.1.

Risk Assessment

11.4.1.2.

Incident Reporting

11.4.1.3.

11.4.2.

Data Privacy and Security

11.4.2.1.

HIPAA Compliance

11.4.2.2.

Data Encryption

11.4.2.3.

Access Controls

11.4.3.

Informed Consent

11.4.3.1.

Risk Communication

11.4.3.2.

Consent Documentation

11.4.3.3.

Special Populations

11.4.4.

Medical Error Prevention

11.4.4.1.

Human Factors Engineering

11.4.4.2.

Fail-Safe Design

11.4.4.3.

Error Reporting Systems

11.5.

Ethical Issues in Medical Imaging

11.5.1.

Research Ethics

11.5.1.1.

Institutional Review Boards

11.5.1.2.

Vulnerable Populations

11.5.1.3.

International Guidelines

11.5.2.

Clinical Ethics

11.5.2.1.

Incidental Findings

11.5.2.2.

11.5.2.3.

Resource Allocation

11.5.3.

Technology Ethics

11.5.3.1.

Artificial Intelligence Bias

11.5.3.2.

Algorithmic Transparency

11.5.3.3.

Equity of Access

11.5.4.

Professional Responsibilities

11.5.4.1.

Competency Requirements

11.5.4.2.

Continuing Education

11.5.4.3.

Professional Standards

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10. Advanced Topics and Applications

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1. Fundamentals of Biomedical Engineering