Week 7: HIPAA Training
Comprehensive HIPAA compliance training specifically designed for biotechnology professionals
What You'll Learn
🔍 HIPAA Fundamentals
- Understanding HIPAA's purpose and scope
- Key definitions: PHI, covered entities, business associates
- The Privacy Rule vs. Security Rule distinctions
- HITECH Act modifications and enforcement
🏢 Entity Classification
- Covered entity determination for biotech companies
- Business associate relationships and obligations
- Hybrid entity designations and implications
- When biotech firms fall outside HIPAA scope
👥 Patient Rights
- Right of access and timely response requirements
- Amendment requests and correction procedures
- Accounting of disclosures and record keeping
- Restriction requests and confidential communications
🔬 Research Applications
- PHI use in clinical trials and research studies
- IRB waivers and authorization requirements
- Data de-identification techniques and standards
- Limited data sets and Data Use Agreements
📋 Compliance Framework
- Business Associate Agreements (BAAs) essentials
- Minimum necessary standards implementation
- Notice of Privacy Practices requirements
- Workforce training and sanctions
⚖️ Enforcement & Best Practices
- OCR enforcement trends and case studies
- Penalty structures and violation consequences
- Breach notification requirements
- Strategic compliance for biotech innovation
⏱️
Duration
Comprehensive 45-minute training
🎯
Focus
Biotech-specific HIPAA applications
📚
Coverage
50+ key concepts and regulations
🏆
Certification
Quiz completion certificate
Essential Topics Covered
TPO Disclosures
Treatment, Payment, and Operations - when authorization isn't required
Minimum Necessary Standard
Using only the minimum PHI required for specific purposes
18 HIPAA Identifiers
Complete list of identifiers that must be removed for de-identification
Clinical Trial Compliance
Special considerations for research studies and sponsor relationships
BAA Requirements
Essential elements of Business Associate Agreements
Enforcement Trends
OCR's Right of Access Initiative and recent penalty cases