Week 7: HIPAA Resources
Essential tools, templates, and resources for maintaining HIPAA compliance in biotechnology
Compliance Checklists
Comprehensive checklists for Privacy Rule, Security Rule, and Breach Notification requirements specific to biotech operations.
Template Library
Ready-to-use templates for Business Associate Agreements, Privacy Notices, and Risk Assessment forms.
Regulatory Updates
Stay current with the latest HIPAA enforcement trends, OCR guidance, and regulatory changes affecting biotech.
Case Studies
Real-world examples of HIPAA compliance challenges and solutions in biotechnology research and development.
Assessment Tools
Interactive tools to evaluate your compliance status and identify areas for improvement.
Training Materials
Downloadable training materials, presentations, and educational resources for your team.
Quick Reference Guide
Key HIPAA Dates
- HIPAA Enacted: August 21, 1996
- Privacy Rule Effective: April 14, 2003
- Security Rule Effective: April 21, 2005
- HITECH Act: February 17, 2009
- Omnibus Rule: March 26, 2013
Important Deadlines
- Access Requests: 30 days (+ 30 day extension)
- Breach Notification: 60 days to HHS, 60 days to individuals
- Amendment Response: 60 days
- Complaint Response: 180 days from incident
Entity Types
- Covered Entities: Health plans, healthcare clearinghouses, healthcare providers
- Business Associates: Entities performing functions involving PHI
- Hybrid Entities: Organizations with both covered and non-covered functions
Patient Rights
- Right of Access to PHI
- Right to Request Amendments
- Right to Accounting of Disclosures
- Right to Request Restrictions
- Right to Confidential Communications
18 HIPAA Identifiers
- Names
- Geographic subdivisions smaller than state
- Dates (except year)
- Telephone numbers
- Fax numbers
- Email addresses
- Social Security numbers
- Medical record numbers
- Health plan beneficiary numbers
- Account numbers
- Certificate/license numbers
- Vehicle identifiers
- Device identifiers
- Web URLs
- IP addresses
- Biometric identifiers
- Full-face photos
- Any other unique identifying number
Common Violations
- Failure to provide timely access
- Impermissible disclosures
- Inadequate safeguards
- Failure to enter BAAs
- Insufficient breach response
- Lack of workforce training