Master HIPAA Compliance - Healthcare Data Protection

1. Privacy Rule (45 CFR Parts 160 & 164 Subpart E)

Effective April 14, 2003 - Establishes national standards protecting individually identifiable health information held by covered entities and business associates.

• Notice of Privacy Practices: Written notice explaining PHI use/disclosure, readily available to patients
• Patient Rights: Access records (30 days), amend records, accounting of disclosures
• Permitted Uses: Treatment, payment, healthcare operations (TPO), court orders, public health, research, law enforcement
• Minimum Necessary Standard: Only share minimum PHI needed for stated purpose
• Enforcement: OCR enforces; penalties $100-$50,000 per violation, $1.5M annual maximum

2. Security Rule (45 CFR Part 164 Subparts A & C)

Protects ePHI confidentiality, integrity, and availability through specific administrative, physical, and technical safeguards.

• Administrative Safeguards (9 standards): Security policies, staff training, security official designation, risk assessments
• Physical Safeguards (4 standards): Facility access controls, workstation security, device/media controls
• Technical Safeguards (5 standards): Access control, audit logs, integrity controls, authentication, transmission security
• Required vs Addressable: Must implement Required specs; assess and document Addressable specs
• Formal Risk Analysis Required: Must identify vulnerabilities/threats before implementing safeguards

3. Breach Notification Rule

60-day notification timeline for impermissible use, access, or disclosure of unsecured PHI that compromises security or privacy.

• Notify Individuals: Within 60 days of breach discovery, as quickly as possible
• Notify HHS: <500 people = annual report within 60 days of year-end; 500+ people = within 60 days of discovery
• Media Notification: Required for breaches affecting 500+ residents of a state/jurisdiction
• Three Exceptions: (1) Unintentional access by authorized employee, (2) Accidental disclosure between authorized persons, (3) Reasonable belief recipient won't retain/compromise data
• Business Associate Duty: Notify covered entity within 60 days with identification of affected individuals

4. Omnibus Rule / HITECH Act (2013)

Released January 17, 2013; Effective March 26, 2013 - Strengthened privacy/security protections and made business associates directly liable for HIPAA compliance.

• BA Direct Liability: Business associates now face independent audits and fines from HHS (previously only covered entities were liable)
• Extended PHI Protections: Marketing, fundraising, sold data, genetic information, student immunization records, ePHI
• Breach Notification Change: Threshold shifted from 500+ records to ANY unauthorized PHI access under Privacy Rule
• Clarified Scope: Encompasses health information exchanges, personal health records through EHR systems
• Consolidated 4 Rules: Implemented provisions from HITECH Act, ARRA 2009, and GINA

5. Minimum Necessary Rule

Limit PHI sharing to only what's essential for completing a task - ensuring complete medical records aren't disclosed when partial information suffices.

• Six Exceptions: (1) Healthcare providers requesting for treatment, (2) Patients requesting own records, (3) Valid patient authorization, (4) HIPAA Transactions Rule compliance, (5) HHS investigations, (6) Law requires disclosure
• Access Policies: Identify roles needing PHI access, specify categories required, document conditions
• Disclosure Policies: Document processes for limiting PHI in responses, establish criteria, review each request
• Implementation: Discover/classify PHI, include sanctions, train employees, develop role-based permissions, monitor access with audit logs
• Example: Lab staff process blood work with ID/billing info only, not test results; only ordering physician sees complete results

Administrative Safeguards (9 Standards)

Focus on "administrative actions to protect ePHI" through policies, procedures, and organizational structures.

1. Security Management Process

• Risk Analysis: Identify threats/vulnerabilities (Required)
• Risk Management: Implement security measures (Required)
• Sanction Policy: Enforce workforce violations (Required)
• Information System Activity Review: Monitor logs/reports (Required)

2. Assigned Security Responsibility

• Security Official: Designate compliance officer (Required)
• Clear assignment of security responsibilities
• Authority to develop and implement policies

3. Workforce Security

• Authorization/Supervision: Implement procedures (Addressable)
• Workforce Clearance: Determine access authorization (Addressable)
• Termination Procedures: End access upon termination (Addressable)

4. Information Access Management

• Isolating Healthcare Clearinghouse: If applicable (Required)
• Access Authorization: Grant appropriate access (Addressable)
• Access Establishment/Modification: Manage permissions (Addressable)

5. Security Awareness & Training

• Security Training Program: All workforce (Required)
• Security Reminders: Periodic updates (Addressable)
• Protection from Malware: Detection/reporting (Addressable)
• Log-in Monitoring: Track login attempts (Addressable)
• Password Management: Creation/change procedures (Addressable)

6. Security Incident Procedures

• Response and Reporting: Identify, respond, report (Required)
• Incident identification protocols
• Documentation and tracking procedures

7. Contingency Plan

• Data Backup Plan: Exact copy of ePHI (Required)
• Disaster Recovery Plan: Restore data (Required)
• Emergency Mode Operation: Continue operations (Required)
• Testing/Revision: Verify effectiveness (Addressable)
• Applications Criticality Analysis: Assess data criticality (Addressable)

8. Evaluation

• Periodic Assessments: Technical/non-technical evaluations (Required)
• Document safeguard effectiveness
• Conduct in response to environmental/operational changes

9. Business Associate Contracts

• Written Contract/Arrangement: BA must satisfy safeguards (Required)
• Ensure BA implements appropriate safeguards
• Document BA compliance responsibilities

Physical Safeguards (4 Standards)

Address "physical access and storage of PHI" to protect facilities, workstations, and devices.

1. Facility Access Controls

• Contingency Operations: Restore access post-emergency (Addressable)
• Facility Security Plan: Safeguard facility/equipment (Addressable)
• Access Control/Validation: Control facility access (Addressable)
• Maintenance Records: Document repairs/modifications (Addressable)
• ID badge requirements, visitor logs, locked entry points

2. Workstation Use

• Functions/Manner/Surroundings: Specify workstation functions (Required)
• Define how functions are performed
• Determine physical attributes of surroundings
• Screen visibility controls, proper positioning

3. Workstation Security

• Physical Safeguards: Restrict unauthorized access (Required)
• Implement appropriate policies/procedures
• Locked screens, cable locks, secure areas

4. Device and Media Controls

• Disposal: Final disposition procedures (Required)
• Media Re-use: Remove ePHI before re-use (Required)
• Accountability: Track hardware/media movements (Addressable)
• Data Backup/Storage: Exact retrievable copy (Addressable)
• Secure destruction (shredding, wiping, degaussing)

Technical Safeguards (5 Standards)

Concern "technologies that store and access ePHI" through technological controls.

1. Access Control

• Unique User Identification: Assign unique name/number (Required)
• Emergency Access Procedure: Access during crisis (Required)
• Automatic Logoff: Terminate session after inactivity (Addressable)
• Encryption/Decryption: Encrypt ePHI (Addressable but recommended)

2. Audit Controls

• Record/Examine Activity: Hardware, software, procedures (Required)
• Access control and monitoring systems
• Audit logs tracking who accessed what/when
• Regular review of audit trails

3. Integrity

• Mechanism to Authenticate: ePHI not improperly altered/destroyed (Addressable)
• Implement integrity controls
• Prevent improper alteration or destruction
• Digital signatures, checksums, version control

4. Person or Entity Authentication

• Verify Identity: Procedures to verify person/entity (Required)
• Multi-factor authentication (MFA)
• Biometric verification systems
• Password + token/SMS/app authentication

5. Transmission Security

• Integrity Controls: Ensure data not improperly modified (Addressable)
• Encryption: Encrypt transmitted ePHI (Addressable but recommended)
• SSL/TLS for data in transit
• VPNs for secure remote access
• Secure email encryption

Tier 1: Unknown Violation

• Culpability: Entity did not know and could not have known of violation
• Penalty Range: $100 - $50,000 per violation
• Annual Maximum: $1.5 million per violation type
• Example: Technical error causing unintentional PHI disclosure despite reasonable safeguards

Tier 2: Reasonable Cause

• Culpability: Violation due to reasonable cause, not willful neglect
• Penalty Range: $1,000 - $50,000 per violation
• Annual Maximum: $1.5 million per violation type
• Example: Inadequate access controls despite good faith effort

Tier 3: Willful Neglect (Corrected)

• Culpability: Violation due to willful neglect but corrected within 30 days
• Penalty Range: $10,000 - $50,000 per violation
• Annual Maximum: $1.5 million per violation type
• Example: Known security gap left unaddressed then fixed after discovery

Tier 4: Willful Neglect (Not Corrected)

• Culpability: Violation due to willful neglect, not corrected within 30 days
• Penalty Range: $50,000 per violation (mandatory minimum)
• Annual Maximum: $1.5 million per violation type
• Example: Persistent failure to implement required safeguards despite repeated warnings

Top 5 Most Expensive HIPAA Violations

• 1. Anthem Inc. (2015): $16 million - 78.8M records breached, inadequate risk analysis/encryption
• 2. Premera Blue Cross (2015): $6.85 million - 10.4M records, insufficient risk management
• 3. AvMed Inc. (2009): $5.5 million - Unencrypted laptops stolen from vehicle
• 4. Blue Cross Blue Shield of Tennessee (2012): $1.5 million - 1M records on unencrypted drives
• 5. New York Presbyterian & Columbia University (2014): $3.3 million combined - 6,800 patients, server incident

Recent 2025 Case

• Solara Medical Supplies LLC: $3 million settlement
• Breach affected undisclosed number of patients
• Highlights continued OCR enforcement in 2025
• Demonstrates importance of ongoing compliance

Common Violation Types

• 1. Inadequate Risk Analysis: Failure to identify all systems/threats
• 2. Insufficient Access Controls: Not implementing proper administrative restrictions
• 3. Lack of Encryption: Unencrypted devices/transmissions (addressable but recommended)
• 4. Improper Disposal: PHI not properly destroyed/wiped
• 5. Delayed Breach Notification: Missing 60-day notification timeline
• 6. Stale BAAs: Outdated agreements with vendors
• 7. Inadequate Training: Not ensuring 100% staff completion or annual refreshers

OCR Enforcement Process (6 Steps)

• Step 1: Complaint/Breach Notification - OCR receives complaint or breach report
• Step 2: Initial Review - OCR determines if complaint warrants investigation
• Step 3: Investigation - OCR requests documentation, conducts on-site reviews
• Step 4: Findings - OCR determines whether violation occurred
• Step 5: Resolution - Corrective action plan, settlement, or civil monetary penalty
• Step 6: Follow-up - OCR monitors corrective action implementation