HIPAA9 min read

HIPAA Privacy Rule Requirements

The HIPAA Privacy Rule establishes standards for protecting the privacy of Protected Health Information (PHI). While the Security Rule focuses on electronic safeguards, the Privacy Rule governs how PHI can be used and disclosed, and establishes patient rights.

For technology companies operating as business associates, understanding the Privacy Rule helps you handle PHI appropriately and meet your contractual obligations.

Key Takeaways

Aspect Details
Purpose Establish standards for PHI use, disclosure, and patient rights
Applies to All forms of PHI (paper, electronic, oral)
Core principle Minimum necessary: use only the PHI needed
Patient rights Access, amendment, accounting of disclosures, restrictions
Business associates Must use PHI only as permitted by BAA

Quick Answer: The Privacy Rule defines when and how PHI can be used or shared. For business associates, the key requirements are: only use PHI as permitted by your Business Associate Agreement, apply the minimum necessary standard, help covered entities respond to patient rights requests, and report unauthorized uses or disclosures.

Privacy Rule Overview

The Privacy Rule establishes:

  1. When PHI can be used and disclosed
  2. Patient rights regarding their PHI
  3. Administrative requirements for covered entities
  4. Requirements for business associates

What PHI Does the Privacy Rule Cover?

The Privacy Rule protects PHI in any form:

  • Paper records
  • Electronic records (also covered by Security Rule)
  • Oral communications

The Security Rule specifically addresses electronic PHI (ePHI), while the Privacy Rule covers all PHI regardless of format.

Permitted Uses and Disclosures

The Privacy Rule defines when PHI can be used (internal operations) or disclosed (shared externally).

Uses and Disclosures Without Authorization

PHI can be used or disclosed without patient authorization for:

Purpose Description
Treatment Providing, coordinating, or managing healthcare
Payment Billing, claims management, collection activities
Healthcare Operations Quality assessment, training, business management
As required by law Court orders, law enforcement, public health reporting
Public health activities Disease prevention, FDA reporting
Abuse, neglect, domestic violence Reporting to appropriate authorities
Health oversight activities Audits, investigations, inspections
Judicial and administrative proceedings Court orders, subpoenas
Law enforcement purposes Specific law enforcement requests
Research With appropriate approvals or waivers
Serious threat to health or safety Preventing or lessening serious threats
Essential government functions Military, national security, protective services
Workers' compensation As authorized by workers' compensation laws

Uses and Disclosures Requiring Authorization

Patient authorization is required for:

  • Marketing communications
  • Sale of PHI
  • Psychotherapy notes (with exceptions)
  • Uses not listed above

The Minimum Necessary Standard

A core Privacy Rule principle: use or disclose only the minimum PHI necessary to accomplish the intended purpose.

This means:

  • Limit PHI access to workforce members who need it
  • Develop policies identifying who needs access to what
  • Limit PHI in requests to what's necessary
  • Limit PHI in disclosures to what's requested and needed

Exceptions to minimum necessary:

  • Disclosures to healthcare providers for treatment
  • Disclosures to the individual
  • Uses or disclosures authorized by the individual
  • Disclosures required by law
  • Disclosures to HHS for compliance investigations

What This Means for Business Associates

As a business associate, you:

  • Can only use PHI as permitted by your BAA
  • Must apply minimum necessary to your operations
  • Cannot use PHI for purposes beyond the BAA scope
  • Must return or destroy PHI when the BAA terminates (if feasible)

Patient Rights Under the Privacy Rule

The Privacy Rule establishes six patient rights. Covered entities must honor these rights, and business associates may need to support covered entities in responding.

1. Right to Access

Patients have the right to access and obtain copies of their PHI.

Requirement Details
Timeline 30 days (one 30-day extension permitted)
Format Electronic copy if maintained electronically and patient requests it
Fees Limited to cost of copying (labor, supplies, postage)
Denials Limited circumstances; must provide written denial and appeal process

Business associate implications:

  • May need to provide PHI to covered entity to fulfill access requests
  • Should have processes to respond to access requests quickly
  • Consider APIs or export features for covered entities

2. Right to Amendment

Patients can request amendments to their PHI.

Requirement Details
Timeline 60 days (one 30-day extension permitted)
Denial permitted If PHI is accurate/complete, not created by you, or not accessible to patient
If denied Must allow patient to submit statement of disagreement

Business associate implications:

  • May need to amend PHI at covered entity's direction
  • Maintain audit trails of amendments
  • Propagate amendments to those who received the original

3. Right to Accounting of Disclosures

Patients can request an accounting of disclosures of their PHI.

Requirement Details
Period Disclosures in the 6 years prior to request
Exceptions Treatment, payment, healthcare operations, and others
Contents Date, recipient, description, purpose

Business associate implications:

  • Track disclosures you make (outside treatment, payment, operations)
  • Provide disclosure information to covered entity upon request
  • Maintain records for 6 years

4. Right to Request Restrictions

Patients can request restrictions on uses and disclosures.

Requirement Details
Covered entity obligation Not required to agree (with one exception)
Exception Must agree to restrict disclosures to health plan for services paid out-of-pocket in full
If agreed Must honor the restriction

Business associate implications:

  • Honor restrictions communicated by covered entity
  • Implement mechanisms to flag restricted PHI

5. Right to Confidential Communications

Patients can request communications through alternative means or at alternative locations.

Requirement Details
Example Send appointment reminders to work email instead of home
Covered entity obligation Must accommodate reasonable requests

Business associate implications:

  • Support communication preferences in your platform
  • Allow covered entities to configure communication channels

6. Right to Receive Breach Notification

Patients have the right to be notified of breaches affecting their PHI.

Requirement Details
Timeline Within 60 days of breach discovery
Contents Description of breach, types of PHI involved, steps to protect, what you're doing
Format First-class mail (or email if patient agreed)

Business associate implications:

  • Report breaches to covered entity promptly
  • Provide information needed for notification
  • Potentially assist with notification logistics

Business Associate Privacy Requirements

As a business associate, the Privacy Rule requires you to:

1. Use PHI Only as Permitted by BAA

Your Business Associate Agreement defines how you can use PHI. Typical permitted uses include:

  • Performing services specified in the underlying service agreement
  • Proper management and administration of your organization
  • Fulfilling legal responsibilities
  • Providing data aggregation services (if specified)

2. Implement Appropriate Safeguards

You must implement safeguards to prevent uses or disclosures not permitted by your BAA. This includes:

  • Technical safeguards (access controls, encryption)
  • Administrative safeguards (policies, training)
  • Physical safeguards (facility security)

The Security Rule provides detailed requirements for ePHI.

3. Report Unauthorized Uses or Disclosures

You must report to the covered entity:

  • Any use or disclosure not permitted by the BAA
  • Any security incident (successful or unsuccessful attacks)
  • Any breach of unsecured PHI

4. Ensure Subcontractors Comply

If you use subcontractors who access PHI:

  • Obtain BAAs with each subcontractor
  • Ensure subcontractors implement appropriate safeguards
  • You remain responsible for subcontractor compliance

5. Make PHI Available for Patient Rights

Support covered entities in fulfilling patient rights:

  • Provide PHI for access requests
  • Amend PHI as directed
  • Provide disclosure accounting information

6. Return or Destroy PHI at Termination

When the BAA ends:

  • Return PHI to covered entity, or
  • Destroy PHI, or
  • If neither is feasible, retain with continued protections

Privacy Rule vs Security Rule

Aspect Privacy Rule Security Rule
Scope All PHI (paper, electronic, oral) Electronic PHI only
Focus How PHI can be used and disclosed How ePHI must be protected
Patient rights Establishes patient rights Does not address patient rights
Safeguards Requires "appropriate" safeguards Specifies administrative, physical, technical safeguards
Flexibility Provides flexibility in implementation More detailed specifications

Both rules apply to ePHI. The Privacy Rule governs use and disclosure; the Security Rule governs protection.

Common Privacy Rule Scenarios

Scenario 1: Customer Requests Feature Using PHI

Question: A healthcare customer asks you to use PHI in your platform to build a new analytics feature.

Privacy Rule answer: Check your BAA. You can only use PHI for purposes permitted by the BAA. If analytics is not covered:

  • Amend the BAA to include the new use, or
  • Obtain patient authorizations, or
  • De-identify the data (remove all 18 identifiers)

Scenario 2: Subcontractor Needs PHI Access

Question: You want to use a third-party tool that would process PHI.

Privacy Rule answer: You must:

  • Execute a BAA with the subcontractor
  • Ensure they implement appropriate safeguards
  • Limit their access to minimum necessary

Scenario 3: Law Enforcement Request

Question: Law enforcement requests PHI about a specific patient.

Privacy Rule answer: You should not respond directly. Refer the request to the covered entity, who can evaluate whether disclosure is permitted. Document the request.

Scenario 4: Employee Accesses PHI Inappropriately

Question: An employee accessed PHI without a legitimate work reason.

Privacy Rule answer: This is an unauthorized access:

  • Investigate the scope
  • Determine if it's a reportable breach
  • Report to covered entity
  • Apply sanctions per your sanction policy

Implementing Privacy Rule Requirements

Step 1: Map Your PHI

Document:

  • What PHI you receive
  • How it flows through your systems
  • Who has access
  • What you do with it
  • How long you retain it

Step 2: Review Your BAA

Ensure your BAA clearly defines:

  • Permitted uses and disclosures
  • Your obligations
  • Subcontractor requirements
  • Breach notification requirements
  • Termination procedures

Step 3: Implement Minimum Necessary

  • Implement role-based access control
  • Limit access to workforce members who need it
  • Log and monitor PHI access
  • Regular access reviews

Step 4: Support Patient Rights

Build capabilities to support covered entities:

  • Data export functionality
  • Amendment tracking
  • Disclosure logging
  • Access request workflows

Step 5: Train Your Workforce

Ensure all workforce members understand:

  • What PHI is
  • Permitted and prohibited uses
  • Minimum necessary principle
  • How to handle PHI appropriately
  • How to report concerns

Privacy Rule Checklist for Business Associates

  • BAA in place with all covered entities
  • PHI use limited to BAA-permitted purposes
  • Minimum necessary implemented
  • Subcontractor BAAs in place
  • Unauthorized disclosure reporting process
  • Breach notification process
  • Patient rights support capabilities
  • Workforce training completed
  • PHI return/destruction process for BAA termination
  • Documentation maintained

How Bastion Helps

Bastion helps technology companies meet Privacy Rule requirements:

  • BAA review and development: Ensure your agreements include required provisions
  • Privacy program development: Policies and procedures for PHI handling
  • Minimum necessary implementation: Access control and data handling guidance
  • Workforce training: Privacy awareness training for your team
  • Patient rights support: Guidance on supporting covered entity obligations

Ready to discuss your Privacy Rule compliance? Talk to our team


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