HIPAA

Requirements and controls

• 164.308 Administrative safeguards

  • 164.308(a)(1)(i) Security management process

    Implement policies and procedures to prevent, detect, contain and correct security violations.

    • Privacy by Design Policy
    • Automated Incident Reporting
    • Incident Management Policy & Procedure
    • Data Breach Notification Policy
    • Test Data Protection
    • Endpoint Security Policy
    • Unauthorized Activity Monitoring

  • 164.308(a)(1)(ii)(A) Risk analysis

    Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the covered entity or business associate.

    • Risk Framing
    • Risk Assessment Policy & Procedure
    • Vulnerability Management Policy & Procedure

  • 164.308(a)(1)(ii)(B) Risk management

    Implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with § 164.306(a). Factors identified in §164.306 include: · The size, complexity, capability of the covered entity; · The covered entity’s technical infrastructure; · The costs of security measures; and · The probability and criticality of potential risks to ePHI

    • Risk Framing
    • Risk Assessment Policy & Procedure
    • Personnel Screening

  • 164.308(a)(1)(ii)(C) Sanction policy

    Apply appropriate sanctions against workforce members who fail to comply with the security policies and procedures of the covered entity or business associate.

    • New Hire Policy Acknowledgement
    • Periodic Policy Acknowledgement
    • Publishing Security & Privacy Documentation
    • Information Security & Privacy Policies

  • 164.308(a)(1)(ii)(D) Information system activity review

    Implement procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports.

    • Access Control Policy & Procedure
    • Incident Management Policy & Procedure
    • Incident Tracking

  • 164.308(a)(2) Assigned security responsibility

    Identify the security official who is responsible for the development and implementation of the policies and procedures required by this subpart for the covered entity or business associate.

    • Assigned Security & Privacy Responsibilities
    • Security & Privacy Program Review
    • Asset Ownership Assignment
    • People Operations Owner
    • Compliance Program Manager

  • 164.308(a)(3)(i) Workforce security

    Implement policies and procedures to ensure that all members of its workforce have appropriate access to electronic protected health information, as provided under the Information Access Management standard and to prevent those who do not have appropriate access from obtaining access to ePHI. Policies and procedures should include Authorization and/or Supervision procedures, Workforce Clearance Procedure, and Termination Procedures.

    • Code of Business Conduct
    • Organizational Structure
    • Roles & Responsibilities
    • Competency Screening
    • Performance Review
    • External System Connections
    • Access Control Policy & Procedure
    • Identity Validation
    • Termination of Employment
    • Production Database Access Restriction
    • Limit Network Connections
    • Multi-Factor Authentication
    • User Privilege Reviews
    • User Access Reviews

  • 164.308(a)(3)(ii)(A) Authorization and/or supervision

    Implement procedures for the authorization and/or supervision of workforce members who work with electronic protected health information or in locations where it might be accessed.

    • External System Connections
    • Access Control Policy & Procedure
    • Identity Validation
    • Termination of Employment
    • Production Database Access Restriction
    • Limit Network Connections
    • Multi-Factor Authentication
    • User Privilege Reviews
    • User Access Reviews

  • 164.308(a)(3)(ii)(B) Workforce clearance procedure

    Implement procedures to determine that the access of a workforce member to electronic protected health information is appropriate.

    • External System Connections
    • Access Control Policy & Procedure
    • Identity Validation
    • Termination of Employment
    • Production Database Access Restriction
    • Limit Network Connections
    • Multi-Factor Authentication
    • User Privilege Reviews
    • User Access Reviews

  • 164.308(a)(3)(ii)(C) Termination procedures

    Implement procedures for terminating access to electronic protected health information when the employment of, or other arrangement with, a workforce member ends or as required by determinations made as specified in paragraph (a)(3)(ii)(B) [the Workforce Clearance Procedure] of this section.

    • Termination of Employment
    • Access Control Policy & Procedure

  • 164.308(a)(4)(i) Information access management

    Implement policies and procedures for authorizing access to electronic protected health information that are consistent with the applicable requirements of the Privacy Rule. Policies and procedures should include: Isolating Health Care Clearinghouse Functions, Access Authorization and Access Establishment and Modification.

    • External System Connections
    • Access Control Policy & Procedure
    • Identity Validation
    • Termination of Employment
    • Production Database Access Restriction
    • Limit Network Connections
    • Multi-Factor Authentication
    • User Privilege Reviews
    • User Access Reviews

  • 164.308(a)(4)(ii)(B) Access authorization

    Implement policies and procedures for granting access to ePHI, for example, through access to a workstation, transaction, program, process, or other mechanism.

    • External System Connections
    • Access Control Policy & Procedure
    • Identity Validation
    • Termination of Employment
    • Limit Network Connections
    • Production Database Access Restriction
    • Multi-Factor Authentication
    • User Privilege Reviews
    • User Access Reviews

  • 164.308(a)(4)(ii)(C) Access establishment and modification

    Implement policies and procedures that, based upon the covered entity's or the business associate’s access authorization policies, establish, document, review, and modify a user's right of access to a workstation, transaction, program, or process.

    • Access Control Policy & Procedure
    • Identity Validation
    • User Privilege Reviews
    • User Access Reviews

  • 164.308(a)(5)(i) Security awareness and training

    Implement a security awareness and training program for all members of the workforce (including management). Component of the Security Awareness and Training program should include Security Reminders, Protection Malicious Software, Log-in Monitoring and Password Management.

    • Code of Business Conduct
    • Security & Privacy Awareness
    • New Hire Security & Privacy Training
    • Periodic Security & Privacy Training

  • 164.308(a)(5)(ii)(A) Security reminders

    Periodic security updates.

    • Endpoint Security Validation
    • Deployment Notifications

  • 164.308(a)(5)(ii)(B) Protection from malicious software

    Procedures for guarding against, detecting, and reporting malicious software.

    • Malware Protection
    • Endpoint Security Policy

  • 164.308(a)(5)(ii)(C) Log-in monitoring

    Procedures for monitoring log-in attempts and reporting discrepancies.

    • Centralized Security Logging
    • External System Connections

  • 164.308(a)(5)(ii)(D) Password management

    Procedures for creating, changing, and safeguarding passwords.

    • Access Control Policy & Procedure
    • Password Management Guidelines

  • 164.308(a)(6)(i) Security incident procedures

    Implement policies and procedures to address security incidents. Policies and procedures should include response reporting.

    • Automated Incident Reporting
    • Incident Reporting Assistance
    • Incident Management Policy & Procedure
    • Incident Tracking
    • Anomalous Behavior Detection
    • Capacity & Performance Management

  • 164.308(a)(6)(ii) Response and reporting

    Identify and respond to suspected or known security incidents; mitigate, to the extent practicable, harmful effects of security incidents that are known to the covered entity or business associate; and document security incidents and their outcomes.

    • PHI Breach Notification Guidelines
    • Automated Incident Reporting
    • Incident Reporting Assistance
    • Incident Tracking
    • Incident Management Policy & Procedure
    • Data Breach Notification Policy

  • 164.308(a)(7)(i) Contingency plan

    Establish (and implement as needed) policies and procedures for responding to an emergency or other occurrence (for example, fire, vandalism, system failure, and natural disaster) that damages systems that contain ePHI.

    • Incident Management Policy & Procedure
    • Business Continuity Policy & Procedure
    • Disaster Recovery Policy

  • 164.308(a)(7)(ii)(A) Data backup plan

    Establish and implement procedures to create and maintain retrievable exact copies of ePHI.

    • Data Backup Policy
    • Data Backups
    • Backup Restoration Testing

  • 164.308(a)(7)(ii)(B) Disaster recovery plan

    Establish (and implement as needed) procedures to restore any loss of data.

    • Backup Restoration Testing
    • Disaster Recovery Testing
    • Disaster Recovery Policy
    • Business Continuity Policy & Procedure

  • 164.308(a)(7)(ii)(C) Emergency Mode Operation Plan

    Establish and implement procedures to enable continuation of critical business processes for protection of the security of ePHI while operating in emergency mode.

    • Incident Management Policy & Procedure
    • Data Breach Notification Policy
    • Breach Risk Assessment & Notification

  • 164.308(a)(7)(ii)(D) Testing and revision procedures

    Implement procedures for periodic testing and revision of contingency plans.

    • Business Continuity Policy & Procedure
    • Disaster Recovery Policy

  • 164.308(a)(7)(ii)(E) Applications and data criticality analysis

    Assess the relative criticality of specific applications and data in support of another contingency plan component.

    • Risk Framing
    • Risk Assessment
    • Fraud Risk Assessment
    • Risk Assessment Policy & Procedure

  • 164.308(a)(8) Evaluation

    Perform a periodic technical and nontechnical evaluation based initially upon the standards implemented under this rule and subsequently, in response to environmental or operations changes affecting the security of ePHI, that establishes the extent to which an entity’s security policies and procedures meet the requirement.

    • Risk Framing
    • Risk Assessment
    • Fraud Risk Assessment
    • Management Review of Risks
    • Risk Assessment Policy & Procedure
    • Penetration Testing
    • Vulnerability Remediation Process
    • Centralized Flaw Remediation

  • 164.308(b)(1) Business associate contracts and other arrangements

    A covered entity, in accordance with 164.306 [The Security Standards: General Rules], may permit a business associate to create, receive, maintain, or transmit ePHI on the covered entity’s behalf only if the covered entity obtains satisfactory assurances, in accordance with 164.314 [the Organization Requirements] that the business associate will appropriately safeguard the information.

    • Third-Party Criticality Assessments
    • Management Review of Third-Party Risks
    • Vendor Management Policy & Procedure
    • Processor Data Protection Agreements

  • 164.308(b)(2) Subcontractor assurances

    A business associate may permit a business that is a subcontractor to create, receive, maintain, or transmit ePHI on its behalf only if the business associate obtains satisfactory assurances, in accordance with §164.314(a), that the subcontractor will appropriately safeguard the information.

    • Third-Party Criticality Assessments
    • Management Review of Third-Party Risks
    • Vendor Management Policy & Procedure

  • 164.308(a)(4)(ii)(A) Isolating health care clearinghouse functions

    If a health care clearinghouse is part of a larger organization, the clearinghouse must implement policies and procedures that protect the electronic protected health information of the clearinghouse from unauthorized access by the larger organization.

    • Access Control Policy & Procedure
    • Identity Validation
    • Termination of Employment
    • Production Database Access Restriction
    • Limit Network Connections
    • Multi-Factor Authentication
    • User Privilege Reviews
    • User Access Reviews
    • External System Connections

• 164.310 Physical safeguards

  • 164.310(a)(1) Facility access controls

    Implement policies and procedures to limit physical access to its electronic information systems and the facility or facilities in which they are housed, while ensuring that properly authorized access is allowed.

    • Physical Protection Policy & Procedure
    • Third-Party Criticality Assessments
    • Management Review of Third-Party Risks
    • Vendor Management Policy & Procedure

  • 164.310(a)(2)(i) Contingency operations

    Establish (and implement as needed) procedures that allow facility access in support of restoration of lost data under the disaster recovery plan and emergency mode operations plan in the event of an emergency.

    • Incident Management Policy & Procedure
    • Disaster Recovery Policy
    • Business Continuity Policy & Procedure

  • 164.310(a)(2)(ii) Facility security plan

    Implement policies and procedures to safeguard the facility and the equipment therein from unauthorized physical access, tampering, and theft.

    • Physical Protection Policy & Procedure
    • Third-Party Criticality Assessments
    • Management Review of Third-Party Risks
    • Vendor Management Policy & Procedure

  • 164.310(a)(2)(iii) Access control and validation procedures

    Implement procedures to control and validate a person's access to facilities based on their role or function, including visitor control, and control of access to software programs for testing and revision.

    • Third-Party Criticality Assessments
    • Management Review of Third-Party Risks
    • Subservice Organization Evaluation
    • Vendor Management Policy & Procedure
    • Access Control Policy & Procedure
    • Identity Validation
    • User Privilege Reviews
    • User Access Reviews

  • 164.310(a)(2)(iv) Maintenance records

    Implement policies and procedures to document repairs and modifications to the physical components of a facility which are related to security (for example, hardware, walls, doors, and locks).

    • Media Disposal Policy
    • Physical Protection Policy & Procedure
    • Information Security & Privacy Policies

  • 164.310(b) Workstation use

    Implement policies and procedures that specify the proper functions to be performed, the manner in which those functions are to be performed, and the physical attributes of the surroundings of a specific workstation or class of workstation that can access ePHI.

    • Endpoint Security Policy
    • Malware Protection
    • Full Device Encryption
    • Endpoint Security Validation
    • Session Lock
    • Media Disposal Policy

  • 164.310(c) Workstation security

    Covered entities should implement physical safeguards for all workstations that access ePHI, to restrict access to authorized users.

    • Malware Protection
    • Full Device Encryption
    • Endpoint Security Validation
    • Session Lock
    • Media Disposal Policy
    • Endpoint Security Policy

  • 164.310(d)(1) Device and media control

    Implement policies and procedures that govern the receipt and removal of hardware and electronic media that contain ePHI into and out of a facility, and the movement of these items within the facility.

    • Media Disposal Policy
    • Rules of Behavior
    • Data Classification Policy
    • Data Classification Labels
    • Security Governance Program
    • Inventory of Endpoint Assets

  • 164.310(d)(2)(i) Disposal

    Implement policies and procedures to address the final disposition of ePHI, and/or the hardware or electronic media on which it is stored.

    • Media Disposal Policy

  • 164.310(d)(2)(ii) Media re-use

    Implement procedures for removal of ePHI from electronic media before the media are made available for re-use. Ensure that ePHI previously stored on electronic media cannot be accessed and reused. Identify removable media and their use. Ensure that ePHI is removed from reusable media before they are used to record new information.

    • Data Classification Labels
    • Data Classification Policy

  • 164.310(d)(2)(iii) Accountability

    Maintain a record of the movements of hardware and electronic media and any person responsible therefore.

    • Data Classification Labels
    • Data Retention Policy
    • Data Protection Policy & Procedure
    • Media Disposal Policy
    • Endpoint Security Policy

  • 164.310(d)(2)(iv) Data backup and storage

    Create a retrievable, exact copy of ePHI, when needed, before movement of equipment.

    • Data Backup Policy
    • Data Backups

• 164.312 Technical safeguards

  • 164.312(a)(1) Access control

    Implement technical policies and procedures for electronic information systems that maintain ePHI to allow access only to those persons or software programs that have been granted access rights as specified in §164.308(a)(4) [Information Access Management].

    • External System Connections
    • Access Control Policy & Procedure
    • Identity Validation
    • Termination of Employment
    • Production Database Access Restriction
    • Limit Network Connections
    • Multi-Factor Authentication
    • User Privilege Reviews
    • User Access Reviews

  • 164.312(a)(2)(i) Unique user identification

    Assign a unique name and/or number for identifying and tracking user identity. Ensure that system activity can be traced to a specific user. Ensure that the necessary data is available in the system logs to support audit and other related business functions.

    • External System Connections
    • Multi-Factor Authentication
    • Production Database Access Restriction
    • Limit Network Connections
    • User Privilege Reviews
    • User Access Reviews

  • 164.312(a)(2)(ii) Emergency access procedure

    Establish (and implement as needed) procedures for obtaining necessary ePHI during an emergency.

    • Incident Management Policy & Procedure
    • Disaster Recovery Policy
    • Business Continuity Policy & Procedure

  • 164.312(a)(2)(iii) Automatic logoff

    Implement electronic procedures that terminate an electronic session after a predetermined time of inactivity.

    • Session Lock
    • Cloud Console Session Timeout

  • 164.312(a)(2)(iv) Encryption and decryption

    Implement a mechanism to encrypt and decrypt ePHI.

    • Full Device Encryption
    • Encryption of Data at Rest
    • Transmission Confidentiality
    • Encryption Policy & Procedure

  • 164.312(b) Audit controls

    Implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use ePHI.

    • Anomalous Behavior Detection
    • Capacity & Performance Management
    • Centralized Security Logging

  • 164.312(c)(1) Integrity

    Implement policies and procedures to protect ePHI from improper alteration or destruction.

    • Data Retention Policy
    • Data Protection Policy & Procedure
    • Data Classification Labels

  • 164.312(c)(2) Mechanism to authenticate ePHI

    Implement electronic mechanisms to corroborate that ePHI has not been altered or destroyed in an unauthorized manner.

    • Anomalous Behavior Detection
    • Penetration Testing
    • Capacity & Performance Management
    • Centralized Flaw Remediation
    • Vulnerability Remediation Process

  • 164.312(d) Person or entity authentication

    Implement procedures to verify that a person or entity seeking access to ePHI is the one claimed.

    • External System Connections
    • Access Control Policy & Procedure
    • Identity Validation
    • Termination of Employment
    • Production Database Access Restriction
    • Limit Network Connections
    • Multi-Factor Authentication
    • User Privilege Reviews
    • User Access Reviews

  • 164.312(e)(1) Transmission security

    Implement technical security measures to guard against unauthorized access to ePHI that is being transmitted over an electronic communications network.

    • Data Classification Labels
    • Security Governance Program
    • Encryption Policy & Procedure
    • Encryption of Data at Rest
    • Transmission Confidentiality
    • Full Device Encryption
    • Personal Data Inventory

  • 164.312(e)(2)(i) Integrity controls

    Implement security measures to ensure that electronically transmitted ePHI is not improperly modified without detection until disposed of.

    • Encryption Policy & Procedure
    • Security & Privacy Awareness
    • New Hire Policy Acknowledgement

  • 164.312(e)(2)(ii) Encryption

    Implement a mechanism to encrypt ePHI whenever deemed appropriate.

    • Full Device Encryption
    • Encryption of Data at Rest
    • Transmission Confidentiality
    • Encryption Policy & Procedure

• 164.314 Organizational requirements

  • 164.314(a)(1) Business associate contracts or other arrangements

    A covered entity is not in compliance with the standards in § 164.502(e) if the covered entity knew of a pattern of an activity or practice of the business associate that constituted a material breach or violation of the business associate’s obligation under the contract or other arrangement, unless the covered entity took reasonable steps to cure the breach or end the violation, as applicable, and, if such steps were unsuccessful - (A)Terminated the contract or arrangement, if feasible; or (B) If termination is not feasible, reported the problem to the Secretary.”

    • Third-Party Criticality Assessments
    • Management Review of Third-Party Risks
    • Subservice Organization Evaluation
    • Vendor Management Policy & Procedure
    • Processor Data Protection Agreements

  • 164.314(a)(2)(i) Business Associate Contracts

    A business associate contract must provide that the business associate will: “Implement safeguards that protect the confidentiality, integrity, and availability of the electronic protected health...; Report to the covered entity any security incident of which it becomes aware; Authorize termination of the contract, if the covered entity determines that the business associate has violated a material term of the contract.”

    • Third-Party Criticality Assessments
    • Management Review of Third-Party Risks
    • Subservice Organization Evaluation
    • Processor Data Protection Agreements
    • Vendor Management Policy & Procedure
    • Personal Data Inventory
    • Consent Management
    • Data Protection Impact Assessments
    • Data Subject Requests
    • Clear Desk & Clear Screen

  • 164.314(a)(2)(iii) Business associate contracts with subcontractors

    The requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section apply to the contract or other arrangement between a business associate and a subcontractor required by §164.308(b)(4) in the same manner as such requirements apply to contracts or other arrangements between a covered entity and business associate.

    • Third-Party Criticality Assessments
    • Management Review of Third-Party Risks
    • Subservice Organization Evaluation
    • Vendor Management Policy & Procedure
    • Processor Data Protection Agreements

  • 164.314(b)(2)(i) Safeguards

    Implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the ePHI that it creates, receives, maintains, or transmits on behalf of the group health plan

    • Change Management Policy & Procedure
    • Secure System Modification
    • Approval of Changes
    • Network Security Policy & Procedure
    • Cybersecurity Responsibilities
    • Third-Party Criticality Assessments
    • Management Review of Third-Party Risks
    • Subservice Organization Evaluation
    • Vendor Management Policy & Procedure
    • Processor Data Protection Agreements
    • Disaster Recovery Testing
    • Contractual Obligations Register
    • Test Data Protection
    • Published Privacy Policy
    • Privacy Notices on Data Collection Forms
    • Endpoint Encryption
    • Data Backups
    • Capacity & Performance Management
    • Security Governance Program
    • Cross-Border Data Transfers
    • Privacy Officer
    • New Hire Security & Privacy Training
    • Periodic Security & Privacy Training
    • Inventory of Endpoint Assets
    • Asset Inventory Updates
    • Performance Review
    • Impact Analysis
    • Risk Assessment
    • Internal Audit
    • Encryption of Data at Rest
    • Inventory of Infrastructure Assets

  • 164.314(b)(2)(iii) Agreement

    Ensure that any agent, including a subcontractor, to whom it provides this information agrees to implement reasonable and appropriate security measures to protect the information

    • Third-Party Criticality Assessments
    • Management Review of Third-Party Risks
    • Subservice Organization Evaluation
    • Vendor Management Policy & Procedure
    • Processor Data Protection Agreements

  • 164.314(b)(2)(iv) Reporting

    Report to the group health plan any security incident of which it becomes aware

    • Incident Management Policy & Procedure
    • Data Breach Notification Policy
    • Breach Risk Assessment & Notification

  • 164.314(b)(2)(ii) Adequate separation of plan sponsor functions

    Ensure that the adequate separation required by § 164.504(f)(2)(iii) is supported by reasonable and appropriate security measures.

    • Shared Responsibility Model

• 164.316 Policies, procedures and documentation requirements

  • 164.316(a) Policies and Procedures

    Implement reasonable and appropriate policies and procedures to comply with the standards, implementation specifications, or other requirements of this subpart, taking into account those factors specified in 164.306(b)(2)(i), (ii), (iii), and (iv) [the Security Standards: General Rules, Flexibility of Approach]. This standard is not to be construed to permit or excuse an action that violates any other standard. A covered entity or business associate may change its policies and procedures at any time, provided that the changes are documented and are implemented in accordance with this subpart.

    • Management Review of Policies
    • Information Security & Privacy Policies
    • Policy Documentation Retention

  • 164.316(b)(1)(i) Documentation

    Maintain the policies and procedures implemented to comply with this subpart in written (which may be electronic) form; and (ii) if an action, activity or assessment is required by this subpart to be documented, maintain a written (which may be electronic) record of the action, activity, or assessment.

    • Management Review of Policies
    • Information Security & Privacy Policies

  • 164.316(b)(1)(ii) Documentation

    if an action, activity or assessment is required by this subpart to be documented, maintain a written (which may be electronic) record of the action, activity, or assessment.

    • Information Security & Privacy Policies
    • Management Review of Policies

  • 164.316(b)(2)(i) Time Limit

    Retain the documentation required by paragraph (b) (1) of this section for 6 years for the date of its creation or the date when it last was in effect, whichever is later.

    • Data Retention Policy
    • Policy Documentation Retention

  • 164.316(b)(2)(ii) Availability

    Make documentation available to those persons responsible for implementing the procedures to which the documentation pertains

    • New Hire Policy Acknowledgement
    • Periodic Policy Acknowledgement
    • Publishing Security & Privacy Documentation
    • Information Security & Privacy Policies
    • Management Review of Policies

  • 164.316(b)(2)(iii) Updates

    Review documentation periodically, and update as needed, in response to environmental or operational changes affecting the security of the ePHI.

    • Data Breach Notification Policy

• 164.410 Notification by a business associate in the case of breach of unsecured Protected Health Information (PHI)

  • 164.410(a)(1) Breach notification to the covered entity

    A business associate shall, following the discovery of a breach of unsecured protected health information, notify the covered entity of such breach.

    • Data Breach Notification Policy
    • Breach Risk Assessment & Notification
    • Incident Management Policy & Procedure
    • Incident Tracking

  • 164.410(a)(2) When a breach is treated as discovered

    For the purposes of paragraph (1) of this section, a breach shall be treated as discovered by a business associate as of the first day on which such breach is known to the business associate or, by exercising reasonable diligence, would have been known to the business associate. A business associate shall be deemed to have knowledge of a breach if the breach is known, or by exercising reasonable diligence would have been known, to any person, other than the person committing the breach, who is an employee, officer, or other agent of the business associate (determined in accordance with the federal common law of agency).

    • Incident Management Policy & Procedure
    • Data Breach Notification Policy
    • Breach Risk Assessment & Notification

  • 164.410(b) Timeliness of breach notification

    Except as provided in §164.412, a business associate shall provide the notification required by paragraph (a) of this section without unreasonable delay and in no case later than 60 calendar days after the discovery of a breach.

    • New Hire Policy Acknowledgement
    • Periodic Policy Acknowledgement
    • Data Breach Notification Policy
    • Breach Risk Assessment & Notification
    • Incident Management Policy & Procedure
    • Incident Tracking

  • 164.410(c)(1) Identification of affected individuals

    The notification required by paragraph (a) of this section shall include, to the extent possible, the identification of each individual whose unsecured protected health information has been, or is reasonably believed by the business associate to have been, accessed, acquired, used, or disclosed during the breach.

    • Incident Management Policy & Procedure
    • Data Breach Notification Policy
    • Breach Risk Assessment & Notification

  • 164.410(c)(2) Additional information for the covered entity

    A business associate shall provide the covered entity with any other information that the covered entity is required to include in the notification to the individual under §164.404(c) at the time of the notification required by paragraph (a) of this section or promptly thereafter as information becomes available.

    • Data Breach Notification Policy
    • Incident Management Policy & Procedure