How Identity and Access Management Supports the HIPAA Security Rule

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 paragraph (a)(4) of this section, and to prevent those workforce members who do not have access under paragraph (a)(4) of this section from obtaining access to electronic protected health information.

In practice: New hires, job changes and departures flow through a standard lifecycle that assigns access to patient data by role, and managers review that access periodically.

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.

In practice: When someone needs access to patient records, a request goes to their manager and the data owner, and the workflow keeps a record of who authorized what.

Workforce clearance procedure

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

In practice: Managers run user access reviews, often quarterly, to confirm that their team's access to ePHI is appropriate and required for their jobs.

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) of this section.

In practice: When HR records a departure, the leaver workflow removes the person's accounts, and reports flag dormant accounts that slipped through for follow-up.

Information access management

Implement policies and procedures for authorizing access to electronic protected health information that are consistent with the applicable requirements of subpart E of this part.

In practice: A written access policy and a role model define who may reach patient information systems, and the access request workflow applies those rules each time someone asks.

Access authorization

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

In practice: A nurse's role grants a defined set of clinical applications automatically, and anything beyond that goes through a request that a manager must authorize.

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.

In practice: When someone changes departments, a mover workflow updates their access, and periodic review campaigns let managers confirm, document or change what remains.

Log-in monitoring

Procedures for monitoring log-in attempts and reporting discrepancies.

In practice: Sign-in logs record failed and unusual log-in attempts, lockout rules slow guessing, and alerts go to the security team so discrepancies get reported.

Password management

Procedures for creating, changing, and safeguarding passwords.

In practice: A password policy sets how passwords are created and changed, self-service reset lowers help desk load, and administrator credentials sit in a privileged access vault.

Access control

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

In practice: Applications holding patient records admit only people and software accounts that were granted rights, using directory groups and role-based rules to enforce it.

Unique user identification

Assign a unique name and/or number for identifying and tracking user identity.

In practice: Each person has one authoritative identity, administrators use named accounts instead of shared logins, and service accounts have an owner, so activity traces to someone.

Emergency access procedure

Establish (and implement as needed) procedures for obtaining necessary electronic protected health information during an emergency.

In practice: An emergency access account is kept in a vault, its use triggers an alert, and a reviewer checks afterward why it was needed.

Person or entity authentication

Implement procedures to verify that a person or entity seeking access to electronic protected health information is the one claimed.

In practice: Staff sign in through single sign-on with MFA, often phishing-resistant, and access rules can also consider whether the device is known before opening patient systems.

Security management process

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

In practice: The security team runs the overall security program; identity contributes the account inventory, access review results and sign-in records that feed its reviews.

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.

In practice: The security team leads the risk assessment; identity adds a count of privileged, orphaned and shared accounts that touch systems holding patient records.

Risk management

Implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with § 164.306(a).

In practice: Risk owners log fixes such as removing shared accounts, turning on MFA and closing orphaned access as tracked items, each with an owner and a due date.

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.

In practice: Security staff regularly look over audit logs and access reports; identity supplies review campaign results and records of who changed access to patient systems.

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.

In practice: The clearinghouse sets its own access policies; identity supports them with separate roles, so staff elsewhere in the larger organization do not get its data by default.

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.

In practice: During an incident the security team leads; identity audit trails show what an account did, and administrators can disable that account to help contain it.

Evaluation

Perform a periodic technical and nontechnical evaluation, based initially upon the standards implemented under this rule and, subsequently, in response to environmental or operational changes affecting the security of electronic protected health information, that establishes the extent to which a covered entity's or business associate's security policies and procedures meet the requirements of this subpart.

In practice: The compliance team runs the periodic evaluation; identity adds completed access review records and control assessments as source material.

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.

In practice: Facilities staff control building access; where badges are issued from the identity lifecycle, new hire, transfer and departure events keep badge rights in line with each role.

Automatic logoff

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

In practice: The application team sets inactivity timeouts; the single sign-on service adds idle-session and re-sign-in rules where the platform supports them, so a user returning to an idle session must sign in again.

Audit controls

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

In practice: System owners keep their own application logs; identity adds sign-in records, privileged session records and a history of access changes for systems holding patient records.

Time limit

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

In practice: The records team sets the retention schedule; identity records kept as required documentation, such as review results and request sign-offs, are retained for the same period.

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.

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.

Security awareness and training

Implement a security awareness and training program for all members of its workforce (including management).

Security reminders

Periodic security updates.

Protection from malicious software

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

Security incident procedures

Implement policies and procedures to address security incidents.

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 electronic protected health information.

Data backup plan

Establish and implement procedures to create and maintain retrievable exact copies of electronic protected health information.

Disaster recovery plan

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

Emergency mode operation plan

Establish (and implement as needed) procedures to enable continuation of critical business processes for protection of the security of electronic protected health information while operating in emergency mode.

Testing and revision procedures

Implement procedures for periodic testing and revision of contingency plans.

Applications and data criticality analysis

Assess the relative criticality of specific applications and data in support of other contingency plan components.

Business associate contracts and other arrangements

A covered entity may permit a business associate to create, receive, maintain, or transmit electronic protected health information on the covered entity's behalf only if the covered entity obtains satisfactory assurances, in accordance with § 164.314(a), that the business associate will appropriately safeguard the information. A covered entity is not required to obtain such satisfactory assurances from a business associate that is a subcontractor.

Written contract or other arrangement

Document the satisfactory assurances required by paragraph (b)(1) or (b)(2) of this section through a written contract or other arrangement with the business associate that meets the applicable requirements of § 164.314(a).

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.

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.

Facility security plan

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

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).

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 electronic protected health information.

Workstation security

Implement physical safeguards for all workstations that access electronic protected health information, to restrict access to authorized users.

Device and media controls

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

Disposal

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

Media re-use

Implement procedures for removal of electronic protected health information from electronic media before the media are made available for re-use.

Accountability

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

Data backup and storage

Create a retrievable, exact copy of electronic protected health information, when needed, before movement of equipment.

Encryption and decryption

Implement a mechanism to encrypt and decrypt electronic protected health information.

Integrity

Implement policies and procedures to protect electronic protected health information from improper alteration or destruction.

Mechanism to authenticate electronic protected health information

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

Transmission security

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

Integrity controls

Implement security measures to ensure that electronically transmitted electronic protected health information is not improperly modified without detection until disposed of.

Encryption

Implement a mechanism to encrypt electronic protected health information whenever deemed appropriate.

Business associate contracts or other arrangements

The contract or other arrangement required by § 164.308(b)(3) must meet the requirements of paragraph (a)(2)(i), (a)(2)(ii), or (a)(2)(iii) of this section, as applicable.

Business associate contracts

The contract must provide that the business associate will— (A) Comply with the applicable requirements of this subpart; (B) In accordance with § 164.308(b)(2), ensure that any subcontractors that create, receive, maintain, or transmit electronic protected health information on behalf of the business associate agree to comply with the applicable requirements of this subpart by entering into a contract or other arrangement that complies with this section; and (C) Report to the covered entity any security incident of which it becomes aware, including breaches of unsecured protected health information as required by § 164.410.

Other arrangements

The covered entity is in compliance with paragraph (a)(1) of this section if it has another arrangement in place that meets the requirements of § 164.504(e)(3).

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.

Requirements for group health plans

Except when the only electronic protected health information disclosed to a plan sponsor is disclosed pursuant to § 164.504(f)(1)(ii) or (iii), or as authorized under § 164.508, a group health plan must ensure that its plan documents provide that the plan sponsor will reasonably and appropriately safeguard electronic protected health information created, received, maintained, or transmitted to or by the plan sponsor on behalf of the group health plan.

The plan documents of the group health plan must be amended to incorporate provisions to require the plan sponsor to— (i) Implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits on behalf of the group health plan; (ii) Ensure that the adequate separation required by § 164.504(f)(2)(iii) is supported by reasonable and appropriate security measures; (iii) Ensure that any agent to whom it provides this information agrees to implement reasonable and appropriate security measures to protect the information; and (iv) Report to the group health plan any security incident of which it becomes aware.

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). This standard is not to be construed to permit or excuse an action that violates any other standard, implementation specification, or other requirements of this subpart. 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.

Documentation

(i) 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.

Availability

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

Updates

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