HIPAA Security Rule Control Guide

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

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.

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

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

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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

Periodic security updates.

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

Procedures for monitoring log-in attempts and reporting discrepancies.

Procedures for creating, changing, and safeguarding passwords.

Implement policies and procedures to address security incidents.

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.

Identify and respond to suspected or known security incidents, mitigate their harmful effects as far as practicable, and document each incident and its outcome. The deadlines for notifying people of a breach are set by the Breach Notification Rule (45 CFR 164.400 to 164.414), not by this specification.

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.

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

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

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.

Implement procedures for periodic testing and revision of contingency plans.

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

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.

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.

tiCrypt does not address business associate contracts. Tera Insights supplies tiCrypt as software and has no access to a deployment, unless the organization sends it data or engages it to administer the deployment.

Decide which parties are business associates and hold the written contracts. If you send Tera Insights ePHI or engage it to administer the deployment, make that determination for Tera Insights as well.

A business associate may permit a business associate that is a subcontractor to create, receive, maintain, or transmit electronic protected health information 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.

tiCrypt does not address business associate contracts. Tera Insights supplies tiCrypt as software and has no access to a deployment, unless the organization sends it data or engages it to administer the deployment.

Decide which parties are business associates and hold the written contracts. If you send Tera Insights ePHI or engage it to administer the deployment, make that determination for Tera Insights as well.

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).

tiCrypt does not address business associate contracts. Tera Insights supplies tiCrypt as software and has no access to a deployment, unless the organization sends it data or engages it to administer the deployment.

Decide which parties are business associates and hold the written contracts. If you send Tera Insights ePHI or engage it to administer the deployment, make that determination for Tera Insights as well.

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.

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.

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

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.

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).

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.

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

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.

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.

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

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

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

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).

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

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

tiCrypt has no administrative override: administrators at every tier are cryptographically excluded from user data. The one recovery path is key escrow, which reconstructs a user's private key only with one member of every escrow group, three groups by default. Escrow is optional.

Write the emergency access procedure. Decide whether accounts are escrowed, define the escrow groups and say who may ask for a recovery. Without escrow, a lost key or forgotten password leaves that user's data unrecoverable.

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

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

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

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

A user can read a resource only if its key has been re-encrypted to that user's public key, Permission Profiles restrict which operations each role may perform, and file and drive operations are recorded in the SHA-512 hash-chained audit log. The at-rest ciphers provide confidentiality: integrity of stored content relies on the surrounding platform controls, not on an authenticated-encryption mode.

Write the integrity policies and procedures, and keep backups from which improperly altered or destroyed ePHI can be restored.

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

tiCrypt records file creation, deletion and chunk-level read and write events with the acting user in the SHA-512 hash-chained audit log, so a change to stored content can be traced to an authenticated user. It does not corroborate the content itself: Vault files and drives are not stored in an authenticated-encryption mode.

Decide in your risk analysis whether the audit trail is enough or a content-integrity mechanism of your own is needed.

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

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

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

In transit, data is encrypted twice (TLS 1.2 or later plus Diffie-Hellman session keys) and SHA-256 verifies its integrity, so a modification on the network is detected. After receipt, tiCrypt records file creation, deletion and chunk-level read and write events with the acting user in the SHA-512 hash-chained audit log, so a change to stored content can be traced to an authenticated user. It does not corroborate the stored content itself: Vault files and drives are not stored in an authenticated-encryption mode.

Decide in your risk analysis whether the audit trail is enough for ePHI once it is stored, or whether a content-integrity mechanism of your own is needed until the data is disposed of, for example checksums in the storage or backup system.

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

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.

tiCrypt does not address business associate contracts. Tera Insights supplies tiCrypt as software and has no access to a deployment, unless the organization sends it data or engages it to administer the deployment.

Decide which parties are business associates and hold the written contracts. If you send Tera Insights ePHI or engage it to administer the deployment, make that determination for Tera Insights as well.

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.

tiCrypt does not address business associate contracts. Tera Insights supplies tiCrypt as software and has no access to a deployment, unless the organization sends it data or engages it to administer the deployment.

Decide which parties are business associates and hold the written contracts. If you send Tera Insights ePHI or engage it to administer the deployment, make that determination for Tera Insights as well.

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).

tiCrypt does not address business associate contracts. Tera Insights supplies tiCrypt as software and has no access to a deployment, unless the organization sends it data or engages it to administer the deployment.

Decide which parties are business associates and hold the written contracts. If you send Tera Insights ePHI or engage it to administer the deployment, make that determination for Tera Insights as well.

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.

tiCrypt does not address business associate contracts. Tera Insights supplies tiCrypt as software and has no access to a deployment, unless the organization sends it data or engages it to administer the deployment.

Decide which parties are business associates and hold the written contracts. If you send Tera Insights ePHI or engage it to administer the deployment, make that determination for Tera Insights as well.

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.

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.

(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.

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.

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

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