| TD: Documentation Retention - Meet Burden of Proof

Documentation Retention - Meet Burden of Proof, v1.0

Specifies that a health care provider organization must maintain documentation sufficient to meet its burden of proof to demonstrate that all required notifications were made in the event of a data breach.

Section 164.414(b) states: In the event of a use or disclosure in violation of subpart E (Section 164.500-599 - Privacy of PHI), the covered entity or business associate, as applicable, shall have the burden of demonstrating that all notifications were made as required by subpart D (Section 164.450-499 - Notification in the Case of Breach of Unsecured PHI) or that the use or disclosure did not constitute a breach, as defined at Section 164.402.

Assessment Step

1 Documentation Retention (DocumentationRetention) Does the covered entity have policies and procedures to maintain documentation sufficient to meet its burden of proof under Section 164.414(b)? Artifact A1 Provide evidence (e.g. organizational policies, procedures, compliance/assessment reports, etc.) that support the assessor's response to this assessment step.

Conformance Criteria (1)

Meet Burden of Proof A covered entity must maintain documentation sufficient to meet its burden of proof under Section 164.414(b). Burden of Proof is to demonstrate that all required notifications were made in the event of an unauthorized use or disclosure of PHI or that a breach did not occur. Citation HIPAA-Privacy-Rule 45 CFR Section 164.530(j)(1)(iv) and Section 164.414(b)

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Metadata

Identifier

https://artifacts.trustmarkinitiative.org/lib/tds/documentation-retention---meet-burden-of-proof/1.0/

Publication Date

2017-02-17

Issuing Organization

Trustmark Initiative (https://trustmarkinitiative.org/) View Contact

No Responder

help@trustmarkinitiative.org

404-407-8956

75 5th Street NW, Suite 900, Atlanta, GA 30308

Keywords

Health Care, HIPAA Privacy, Administrative Requirements

Issuance Criteria

yes(ALL)

Target Stakeholder

Health care related organizations that use protected health information (PHI) in a manner that is subject to regulations in the Health Insurance Portability and Accountability Act (HIPAA).

Target Recipient

Health care related organizations that want to demonstrate that they use, disclose, process and store protected health information (PHI) in a manner that complies with HIPAA regulations 45 CFR Parts 160 - 164.

Target Relying Party

Health care related organizations and individuals that require their trusted partners' privacy and security policies and procedures to comply with the Health Insurance Portability and Accountability Act (HIPAA).

Target Provider

Organizations that audit or evaluate health care related organizations for compliance with privacy and security policies and procedures in the Health Insurance Portability and Accountability Act (HIPAA).

Provider Eligibility Criteria

Any organization or business entity may act as a Trustmark Provider for trustmarks under this Trustmark Definition.

Assessor Qualifications

Any individual employed or contracted by the Trustmark Provider may act as the assessor for trustmarks under this Trustmark Definition.

Trustmark Revocation Criteria

For any trustmark issued under this Trustmark Definition, the Trustmark Provider must revoke the trustmark upon any condition whereby one or more Conformance Criteria cease to be satisfied.

Extension Description

This Trustmark Definition requires no extension data.

Legal Notice

This document and the information contained herein is provided on an "AS IS" basis, and the Georgia Tech Research Institute disclaims all warranties, express or implied, including but not limited to any warranty that the use of the information herein will not infringe any rights or any implied warranties or merchantability or fitness for a particular purpose. In addition, the Georgia Tech Research Institute disclaims legal liability for any loss incurred as a result of the use or reliance on the document or the information contained herein.

Sources (1)

HIPAA-Privacy-Rule	HIPAA Privacy Rule, published by U.S. Dept of Health and Human Services, HIPAA Administrative Simplification Regulation Text 45 CFR Part 160 and subparts A and E of Part 164, available at http://www.hhs.gov/hipaa/for-professionals

Terms (10)

Term Name	Abbreviations	Definition
Business Associate	BA	Covered entities engage "business associates" to work on their behalf. A business associate is a person (not part of the workforce of the covered entity) or organization that creates, receives, maintains, or transmits protected health information on behalf of the covered entity. Covered entities must have contracts or other arrangements in place with their business associates to ensure that the business associates safeguard protected health information, and use and disclose the information only as permitted or required by the Privacy Rule. A covered entity may be a business associate of another covered entity.
Correctional Institution	CI	Correctional institution means any penal or correctional facility, jail, reformatory, detention center, work farm, halfway house, or residential community program center operated by, or under contract to, the United States, a State, a territory, a political subdivision of a State or territory, or an Indian tribe, for the confinement or rehabilitation of persons charged with or convicted of a criminal offense or other persons held in lawful custody. Other persons held in lawful custody includes juvenile offenders adjudicated delinquent, aliens detained awaiting deportation, persons committed to mental institutions through the criminal justice system, witnesses, or others awaiting charges or trial.
Covered Entity	CE	The Administrative Simplification provisions of HIPAA apply to three types of entities, which are known as "covered entities": 1) health care providers if they transmit any information in an electronic form in connection with a transaction for which HHS has adopted a standard, 2) health plans, and 3) health care clearinghouses. A covered entity may be a business associate of another covered entity.
Disclosure		Disclosure means the release, transfer, provision of access to, or divulging in any manner of information outside the entity holding the information.
Electronic Protected Health Information	e-PHI	Electronic protected health information means protected health information (PHI) that is transmitted by electronic means or maintained in electronic media.
Health Insurance Portability and Accountability Act of 1996	HIPAA	The HIPAA law includes Administrative Simplification provisions that require adoption of national standards for electronic health care transactions and code sets, unique health identifiers, and security. Additionally, Congress recognized that advances in electronic technology could erode the privacy of health information. Consequently, Congress incorporated into HIPAA provisions that mandated the adoption of Federal privacy protections for individually identifiable health information.
Plan Administration Functions	PAF	Plan administration functions means administration functions performed by the plan sponsor of a group health plan on behalf of the group health plan and excludes functions performed by the plan sponsor in connection with any other benefit or benefit plan of the plan sponsor.
Protected Health Information	PHI	Protected health information (PHI) means "individually identifiable health information" that is transmitted by electronic means or maintained in electronic media or transmitted or maintained in any other form or medium, except it excludes individually identifiable health information: In education records covered by the Family Educational Rights and Privacy Act; In records described at 20 U.S.C. 1232g(a)(4)(B)(iv); In employment records held by a covered entity in its role as employer; Regarding a person who has been deceased for more than 50 years. HIPAA rules protect most PHI held or transmitted by a covered entity or its business associate, in any form or medium, whether electronic, on paper, or oral. PHI is information, including demographic information, which relates to the individual's past, present, or future physical or mental health or condition, the provision of health care to the individual, or the past, present, or future payment for the provision of health care to the individual. For example, PHI includes name, address, birth date, Social Security Number, a medical record, laboratory report, or hospital bill. However, reporting or aggregating data that cannot be used to individually identify a person would not be considered PHI.
Summary Health Information		Information, that may be individually identifiable health information, and that summarizes the claims history, claims expenses, or type of claims experienced by individuals.
U.S. Department of Health and Human Services	HHS	The U.S. Department of Health and Human Services' (HHS) mission is to enhance and protect the health and well-being of all Americans by providing for effective health and human services and fostering advances in medicine, public health, and social services.

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