§ 164.314 Organizational requirements
§ 164.314 Organizational requirements.
(a)
(1) Standard: 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.
(2) Implementation specifications (Required) -
(i) 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.
(ii) 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).
(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.
(b)
(1) Standard: 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.
(2) Implementation specifications (Required). 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.
[68 FR 8376, Feb. 20, 2003, as amended at 78 FR 5694, Jan. 25, 2013; 78 FR 34266, June 7, 2013]
| A Covered Entity is: A health plan. An individual or group plan that provides, or pays the cost of, medical care. Health plans include private entities (e.g., health insurers and managed care organizations) and government organizations (e.g., Medicaid, Medicare, and the Veterans Health Administration) A health care provider. A provider of health care services and any other person or organization that furnishes, bills, or is paid for health care in the normal course of business. Health care providers (e.g., physicians, hospitals, and clinics) are covered entities if they transmit health information in electronic form in connection with a transaction ...read more |
| Public Hospital Corrects Impermissible Disclosure of PHI in Response to a Subpoena Covered Entity: General Hospital Issue: Impermissible Uses and Disclosures A public hospital, in response to a subpoena (not accompanied by a court order), impermissibly disclosed the protected health information (PHI) of one of its patients. Contrary to the Privacy Rule protections for information sought for administrative or judicial proceedings, the hospital failed to determine that reasonable efforts had been made to insure that the individual whose PHI was being sought received notice of the request and/or failed to receive satisfactory assurance that the party seeking the information ...read more |
| National Pharmacy Chain Extends Protections for PHI on Insurance Cards Covered Entity: Pharmacies Issue: Impermissible Uses and Disclosures; Safeguards A pharmacy employee placed a customer's insurance card in another customer's prescription bag. The pharmacy did not consider the customer's insurance card to be protected health information (PHI). OCR clarified that an individual's health insurance card meets the statutory definition of PHI and, as such, needs to be safeguarded. Among other corrective actions to resolve the specific issues in the case, the pharmacy revised its policies regarding PHI and retrained its staff. The revised policies are applicable to all individual ...read more |
| If a CSP stores only encrypted ePHI and does not have a decryption key, is it a HIPAA business associate? Answer: Yes, because the CSP receives and maintains (e.g., to process and/or store) electronic protected health information (ePHI) for a covered entity or another business associate. Lacking an encryption key for the encrypted data it receives and maintains does not exempt a CSP from business associate status and associated obligations under the HIPAA Rules. An entity that maintains ePHI on behalf of a covered entity (or another business associate) is a business associate, even if the entity cannot actually ...read more |
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