§ 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]
| Hospital Implements New Minimum Necessary Polices for Telephone Messages Covered Entity: General Hospital Issue: Minimum Necessary; Confidential Communications A hospital employee did not observe minimum necessary requirements when she left a telephone message with the daughter of a patient that detailed both her medical condition and treatment plan. An OCR investigation also indicated that the confidential communications requirements were not followed, as the employee left the message at the patient’s home telephone number, despite the patient’s instructions to contact her through her work number. To resolve the issues in this case, the hospital developed and implemented several new procedures. ...read more |
| Hospital Revises Email Distribution as a Result of a Disclosure to Persons Without a "Need to Know" Covered Entity: General Hospital Issue: Impermissible Use and Disclosure A complainant, who was both a patient and an employee of the hospital, alleged that her protected health information (PHI) was impermissibly disclosed to her supervisor. OCR’s investigation revealed that: the hospital distributed an Operating Room (OR) schedule to employees via email; the hospital’s OR schedule contained information about the complainant’s upcoming surgery. While the Privacy Rule may permit the disclosure of an OR schedule containing PHI, in this case, a hospital employee ...read more |
| Hospital Revises Email Distribution as a Result of a Disclosure to Persons Without a "Need to Know" Covered Entity: General Hospital Issue: Impermissible Use and Disclosure A complainant, who was both a patient and an employee of the hospital, alleged that her protected health information (PHI) was impermissibly disclosed to her supervisor. OCR’s investigation revealed that: the hospital distributed an Operating Room (OR) schedule to employees via email; the hospital’s OR schedule contained information about the complainant’s upcoming surgery. While the Privacy Rule may permit the disclosure of an OR schedule containing PHI, in this case, a hospital employee ...read more |
| Private Practice Revises Policies and Procedures Addressing Activities Preparatory to Research Covered Entity: Private Practice Issue: Impermissible Disclosure-Research A private practice physician who was the principal investigator of a clinical research study disclosed a list of patients and diagnostic codes to a contract research organization to telephone patients for recruitment purposes. The disclosure was not consistent with documents approved by the Institutional Review Board (IRB). The private practice maintained that the disclosure to the contract research organization was permissible as a review preparatory to research. Activities considered “preparatory to research” include: preparing a research protocol; developing a research hypothesis; ...read more |
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