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Based on the information received through public comments, testimony at public hearings, meetings at the request of industry and other stakeholders, as well as other communications, HHS identified a number of areas in which the Privacy Rule, as issued in December 2000, would have had potential unintended effects on health care quality or access.
No. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) gives the Secretary authority to directly regulate health plans, health care clearinghouses, and certain health care providers.
The HIPAA Privacy Rule requires covered entities to enter into written contracts or other arrangements with business associates which protect the privacy of protected health information; but covered entities are not required to monitor or oversee the means by which their business associates carry out privacy safeguards or the extent to which the business associate abides by the privacy requirements of the contract.
No. A covered entity is required to enter into a contract or other written arrangement with a business associate that meets the requirements at 45 CFR 164.504(e).
Yes. The HIPAA Privacy Rule explicitly defines organizations that accredit covered entities as business associates.
No. Disclosures from a covered entity to a researcher for research purposes do not require a business associate contract, even in those instances where the covered entity has hired the researcher to perform research on the covered entity’s own behalf.
The HIPAA Privacy Rule explicitly excludes from the business associate requirements disclosures by a covered entity to a health care provider for treatment purposes. See 45 CFR 164.502(e)(1).
Yes. If the HIPAA Privacy Rule permits a covered entity to share protected health information with another covered entity, the covered entity is permitted to make the disclosure directly to a business associate acting on behalf of that other covered entity.
No. Covered entities that participate in an OHCA are permitted to share protected health information for the joint health care activities of the OHCA without entering into business associate contracts with each other. Of course, each such entity is independently required to observe its obligations under the HIPAA Privacy Rule with respect to protected health information.
A business associate contract is not required with persons or organizations whose functions, activities, or services do not involve the use or disclosure of protected health information, and where any access to protected health information by such persons would be incidental, if at all.
No, the Privacy Rule does not require a covered entity to enter into business associate contracts with organizations, such as the US Postal Service, certain private couriers and their electronic equivalents that act merely as conduits for protected health information.
The Privacy Rule regulates covered entities, not business associates. he Rule requires covered entities to include specific provisions in agreements with business associates to safeguard protected health information, and addresses how covered entities may share this information with business associates.
Yes, assuming that the electronic contract satisfies the applicable requirements of State contract law.
No. The hospital and such physicians participate in what the HIPAA Privacy Rule defines as an organized health care arrangement (OHCA).
Yes. See 45 CFR 164.514(e)(3)(ii). For example, if a researcher needs county data, but the covered entity’s data contains only the postal address of the individual, a business associate may be used to convert the covered entity’s geographical information into that needed by the researcher.
Yes. A data use agreement can be combined with a business associate agreement into a single agreement that meets the requirements of both provisions of the HIPAA Privacy Rule.
No. Where a covered entity discloses only a limited data set to a business associate for the business associate to carry out a health care operations function, the covered entity satisfies the Rule’s requirements that it obtain satisfactory assurances from its business associate with the data use agreement.
A covered entity’s contract with a business associate may not authorize the business associate to use or further disclose the information in a manner that would violate the HIPAA Privacy Rule if done by the covered entity.
Generally, providers are not business associates of payers. For example, if a provider is a member of a health plan network and the only relationship between the health plan (payer) and the provider is one where the provider submits claims for payment to the plan, then the provider is not a business associate of the health plan.
A health insurance issuer or HMO does not become a business associate simply by providing health insurance or health coverage to a group health plan.
Generally, no. A reinsurer does not become a business associate of a health plan simply by selling a reinsurance policy to a health plan and paying claims under the reinsurance policy.
The mere selling or providing of software to a covered entity does not give rise to a business associate relationship if the vendor does not have access to the protected health information of the covered entity.
However, a covered entity must ensure through its contract with the business associate that the business associate's uses and disclosures of protected health information and other actions are consistent with the covered entity's privacy policies, as stated in covered entity's notice.
A covered entity may enter into a business associate agreement with the public health authority for the sole purpose of creating a limited data set, even if the same public health authority is also the intended recipient of the information (45 CFR 164.514(e)(3)(ii)).
In general, and as explained below, the Privacy Rule permits a covered health care provider (covered provider), without the individual’s written authorization, to disclose protected health information to a medical device company representative (medical device company)
There are two deadlines for compliance with the HIPAA Privacy Rule on April 14, 2004:
Under the Privacy Rule, a covered entity such as a doctor can contact a patient using a Telecommunications Relay Service (TRS), without the need for a business associate contract with the TRS.
It depends on who the recipient is.
When a covered health care provider uses an interpreter to communicate with an individual, the individual’s authorization is not required when the provider meets the conditions below.
First, a business associate may not use PHI in a manner or to accomplish a purpose or result that would violate the HIPAA Privacy Rule. See 45 CFR § 164.502(a)(3).
Yes, provided the covered entity or business associate enters into a HIPAA-compliant business associate contract or agreement (BAA) with the CSP that will be creating, receiving, maintaining, or transmitting electronic protected health information (ePHI) on its behalf, and otherwise complies with the HIPAA Rules.
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.
Generally, no. CSPs that provide cloud services to a covered entity or business associate that involve creating, receiving, or maintaining (e.g., to process and/or store) electronic protected health information (ePHI) meet the definition of a business associate, even if the CSP cannot view the ePHI because it is encrypted and the CSP does not have the decryption key.
OCR does not endorse, certify, or recommend specific technology or products.
If a covered entity (or business associate) uses a CSP to maintain (e.g., to process or store) electronic protected health information (ePHI) without entering into a BAA with the CSP, the covered entity (or business associate) is in violation of the HIPAA Rules. 45 C.F.R §§164.308(b)(1) and §164.502(e).
Yes. The Security Rule at 45 CFR § 164.308(a)(6)(ii) requires business associates to identify and respond to suspected or known security incidents; mitigate, to the extent practicable, harmful effects of security incidents that are known to the business associate; and document security incidents and their outcomes.
Yes. Health care providers, other covered entities, and business associates may use mobile devices to access electronic protected health information (ePHI) in a cloud as long as appropriate physical, administrative, and technical safeguards are in place to protect the confidentiality, integrity, and availability of the ePHI on the mobile device and in the cloud, and appropriate BAAs are in place with any third party service providers for the device and/or the cloud that will have access to the e-PHI.
No, the HIPAA Rules generally do not require a business associate to maintain electronic protected health information (ePHI) beyond the time it provides services to a covered entity or business associate.
Yes, provided the covered entity (or business associate) enters into a business associate agreement (BAA) with the CSP and otherwise complies with the applicable requirements of the HIPAA Rules.
No. The HIPAA Rules require covered entity and business associate customers to obtain satisfactory assurances in the form of a business associate agreement (BAA) with the CSP that the CSP will, among other things, appropriately safeguard the protected health information (PHI) that it creates, receives, maintains or transmits for the covered entity or business associate in accordance with the HIPAA Rules.
No. A CSP is not a business associate if it receives and maintains (e.g., to process and/or store) only information de-identified following the processes required by the Privacy Rule.