It depends on the relationship between the app developer, and the covered entity and/or its EHR system developer. A business associate is a person or entity who creates, receives, maintains or transmits PHI on behalf of (or for the benefit of) a covered entity (directly or through another business associate) to carry out covered functions of the covered entity. An app’s facilitation of access to the individual’s ePHI at the individual’s request alone does not create a business associate relationship. Such facilitation may include API terms of use agreed to by the third-party app (i.e., interoperability arrangements).

HIPAA does not require a covered entity or its business associate (e.g., EHR system developer) to enter into a business associate agreement with an app developer that does not create, receive, maintain, or transmit ePHI on behalf of or for the benefit of the covered entity (whether directly or through another business associate).

However if the app was developed to create, receive, maintain, or transmit ePHI on behalf of the covered entity, or was provided by or on behalf of the covered entity (directly or through its EHR system developer, acting as the covered entity’s business associate), then a business associate agreement would be required.

More information about apps, business associates, and HIPAA is available at https://www.hhs.gov/hipaa/for-professionals/special-topics/developer-portal/index.html.

No. The HIPAA Privacy Rule generally prohibits a covered entity from refusing to disclose ePHI to a third-party app designated by the individual if the ePHI is readily producible in the form and format used by the app. See 45 CFR 164.524(a)(1), (c)(2)(ii), (c)(3)(ii). The HIPAA Rules do not impose any restrictions on how an individual or the individual’s designee, such as an app, may use the health information that has been disclosed pursuant to the individual’s right of access. For instance, a covered entity is not permitted to deny an individual’s right of access to their ePHI where the individual directs the information to a third-party app because the app will share the individual’s ePHI for research or because the app does not encrypt the individual’s data when at rest. In addition, the HIPAA Rules do not apply to entities that do not meet the definition of a HIPAA covered entity or business associate.

The answer depends on the relationship, if any, between the covered entity, the EHR system developer, and the app chosen by the individual to receive the individual’s ePHI. A business associate relationship exists if an entity creates, receives, maintains, or transmits ePHI on behalf of a covered entity (directly or through another business associate) to carry out the covered functions of the covered entity. A business associate relationship exists between an EHR system developer and a covered entity. If the EHR system developer does not own the app, or if it owns the app but does not provide the app to, through, or on behalf of, the covered entity – e.g., if it creates the app and makes it available in an app store as part of a different line of business (and not as part of its business associate relationship with any covered entity) – the EHR system developer would not be liable under the HIPAA Rules for any subsequent use or disclosure of the requested ePHI received by the app.

If the EHR system developer owns the app or has a business associate relationship with the app developer, and provides the app to, through, or on behalf of, the covered entity (directly or through another business associate), then the EHR system developer could potentially face HIPAA liability (as a business associate of a HIPAA covered entity) for any impermissible uses and disclosures of the health information received by the app. For example, if an EHR system developer contracts with the app developer to create the app on behalf of a covered entity and the individual later identifies that app to receive ePHI, then the EHR system developer could be subject to HIPAA liability if the app impermissibly uses or discloses the ePHI received.

Under the individual right of access, an individual may request a covered entity to direct their ePHI to a third-party app in an unsecured manner or through an unsecured channel. See 45 CFR 164.524(a)(1), (c)(2)(ii), (c)(3)(ii). For instance, an individual may request that their unencrypted ePHI be transmitted to an app as a matter of convenience. In such a circumstance, the covered entity would not be responsible for unauthorized access to the individual’s ePHI while in transmission to the app. With respect to such apps, the covered entity may want to consider informing the individual of the potential risks involved the first time that the individual makes the request.

The answer depends on the relationship between the covered entity and the app. Once health information is received from a covered entity, at the individual’s direction, by an app that is neither a covered entity nor a business associate under HIPAA, the information is no longer subject to the protections of the HIPAA Rules. If the individual’s app – chosen by an individual to receive the individual’s requested ePHI – was not provided by or on behalf of the covered entity (and, thus, does not create, receive, transmit, or maintain ePHI on its behalf), the covered entity would not be liable under the HIPAA Rules for any subsequent use or disclosure of the requested ePHI received by the app. For example, the covered entity would have no HIPAA responsibilities or liability if such an app that the individual designated to receive their ePHI later experiences a breach.

If, on the other hand, the app was developed for, or provided by or on behalf of the covered entity – and, thus, creates, receives, maintains, or transmits ePHI on behalf of the covered entity – the covered entity could be liable under the HIPAA Rules for a subsequent impermissible disclosure because of the business associate relationship between the covered entity and the app developer. For example, if the individual selects an app that the covered health care provider uses to provide services to individuals involving ePHI, the health care provider may be subject to liability under the HIPAA Rules if the app impermissibly discloses the ePHI received.

Yes. The Privacy Rule requires a covered entity to have in place appropriate administrative, technical, and physical safeguards to protect the privacy of protected health information (PHI), including reasonable safeguards to protect against any intentional or unintentional use or disclosure in violation of the Privacy Rule. See 45 CFR § 164.530(c). Each covered entity can evaluate its own business functions and needs, the types and amounts of PHI it collects, uses, and discloses, size, and business risks to determine adequate safeguards for its particular circumstances.

With respect to electronic health information exchange, the Privacy Rule would allow covered entities participating in an exchange with a HIO to agree on a common set of privacy safeguards that are appropriate to the risks associated with exchanging PHI to and through the HIO. In addition, as a requirement of participation in the electronic health information exchange with the HIO, these commonly agreed to safeguards also could be extended to other participants, even if they are not covered entities. A common or consistent set of standards applied to the HIO and its participants may help not only to facilitate the efficient exchange of information, but also to foster trust among both participants and individuals.

Yes. The Privacy Rule allows covered health care providers to communicate electronically, such as through e-mail, with their patients, provided they apply reasonable safeguards when doing so. See 45 CFR § 164.530(c). For example, certain precautions may need to be taken when using e-mail to avoid unintentional disclosures, such as checking the e-mail address for accuracy before sending, or sending an e-mail alert to the patient for address confirmation prior to sending the message. Further, while the Privacy Rule does not prohibit the use of unencrypted e-mail for treatment-related communications between health care providers and patients, other safeguards should be applied to reasonably protect privacy, such as limiting the amount or type of information disclosed through the unencrypted e-mail. In addition, covered entities will want to ensure that any transmission of electronic protected health information is in compliance with the HIPAA Security Rule requirements at 45 CFR Part 164, Subpart C.

Note that an individual has the right under the Privacy Rule to request and have a covered health care provider communicate with him or her by alternative means or at alternative locations, if reasonable. See 45 CFR § 164.522(b). For example, a health care provider should accommodate an individual’s request to receive appointment reminders via e-mail, rather than on a postcard, if e-mail is a reasonable, alternative means for that provider to communicate with the patient. By the same token, however, if the use of unencrypted e-mail is unacceptable to a patient who requests confidential communications, other means of communicating with the patient, such as by more secure electronic methods, or by mail or telephone, should be offered and accommodated.

Patients may initiate communications with a provider using e-mail. If this situation occurs, the health care provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual. If the provider feels the patient may not be aware of the possible risks of using unencrypted e-mail, or has concerns about potential liability, the provider can alert the patient of those risks, and let the patient decide whether to continue e-mail communications.

The Privacy Rule requires covered entities to verify the identity and authority of a person requesting protected health information (PHI), if not known to the covered entity. See 45 CFR § 164.514(h). The Privacy Rule allows for verification in most instances in either oral or written form, although verification does require written documentation when such documentation is a condition of the disclosure.
The Privacy Rule generally does not include specific or technical verification requirements and thus, can flexibly be applied to an electronic health information exchange environment in a manner that best supports the needs of the exchange participants and the health information organization (HIO). For example, in an electronic health information exchange environment:

• Participants can agree by contract or otherwise to keep current and provide to the HIO a list of authorized persons so the HIO can appropriately authenticate each user of the network.
• For persons claiming to be government officials, proof of government status may be provided by having a legitimate government e-mail extension (e.g., xxx.gov).
• Documentation required for certain uses and disclosures may be provided in electronic form, such as scanned images or PDF files.
• Documentation requiring signatures may be provided as a scanned image of the signed documentation or as an electronic document with an electronic signature, to the extent the electronic signature is valid under applicable law.

Yes. The Privacy Rule allows covered health care providers to share PHI electronically (or in any other form) for treatment purposes, as long as they apply reasonable safeguards when doing so. Thus, for example, a physician may consult with another physician by e-mail about a patient’s condition, or health care providers may electronically exchange PHI to and through a health information organization (HIO) for patient care.

Yes, provided the individual agrees to receive the covered entity’s NPP electronically and such agreement has not been withdrawn (although the individual always retains the right to receive a paper copy of the NPP upon request). Further, where health care is delivered to an individual electronically, such as through e-mail, or over the Internet, the provider must send an electronic NPP automatically and contemporaneously in response to the individual’s request for service. Except in an emergency treatment situation, a covered entity that has a direct treatment relationship with an individual and who delivers an NPP electronically also must make a good faith effort to obtain a written acknowledgment of receipt, either electronically or through other means. In addition, the HIPAA Privacy Rule requires a covered entity that maintains a website providing information about the covered entity’s services or benefits to prominently post its NPP on its website. See 45 CFR § 164.520(c).

Generally, no. The HIPAA Privacy Rule’s NPP obligations extend only to HIPAA covered entities and the functions a HIO generally performs do not make it a HIPAA covered entity (i.e., a health plan, health care clearinghouse, or covered health care provider). See 45 CFR § 160.103 (definition of “covered entity”). However, while a HIO does not itself have a HIPAA obligation to provide a NPP to individuals, the Privacy Rule permits covered entities that participate in electronic health information exchange with the HIO to provide notice to individuals of the disclosures that will be made to and through the HIO and through the network, as well as how individuals’ health information will be protected by the HIO.

Yes, covered entities are permitted to include such information in their NPPs. The HIPAA Privacy Rule requires that a covered entity’s NPP describe the types of uses and disclosures of PHI a covered entity is permitted to make. The Rule also requires that a covered entity’s NPP include at least one example of the uses and disclosures the covered entity is permitted to make for treatment, payment, and health care operations purposes. See 45 CFR § 164.520(b). While the Privacy Rule does not require that these examples describe the covered entity’s disclosure of PHI to and through a HIO for treatment and other purposes, or that a covered health care provider uses an EHR, the Privacy Rule does not preclude a covered entity from including in its NPP additional information concerning the covered entity’s participation in these activities. Alternatively, a covered entity may wish to provide the individual with a separate notice of the disclosures that may be made to and through a HIO, and how the individual’s health information will be protected.

Such notice that mentions that PHI will be disclosed to and through a HIO or that the covered health care provider uses an EHR would help facilitate the openness and transparency in electronic health information exchange that is important for building trust and thus, is encouraged. Some individuals also may find the fact that a health care provider participates in electronic health information exchange, or that the provider uses an EHR, to be an important factor that could lead individuals to choose that provider over another. Also, to the extent the individual is provided with certain choices of how or if the individual’s information is to be exchanged through a HIO, notice of the disclosures a covered entity may make to and through a HIO, as well as how the individual’s information will be protected, would be an important element of informing such choices.

A HIO generally is not a HIPAA covered entity and the HIPAA Privacy Rule allows only certain legally separate covered entities to designate themselves as a single affiliated covered entity for purposes of complying with the Privacy Rule. Thus, a HIO generally may not participate as part of an affiliated covered entity. See 45 CFR § 164.105(b) for the requirements and conditions regarding affiliated covered entities.

A HIO, by definition, cannot participate as part of an OHCA because the HIPAA Privacy Rule defines OHCA as an arrangement involving only health care providers or health plans, neither of which a HIO qualifies as. However, a HIO may be a business associate of an OHCA if the HIO performs functions or activities on behalf of the OHCA. See 45 CFR § 160.103 (definitions of “organized health care arrangement” and “business associate”). For example, a hospital and the health care providers with staff privileges at the hospital are an OHCA for purposes of the Privacy Rule. To the extent such an arrangement uses a HIO for electronic health information exchange, the HIO would be a business associate of the OHCA.

Yes, so long as the disclosure of PHI is authorized by the HIO’s business associate agreement and the information exchange would be permitted by the HIPAA Privacy Rule. For example, a HIO may disclose, on behalf of a primary care physician, PHI about an individual for treatment purposes in response to a query from another HIO, acting on behalf of a hospital at which the individual is a patient, unless, for instance, the primary care physician has agreed to the patient’s request to restrict such disclosures. Similarly, a HIO that is a business associate of two different covered entities may share PHI it receives from one covered entity with the other covered entity as permitted by the Privacy Rule and its business associate agreement, for example, for treatment purposes, subject to any applicable restrictions.

In general, the HIPAA Privacy Rule requires that the contract between a covered entity and its business associate establish the permitted and required uses and disclosures of protected health information (PHI) by the business associate, but provides that the contract may not authorize the business associate to use or disclose PHI in a manner that would violate the Privacy Rule. In addition, the contract must require the business associate to appropriately safeguard PHI. See 45 CFR § 164.504(e). See also the relevant business associate requirements of the HIPAA Security Rule at 45 CFR § 164.314(a). Given these required elements of a business associate agreement, covered entities participating in a networked environment with a HIO can use the business associate agreement as a tool to help shape the specific terms and conditions of the information exchange the HIO will manage, as well as the safeguards that will be in place to ensure information is protected and only shared appropriately.

While a business associate contract technically can authorize the business associate to make any number of uses and disclosures permitted under the Privacy Rule, the parties can, and likely would want to, further restrict in the contract what the HIO can and will do with PHI. Defining the permitted uses and disclosures by the HIO may depend on a number of factors, including the purposes of the information exchange through the network (e.g., for treatment purposes), how individual preferences and choice will be honored, as applicable, and any other legal obligations on covered entities and/or HIOs with respect to the PHI in the network. For instance, if the HIO will primarily manage the exchange of PHI among participating entities for treatment purposes, then the parties should, in the business associate agreement, define the HIO’s permitted uses and disclosures of PHI with those limited purposes in mind.

Yes. A HIO can operate as a business associate of multiple covered entities participating in a networked environment. The HIPAA Privacy Rule does not prohibit an entity from acting as a business associate of multiple covered entities and performing functions or activities that involve access to protected health information for the collective benefit of the covered entities. In addition, the Privacy Rule would not require separate business associate agreements between each of the covered entities and the business associate. Rather, the Privacy Rule would permit the covered entities participating in a networked environment and the HIO to operate under a single business associate agreement that was executed by all participating covered entities and the common business associate.

As with a minor’s paper medical record, generally a parent, guardian, or other person acting in loco parentis with legal authority to make health care decisions on behalf of the minor is the personal representative of the minor under the HIPAA Privacy Rule and, thus, is able to exercise all of the HIPAA rights with respect to the minor’s health information. Thus, a parent, guardian, or other person acting in loco parentis who is a personal representative would be able to consent to, if the covered entity has adopted a consent process under the Privacy Rule, or to request restrictions on, disclosures of the minor’s health information to or through a HIO for treatment or other certain purposes. However, there are a few exceptions when the parent, guardian, or other person acting in loco parentis is not the personal representative of the minor child, such as:

1. when State or other law does not require the consent of a parent or other person before a minor can obtain a particular health care service, and the minor consents to the health care service;
2. when a court determines or other law authorizes someone other than the parent, guardian, or person acting in loco parentis to make treatment decisions for a minor; and
3. when a parent, guardian, or person acting in loco parentis agrees to a confidential relationship between the minor and a health care provider. In such cases, it is only the minor, and not the parent(s), who may exercise the HIPAA rights with respect to the minor’s health information.

Yes. In particular, the Privacy Rule’s provisions for optional consent and the right to request restrictions can support and facilitate individual choice with respect to the electronic exchange of health information through a networked environment, depending on the purposes of the exchange. The Privacy Rule allows covered entities to obtain the individual’s consent in order to use or disclose protected health information (PHI) for treatment, payment, and health care operations purposes. If a covered entity chooses to obtain consent, the Privacy Rule provides the covered entity with complete flexibility as to the content and manner of obtaining the consent. 45 CFR § 164.506(b). Similarly, the Privacy Rule also provides individuals with a right to request that a covered entity restrict uses or disclosures of PHI about the individual for treatment, payment, or health care operations purposes. See 45 CFR § 164.522(a). While covered entities are not required to agree to an individual’s request for a restriction, they are required to have policies in place by which to accept or deny such requests. Thus, covered entities may use either the Privacy Rule’s provisions for consent or right to request restrictions to facilitate individual choice with respect to electronic health information exchange.

Further, given the Privacy Rule’s flexibility, covered entities could design processes that apply on a more global level (e.g., by requiring an individual’s consent prior to making any disclosure of PHI to or through a health information organization (HIO), or granting restrictions only in which none of the individual’s information is to be exchanged to or through the HIO) or at a more granular level (such as by type of information, potential recipients, or the purposes for which a disclosure may be made). Whatever the policy, such decisions may be implemented on an organization-wide level, or across a HIO’s health information exchange (such as based on the consensus of the health information exchange participants).

The HIPAA Privacy Rule requires the individual’s written authorization for any use or disclosure of protected health information (PHI) not otherwise expressly permitted or required by the Privacy Rule. For example, authorizations are not generally required to disclose PHI for treatment, payment, or health care operations purposes because covered entities are permitted to use and disclose PHI for such purposes, with few exceptions. Thus, to the extent the primary purpose of any electronic health information exchange is to exchange clinical information among health care providers for treatment, HIPAA authorizations are unlikely to be a common method of effectuating individual choice for the exchange. However, if the purpose of a covered entity sharing PHI through a health information organization is for a purpose not otherwise permitted by the Privacy Rule, then a HIPAA authorization would be required. In such cases, the Privacy Rule would allow covered entities to disclose PHI pursuant to an electronic copy of a valid and signed authorization. Further, the Privacy Rule allows HIPAA authorizations to be obtained electronically from individuals, provided any electronic signature is valid under applicable law.

No. The Privacy Rule establishes a federal baseline of privacy protections and rights, which applies to covered entities consistently across state borders. The Privacy Rule, however, as required by HIPAA, does not preempt State laws that provide greater privacy protections and rights. Thus, as with covered entities that conduct business today on paper in a multi-jurisdictional environment, covered entities participating in electronic health information exchange need to be cognizant of States with more stringent privacy laws that will affect the exchange of electronic health information across State lines. In addition, other Federal laws also may apply more stringent or different requirements to such exchanges depending on the circumstances. Covered entities and health information organizations (acting as their business associates) which participate in multi-jurisdictional electronic health information exchange should establish privacy policies for the network that accommodate these variances.

To the extent covered entities maintain their own electronic records systems, their choice to link those systems to a network for electronic health information exchange purposes would not necessarily change the status of information maintained within their designated record sets. That is, information that meets the definition of a designated record set remains part of the designated record set even if that information is linked to a network. See 45 CFR § 164.501 (definition of “designated record set”). Covered entities should be aware, however, that whatever information they import into their electronic records via a network may become an integrated part of their designated record set(s). Network participation alone, however, would not make all other information about the individual that is accessible through the network part of a covered entity’s designated record set. Thus, the ability to link to information through a network does not obligate a covered entity to provide access to the designated record set of another entity participating in the network.

Under the HIPAA Privacy Rule, a covered entity must make reasonable efforts to communicate an amendment to others in the network identified by the individual as needing the amendment, as well as generally to other parties that are known to have the information about the individual. It is also the entity’s responsibility to communicate the amendment within a reasonable time-frame. A health information organization (HIO), with the ability to track where information was exchanged in the past, or to otherwise identify where an individual’s information resides on the network, can assist the covered entity, as its business associate, in efficiently disseminating amended information to appropriate recipients throughout the electronic network.

The HIPAA Privacy Rule designates a covered entity as the responsible party for acting on an amendment request. However, a health information organization (HIO), acting as a business associate of the covered entity, may be required by its business associate contract to perform certain functions related to amendments, such as informing other participants in the HIO’s health information exchange who are known to have the individual’s information, of the amendment. See 45 CFR § 164.504(e)(2)(i)(F).

The Privacy Rule would permit a HIO, acting as a business associate of one or more covered entities, to make any disclosure the covered entities are permitted by the Privacy Rule to make, provided the HIO’s business associate agreement(s) authorizes the disclosure. See 45 CFR § 164.504(e). For example, the Privacy Rule permits a covered entity to make disclosures of PHI for public health and research purposes, provided certain conditions are met. Such disclosures may be made by a HIO, on behalf of one or more covered entities, provided the covered entities or HIO satisfy all of the Privacy Rule’s applicable conditions, and the business associate agreement(s) with the HIO authorize the HIO to make the disclosure.

A HIO, as a business associate, may only use or disclose protected health information (PHI) as authorized by its business associate agreement with the covered entity. See 45 CFR § 164.504(e). The process of de-identifying PHI constitutes a use of PHI. Thus, a HIO may only de-identify PHI it has on behalf of a covered entity to the extent that the business associate agreement authorizes the HIO to do so. However, once PHI is de-identified in accordance with the HIPAA Privacy Rule, it is no longer PHI and, thus, may be used and disclosed by the covered entity or HIO for any purpose (subject to any other applicable laws).

A business associate agreement may authorize a business associate to make uses and disclosures of PHI the covered entity itself is permitted by the HIPAA Privacy Rule to make. See 45 CFR § 164.504(e). In addition, the Privacy Rule permits a business associate agreement to authorize a business associate (e.g., a HIO) to: (1) use and disclose PHI for the proper management and administration of the business associate, in accordance with 45 CFR § 164.504(e)(4); and (2) to provide data aggregation services related to the health care operations of the covered entities for which it has agreements. In most cases, the permitted uses and disclosures established by a business associate agreement will vary based on the particular functions or services the business associate is to provide the covered entity. Similarly, a covered entity’s business associate agreement with a HIO will vary depending on a number of factors, such as the electronic health information exchange purpose which the HIO is to manage, the particular functions or services the HIO is to perform for the covered entity, and any other legal obligations a HIO may have with respect to the PHI. For example, the business associate agreements between covered entities and a HIO may authorize the HIO to:

• Manage authorized requests for, and disclosures of, PHI among participants in the network;
• Create and maintain a master patient index;
• Provide a record locator or patient matching service;
• Standardize data formats;
• Implement business rules to assist in the automation of data exchange;
• Facilitate the identification and correction of errors in health information records; and
• Aggregate data on behalf of multiple covered entities.

Yes. A HIO may receive protected health information from multiple covered entities, and manage, as a business associate on their behalf, a master patient index for purposes of identifying and linking all information about a particular individual. Disclosures to, and use of, a HIO for such purposes is permitted as part of the participating covered entities’ health care operations under the HIPAA Privacy Rule, to the extent the purpose of the master patient index is to facilitate the exchange of health information by those covered entities for purposes otherwise permitted by the Privacy Rule, such as treatment.

Yes. The Privacy Rule permits a covered entity to disclose PHI to another health care provider for treatment purposes. See 45 CFR § 164.506. Further, a covered entity may use a HIO to facilitate the exchange of such information for treatment purposes, provided it has a business associate agreement with the HIO that requires the HIO to protect the information. See 45 CFR §§ 164.502(e), 164.504(e).

The Privacy Rule is flexible enough to allow multiple covered entities to exchange information with each other in an electronically networked environment upon entering into a single, multi-party business associate agreement. Regardless of the number of signatories, the obligations in a multi-party business associate agreement will be largely bi-directional. Covered entities will still be accountable for the actions of their workforce, as well as the contents and enforcement of its business associate agreement with the health information organization (HIO). See 45 CFR §§ 164.530(b),(e) and 164.504(e). Covered entities will not be liable, however, for the violations of other participants in the HIO’s health information exchange.

The Privacy Rule establishes a series of steps a covered entity should take in response to any complaints or other evidence it receives that a HIO has violated its business associate agreement, which include the following:

• investigation of any complaint received, as well as of other information containing credible evidence of a violation;
• reasonable steps to cure/end any material breaches or violations it becomes aware of;
• termination of the agreement where attempts to cure a material breach are unsuccessful; and
• in the event termination of the agreement is not feasible, the report of violation(s) to the Secretary of HHS, through OCR. See 45 CFR § 164.504(e).

No. As with other business associates, the Privacy Rule would require that a covered entity enter into a relationship with a HIO in a way which anticipates and reasonably safeguards against the potential for inappropriate uses and disclosures, specifically through the use of a business associate agreement. The Privacy Rule also would require the covered entity to respond appropriately to complaints and evidence of violations, but it would not otherwise require the covered entity to actively monitor or oversee the extent to which a HIO, acting as its business associate, abides by the privacy provisions of the agreement, or the means by which the HIO carries out its privacy safeguard obligations. See 45 CFR §§ 164.502(e), 164.504(e).

A covered entity that exchanges protected health information (PHI) to or through a HIO or otherwise participates in electronic health information exchange is responsible for its own non-compliance with the Privacy Rule, and for violations by its workforce. A covered entity is not directly liable for a violation of the Privacy Rule by a HIO acting as its business associate, if an appropriate business associate agreement is in place. Nor can a HIO as a business associate be held liable for civil money penalties arising from violations of the Privacy Rule. Rather, where a business associate agreement exists between a covered entity and a HIO for the electronic exchange of PHI, the HIO will be contractually obligated to adequately safeguard the PHI and to report noncompliance with the agreement terms to the covered entity, and the covered entity will be held accountable for taking appropriate action to cure known noncompliance by the business associate, and if unable to do so, to terminate the business associate relationship. See 45 CFR §§ 164.502(e), 164.504(e). Furthermore, a covered entity is not liable for a disclosure that is based on the non-compliance of another entity within the health information exchange, as long as the covered entity has complied with the Privacy Rule.