HIPAA Technology and Clinical Research Guidance Library

Health Information Technology | Access Rights, Apps, and APIs

1. Does a HIPAA covered entity that fulfills an individual’s request to transmit electronic protected health information (ePHI) to an application or other software (collectively “app”) bear liability under the HIPAA Privacy, Security, or Breach Notification Rules (HIPAA Rules) for the app’s use or disclosure of the health information it received?

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.

2. What liability does a covered entity face if it fulfills an individual’s request to send their ePHI using an unsecure method to an app?

Under the individual right of access, an individual may request a covered entity to direct their ePHI to a third-party app in an unsecure manner or through an unsecure 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.

Where an individual directs a covered entity to send ePHI to a designated app, does a covered entity’s electronic health record (EHR) system developer bear HIPAA liability after completing the transmission of ePHI to the app on behalf of the covered entity?

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.

3. Can a covered entity refuse to disclose ePHI to an app chosen by an individual because of concerns about how the app will use or disclose the ePHI it receives?

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, as discussed in a separate FAQ, the HIPAA Rules do not apply to entities that do not meet the definition of a HIPAA covered entity or business associate.

4. Does HIPAA require a covered entity or its EHR system developer to enter into a business associate agreement with an app designated by the individual in order to transmit ePHI to the app?

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

The information presented in our library is for informational purposes only, they are not for implementation in operations. Please consult official HIPAA guidance documents for operational use.

This information was sourced from HIPAA FAQs for Professionals.

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HIPAA Technology and Clinical Research Guidance Library

Health Information Technology | Safeguards

1. Does the HIPAA Privacy Rule permit a covered health care provider to e-mail or otherwise electronically exchange protected health information (PHI) with another provider for treatment purposes?

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.

2. How may the HIPAA Privacy Rule’s requirements for verification of identity and authority be met in an electronic health information exchange environment?

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 C.F.R. § 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.

3. Does the HIPAA Privacy Rule permit health care providers to use e-mail to discuss health issues and treatment with their patients?

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 C.F.R. § 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 C.F.R. 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 C.F.R. § 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.

4. Does the HIPAA Privacy Rule allow covered entities participating in electronic health information exchange with a health information organization (HIO) to establish a common set of safeguards?

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 C.F.R. § 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.

The information presented in our library is for informational purposes only, they are not for implementation in operations. Please consult official HIPAA guidance documents for operational use.

This information was sourced from HIPAA FAQs for Professionals.

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