- Authorizations (30)
                              - Business Associates (41)
                              - Compliance Dates (2)
                              - Covered Entities (14)
                              - Decedents (9)
                              - Disclosures for Law Enforcement Purposes (5)
                              - Disclosures for Rule Enforcement (1)
                              - Disclosures in Emergency Situations (2)
                              - Disclosures Required by Law (6)
                              - Disclosures to Family and Friends (28)
                              - Disposal of Protected Health Information (6)
                              - Facility Directories (7)
                              - Family Medical History Information (3)
                              - FERPA and HIPAA (10)
                              - Group Health Plans (3)
                              - Incidental Uses and Disclosures (10)
                              - Judicial and Administrative Proceedings (8)
                              - Minimum Necessary (14)
                              - Notice of Privacy Practice (20)
                              - Preemption of State Law (10)
                              - Privacy Rule: General Topics (12)
                              - Protected Health Information (2)
                              - Public Health Uses and Disclosures (13)
                              - Research Uses and Disclosures (20)
                              - Right to an Accounting of Disclosures (8)
                              - Right to File a Complaint (1)
                              - Right to Request a Restriction (4)
                              - Safeguards (13)
                              - Security Rule (24)
                              - Smaller Providers and Businesses (145)
                              - Student Immunizations (8)
                              - Transition Provisions (3)
                              - Treatment, Payment, and Health Care Operations Disclosures (30)
                              - Workers Compensation Disclosures (5)
                              - Limited Data Set (6)
                              - Marketing (17)
                              - Marketing - Refill Reminders (16)
                              - Personal Representatives and Minors (12)
                              - Right to Access and Research (58)
                              - Mental Health (35)
                              - Health Information Technology (41)
                              - Telehealth (11)

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# Right to Access and Research

##         220-Can  a health care power of attorney obtain access to the individual's medical record      

Yes, an individual that has been given a health care power of attorney will have the right to access the medical records of the individual related to such representation to the extent permitted by the HIPAA Privacy Rule at 45 CFR 164.524. However, when a physician or other covered entity reasonably believes that an individual, including an unemancipated minor, has been or may be subjected to domestic violence, abuse or neglect by the personal representative, or that treating a person as an individual’s personal representative could endanger the individual, the covered entity may choose not to treat that person as the individual’s personal representative, if in the exercise of professional judgment, doing so would not be in the best interests of the individual.

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##         221-Can a personal representative access to the individual's medical record       

The HIPAA Privacy Rule treats an adult or emancipated minor’s personal representative as the individual for purposes of the Rule regarding the health care matters that relate to the representation, including the right of access under 45 CFR 164.524.

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##         222-How a deceased individual's family obtain the deceased's information relevant to their own health care      

The HIPAA Privacy Rule recognizes that a deceased individual’s protected health information may be relevant to a family member’s health care.

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##         227-Does the HIPAA Privacy Rule allow parents the right to see their children’s medical records      

Yes, the Privacy Rule generally allows a parent to have access to the medical records about his or her child, as his or her minor child’s personal representative when such access is not inconsistent with State or other law.

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##         228-If a child receives emergency medical care without a parent's consent, can the parent get all information about the child's treatment and condition      

Generally, yes. Even though the parent did not consent to the treatment in this situation, the parent would be the child’s personal representative under the HIPAA Privacy Rule.

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##         246-Does HIPAA require business associates to provide individuals with access to their 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.

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##         311-What does HIPAA say about a research participant's right of access to research records or results      

With few exceptions, the Privacy Rule gives patients the right to inspect and obtain a copy of health information about themselves that is maintained by a covered entity or its business associate in a “designated record set.”

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##         353-If patients request copies of their medical records as permitted by the Privacy Rule, are they required to pay for the copies      

The Privacy Rule permits the covered entity to impose reasonable, cost-based fees. The fee may include only the cost of copying (including supplies and labor) and postage, if the patient requests that the copy be mailed.

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##         369-Does the HIPAA Privacy Rule require that covered entities provide patients with access to oral information      

The Privacy Rule requires covered entities to provide individuals with access to protected health information about themselves that is contained in their “designated record sets.”

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##         551-How would an HIO know if someone were a personal representative       

How would a covered entity or health information organization (HIO), acting on its behalf, know if someone were a personal representative for the purpose of granting access under the HIPAA Privacy Rule?

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##         552-How may judgments be made electronically about denial of access under HIPAA      

How may judgments be made electronically about denial of access under the HIPAA Privacy Rule?

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##         2024-May a covered entity charge individuals a fee for providing the individuals with a copy of their PHI?      

Yes, but only within specific limits. The Privacy Rule permits a covered entity to impose a reasonable, cost-based fee to provide the individual (or the individual’s personal representative) with a copy of the individual’s PHI, or to direct the copy to a designated third party. The fee may include only the cost of certain labor, supplies, and postage:

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##         2025-What labor costs may a covered entity include in the fee that may be charged to individuals to provide them with a copy of their PHI?      

A covered entity may include reasonable labor costs associated only with the: (1) labor for copying the PHI requested by the individual, whether in paper or electronic form; and (2) labor to prepare an explanation or summary of the PHI, if the individual in advance both chooses to receive an explanation or summary and agrees to the fee that may be charged.

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##         2026-May a covered health care provider charge a fee under HIPAA for individuals to access the PHI that is available through the provider’s EHR technology that has been certified as being capable of making the PHI accessible?      

No. The HIPAA Privacy Rule at 45 CFR 164.524(c)(4) permits a covered entity to charge a reasonable, cost-based fee that covers only certain limited labor, supply, and postage costs that may apply in providing an individual with a copy of PHI in the form and format requested or agreed to by the individual. Where an individual requests or agrees to access her PHI available through the View, Download, and Transmit functionality of the CEHRT, we believe there are no labor costs and no costs for supplies to enable such access. Thus, a covered health care provider cannot charge an individual a fee when it fulfills an individual’s HIPAA access request using the View, Download, and Transmit functionality of the provider’s CEHRT.

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##         2027-May a covered entity that uses a business associate to act on individual requests for access pass on the costs of outsourcing this function to individuals when they request copies of their PHI?      

No. A covered entity may charge individuals a reasonable, cost-based fee that includes only labor for copying the PHI, costs for supplies, labor for creating a summary or explanation of the PHI if the individual requests a summary or explanation, and postage, if the PHI is to be mailed. See 45 CFR 164.524(c)(4). Administrative and other costs associated with outsourcing the function of responding to individual requests for access cannot be the basis for any fees charged to individuals for providing that access.

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##         2028-Must a covered entity inform individuals in advance of any fees that may be charged when the individuals request a copy of their PHI?      

Yes. When an individual requests access to her PHI and the covered entity intends to charge the individual the limited fee permitted by the HIPAA Privacy Rule for providing the individual with a copy of her PHI, the covered entity must inform the individual in advance of the approximate fee that may be charged for the copy. An individual has a right to receive a copy of her PHI in the form and format and manner requested, if readily producible in that way, or as otherwise agreed to by the individual. Since the fee a covered entity is permitted to charge will vary based on the form and format and manner of access requested or agreed to by the individual, covered entities must, at the time such details are being negotiated or arranged, inform the individual of any associated fees that may impact the form and format and manner in which the individual requests or agrees to receive a copy of her PHI. The failure to provide advance notice is an unreasonable measure that may serve as a barrier to the right of access. Thus, this requirement is necessary for the right of access to operate consistent with the HIPAA Privacy Rule.  Further, covered entities should post on their web sites or otherwise make available to individuals an approximate fee schedule for regular types of access requests.  In addition, if an individual requests, covered entities should provide the individual with a breakdown of the charges for labor, supplies, and postage, if applicable, that make up the total fee charged.  We note that this information would likely be requested in any action taken by OCR in enforcing the individual right of access, so entities will benefit from having this information readily available.

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##         2029-How can covered entities calculate the limited fee that can be charged to individuals to provide them with a copy of their PHI?      

The HIPAA Privacy Rule permits a covered entity to charge a reasonable, cost-based fee for individuals (or their personal representatives) to receive (or direct to a third party) a copy of the individuals’ PHI. In addition to being reasonable, the fee may include only certain labor, supply, and postage costs that may apply in providing the individual with the copy in the form and format and manner requested or agreed to by the individual. The following methods may be used, as specified below, to calculate this fee.

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##         2030-Is $6.50 the maximum amount that can be charged to provide individuals with a copy of their PHI?      

No. For any request from an individual, a covered entity (or business associate operating on its behalf) may calculate the allowable fees for providing individuals with copies of their PHI: (1) by calculating actual allowable costs to fulfill each request; or (2) by using a schedule of costs based on average allowable labor costs to fulfill standard requests. Alternatively, in the case of requests for an electronic copy of PHI maintained electronically, covered entities may: (3) charge a flat fee not to exceed $6.50 (inclusive of all labor, supplies, and postage). Charging a flat fee not to exceed $6.50 per request is therefore an option available to entities that do not want to go through the process of calculating actual or average allowable costs for requests for electronic copies of PHI maintained electronically.

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##         2031-Are costs authorized by State fee schedules permitted to be charged to individuals when providing them with a copy of their PHI under the HIPAA Privacy Rule?      

No, except in cases where the State authorized costs are the same types of costs permitted under 45 CFR 164.524(c)(4) of the HIPAA Privacy Rule, and are reasonable. The bottom line is that the costs authorized by the State must be those that are permitted by the HIPAA Privacy Rule and must be reasonable. The HIPAA Privacy Rule at 45 CFR 164.524(c)(4) permits a covered entity to charge a reasonable, cost-based fee that covers only certain limited labor, supply, and postage costs that may apply in providing an individual with a copy of PHI in the form and format requested or agreed to by the individual. Thus, labor (e.g., for search and retrieval) or other costs not permitted by the Privacy Rule may not be charged to individuals even if authorized by State law. Further, a covered entity’s fee for providing an individual with a copy of her PHI must be reasonable in addition to cost-based, and there may be circumstances where a State authorized fee is not reasonable, even if the State authorized fee covers only permitted labor, supply, and postage costs. For example, a State-authorized fee may be higher than the covered entity’s cost to provide the copy of PHI. In addition, many States with authorized fee structures have not updated their laws to account for efficiencies that exist when generating copies of information maintained electronically. Therefore, these State authorized fees for copies of PHI maintained electronically may not be reasonable for purposes of 45 CFR 164.524(c)(4).

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##         2032-A State law requires that a health care provider give individuals one free copy of their medical records but HIPAA permits the provider to charge a fee.  Does HIPAA override the State law?      

No, so the health care provider must comply with the State law and provide the one free copy. In contrast to State laws that authorize higher or different fees than are permitted under HIPAA, HIPAA does not override those State laws that provide individuals with greater rights of access to their health information than the HIPAA Privacy Rule does. See 45 CFR 160.202 and 160.203. This includes State laws that: (1) prohibit fees to be charged to provide individuals with copies of their PHI; or (2) allow only lesser fees than what the Privacy Rule would allow to be charged for copies.

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##         2033-When do the HIPAA Privacy Rule limitations on fees that can be charged for individuals to access copies of their PHI apply to disclosures of the individual’s PHI to a third party?      

The fee limits apply when an individual directs a covered entity to send the PHI to the third party. Under the HIPAA Privacy Rule, a covered entity is prohibited from charging an individual who has requested a copy of her PHI more than a reasonable, cost-based fee for the copy that covers onlycertain labor, supply, and postage costs that may apply in fulfilling the request. See 45 CFR 164.524(c)(4). This limitation applies regardless of whether the individual has requested that the copy of PHI be sent to herself, or has directed that the covered entity send the copy directly to a third party designated by the individual (and it doesn’t matter who the third party is). To direct a copy to a third party, the individual’s access request must be in writing, signed by the individual, and clearly identify the designated person or entity and where to send the PHI. See 45 CFR 164.524(c)(3)(ii). Thus, written access requests by individuals to have a copy of their PHI sent to a third party that include these minimal elements are subject to the same fee limitations in the Privacy Rule that apply to requests by individuals to have a copy of their PHI sent to themselves. This is true regardless of whether the access request was submitted to the covered entity by the individual directly or forwarded to the covered entity by a third party on behalf and at the direction of the individual (such as by an app being used by the individual). Further, these same limitations apply when the individual’s personal representative, rather than the individual herself, has made the request to send a copy of the individual’s PHI to a third party.

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##         2034-May a health care provider withhold a copy of an individual’s PHI from the individual who requested it because the covered entity used the individual’s payment of the allowable fee for the copy to instead pay an outstanding bill for health care servi      

No. Just as a covered entity may not withhold or deny an individual access to his PHI on the grounds that the individual has not paid the bill for health care services the covered entity provided to the individual, a covered entity may not withhold or deny access on the grounds that the covered entity used the individual’s payment of the fee for a copy of his PHI to offset or pay the individual’s outstanding bill for health care services.

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##         2035-Can an individual be charged a fee if the individual requests only to inspect her PHI at the covered entity (i.e., does not request that the covered entity produce a copy of the PHI)?      

No. The fees that can be charged to individuals exercising their right of access to their PHI apply only in cases where the individual is to receive a copy of the PHI, versus merely being provided the opportunity to view and inspect the PHI. The HIPAA Privacy Rule provides individuals with the right to inspect their PHI held in a designated record set, either in addition to obtaining copies or in lieu thereof, and requires covered entities to arrange with the individual for a convenient time and place to inspect the PHI. See 45 CFR 164.524(c)(1) and (c)(2). Consequently, covered entities should have in place reasonable procedures to enable individuals to inspect their PHI, and requests for inspection should trigger minimal additional effort by the entity, particularly where the PHI requested is of the type easily accessed onsite by the entity itself in the ordinary course of business. For example, covered entities could use the capabilities of Certified EHR Technology (CEHRT) to enable individuals to inspect their PHI, if the individuals agree to the use of this functionality.

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##         2036-Can an individual, through the HIPAA right of access, have his or her health care provider or health plan send the individual’s PHI to a third party?      

Yes. If requested by an individual, a covered entity must transmit an individual’s PHI directly to another person or entity designated by the individual. The individual’s request must be in writing, signed by the individual, and clearly identify the designated person or entity and where to send the PHI. See 45 CFR 164.524(c)(3)(ii). A covered entity may accept an electronic copy of a signed request (e.g., PDF or scanned image), an electronically executed request (e.g., via a secure web portal) that includes an electronic signature, or a faxed or mailed copy of a signed request.

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##         2037-Are there any limits or exceptions to the individual’s right to have the individual’s PHI sent directly to a third party?      

The right of an individual to have PHI sent directly to a third party is an extension of the individual’s right of access; consequently, all of the provisions that apply when an individual obtains access to her PHI apply when she directs a covered entity to send the PHI to a third party. As a result:

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##         2038-Can an individual’s personal representative, through the HIPAA right of access, have the individual’s health care provider or health plan send the individual’s PHI to a third party?      

Yes. An individual’s personal representative (generally, a person with authority under State law to make health care decisions for the individual) has the right both to receive a copy of PHI about the individual in a designated record set, and to direct the covered entity to transmit a copy of the PHI to another person or entity, upon request, consistent with the scope of such representation and the requirements of 45 CFR 164.524. See 45 CFR 164.502(g). The same requirements for fulfilling an individual’s request to send the individual’s PHI to a third party (e.g., with respect to timeliness, form and format, bases for denial, fee limitations, etc.) also apply to requests made by an individual’s personal representative.

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##         2039-What is the liability of a covered entity in responding to an individual’s access request to send the individual’s PHI to a third party?      

Covered entities may rely on the information provided in writing by the individual about the identity of the designated person and where to send the PHI for purposes of verification of the designated third party as an authorized recipient. However, covered entities must implement reasonable safeguards in otherwise carrying out the request, such as taking reasonable steps to verify the identity of the individual making the access request and to enter the correct information into the covered entity’s system. For example, while a covered entity is not required to confirm that the individual provided the correct e-mail address of the third party, the covered entity is required to have reasonable procedures to ensure that it correctly enters the provided e-mail address into the covered entity’s system.

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##         2040-What is a covered entity’s obligation under the Breach Notification Rule if it transmits an individual’s PHI to a third party designated by the individual in an access request, and the entity discovers the information was breached in transit?      

If a covered entity discovers that the PHI was breached in transit to the designated third party, and the PHI was “unsecured PHI” as defined at 45 CFR 164.402, the covered entity generally is obligated to notify the individual and HHS of the breach and otherwise comply with the HIPAA Breach Notification Rule at 45 CFR 164, Subpart D. However, if the individual requested that the covered entity transmit the PHI in an unsecure manner (e.g., unencrypted), and, after being warned of the security risks to the PHI associated with the unsecure transmission, maintained her preference to have the PHI sent in that manner, the covered entity is not responsible for a disclosure of PHI while in transmission to the designated third party, including any breach notification obligations that would otherwise be required. Further, a covered entity is not liable for what happens to the PHI once the designated third party receives the information as directed by the individual in the access request.

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##         2041-Why depend on the individual’s right of access to facilitate the disclosure of PHI to a third party – why not just have the individual execute a HIPAA authorization to enable the covered entity to make this disclosure?      

The PHI that an individual wants to have disclosed to a third party under the HIPAA right of access also could be disclosed by a covered entity pursuant to a valid HIPAA authorization. However, there are differences between the two methods – the primary difference being that one is a required disclosure and one is a permitted disclosure -- that may make the right of access a more favorable choice for most disclosures the individual is initiating on her own behalf. These differences are illustrated in the following table:

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##         2042-What personal health information do individuals have a right under HIPAA to access from their health care providers and health plans?       

With limited exceptions, the HIPAA Privacy Rule gives individuals the right to access, upon request, the medical and health information (protected health information or PHI) about them in one or more designated record sets maintained by or for the individuals’ health care providers and health plans (HIPAA covered entities). See 45 CFR 164.524. Designated record sets include medical records, billing records, payment and claims records, health plan enrollment records, case management records, as well as other records used, in whole or in part, by or for a covered entity to make decisions about individuals. See 45 CFR 164.501. Thus, individuals have a right to access a broad array of health information about themselves, whether maintained by a covered entity or by a business associate on the covered entity’s behalf, including medical records, billing and payment records, insurance information, clinical laboratory test reports, X-rays, wellness and disease management program information, and notes (such as clinical case notes or “SOAP” notes (a method of making notes in a patient’s chart) but not including psychotherapy notes as explained below), among other information generated from treating the individual or paying for the individual’s care or otherwise used to make decisions about individuals. In responding to a request for access, a covered entity is not, however, required to create new information, such as explanatory materials or analyses, that does not already exist in the designated record set. Further, while individuals have a right to a broad array of PHI about themselves in a designated record set, a covered entity is only required to provide access to the PHI to which the individual requests access.

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##         2043-Does an individual’s right under HIPAA to access their health information apply only to the information a health care provider maintains about the individual in an Electronic Health Record (EHR), or paper medical record?      

No. An individual has a broad right under the HIPAA Privacy Rule to access the PHI about the individual in all designated record sets maintained by or for a covered entity, whether in electronic or paper form, not just the designated record set that comprises the “medical record.” See 45 CFR 164.524(a). (However, if the same PHI is maintained in more than one designated record set, a covered entity need only produce the information once in response to a request for access.) A designated record set also includes billing and payment records, claims and insurance information, as well as other records that are used, in whole or in part, by or for the covered entity to make decisions about individuals. See the definition of “designated record set” at 45 CFR 164.501.

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##         2044-Does the individual have a right to access PHI about themselves maintained by a covered entity that is very old or is archived?      

Yes. An individual has a right to access PHI about themselves in a medical record or other designated record set maintained by a covered entity, regardless of the date the information was created or whether the information is maintained onsite, remotely, or is archived. There are only very limited grounds under which a covered entity may deny an individual access to PHI about herself in a designated record set, which do not include the age or location of the information. See 45 CFR 164.524(a)(2) – (a)(3).

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##         2045-Does an individual have a right to access all of the information a covered entity maintains in the individual’s medical record?      

Yes. Except in very limited circumstances, an individual has a right to access all PHI about the individual that a covered entity (or its business associate) maintains in one or more designated record sets. A designated record set is defined to include the medical record about the individual. Thus, an individual generally has a right to access all of the information about the individual that a covered entity maintains in the individual’s medical record, including information the individual provided to the covered entity herself, as well as PHI about the individual contributed to the record by other health care providers or covered entities. See 45 CFR 164.524(a)(2) – (a)(3) for the limited grounds upon which a covered entity may deny an individual access to PHI in a designated record set.

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##         2046-Under what circumstances may a covered entity deny an individual’s request for access to the individual’s PHI?      

A covered entity may deny an individual access to all or a portion of the PHI requested in only very limited circumstances. For example, a covered entity may deny an individual access if the information requested is not part of a designated record set maintained by the covered entity (or by a business associate for a covered entity), or the information is excepted from the right of access because it is psychotherapy notes or information compiled in reasonable anticipation of, or for use in, a legal proceeding (but the individual retains the right to access the underlying PHI from the designated record set(s) about the individual used to generate this information).

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##         2047-Does an individual have a right under HIPAA to access PHI about the individual maintained by a business associate of a covered entity?      

Yes. An individual’s right under the HIPAA Privacy Rule to access PHI about themselves extends to PHI in a designated record set maintained by a business associate on behalf of a covered entity. Thus, if an individual submits a request for access to PHI, the covered entity is responsible for providing the individual with access not only to the PHI it holds but also to the PHI held by one or more of its business associates. However, if the same PHI that is the subject of an access request is maintained in both the designated record set of the covered entity and the designated record set of the business associate, the PHI need only be produced once in response to the request for access. See 45 CFR 164.524(c)(1).

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##         2048-Does an individual have a right under HIPAA to access from a clinical laboratory the genomic information the laboratory has generated about the individual?      

Yes. An individual has a right under the HIPAA Privacy Rule to access, upon request, PHI about the individual in a designated record set maintained by or for a clinical laboratory that is a covered entity. The designated record set includes not only the laboratory test reports but also the underlying information generated as part of the test, as well as other information concerning tests a laboratory runs on an individual. For example, a clinical laboratory that is a HIPAA covered entity and that conducts next generation sequencing (NGS) of DNA on an individual must provide the individual, upon the individual’s request for PHI concerning the NGS, with a copy of the completed test report, the full gene variant information generated by the test, as well as any other information in the designated record set concerning the test.

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##         2049-Does an individual have a right under HIPAA to access more than just test results from a clinical laboratory?       

Yes. Under the HIPAA Privacy Rule, an individual has a general right to access, upon request, PHI about the individual in a designated record set maintained by or for a clinical laboratory that is a covered entity. A test result or test report is only part of the designated record set a clinical laboratory may hold. To the extent an individual requests access to all of her information held by the laboratory, the laboratory is required to provide access to all of the PHI about the individual in its designated record set. This could include, for example, completed test reports and the underlying data used to generate the reports, test orders, ordering provider information, billing information, and insurance information.

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##         2050-How timely must a covered entity be in responding to individuals’ requests for access to their PHI?      

Under the HIPAA Privacy Rule, a covered entity must act on an individual’s request for access no later than 30 calendar days after receipt of the request. If the covered entity is not able to act within this timeframe, the entity may have up to an additional 30 calendar days, as long as it provides the individual – within that initial 30-day period – with a written statement of the reasons for the delay and the date by which the entity will complete its action on the request. See 45 CFR 164.524(b)(2).

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##         2051-Under the EHR Incentive Program, participating providers are required to provide individuals with access to certain information on much faster timeframes (e.g., a discharge summary within 36 hours of discharge, a lab result within 4 business days aft      

Health care providers participating in the EHR Incentive Program may use the patient engagement tools of their Certified EHR Technology to make certain information available to patients quickly and satisfy their EHR Incentive Program objectives. Doing so also has the added benefit of satisfying an individual’s request for access under HIPAA, where the PHI requested by the individual is available through the Certified EHR Technology, and the individual agrees to access the information in this way. While the Privacy Rule permits a covered entity to take up to 30 calendar days from receipt of a request to provide access (with one extension for up to an additional 30 calendar days when necessary), covered entities are strongly encouraged to provide individuals with access to their health information much sooner, and to take advantage of technologies that enable individuals to have faster or even immediate access to the information.

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##         2052-Why does HIPAA give covered entities 30 days to respond to individuals’ requests for access to their PHI?  In the digital age, allowing covered entities 30 days to provide individuals with access to their health information seems too long; individual      

While some individual access requests should be fairly easy to fulfill (e.g., those that can be satisfied through the use of Certified EHR Technology), the HIPAA Privacy Rule recognizes that there may be other circumstances where additional time and effort may be necessary to locate and obtain the PHI that is the subject of the request, or to provide the PHI in the format requested or agreed to by the individual, or otherwise to act on the request. The Privacy Rule is intended to set the outer time limit for providing access, not indicate the desired or best result, and it is expected that many covered entities should be able to respond to requests for access well before the 30 day outer limit. Further, as technology evolves and PHI becomes more readily available via easy-to-use digital technologies, the ability to provide very prompt or almost instantaneous access to individuals will increase. The Department will continue to monitor these developments.

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##         2053-In some cases, the 30-day timeframe from a request to provide an individual with access to her PHI may not be sufficient time for a clinical laboratory to complete the test report that is the subject of the individual’s request.  What can a clinical       

In those limited cases where, due to the nature of the test and the timing of the individual’s request, 30 calendar days may not be sufficient to complete a test report to which the individual has requested access, the laboratory may notify the individual in writing within the 30-day period of the need and specific reason for the delay in providing access to the completed test result and the date by which the laboratory will complete its action on the request, in accordance with § 164.524(b)(2)(iii) of the HIPAA Privacy Rule. The Privacy Rule allows only one extension on an access request and the extension may not exceed an additional 30 calendar days. In the rare circumstance where 60 calendar days is not sufficient to provide the individual with access to the completed test report requested by the individual, the covered laboratory may, at the end of the 60 day period, satisfy the access request by providing the individual with access to the PHI that does exist at the time (e.g., test requisitions, the underlying data being used to generate the reports, other completed test reports) in the designated record set.

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##         2054-Under the HIPAA Privacy Rule, do individuals have the right to an electronic copy of their PHI?      

Yes, in most cases. If the PHI is maintained by a covered entity electronically, an individual has a right to receive an electronic copy of the information upon request (assuming the covered entity does not have a ground for denial under 45 CFR 164.524(a)(2) or (a)(3)). The covered entity must provide the individual with access to the PHI in the electronic form and format requested by the individual, if it is readily producible in that form and format, or if not, in a readable alternative electronic format as agreed to by the individual and covered entity. See 45 CFR 164.524(c)(2)(ii). Where an individual requests access to PHI that is maintained electronically by a covered entity, the covered entity may provide the individual with a paper copy of the PHI to satisfy the request only in cases where the individual declines to accept any of the electronic formats readily producible by the covered entity.

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##         2055-If an individual requests an electronic copy of the individual’s PHI that the covered entity maintains only on paper, is the covered entity required to scan the paper records to create an electronic copy of the PHI for the individual?      

While a covered entity is not required to purchase a scanner to create electronic copies, if a covered entity can readily produce an electronic copy of the PHI for the individual by scanning the records, it must do so. In particular, if an individual requests an electronic copy of PHI in a specific format, and a covered entity maintains that PHI only on paper, the covered entity must provide the individual with the electronic copy, in the format requested, if the copy is readily producible electronically and readily producible in the electronic format requested. If the copy is readily producible electronically but not in the specific format requested, the covered entity may offer the individual the copy in an alternative readable electronic format. If the copy is not readily producible in electronic form, or the individual declines to accept the electronic format(s) that are readily producible by the covered entity, then the covered entity may provide the individual with a readable hard copy of the PHI to satisfy the access request. See § 164.524(c)(2)(i). For example, a covered entity that maintains the requested PHI only on paper may be able to readily produce a scanned PDF version of the PHI but not the requested Word version. In this case, the covered entity may provide the individual with the PDF version if the individual agrees to accept the PDF version. If the individual declines to accept the PDF version, or if the covered entity is not able to readily produce a PDF or other electronic version of the PHI, the covered entity may provide the individual with a hard copy, such as a photocopy, of the PHI.

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##         2056-When an individual exercises her HIPAA right to get an electronic copy of her PHI, can the individual choose the electronic format of the copy?      

While individuals do not have an unlimited choice in the form of electronic copy requested, and covered entities are not required to purchase new software or other equipment in order to accommodate every possible individual request, the individual does have a right to receive the copy in the form and format requested by the individual if the copy is readily producible in that form and format. For example, an individual may request that an electronic copy of her PHI be provided to her in Microsoft (MS) Word; MS Excel; Portable Document Format (PDF); or as structured, machine readable data (e.g., a document following the Consolidated Clinical Document Architecture (CCDA) standard using LOINC (to represent lab tests) and RxNorm (to represent medications)); or other electronic format; and the covered entity must provide the copy in the requested format if readily producible in that format.

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##         2057-What is the intersection of the HIPAA right of access and the HITECH Act’s Medicare and Medicaid Electronic Health Record Incentive Program’s “View, Download, and Transmit” provisions?      

Under the HIPAA Privacy Rule, an individual has the right to access PHI maintained about the individual by a covered entity in a designated record set. This may contain electronic or non-electronic PHI. See 45 CFR 164.524(a)(1). Under the HITECH Act’s Electronic Health Record (EHR) Incentive Program, eligible professionals, eligible hospitals, and critical access hospitals (CAHs) may receive incentive payments under Medicare and Medicaid and avoid payment reductions under Medicare for successfully demonstrating meaningful use of Certified EHR Technology, which includes providing patients the ability to view online, download, and transmit their health information. It is important to note that in some respects the EHR Incentive Program contains more exacting standards than the baseline requirements of the HIPAA Privacy Rule, while the HIPAA Privacy Rule contains more comprehensive requirements than the EHR Incentive Program (e.g., the HIPAA Privacy Rule access right applies to electronic and paper records, while the EHR Incentive Program applies to certain electronic records).

Below are some key distinctions between the HIPAA right of access and the individual access opportunities that may be offered through the EHR Incentive Program:

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##         2058-Does an individual have a right under HIPAA to access his PHI in a particular technical standard?      

In some circumstances, an individual may request access to an electronic copy of his PHI in a particular technical standard – for example, a copy of the individual’s medication data represented in RxNorm or a lab test represented in LOINC. An individual may request PHI in a particular standard in order to use that information in other software the individual is using. If the covered entity is able to readily produce the PHI in the requested standard format, the covered entity must do so (unless the entity has a ground for denial as specified in the Privacy Rule at 45 CFR 164.524(a). (We note that individuals, in exercising their rights of access under the Privacy Rule, are not required to state their purpose for requesting access, regardless of whether or not a particular form or format for the request is specified, and an individual’s rationale for requesting access is not a reason to deny access.)

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##         2059-Do individuals have a right under HIPAA to get copies of their x-rays or other diagnostic images, and if so, in what format?      

Yes. An individual has a right to receive PHI about the individual maintained by a covered entity in a designated record set, such as a medical record. See 45 CFR 164.524(a)(1). This includes x-rays or other images in the record. As with other PHI in a designated record set, the individual has a right to access the information in the form and format she requests, as long as the covered entity can readily produce it in that form and format. See 45 CFR 164.524(c). The large file size of some x-rays or other images may impact the mechanism for access (e.g., the format agreed upon by the individual and the covered entity must accommodate the file size).

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##         2060-Do individuals have the right under HIPAA to have copies of their PHI transferred or transmitted to them in the manner they request, even if the requested mode of transfer or transmission is unsecure?      

Yes, as long as the PHI is “readily producible” in the manner requested, based on the capabilities of the covered entity and transmission or transfer in such a manner would not present an unacceptable level of security risk to the PHI on the covered entity’s systems, such as risks that may be presented by connecting an outside system, application, or device directly to a covered entity’s systems (as opposed to security risks to PHI once it has left the systems). For example, individuals generally have a right to receive copies of their PHI by mail or e-mail, if they request. It is expected that all covered entities have the capability to transmit PHI by mail or e-mail and transmitting PHI in such a manner does not present unacceptable security risks to the systems of covered entities, even though there may be security risks to the PHI once it has left the systems. Thus, a covered entity may not require that an individual travel to the covered entity’s physical location to pick up a copy of her PHI if the individual requests the copy be mailed or e-mailed. In the limited case where a covered entity is unable to e-mail the PHI as requested, such as in the case where diagnostic images are requested and e-mail cannot accommodate the file size of the images, the covered entity should offer the individual alternative means of receiving the PHI, such as on portable media that can be mailed to the individual.

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##         2061-Is a covered entity responsible if it complies with an individual’s access request to receive PHI in an unsecure manner (e.g., unencrypted e-mail) and the information is intercepted while in transit?      

No. While covered entities are responsible for adopting reasonable safeguards in implementing the individual’s request (e.g., correctly entering the e-mail address), covered entities are not responsible for a disclosure of PHI while in transmission to the individual based on the individual’s access request to receive the PHI in an unsecure manner (assuming the individual was warned of and accepted the risks associated with the unsecure transmission). This includes breach notification obligations and liability for disclosures that occur in transit. Further, covered entities are not responsible for safeguarding the information once delivered to the individual. Covered entities are responsible for breach notification for unsecured transmissions and may be liable for impermissible disclosures of PHI that occur in all contexts except when fulfilling an individual’s right of access under 45 CFR 164.524 to receive his or her PHI or direct the PHI to a third party in an unsecure manner.

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##         2062-Do individuals have a right under HIPAA to have their PHI downloaded on portable media that they provide?      

Whether PHI is “readily producible” for purposes of providing access will depend on the extent to which the requested method of copying, transfer, or transmission is within the capabilities of the covered entity and would not present an unacceptable level of risk to the security of the PHI on the covered entity’s systems, based on the covered entity’s Security Rule risk analysis.

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##         2063-Do individuals have a right under HIPAA to have a covered entity establish a direct connection between the covered entity’s system and the individual’s app or device in order to provide the individuals with access to their PHI?      

Whether PHI is “readily producible” for purposes of providing access will depend on the extent to which establishing the connection is within the capabilities of the covered entity and would not present an unacceptable level of risk to the security of the PHI on a covered entity’s systems, based on the covered entity’s Security Rule risk analysis.

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##         2064-Does an individual have a right under HIPAA to access their health information in human readable form?      

Yes. In general, a covered entity must provide an individual with access to PHI about the individual in a designated record set in the form and format requested by the individual, if it is readily producible in such form and format. In cases where the PHI is not readily producible in the requested form and format, the covered entity must provide the PHI in a readable alternative form and format as agreed to by the covered entity and the individual. See 45 CFR 164.524(c)(2). Thus, individuals have a right under HIPAA to access PHI about themselves in human readable form. In cases where a covered entity is providing an individual with an electronic copy of PHI, we also expect the covered entity to provide the copy in machine readable form (i.e., in a form able to be processed by a computer), to the extent possible and where consistent with the individual’s request.

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##         2065-Is a health care provider permitted to deny an individual’s request for access because the individual has not paid for health care services provided to the individual?      

No. A covered entity may charge an individual that has requested a copy of her PHI a reasonable, cost-based fee for the copy. See 45 CFR 164.524(c)(4). However, a covered entity may not withhold or deny an individual access to her PHI on the grounds that the individual has not paid the bill for health care services the covered entity provided to the individual.

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##         2066-If an individual’s physician orders a test from a clinical laboratory that may take multiple steps or a series of tests to complete, at what point does the test report become part of the laboratory’s designated record set to which an individual has a      

For purposes of the HIPAA Privacy Rule, clinical laboratory test reports become part of the laboratory’s designated record set when they are “complete,” which means that all results associated with an ordered test are finalized and ready for release.

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##         2067-Is a clinical laboratory required to provide an individual with access to a test report that is not yet complete?      

No. For purposes of the HIPAA Privacy Rule, clinical laboratory test reports become part of the laboratory’s designated record set when they are “complete,” which means that all results associated with an ordered test are finalized and ready for release. However, other information concerning the test may be part of the designated record set and thus, accessible to the individual, even if the test report has not yet been completed, such as test orders, ordering provider information, billing information, and insurance information.

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##         2068-If an individual requests access from a clinical laboratory to a test report on the individual, is the laboratory required to interpret the test results for the individual?      

No. There is no requirement in the HIPAA Privacy Rule that clinical laboratories interpret test results for patients. An individual has a right under the HIPAA Privacy Rule merely to inspect or receive a copy (or direct the copy to a designated third party), upon request, of the completed test reports (as well as other information in the designated record set) maintained by a laboratory that is a covered entity. Laboratories may continue to refer patients with questions about the test results back to their ordering or treating providers. However, while not required, a laboratory providing a test report to an individual that has requested access to the report may also provide educational or explanatory materials regarding the test results to individuals if it chooses to do so. Similarly, a laboratory that wishes to include a disclaimer, caveat, or other statement explaining the limitations of the laboratory data for diagnosis or treatment or other purposes may do so.

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##         2069-Under HIPAA, when can a family member of an individual access the individual’s PHI from a health care provider or health plan?      

The HIPAA Privacy Rule provides individuals with the right to access their medical and other health records from their health care providers and health plans, upon request. The Privacy Rule generally also gives the right to access the individual’s health records to a personal representative of the individual. Under the Rule, an individual’s personal representative is someone authorized under State or other applicable law to act on behalf of the individual in making health care related decisions. With respect to deceased individuals, the individual’s personal representative is an executor, administrator, or other person who has authority under State or other law to act on behalf of the deceased individual or the individual’s estate. Thus, whether a family member or other person is a personal representative of the individual, and therefore has a right to access the individual’s PHI under the Privacy Rule, generally depends on whether that person has authority under State law to act on behalf of the individual. See 45 CFR 164.502(g) and 45 CFR 164.524.

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##         2070-May a covered entity accept standing requests from individuals to access their PHI or to have their PHI sent to a third party of their choice?      

Yes, and covered entities should have processes in place that enable individuals to receive access to their PHI, including to direct a copy of their PHI to a third party of their choice, on a standing, regular basis, without requiring individuals to repeat their requests for access every time a copy of their PHI is to be sent or otherwise made accessible. Further, covered entities should take advantage of technology and tools that automate such regular access.

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