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The federal standards for the protection of health information. The federal rules for Medicaid payments. The state rules for Medicaid. All of the above 3. A covered entity CE must have an established complaint process. True 4. The e-Government Act...

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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...

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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. 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.

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Read the full answer Do individuals have a right under HIPAA to get copies of their x-rays or other diagnostic images, and if so, in what format? 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. 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. The large file size of some x-rays or other images may impact the mechanism for access e.

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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 This may contain electronic or non-electronic PHI. 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.

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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.

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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. 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 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.

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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. 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.

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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. 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.

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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. Read the full answer Under the EHR Incentive Program, participating providers are required to provide individuals with access to certain information on much faster timeframes e.

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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. 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 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.

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Read the full answer Does an individual have a right under HIPAA to access more than just test results from a clinical laboratory? 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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Read the full answer Does an individual have a right under HIPAA to access from a clinical laboratory the genomic information the laboratory has generated about the individual? 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.

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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. 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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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. Read the full answer Does the individual have a right to access PHI about themselves maintained by a covered entity that is very old or is archived? 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.

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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. Read the full answer What personal health information do individuals have a right under HIPAA to access from their health care providers and health plans? 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. 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.

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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. 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. However, if the individual requested that the covered entity transmit the PHI in an unsecure manner e. 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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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. A covered entity may accept an electronic copy of a signed request e. Read the full answer Can an individual be charged a fee if the individual requests only to inspect her PHI at the covered entity i. 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.

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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.

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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. 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.

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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. Read the full answer 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. No, so the health care provider must comply with the State law and provide the one free copy. 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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No, except in cases where the State authorized costs are the same types of costs permitted under 45 CFR Thus, labor e. 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. 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.

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Read the full answer How can covered entities calculate the limited fee that can be charged to individuals to provide them with a copy of their 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. Read the full answer Must a covered entity inform individuals in advance of any fees that may be charged when the individuals request a copy of their PHI?

Individuals’ Right under HIPAA to Access their Health Information 45 CFR § 164.524

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.

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Azar, No. Any provision within this guidance that has been vacated by the Ciox Health decision is rescinded. For example, individuals with access to their health information are better able to monitor chronic conditions, adhere to treatment plans, find and fix errors in their health records, track progress in wellness or disease management programs, and directly contribute their information to research. With the increasing use of and continued advances in health information technology, individuals have ever expanding and innovative opportunities to access their health information electronically, more quickly and easily, in real time and on demand. With limited exceptions, the HIPAA Privacy Rule the Privacy Rule provides individuals with a legal, enforceable right to see and receive copies upon request of the information in their medical and other health records maintained by their health care providers and health plans.

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Individuals have a right to access this PHI for as long as the information is maintained by a covered entity, or by a business associate on behalf of a covered entity, regardless of the date the information was created; whether the information is maintained in paper or electronic systems onsite, remotely, or is archived; or where the PHI originated e. This last category includes records that are used to make decisions about any individuals, whether or not the records have been used to make a decision about the particular individual requesting access.

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Thus, individuals have a right to a broad array of health information about themselves maintained by or for covered entities, including: medical records; billing and payment records; insurance information; clinical laboratory test results; medical images, such as X-rays; wellness and disease management program files; and clinical case notes; among other information 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. Information Excluded from the Right of Access An individual does not have a right to access PHI that is not part of a designated record set because the information is not used to make decisions about individuals.

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This may include certain quality assessment or improvement records, patient safety activity records, or business planning, development, and management records that are used for business decisions more generally rather than to make decisions about individuals. See 45 CFR Information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding. Requests for Access Requiring a Written Request A covered entity may require individuals to request access in writing, provided the covered entity informs individuals of this requirement.

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