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Check your eligibility and submit your application by October 26, Azar, No. Any provision within this guidance that has been vacated by the Ciox Health decision is rescinded. Providing individuals with easy access to their health information empowers them to be more in control of decisions regarding their health and well-being.

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. 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.

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 ; 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 Need to release w deated record set.

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An individual does not have a right to access PHI that is not part of a deated record set because the Need to release w is not used to make decisions about individuals. 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 A covered entity may require individuals to request access in writing, provided the covered entity informs individuals of this requirement.

Covered entities also may offer individuals the option of using electronic means e. The Privacy Rule requires a covered entity to take reasonable steps to verify the identity of an individual making a request for access. For those covered entities providing individuals with access to their PHI through web portals, those portals should already be set up with appropriate authentication controls, as required by 45 CFR While the Privacy Rule allows covered entities to require that individuals request access in writing and requires verification of the identity of the person requesting access, a covered entity may not impose unreasonable measures on an individual requesting access that serve as barriers to or unreasonably delay the individual from obtaining access.

For example, a doctor may not require an individual:. While a covered entity may not require individuals to request access in these manners, a covered entity may permit an individual to do so, and covered entities are encouraged to offer individuals multiple options for requesting access. The Privacy Rule requires a covered entity to provide the individual with access to the PHI in the form and format requested, if readily producible in that form and format, or if not, in a readable hard copy form or other form and format as agreed to by the covered entity and individual.

If the individual requests electronic access to PHI that the covered entity maintains electronically, the covered entity must provide the individual with access to the information in the requested electronic form and format, if it is readily producible in that form and format, or if not, in an agreed upon alternative, readable electronic format. The covered entity also may provide the individual with a summary of the PHI requested, in lieu of providing access to the PHI, or may provide an explanation of the PHI to which access has been provided in addition to that PHI, so long as the individual in advance: 1 chooses to receive the summary or explanation including in the electronic or paper form being offered by the covered entity ; and 2 agrees to any fees as explained below in the Section describing permissible Fees for Copies that may be charged by the covered entity for the summary or explanation.

A covered entity also must provide access in the manner requested by the individual, which includes arranging with the individual for a convenient time and place to pick up a copy of the PHI or to inspect the PHI if Need to release w is the manner of access requested by the individualor to have a copy of the PHI mailed or e-mailed, or otherwise transferred or transmitted to the individual to the extent the copy would be readily producible in such a manner.

However, mail and e-mail are generally considered readily producible by all covered entities. It is expected that all covered entities have the capability to transmit PHI by mail or e-mail except in the limited case where e-mail cannot accommodate the file size of requested imagesand 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 while in transit such as where an individual has requested to receive her PHI by, and accepted the risks associated with, unencrypted e-mail.

The 30 calendar days is an outer limit and covered entities are encouraged to respond as soon as possible. Indeed, a covered entity may have the capacity to provide individuals with almost instantaneous or very prompt electronic access to the PHI requested through personal health records, web portals, or similar electronic means.

Further, individuals may reasonably expect Need to release w covered entity to be able to respond in a much faster timeframe when the covered entity is using health information technology in its day to day operations. If a covered entity is unable to provide access within 30 calendar days -- for example, where the information is archived offsite and not readily accessible -- the covered entity may extend the time by no more than an additional 30 days.

To extend the time, the covered entity must, within the initial 30 days, inform the individual in writing of the reasons for the delay and the date by which the covered entity will provide access. Only one extension is permitted per access request. The Privacy Rule permits a covered entity to impose a reasonable, cost-based fee if the individual requests a copy of the PHI or agrees to receive a summary or explanation of the information.

The fee may include only the cost of: 1 labor for copying the PHI requested by the individual, whether in paper or electronic form; 2 supplies for creating the paper copy or electronic media e. The fee may not include costs associated with verification; documentation; searching for and retrieving the PHI; maintaining systems; recouping capital for data access, storage, or infrastructure; or other costs not listed above even if such costs are authorized by State law.

In some of these circumstances, an individual has a right to have the denial reviewed by a d health care professional deated by the covered entity who did not participate in the original decision to deny. Reviewable grounds for denial 45 CFR A d health care professional has determined in the exercise of professional judgment that:.

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In addition, a covered entity may not Need to release w access because a business associate of the covered entity, rather than the covered entity itself, maintains the PHI requested by the individual e. If the covered entity denies access, in whole or in part, to PHI requested by the individual, the covered entity must provide a denial in writing to the individual no later than within 30 calendar days of the request or no later than within 60 calendar days if the covered entity notified the individual of an extension.

If the covered entity or one of its business associates does not maintain the PHI requested, but knows where the information is maintained, the covered entity must inform the individual where to direct the request for access. The covered entity must, to the extent possible and within the above timeframes, provide the individual with access to any other PHI requested, after excluding the PHI to which the entity has a ground to deny access.

Complexity in segregating the PHI does not excuse the obligation to provide access to the PHI to which the ground for denial does not apply. If the denial was based on a reviewable ground for denial and the individual requests review, the covered entity must promptly refer the request to the deated reviewing official. The reviewing official must determine, within a reasonable period of time, whether to reaffirm or reverse the denial. The covered entity must then promptly provide written notice to the individual of the determination of the reviewing official, as well as take other action as necessary to carry out the determination.

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An individual also has a right to direct the covered entity to transmit the PHI about the individual directly to another person or entity deated by the individual. A covered entity may accept an electronic copy of a ed request e.

The same requirements for providing the PHI to the individual, such as Need to release w fee limitations and requirements for providing the PHI in the form and format and manner requested by the individual, apply when an individual directs that the PHI be sent to another person.

For example, a covered entity subject to a State law that requires that access to PHI be provided to an individual in a shorter time frame than that required in the Privacy Rule must provide such access within the shorter time frame because the State law is not contrary to the Privacy Rule. Yes, but only within specific limits. The fee may include only the cost of certain labor, supplies, and postage:.

Thus, costs associated with updates to or maintenance of systems and data, capital for data storage and maintenance, labor associated with ensuring compliance with HIPAA and other applicable law in fulfilling the access request e. Further, while the Privacy Rule permits the limited fee described above, covered entities should provide individuals who request access to their information with copies of their PHI free of charge. While covered entities should forgo fees for all individuals, not charging fees for access is particularly vital in cases where the financial situation of an individual requesting access would make it difficult or impossible for the individual to afford the fee.

Providing individuals with access to their health information is a necessary component of delivering and paying for health care. We will continue to monitor whether the fees that are being charged to individuals are creating barriers to this access, will take enforcement action where necessary, and will reassess as necessary the provisions in the Privacy Rule that permit these fees to be charged.

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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 Need to release w in advance both chooses to receive an Need to release w or summary and agrees to the fee that may be charged.

For example, labor for copying may include labor associated with the following, as necessary to copy and deliver the PHI in the form and format and manner requested or agreed to by the individual:. While we allow labor costs for these limited activities, we note that as technology evolves and processes for converting and transferring files and formats become more automated, we expect labor costs to disappear or at least diminish in many cases.

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. 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.

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. 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 arrangedinform 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. 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.

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.

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. In some cases where an entity chooses generally to use the average cost method, or chooses a flat fee, as described above, for electronic copies of PHI maintained electronically, the entity may receive an unusual or uncommon type of request that it had not considered in setting up its fee structure.

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In these cases, the entity may wish to calculate actual costs to provide the requested copy, and it may do so as long as the costs are reasonable and only of the type permitted by the Privacy Rule. An entity that chooses to calculate actual costs in these circumstances still must—as in other cases—inform the individual in advance of the approximate fee that may be charged for providing the copy requested. No, except in cases where the State authorized costs are the same types of costs permitted under 45 CFR Thus, labor e.

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In addition, many States with authorized fee structures have not updated their laws to for efficiencies that exist when generating Need to release w of information maintained electronically. 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. 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 only certain 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. 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. In contrast, third parties often will directly request PHI from a covered entity and submit a written HIPAA authorization from the individual or rely on another permission in the Privacy Rule for that disclosure.

We note that a covered entity or a business associate may not circumvent the access fee limitations by treating individual requests for access like other HIPAA disclosures — such as by having an individual fill out a HIPAA authorization when the individual requests access to her PHI including to direct a copy of the PHI to a third party. As explained elsewhere in the guidance, a HIPAA authorization is not required for individuals to request access to their PHI, including to direct a copy to a third party — and because a HIPAA authorization requests more information than is necessary or that may not be relevant for individuals to exercise their access rights, requiring execution of a HIPAA authorization may create impermissible obstacles to the exercise of this right.

Where it is unclear to a covered entity, based on the form of a request sent by a third party, whether the request is an access request initiated by the individual or merely a HIPAA authorization by the individual to disclose PHI to the third party, the entity may clarify with the individual whether the request was a direction from the individual or a request from the third party. OCR is open to engaging with the community on ways that technology could easily convey this information. Finally, we note that disclosures to a third party made outside of the right of access under other provisions of the Privacy Rule still may be subject to the prohibition against sales of PHI i.

Where the prohibition applies, a covered entity may charge only a reasonable, cost-based fee to cover the cost to prepare and transmit the PHI or a fee otherwise expressly permitted by other law or must have received a HIPAA authorization from the individual that states that the disclosure will involve remuneration to the covered entity. 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 deated 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. 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.

Further, a covered entity may not charge an individual who, while inspecting her PHI, takes notes, uses a smart phone or other device to take pictures of the PHI, or uses other personal resources to capture the information. If the individual is making the copies of PHI using her own resources, the covered entity may not charge a fee for those copies, as the copying is being done by the individual and not the entity.

The same requirements for providing the PHI to the individual, such as the timeliness requirements, fee limitations, prohibition on imposing unreasonable measures, and form and format requirements, apply when an individual directs that the PHI be sent to another person or entity. As a result:. Further, the same limited grounds for denial of access that apply when the individual is receiving the PHI directly apply in cases where the individual requests that the PHI be provided to a deated third party.

The provisions of the Privacy Rule providing for review of certain denials of access apply in this circumstance as well. Covered Need to release w may rely on the information provided in writing by the individual about the identity of the deated person and where to send the PHI for purposes of verification of the deated third party as an authorized recipient.

In addition, except in the limited circumstance described below, covered entities must safeguard the information in transit, and are responsible for breach notification and may be liable for impermissible disclosures of PHI that occur in transit. The only exception arises when an individual has requested that the PHI be sent to the third party by unencrypted e-mail or in another unsecure Need to release w, which the individual has a right to request. As long as the individual was warned of and accepted the security risks to the PHI associated with the unsecure transmission, the covered entity is not responsible for breach notification or liable for disclosures that occur in transit.

Further, the covered entity is not liable for what happens to the PHI once the deated third party receives the information as directed by the individual in the access request. 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 deated third party receives the information as directed by the individual in the access request.

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.

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