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Individuals’ Right Under HIPAA To Access Their Health Information 45 CFR § 164.524
A section at the end of the chapter also describes the relationships between HIPAA and other federal and state laws. Because a great deal of health research in the United States is also subject to the Common Rule described in Chapter 3 , disparities between these two federal rules are also noted where relevant throughout the chapter. It was intended to make health care delivery more efficient and to increase the number of Americans with health insurance coverage. These objectives were pursued through three main provisions of the Act: 1 the portability provisions, 2 the tax provisions, and 3 the administrative simplification provisions. The portability provisions also aimed to reduce the number of unemployed or self-employed individuals without health insurance by making it easier for individuals to purchase health insurance without their employer. Similarly, the tax provisions of HIPAA were also intended to make it easier for individuals to maintain health insurance.- The tax provisions pursued this goal by modifying existing tax laws to make health insurance more affordable. HIPAA does not regulate the price of health insurance, but rather, it relies on tax breaks and other tax incentives to reduce health care costs Chaikind et al. Department of Health and Human Services HHS to issue several regulations concerning the electronic transmission of health information. These provisions were included in the final version of HIPAA because health plans had requested federal legislation in this area from Congress. The use of electronic health information was expanding in the early s, and the health care industry was unable to standardize the process and use of electronic health information without federal action.
- The Act instructed the Secretary of HHS to develop nationwide security standards and safeguards for the use of electronic health care information. The resulting HHS regulations spell out specific administrative, technical, and physical security procedures that healthcare plans, providers and clearinghouses must incorporate into their operations to prevent unauthorized access, use, and disclosure of protected health information CMS, Health plans and providers were required to be in compliance with these measures by April see Box The administrative simplification provisions of HIPAA also directed the Secretary to develop standards for unique health identifiers for patients, employers, health plans, and providers.
- Unique health identifiers are national numbers that could be used to identify the individual or organization in standard health transactions. However, Congress has prevented CMS from implementing a standard for the unique health identifier for patients by inserting language into the annual appropriations bill every year since HIPAA was enacted Chaikind et al. Finally, the administrative simplification provisions of HIPAA mandated the creation of privacy standards for the protection of personally identifiable medical information. Although privacy protections were not a primary objective of the Act, Congress recognized that advances in electronic technology could erode the privacy of health information, and included the privacy provision in HIPAA IOM, In accordance with the administrative simplification provisions, HHS developed the Privacy Rule, which constitutes a broad-ranging federal health privacy regulation see Table Incorporating many of the basic fair information practices, 2 the Privacy Rule generally restricts the use or disclosure of protected health information, except as permitted by the individual or as authorized or required by the Privacy Rule.
- As a result, Congress passed the responsibility of creating health privacy protections to HHS. First, HHS issued a proposed version of the Privacy Rule for public comment on November 3, , that drew more than 50, comments Stevens, Health care insurers and providers were concerned that the Privacy Rule would make health care industry operations less efficient. They were particularly concerned about the requirement that they obtain authorization prior to making any routine disclosure of personally identifiable health information for health care operations, treatment, or payment. The comments received also suggested that this version of the Privacy Rule would prevent pharmacists from filling prescriptions and searching for potential drug interactions before patients arrived at pharmacies; interfere with providing emergency medicine in situations where it would be impossible to obtain patient authorization before treatment; and delay the scheduling and preparation of hospital procedures until the doctor could obtain patient authorization.
- This version of the Privacy Rule drew more than 24, comments. Incorporating the suggestions collected through the second notice of proposed rule-making period, HHS issued the final version of the Privacy Rule in August 14, Most health care providers and health plans were required to be in compliance with this version of the Privacy Rule by April 14, Small health plans were given until April 14, , to be in compliance.
- Covered entities include health care providers, health plans, and health care clearinghouses. Health plans are entities that provide or pay the cost of medical care, such as private health insurers or managed care organizations, and governmental payors and health programs such as Medicaid, Medicare, or Veterans Affairs. Health care clearinghouses generally refer to billing services, and health care providers include hospitals, doctors, and other health care professionals and facilities that provide treatment Table For example, if a university includes an academic medical center with a hospital, the entire university will be classified as a covered entity unless the university elects to be a hybrid entity by designating only the hospital as the health care component.
- By doing this, only the hospital has to comply with the Privacy Rule. The classification of researchers within a hybrid entity depends on the nature of the work performed e. Type of Information Protected The Privacy Rule protects all personally identifiable health information, known as protected health information PHI , created or received by a covered entity. It also does not apply to information that has been deidentified in accordance with the Privacy Rule 12 see later section on Deidentified Information.
- A covered entity must obtain assurances in writing that the business associate will: 1 use the information only for the purposes for which it was engaged by the covered entity; 2 safeguard the information from misuses; more In the case of public health practice, the Privacy Rule notes that there is a legitimate need for public health authorities and others working to ensure the health and safety of the public to have access to PHI.
- As a result, the Privacy Rule permits, but does not require, 22 covered entities to disclose PHI without authorization for specified public health purposes Box Disclosures for research are discussed in detail in subsequent sections of this chapter. Examples of such use of information include … the transfer of information from a health plan to an organization for the sole purpose of conducting health care-related research. Congress, a , b. One option considered was exempting PHI used in research from the regulations, but HHS rejected this option, noting some reported shortcomings of the protection of the privacy and confidentiality of health information in research reviewed by Pritts, General Accounting Office report prepared in anticipation of federal health privacy legislation noted that confidentiality protections were not a major thrust of the Common Rule , and oversight boards tended to give confidentiality less attention than other research risks because they had the flexibility to decide when it was appropriate to review confidentiality protection issues GAO, HHS also considered requiring researchers to obtain individual authorization in all situations where a covered entity might want to disclose PHI for research.
- But this option would have made many research projects nearly impossible to carry out. Instead, HHS created the current system, which attempted to protect individual privacy while still allowing researchers access to data. In proposing the Privacy Rule, HHS acknowledged that ideally, it would have preferred to directly regulate researchers by extending the protections of the Common Rule to nonfederally funded research and imposing additional criteria for the waiver of authorization in research. The following sections provide a detailed overview of the Privacy Rule provisions regulating research, along with comparisons to the provisions of the Common Rule see Chapter 3 for a general overview of the Common Rule. Research Uses and Disclosures with Individual Authorization Individuals may voluntarily authorize the use and disclosure of their PHI for essentially any reason, including for research purposes.
- The authorization must also be written in plain language, and contain core elements e. In contrast, informed consent describes the potential risks and benefits of research and seeks permission to involve the subject, although it also provides research participants with a description of how the confidentiality of the research records will be protected. In contrast, under the Common Rule , IRBs are required to review and approve informed consent documents for human subjects research. However, if the authorization is combined in the same document as the informed consent document, then IRB approval must be sought for the combination HHS, c. The Common Rule requires IRBs to review research projects involving human subjects for risk of harm to the subjects and to ensure that the more Authorization of Future Research Under the Common Rule , it is permissible to obtain patient consent for future research with biological samples or information stored in databases, with oversight by an IRB, if such future uses are described in sufficient detail to allow an informed consent.
- Historically, IRBs typically have tried to craft informed consent language on a case-by-case basis to allow for some measure of consent to future, largely unspecified research uses, but also to require some level of detail with respect to the categories of types of uses of the information or specimens, and to emphasize confidentiality protections for identified data and tissues Barnes and Heffernan, For example, a consent form may specify that the tissue will be kept for research to learn about, prevent, or treat the type of cancer that affects the subject. However, such language is too general to comply with the more stringent HIPAA authorization requirements. For example, the creation and maintenance of a biospecimen bank or database is considered a specific research activity under the Privacy Rule, but authorization for any future studies undertaken with the data or materials cannot be sought at the time of collection.
- However, the process of recontacting individuals whose biospecimens are stored to obtain consent for each and every research project for which the samples could be used is widely viewed as impractical, if not impossible, especially as more and more samples are collected. This situation can be quite problematic for studies using stored biological samples Barnes and Heffernan, ; Bledsoe, ; Rosati, ; Rothstein, However, the committee recommends that this discordance between the Privacy Rule and the Common Rule be eliminated through guidance explicitly stating that future research may go forward if the authorization describes the types or categories of research that may be conducted with the PHI stored in a biospecimen bank or database, and if an IRB or Privacy Board determines that the proposed new research is not incompatible with the initial consent and authorization and poses no greater than minimal risk to the privacy of individuals Wendler, Future consent for research is ethically valid if appropriate security measures are in place, donors have the right to withdraw consent, and new studies are reviewed and approved by an IRB or Privacy Board Hansson et al.
- Furthermore, a prohibition on future consent actually limits individual autonomy. If individuals desire to authorize the use of their PHI for future research, they should be able to do so. HHS came to this conclusion through a complex series of interpretive steps reviewed by Rosati, First, it is generally not permissible to condition treatment on the provision of an authorization, although the Privacy Rule does permit a covered entity to condition treatment in a clinical trial on signing an authorization. Thus, HHS has determined that the two authorizations cannot be combined in one form unless the form has separate signature lines for each authorization, and the text clearly delineates the two activities and states that the participant is not required to sign the portion authorizing the contribution of PHI to the repository.
- Ideally, all relevant information pertaining to authorization should be integrated into one simple document, but there is much confusion about these complex provisions of the HIPAA Privacy Rule Rosati, Some institutions require two complete authorization forms with all the attendant language rather than two signature lines on the same form. The excess paperwork that results is burdensome for patients, can reduce the informed nature of authorization by confusing patients, and may reduce patient participation in research.
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The committee believes that guidance from HHS to clearly indicate that a single authorization form with two signature lines is permissible in such circumstances would reduce variability and increase the informed nature of authorization. It also recognized the potential for selection bias see Box when authorization is required. In light of these factors, HHS concluded that there were circumstances under which it is appropriate to disclose PHI for research without authorization. A complete waiver of authorization means that no authorization is required for the covered entity to use and disclose PHI.HIPAA And Privacy Act Training ( Hrs) Pretest Test — I Hate CBT's
A partial waiver means that the IRB or Privacy Board determined that a covered entity does not need authorization for the uses and disclosure of the PHI for one part of a research project, but does need to obtain authorization from patients for another part of the project. However, if only a partial waiver of authorization is granted, the researchers will need to obtain HIPAA authorization before the PHI for each individual patient is used for the research project. An IRB or Privacy Board may also approve a request for an alteration that removes some, but not all, required elements of an authorization, using the same criteria for a waiver of authorization.- The final and codified provisions above share only some of the language used in the Common Rule 40 to determine whether it is allowable to alter the elements of informed consent or to waive the requirement of obtaining informed consent. This difference can create a challenge for the IRB decision-making process Rothstein, One focus group study indicated that patients may find it appropriate to consider two factors in determining whether it is practicable to conduct the research without the waiver of authorization: whether having to contact each patient first would 1 make the study less scientifically valid or 2 make the results less useful in improving medical care i. There are also no clear standards regarding what constitutes adequate protection of privacy, or what constitutes a minimal risk to privacy.
- The concept of minimal risk implies that there is a risk threshold, above which protections should be stricter. However, clearly defining the threshold is problematic. If the current waiver criteria are to be retained, the IOM committee believes that a clear and reasonable definition of practicability, along with specific case examples of what should or should not be considered impracticable or of minimal risk, could perhaps reduce variability and overly conservative interpretation of these provisions. Simplification or clarification of the waiver criteria would be especially helpful for multi-institutional studies, which fall under the jurisdiction of multiple IRBs or Privacy Boards. Covered entities are permitted to rely on a waiver of authorization approved by a single IRB or Privacy Board with jurisdiction. However, covered entities often decide to require approval from their own IRB or Privacy Board prior to disclosing PHI to the requesting researcher, regardless of whether another IRB or Privacy Board already granted a waiver of authorization.
- This leads to delays and variability in the protocol at different sites see also Chapter 5. Simplification would also be very helpful for smaller or community-based institutions that do not have internal counsel or regulatory affairs specialists, and are thus more likely to opt out of research that requires decisions about authorizations.
- 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.
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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.- 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. 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.
- 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. Covered entities also may offer individuals the option of using electronic means e. Verification The Privacy Rule requires a covered entity to take reasonable steps to verify the identity of an individual making a request for access.
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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 Unreasonable Measures 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.Standardized Testing: HIT Pro Exams Test Competencies In Health IT Roles
To use a web portal for requesting access, as not all individuals will have ready access to the portal. Providing Access Form and Format and Manner of 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. Thus: Requests for Paper Copies — Where an individual requests a paper copy of PHI maintained by the covered entity either electronically or on paper, it is expected that the covered entity will be able to provide the individual with the paper copy requested.- Requests for Electronic Copies— Where an individual requests an electronic copy of PHI that a covered entity maintains only on paper, the covered entity is required to provide the individual with an electronic copy if it is readily producible electronically e. Where an individual requests an electronic copy of PHI that a 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.
- When the PHI is not readily producible in the electronic form and format requested, then the covered entity must provide access to an agreed upon alternative readable electronic format. This means that, while a covered entity is not required to purchase new software or equipment in order to accommodate every possible individual request, the covered entity must have the capability to provide some form of electronic copy of PHI maintained electronically. 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 that is the manner of access requested by the individual , or 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 images , 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 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 a 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. Fees for Copies 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 licensed health care professional designated by the covered entity who did not participate in the original decision to deny.
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Unreviewable grounds for denial 45 CFR An inmate requests a copy of her PHI held by a covered entity that is a correctional institution, or health care provider acting under the direction of the institution, and providing the copy would jeopardize the health, safety, security, custody, or rehabilitation of the inmate or other inmates, or the safety of correctional officers, employees, or other person at the institution or responsible for the transporting of the inmate. However, in these cases, an inmate retains the right to inspect her PHI. The requested PHI is in a designated record set that is part of a research study that includes treatment e.
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