HIPAA Privacy FAQs From HHS Web Site


http://answers.hhs.gov

Q. Who must comply with these new HIPAA privacy standards?

A. As required by Congress in HIPAA, the Privacy Rule covers:

  • Health plans

  • Health care clearinghouses

  • Health care providers who conduct certain financial and administrative transactions electronically. These electronic transactions are those for which standards have been adopted by the Secretary under HIPAA, such as electronic billing and fund transfers.

These entities (collectively called "covered entities") are bound by the new privacy standards even if they contract with others (called "business associates") to perform some of their essential functions. The law does not give the Department of Health and Human Services (HHS) the authority to regulate other types of private businesses or public agencies through this regulation. For example, HHS does not have the authority to regulate employers, life insurance companies, or public agencies that deliver social security or welfare benefits. See the fact sheet and frequently asked questions on this Web site about the standards on "Business Associates" for a more detailed discussion of the covered entities' responsibilities when they engage others to perform essential functions or services for them.

Q. Generally, what does the HIPAA Privacy Rule require the average provider or health plan to do?

A. For the average health care provider or health plan, the Privacy Rule requires activities, such as:

  • Notifying patients about their privacy rights and how their information can be used.

  • Adopting and implementing privacy procedures for its practice, hospital, or plan.

  • Training employees so that they understand the privacy procedures.

  • Designating an individual to be responsible for seeing that the privacy procedures are adopted and followed.

  • Securing patient records containing individually identifiable health information so that they are not readily available to those who do not need them.

Responsible health care providers and businesses already take many of the kinds of steps required by the rule to protect patients' privacy. Covered entities of all types and sizes are required to comply with the Privacy Rule. To ease the burden of complying with the new requirements, the Privacy Rule gives needed flexibility for providers and plans to create their own privacy procedures, tailored to fit their size and needs. The scalability of the rule provides a more efficient and appropriate means of safeguarding protected health information than would any single standard. For example,

  • The privacy official at a small physician practice may be the office manager, who will have other non-privacy-related duties; the privacy official at a large health plan may be a full-time position, and may have the regular support and advice of a privacy staff or board.

  • The training requirement may be satisfied by a small physician practice's providing each new member of the workforce with a copy of its privacy policies and documenting that new members have reviewed the policies; whereas a large health plan may provide training through live instruction, video presentations, or interactive software programs.

  • The policies and procedures of small providers may be more limited under the rule than those of a large hospital or health plan, based on the volume of health information maintained and the number of interactions with those within and outside of the health care system.

Q. May physician's offices or pharmacists leave messages for patients at their homes, either on an answering machine or with a family member, to remind them of appointments or to inform them that a prescription is ready? May providers continue to mail appointment or prescription refill reminders to patients' homes?

A. Yes. The HIPAA Privacy Rule permits health care providers to communicate with patients regarding their health care. This includes communicating with patients at their homes, whether through the mail or by phone or in some other manner. In addition, the rule does not prohibit covered entities from leaving messages for patients on their answering machines. However, to reasonably safeguard the individual's privacy, covered entities should take care to limit the amount of information disclosed on the answering machine. For example, a covered entity might want to consider leaving only its name and number and other information necessary to confirm an appointment, or ask the individual to call back.

A covered entity also may leave a message with a family member or other person who answers the phone when the patient is not home. The Privacy Rule permits covered entities to disclose limited information to family members, friends, or other persons regarding an individual's care, even when the individual is not present; however, covered entities should use professional judgment to ensure that such disclosures are in the best interest of the individual and limit the information disclosed. See 45 CFR 164.510(b)(3).

In situations where a patient has requested that the covered entity communicate with him in a confidential manner, such as by alternative means or at an alternative location, the covered entity must accommodate that request, if reasonable. For example, the department considers a request to receive mailings from the covered entity in a closed envelope rather than by postcard to be a reasonable request that should be accommodated. Similarly, a request to receive mail from the covered entity at a post office box rather than at home, or to receive calls at the office rather than at home are also considered to be reasonable requests, absent extenuating circumstances. See 45 CFR 164.522(b).

Q. What is the difference between "consent" and "authorization" under the HIPAA Privacy Rule?

A. The Privacy Rule permits, but does not require, a covered entity voluntarily to obtain patient consent for uses and disclosures of protected health information for treatment, payment, and health care operations. Covered entities that do so have complete discretion to design a process that best suits their needs.

By contrast, an "authorization" is required by the Privacy Rule for uses and disclosures of protected health information not otherwise allowed by the rule. Where the Privacy Rule requires patient authorization, voluntary consent is not sufficient to permit a use or disclosure of protected health information unless it also satisfies the requirements of a valid authorization. An authorization is a detailed document that gives covered entities permission to use protected health information for specified purposes, which are generally other than treatment, payment, or health care operations, or to disclose protected health information to a third party specified by the individual. An authorization must specify a number of elements, including a description of the protected health information to be used and disclosed, the person authorized to make the use or disclosure, the person to whom the covered entity may make the disclosure, an expiration date, and, in some cases, the purpose for which the information may be used or disclosed. With limited exceptions, covered entities may not condition treatment or coverage on the individual providing an authorization.

Q. Does the HIPAA Privacy Rule require that covered entities document all oral communications?

A. No. The Privacy Rule does not require covered entities to document any information, including oral information, that is used or disclosed for treatment, payment or health care operations.

The rule includes, however, documentation requirements for some information disclosures for other purposes. For example, some disclosures must be documented in order to meet the standard for providing a disclosure history to an individual upon request. Where a documentation requirement exists in the rule, it applies to all relevant communications, whether in oral or some other form. For example, if a covered physician discloses information about a case of tuberculosis to a public health authority as permitted by the Rule at 45 CFR 164.512, then he or she must maintain a record of that disclosure regardless of whether the disclosure was made orally, by phone, or in writing.

Q. May physicians offices use patient sign-in sheets or call out the names of their patients in their waiting rooms?

A. Yes. Covered entities, such as physician's offices, may use patient sign-in sheets or call out patient names in waiting rooms, so long as the information disclosed is appropriately limited. The HIPAA Privacy Rule explicitly permits the incidental disclosures that may result from this practice, for example, when other patients in a waiting room hear the identity of the person whose name is called, or see other patient names on a sign-in sheet; however, these incidental disclosures are permitted only when the covered entity has implemented reasonable safeguards and the minimum necessary standard, where appropriate. For example, the sign-in sheet may not display medical information that is not necessary for the purpose of signing in (e.g., the medical problem for which the patient is seeing the physician). See 45 CFR 164.502(a)(1)(iii).

Q. Can a physician's office fax patient medical information to another physician's office?

A. The HIPAA Privacy Rule permits physicians to disclose protected health information to another health care provider for treatment purposes. This can be done by fax or by other means. Covered entities must have in place reasonable and appropriate administrative, technical, and physical safeguards to protect the privacy of protected health information that is disclosed using a fax machine. Examples of measures that could be reasonable and appropriate in such a situation include the sender confirming that the fax number to be used is in fact the correct one for the other physician's office, and placing the fax machine in a secure location to prevent unauthorized access to the information. See 45 CFR164.530(c).

Q. Are health care providers required by the HIPAA Privacy Rule to post their entire notice at their facility or may they post just a brief description of the notice?

A. Covered health care providers that maintain an office or other physical site where they provide health care directly to individuals are required to post their entire notice at the facility in a clear and prominent location. The Privacy Rule, however, does not prescribe any specific format for the posted notice, just that it include the same information that is distributed directly to the individual. Covered health care providers have discretion to design the posted notice in a manner that works best for their facility, which may be to simply post a copy of the pages of the notice that is provided directly to individuals.

Q. Does the HIPAA Privacy Rule require a business associate to provide individuals with access to their protected health information or an accounting of disclosures, or an opportunity to amend protected health information?

A. The Privacy Rule regulates covered entities, not business associates. The 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. Covered entities are responsible for fulfilling Privacy Rule requirements with respect to individual rights, including the rights of access, amendment, and accounting, as provided for by 45 CFR 164.524, 164.526, and 164.528. With limited exceptions, a covered entity is required to provide an individual access to his or her protected health information in a designated record set. This includes information in a designated record set of a business associate, unless the information held by the business associate merely duplicates the information maintained by the covered entity. Therefore, the Rule requires covered entities to specify in the business associate contract that the business associate must make such protected health information available if and when needed by the covered entity to provide an individual with access to the information. However, the Privacy Rule does not prevent the parties from agreeing through the business associate contract that the business associate will provide access to individuals, as may be appropriate where the business associate is the only holder of the designated record set, or part thereof.

Under 45 CFR 164.526, a covered entity must amend protected health information about an individual in a designated record set, including any designated record sets (or copies thereof) held by a business associate. Therefore, the rule requires covered entities to specify in the business associate contract that the business associate must amend protected health information in such records (or copies) when requested by the covered entity. The covered entity itself is responsible for addressing requests from individuals for amendment and coordinating such requests with its business associate. However, the Privacy Rule also does not prevent the parties from agreeing through the contract that the business associate will receive and address requests for amendment on behalf of the covered entity.

Under 45 CFR 164.528, the Privacy Rule requires a covered entity to provide an accounting of certain disclosures, including certain disclosures by its business associate, to the individual upon request. The business associate contract must provide that the business associate will make such information available to the covered entity in order for the covered entity to fulfill its obligation to the individual. As with access and amendment, the parties can agree through the business associate contract that the business associate will provide the accounting to individuals, as may be appropriate given the protected health information held by, and the functions of, the business associate.

Q. Does the HIPAA Privacy Rule allow parents the right to see their children's medical records?

A. 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.

There are three situations when the parent would not be the minor's personal representative under the Privacy Rule. These exceptions are: (1) when the minor is the one who consents to care and the consent of the parent is not required under state or other applicable law; (2) when the minor obtains care at the direction of a court or a person appointed by the court; and (3) when, and to the extent that, the parent agrees that the minor and the health care provider may have a confidential relationship. Even in these exceptional situations, however, the parent may have access to the medical records of the minor related to this treatment when state or other applicable law requires or permits such parental access. Parental access would be denied when state or other law prohibits such access. If state or other applicable law is silent on a parent's right of access in these cases, the licensed health care provider may exercise his or her professional judgment to the extent allowed by law to grant or deny parental access to the minor's medical information.

Finally, as is the case with respect to all personal representatives under the Privacy Rule, a provider may choose not to treat a parent as a personal representative when the provider reasonably believes, in his or her professional judgment, that the child has been or may be subjected to domestic violence, abuse or neglect, or that treating the parent as the child's personal representative could endanger the child.

Q. A clinic customarily places patient charts in the plastic box outside an exam room. It does not want the record left unattended with the patient, and physicians want the record close by for fast review right before they walk into the exam room. Will the HIPAA Privacy Rule allow the clinic to continue this practice?

A. Yes, the Privacy Rule permits this practice as long as the clinic takes reasonable and appropriate measures to protect the patient's privacy. The physician or other health care professionals use the patient charts for treatment purposes. Incidental disclosures to others that might occur as a result of the charts being left in the box are permitted, if the minimum necessary and reasonable safeguards requirements are met. See 45 CFR 164.502(a)(1)(iii). As the purpose of leaving the chart in the box is to provide the physician with access to the medical information relevant to the examination, the minimum necessary requirement would be satisfied. Examples of measures that could be reasonable and appropriate to safeguard the patient chart in such a situation would be limiting access to certain areas, ensuring that the area is supervised, escorting non-employees in the area, or placing the patient chart in the box with the front cover facing the wall rather than having protected health information about the patient visible to anyone who walks by. Each covered entity must evaluate what measures are reasonable and appropriate in its environment. Covered entities may tailor measures to their particular circumstances. See 45 CFR 164.530(c).

Q. Is a physician required to give her notice to every patient or can she just post the notice in her waiting room and give a copy to those patients who ask for it?

A. The HIPAA Privacy Rule requires a covered health care provider with direct treatment relationships with individuals to give the notice to every individual no later than the date of first service delivery to the individual and to make a good faith effort to obtain the individual's written acknowledgment of receipt of the notice. If the provider maintains an office or other physical site where she provides health care directly to individuals, the provider must also post the notice in the facility in a clear and prominent location where individuals are likely to see it, as well as make the notice available to those who ask for a copy. See 45 CFR 164.520(c) for other notice provision requirements.

Q. What does the HIPAA Privacy Rule do?

A. Most health plans and health care providers that are covered by the new rule must comply with the new requirements by April 14, 2003.

The HIPAA Privacy Rule for the first time creates national standards to protect individuals' medical records and other personal health information.

  • It gives patients more control over their health information.

  • It sets boundaries on the use and release of health records.

  • It establishes appropriate safeguards that health care providers and others must achieve to protect the privacy of health information.

  • It holds violators accountable, with civil and criminal penalties that can be imposed if they violate patients' privacy rights.

  • And it strikes a balance when public responsibility supports disclosure of some forms of data—for example, to protect public health.

For patients, it means being able to make informed choices when seeking care and reimbursement for care based on how personal health information may be used.

  • It enables patients to find out how their information may be used, and about certain disclosures of their information that have been made.

  • It generally limits release of information to the minimum reasonably needed for the purpose of the disclosure.

  • It generally gives patients the right to examine and obtain a copy of their own health records and request corrections.

  • It empowers individuals to control certain uses and disclosures of their health information.

Q. Does a physician need a patient's written authorization to send a copy of the patient's medical record to a specialist or other health care provider who will treat the patient?

A. No. The HIPAA Privacy Rule permits a health care provider to disclose protected health information about an individual, without the individual's authorization, to another health care provider for that provider's treatment of the individual. See 45 CFR 164.506 and the definition of "treatment" at 45 CFR 164.501.

Q. When is a health care provider a business associate of another health care provider?

A. The HIPAA Privacy Rule explicitly excludes from the business associate requirements disclosures by a covered entity to a health care provider for treatment purposes. See 45 CFR 164.502(e)(1). Therefore, any covered health care provider (or other covered entity) may share protected health information with a health care provider for treatment purposes without a business associate contract. However, this exception does not preclude one health care provider from establishing a business associate relationship with another health care provider for some other purpose. For example, a hospital may enlist the services of another health care provider to assist in the hospital's training of medical students. In this case, a business associate contract would be required before the hospital could allow the health care provider access to patient health information.

Q. Is a business associate contract required with organizations or persons where inadvertent contact with protected health information may result—such as in the case of janitorial services?

A. A business associate contract is not required with persons or organizations whose functions, activities, or services do not involve the use or disclosure of protected health information, and where any access to protected health information by such persons would be incidental, if at all. Generally, janitorial services that clean the offices or facilities of a covered entity are not business associates, because the work they perform for covered entities does not involve the use or disclosure of protected health information, and any disclosure of protected health information to janitorial personnel that occurs in the performance of their duties (such as may occur while emptying trash cans) is limited in nature, occurs as a by-product of their janitorial duties, and could not be reasonably prevented. Such disclosures are incidental and permitted by the HIPAA Privacy Rule. See 45 CFR 164.502(a)(1).

If a service is hired to do work for a covered entity where disclosure of protected health information is not limited in nature (such as routine handling of records or shredding of documents containing protected health information), it likely would be a business associate. However, when such work is performed under the direct control of the covered entity (e.g., on the covered entity's premises), the Privacy Rule permits the covered entity to treat the service as part of its workforce, and the covered entity need not enter into a business associate contract with the service.