LII:HIPAA Compliance - LII 007 04. Use and Disclosure
Permitted uses and disclosures
According to the United States Department of Health and Human Services (HHS), a covered entity (CE) is permitted, but not required, to use and disclose PHI, without an individual’s authorization, for any of the following purposes or situations:
- to provide or reveal to the affected individual, unless required for access or accounting of disclosures
- for treatment, payment, and health care operations
- as an opportunity to agree or object
- as incidental to an otherwise permitted use and disclosure
- in the case of public interest and benefit activities
- as a limited data set for the purposes of research, public health or health care operations
Covered entities may rely on professional ethics and best judgments in deciding which of these permissive uses and disclosures to make. These permissive uses are detailed further below.
To the individual
This is pretty straightforward. A CE may disclose PHI to the individual who is the subject of the information.
Treatment, payment, and healthcare operations:
- the provision, coordination, or management of healthcare and related services for an individual by one or more healthcare providers, including consultation between providers regarding a patient and referral of a patient by one provider to another
- activities of a health plan to obtain premiums, determine or fulfill responsibilities for coverage and provision of benefits, and furnish or obtain reimbursement for healthcare delivered to an individual and activities of a healthcare provider to obtain payment or be reimbursed for the provision of healthcare to an individual
- Healthcare operations
- any of the following activities: (a) quality assessment and improvement activities, including case management and care coordination; (b) competency assurance activities, including provider or health plan performance evaluation, credentialing, and accreditation; (c) arrangement and use of medical reviews, audits, or legal services, including fraud and abuse detection and compliance programs; (d) specified insurance functions, such as underwriting, risk rating, and reinsuring risk; (e) business planning, development, management, and administration; and (f) business management and general administrative activities of the entity, including but not limited to de-identifying PHI, creating a limited data set, and certain fundraising for the benefit of the CE.
Most uses and disclosures of psychotherapy notes for treatment, payment, and healthcare operations purposes require an authorization as described below. Obtaining “consent” (written permission from individuals to use and disclose their PHI for treatment, payment, and healthcare operations) is optional under the Privacy Rule for all covered entities. The content of a consent form, and the process for obtaining consent, are at the discretion of the CE electing to seek consent.
Uses and disclosures with opportunity to agree or object:
Facility Directories: It is a common practice in many healthcare facilities, such as hospitals, to maintain a directory of patient contact information. A covered healthcare provider may rely on an individual’s informal permission to list in its facility directory the individual’s name, general condition, religious affiliation, and location in the provider’s facility. The provider may then disclose the individual’s condition and location in the facility to anyone asking for the individual by name, and also may disclose religious affiliation to clergy. Members of the clergy are not required to ask for the individual by name when inquiring about patient religious affiliation.
For Notification and Other Purposes: A CE also may rely on an individual’s informal permission to disclose to the individual’s family, relatives, or friends, or to other persons whom the individual identifies, PHI directly relevant to that person’s involvement in the individual’s care or payment for care. This provision, for example, allows a pharmacist to dispense filled prescriptions to a person acting on behalf of the patient. Similarly, a CE may rely on an individual’s informal permission to use or disclose PHI for the purpose of notifying (including identifying or locating) family members, personal representatives, or others responsible for the individual’s care of the individual’s location, general condition, or death. In addition, PHI may be disclosed for notification purposes to public or private entities authorized by law or charter to assist in disaster relief efforts.
Incidental use and disclosure
The Privacy Rule does not require that every risk of an incidental use or disclosure of PHI be eliminated. A use or disclosure of this information that occurs as a result of, or as “incident to,” an otherwise permitted use or disclosure is permitted as long as the CE has adopted reasonable safeguards as required by the Privacy Rule, and the information being shared was limited to the “minimum necessary,” as required by the Privacy Rule.
Public interest and benefit activities
The Privacy Rule permits use and disclosure of PHI, without an individual’s authorization or permission, for 12 national priority purposes. These disclosures are permitted, although not required, by the Rule in recognition of the important uses made of health information outside of the healthcare context. Specific conditions or limitations apply to each public interest purpose, striking the balance between the individual privacy interest and the public interest need for this information. Those 12 national priority purposes are detailed below:
1. When required by law: Covered entities may use and disclose PHI without individual authorization as required by law (including by statute, regulation, or court orders).
2. When conducting public health activities: CEs may disclose PHI to any of the following for public health purposes:
- public health authorities authorized by law to collect or receive such information for preventing or controlling disease, injury, or disability and to public health or other government authorities authorized to receive reports of child abuse and neglect
- entities subject to Food and Drug Administration (FDA) regulation regarding FDA-regulated products or activities for purposes such as adverse event reporting, tracking of products, product recalls, and post-marketing surveillance
- individuals who may have contracted or been exposed to a communicable disease when notification is authorized by law
- employers, regarding employees, when requested by employers, for information concerning a work-related illness or injury or workplace-related medical surveillance, because such information is needed by the employer to comply with the Occupational Safety and Health Administration (OHSA), the Mine Safety and Health Administration (MHSA), or similar state law
3. In cases of victims of abuse, neglect or domestic violence: In certain circumstances, CEs may disclose PHI to appropriate government authorities regarding victims of abuse, neglect, or domestic violence.
4. For health oversight activities: CEs may disclose PHI to health oversight agencies (as defined in the Rule) for purposes of legally authorized health oversight activities, such as audits and investigations necessary for oversight of the healthcare system and government benefit programs.
5. During judicial and administrative proceedings: CEs may disclose PHI in a judicial or administrative proceeding if the request for the information is through an order from a court or administrative tribunal. Such information may also be disclosed in response to a subpoena or other lawful process if certain assurances regarding notice to the individual or a protective order are provided.6. For law enforcement purposes: CEs may disclose PHI to law enforcement officials for law enforcement purposes under the following six circumstances, subject to specified conditions:
- as required by law (including court orders, court-ordered warrants, subpoenas) and administrative requests
- to identify or locate a suspect, fugitive, material witness, or missing person
- in response to a law enforcement official’s request for information about a victim or suspected victim of a crime
- to alert law enforcement of a person’s death, if the CE suspects that criminal activity caused the death
- when a CE believes that PHI is evidence of a crime that occurred on its premises
- by a covered healthcare provider in a medical emergency not occurring on its premises, when necessary to inform law enforcement about the commission and nature of a crime, the location of the crime or crime victims, and the perpetrator of the crime
7. To decedents: CEs may disclose PHI to funeral directors as needed, and to coroners or medical examiners to identify a deceased person, determine the cause of death, and perform other functions authorized by law.
8. For honoring cadaveric organ, eye, or tissue donation: CEs may use or disclose PHI to facilitate the donation and transplantation of cadaveric organs, eyes, and tissue.
9. For research: "Research" is defined as any systematic investigation designed to develop or contribute to generalizable knowledge. The Privacy Rule permits a CE to use and disclose PHI for research purposes, without an individual’s authorization, provided the CE obtains either:
- documentation that an alteration or waiver of individuals’ authorization for the use or disclosure of PHI about them for research purposes has been approved by an Institutional Review Board or Privacy Board;
- representations from the researcher that the use or disclosure of the PHI is solely to prepare a research protocol or for similar purpose preparatory to research, that the researcher will not remove any PHI from the CE, and the PHI for which access is sought is necessary for the research; or
- representations from the researcher that the use or disclosure sought is solely for research on the PHI of decedents, that the PHI sought is necessary for the research, and, at the request of the CE, documentation of the death of the individuals about whom information is sought
A CE also may use or disclose, without an individuals’ authorization, a limited data set of PHI for research purposes (see discussion below).
10. In case of serious threat to health or safety: CEs may disclose PHI that they believe is necessary to prevent or lessen a serious and imminent threat to a person or the public, when such disclosure is made to someone they believe can prevent or lessen the threat (including the target of the threat). CEs may also disclose to law enforcement if the information is needed to identify or apprehend an escapee or violent criminal.
11. For essential government functions: An authorization is not required to use or disclose PHI for certain essential government functions. Such functions include:
- assuring proper execution of a military mission
- conducting intelligence and national security activities that are authorized by law
- providing protective services to the President
- making medical suitability determinations for U.S. State Department employees
- protecting the health and safety of inmates or employees in a correctional institution
- determining eligibility for or conducting enrollment in certain government benefit programs
12. For workers’ compensation laws: CEs may disclose PHI as authorized by, and to comply with, workers’ compensation laws and other similar programs providing benefits for work-related injuries or illnesses.
Limited data set
A limited data set is PHI from which certain specified direct identifiers of individuals and their relatives, household members, and employers have been removed. A limited data set may be used and disclosed for research, healthcare operations, and public health purposes, provided the recipient enters into a data use agreement promising specified safeguards for the PHI within the limited data set.
- postal address information, other than town or city, state and zip code (in other words, remove the street address)
- all elements of dates (except year) for dates directly related to an individual
- phone numbers
- fax numbers
- electronic mail (email) addresses
- Social Security numbers
- medical record numbers (MRNs)
- health plan beneficiary numbers
- account numbers
- certificate/license numbers
- vehicle identifiers and serial numbers, including license plate numbers
- device identifiers and serial numbers
- web addresses or Uniform Resource Locators (URLs)
- Internet Protocol (IP) address numbers
- biometric identifiers, including finger and voice prints
- full face photographic images and any comparable images
- any other unique identifying number, characteristic, or code (note this does not mean the unique code assigned by the investigator to code the data)
Authorized use and disclosure:
1. Authorization by the individual: A CE must obtain the individual’s written authorization for any use or disclosure of their PHI that is not for treatment, payment or healthcare operations or otherwise permitted or required by the Privacy Rule. It's also important to note that you cannot make authorization a condition of providing treatment, payment, enrollment or benefits eligibility (except in limited circumstances).
An authorization must be written in specific terms. It may allow use and disclosure of PHI by the CE, or by a third party. Examples of disclosures that would require an individual’s authorization include:
- disclosures to a life insurer for coverage purposes
- disclosures to an employer of the results of a pre-employment physical or lab test
- disclosures to a pharmaceutical firm for their own marketing purposes
All authorizations must be in plain language, and contain specific information regarding:
- the information to be disclosed or used
- the person(s) disclosing and receiving the information
- right to revoke in writing, and other data
The Privacy Rule also contains transition provisions applicable to authorizations and other express legal permissions obtained prior to April 14, 2003.
2. Psychotherapy Notes: Using or disclosing PHI is prohibited without the individual's authorization, except in the following cases:
- when the CE who created the notes is uses them for treatment
- when the CE needs to use them for one or more of the following:
- for its own training
- to defend itself in legal proceedings brought by the individual
- for HHS to investigate or determine the CE’s compliance with the Privacy Rules
- to avert a serious and imminent threat to public health or safety
- to provide to a health oversight agency for lawful oversight of the originator of the psychotherapy notes
- for the lawful activities of a coroner or medical examiner or as required by law
3. Marketing: HIPAA defines "marketing" as any communication about a product or service that encourages recipients to purchase or use the product or service. The Privacy Rule identifies some health-related activities based on this definition of marketing:
- communications to describe health-related products or services, or payment for them, provided by or included in a benefit plan of the CE making the communication
- communications about participating providers in a provider or health plan network, replacement of or enhancements to a health plan, and health-related products or services available only to a health plan’s enrollees that add value to, but are not part of, the benefits plan
- communications for treatment of the individual
- communications for case management or care coordination for the individual, or to direct or recommend alternative treatments, therapies, healthcare providers or care settings to the individual
Marketing also is an arrangement between a CE and any other entity whereby the CE discloses PHI in exchange for direct or indirect remuneration, for the other entity to communicate about its own products or services encouraging the use or purchase of those products or services; in other words, for typical marketing purposes. A CE has to obtain an authorization to use or disclose PHI for marketing, except for face-to-face marketing communications between the CE and an individual, and for a CE’s provision of promotional gifts of nominal value.
No authorization is needed, however, to make a communication that falls within one of the exceptions to the marketing definition. An authorization for marketing that involves the CE’s receipt of direct or indirect remuneration from a third party must reveal that fact.
In use and disclosure, even when authorized, it's always important to keep certain conditions and principles in mind. One main concept to always consider is that of always releasing the minimum necessary information to as few parties as possible, in as few cases as possible. That principle and others are described below.
Basically, HIPAA says that in any case of authorized disclosure, the amount of PHI shared must be the minimum necessary. A CE must make reasonable efforts to use, disclose, and request only the minimum amount of PHI needed to accomplish the intended purpose of the use, disclosure, or request. They must also develop and implement policies and procedures to reasonably limit uses and disclosures to the minimum necessary. When the minimum necessary standard applies to a use or disclosure, a CE may not use, disclose, or request the entire medical record for a particular purpose, unless it can specifically justify the whole record as the amount reasonably needed for the purpose.
Like most rules, there are exceptions to this principle. They are:
- disclosure to or a request by a healthcare provider for treatment
- disclosure to an individual who is the subject of the information, or the individual’s personal representative
- use or disclosure made pursuant to an authorization
- disclosure to HHS for complaint investigation, compliance review or enforcement
- use or disclosure that is required by law
- use or disclosure required for compliance with the HIPAA Transactions Rule or other HIPAA Administrative Simplification Rules
Restrict and control access and uses
For internal uses, a CE must develop and implement policies and procedures that restrict access and uses of PHI based on the specific roles of the members of their workforce. These policies and procedures must identify the persons, or classes of persons, in the workforce who need access to PHI to carry out their duties, the categories of PHI to which access is needed, and any conditions under which they need the information to do their jobs.
Disclosures and requests for disclosures
CEs are required to establish and implement policies and procedures for routine, recurring disclosures or requests for disclosures, so that PHI disclosure meets the "minimum amount reasonably necessary" measurement to achieve the purpose of the disclosure. It can be a policy, so individual review of each disclosure is not required. However, for non-routine, non-recurring disclosures or requests for disclosures that it makes, CEs must develop criteria designed to do the same thing, but with a review of each request individually in accordance with the established criteria.
Reasonable reliance on another CE's compliance
HIPAA allows you to make the reasonable assumption that a request from another CE is in compliance with disclosure rules and principles. The HHS explains it such that if another CE makes a request for PHI, a CE may rely, if reasonable under the circumstances, on the request as complying with this minimum necessary standard. Similarly, a CE may rely upon requests as being the minimum necessary PHI from: (a) a public official, (b) a professional (such as an attorney or accountant) who is the CE’s business associate, seeking the information to provide services to or for the CE; or (c) a researcher who provides the documentation or representation required by the Privacy Rule for research.
Patient notification and rights
Privacy practices notice
Each CE, with certain exceptions, must provide a notice of its privacy practices. The Privacy Rule requires that the notice contain certain elements. The notice must:
- describe the ways in which the CE may use and disclose PHI
- state the CE’s duties to protect privacy, provide a notice of privacy practices, and abide by the terms of the current notice
- describe individuals’ rights, including the right to complain to HHS and to the CE if they believe their privacy rights have been violated
- include a point of contact for further information and for making complaints to the CE
CEs must act in accordance with their notices. The rule also contains specific distribution requirements for direct treatment providers, all other healthcare providers and health plans. That information is available, along with many other resources and additional information, on the HHS site.
A covered healthcare provider with a direct treatment relationship with individuals must have delivered a privacy practices notice to patients as follows:
- not later than the first service encounter by personal delivery (for patient visits)
- by automatic and contemporaneous electronic response (for electronic service delivery), and by prompt mailing (for telephonic service delivery)
- by posting the notice at each service delivery site in a clear and prominent place where people seeking service may reasonably be expected to be able to read the notice
- in emergency treatment situations, the provider must furnish its notice as soon as practicable after the emergency abates
The CEs in an organized healthcare arrangement (OHCA) may use a joint privacy practices notice, as long as each agrees to abide by the notice content with respect to the PHI created or received in connection with the arrangement. Distribution of a joint notice by any CE participating in the OHCA at the first point that an OHCA member has an obligation to provide notice satisfies the distribution obligation of the other participants in the OHCA.
A health plan must distribute its privacy practices notice to each of its enrollees by its Privacy Rule compliance date. Thereafter, the health plan must give its notice to each new enrollee at enrollment, and send a reminder to every enrollee at least once every three years that the notice is available upon request. A health plan satisfies its distribution obligation by furnishing the notice to the “named insured,” that is, the subscriber for coverage that also applies to spouses and dependents.
Acknowledgement of notice receipt
A covered healthcare provider with a direct treatment relationship with individuals must make a good faith effort to obtain written acknowledgement from patients of receipt of the privacy practices notice. The Privacy Rule does not prescribe any particular content for the acknowledgement. However, the provider must document the reason for any failure to obtain the patient’s written acknowledgement. The provider is relieved of the need to request acknowledgement in an emergency treatment situation.
Patients have the right to review and obtain a copy of their PHI in a CE’s designated record set, with some exceptions. The "designated record set" is that group of records maintained by or for a CE that is used, in whole or part, to make decisions about individuals, or is a provider’s medical and billing records about individuals or a health plan’s enrollment, payment, claims adjudication, and case or medical management record systems. The rule excepts from the right of access the following PHI:
- psychotherapy notes
- information compiled for legal proceedings
- laboratory results to which the Clinical Laboratory Improvement Act (CLIA) prohibits access
- information held by certain research laboratories
For information included within the right of access, CEs may deny an individual access in certain specified situations, such as when a healthcare professional believes access could cause harm to the individual or another. In such situations, the individual must be given the right to have such denials reviewed by a licensed healthcare professional for a second opinion. CEs may impose reasonable, cost-based fees for the cost of copying and postage.
The rule gives individuals the right to have CEs amend their PHI in a designated record set when that information is inaccurate or incomplete.
If a CE accepts an amendment request, it must make reasonable efforts to provide the amendment to persons that the individual has identified as needing it, as well as to persons that the CE knows might rely on the information to the individual’s detriment. If the request is denied, CEs must provide the individual with a written denial and allow the individual to submit a statement of disagreement for inclusion in the record. The Rule specifies processes for requesting and responding to a request for amendment. Additionally, if a CE receives notice to amend from another CE, it must amend PHI in its designated record set upon receipt.
Under HIPAA, individuals have a right to an accounting of the disclosures of their PHI by a CE or the CE’s business associates. The maximum disclosure accounting period is the six years immediately preceding the accounting request. However, a CE is not obligated to account for any disclosure made before its Privacy Rule compliance date.
There are, of course, exceptions. The Privacy Rule does not require accounting for disclosures:
- for treatment, payment, or healthcare operations
- to the individual or the individual’s personal representative
- for notification of or to persons involved in an individual’s healthcare or payment for healthcare, for disaster relief or for facility directories
- pursuant to an authorization
- of a limited data set
- for national security or intelligence purposes
- to correctional institutions or law enforcement officials for certain purposes regarding inmates or individuals in lawful custody
- incidental to otherwise permitted or required uses or disclosures
Accounting for disclosures to health oversight agencies and law enforcement officials must be temporarily suspended upon if they provide written representation that an accounting would likely impede their activities.
Individuals have the right to request that a CE restrict use or disclosure of PHI for:
- treatment, payment or healthcare operations
- disclosure to persons involved in the individual’s healthcare or payment for healthcare
- disclosure to notify family members or others about the individual’s general condition, location, or death
A CE is under no obligation to agree to requests for restrictions. If a CE agrees to the request, it must comply with the agreed restrictions, except for purposes of treating the individual in a medical emergency.
Confidential communications requirement
Health plans must accommodate reasonable requests if the individual indicates that the disclosure of all or part of the PHI could endanger the individual. The health plan may not question the individual’s statement of endangerment. Any CE may condition compliance with a confidential communication request on the individual specifying an alternative address or method of contact and explaining how any payment will be handled.
Personal representatives and minors
The HIPAA Privacy Rule recognizes that there may be times when individuals are legally or otherwise incapable of exercising their rights, or simply choose to designate another to act on their behalf with respect to these rights. Under the Rule, a person authorized (under State or other applicable law, e.g., tribal or military law) to act on behalf of the individual in making health care related decisions is the individual’s "personal representative." Section 164.502(g) provides when, and to what extent, the personal representative must be treated as the individual for purposes of the rule. In addition to these formal designations of a personal representative, the rule at 45 CFR 164.510(b) addresses situations in which family members or other persons who are involved in the individual’s healthcare or payment for care may receive PHI about the individual even if they are not expressly authorized to act on the individual’s behalf.
In general, the individual's representative must be treated exactly as if they were the individual whose PHI is in question.
Standard recognized representatives
The HHS lists the following in regards to who must be recognized as the individual’s personal representative. If the individual is:
- an adult or emancipated minor: The personal representative is a person with legal authority to make health care decisions on behalf of the individual. Examples include healthcare power of attorney, a court-appointed legal guardian, and a general power of attorney or durable power of attorney that includes the power to make healthcare decisions. Exceptions: See abuse, neglect, and endangerment situations discussion below.
- an un-emancipated minor: The personal representative is a parent, guardian, or other person acting in loco parentis with legal authority to make healthcare decisions on behalf of the minor child. Exceptions: See parents and un-emancipated minors, and abuse, neglect and endangerment situations discussion below.
- deceased: The personal representative is a person with legal authority to act on behalf of the decedent or the estate (not restricted to persons with authority to make healthcare decisions).
As always, some exceptions and conditions or situational considerations apply, and these are taken into account under the HIPAA regulations.
Parents and un-emancipated minors
However, the Privacy Rule specifies three circumstances in which the parent is not the "personal representative" with respect to certain health information about his or her minor child. These exceptions generally track the ability of certain minors to obtain specified healthcare without parental consent under State or other laws, or standards of professional practice. In these situations, the parent does not control the minor’s healthcare decisions, and thus under the Rule, does not control the PHI related to that care. The three exceptional circumstances when a parent is not the minor’s personal representative are:
- when state or other law does not require the consent of a parent or other person before a minor can obtain a particular healthcare service, and the minor consents to the healthcare service; Example: A state law provides an adolescent the right to obtain mental health treatment without the consent of his or her parent, and the adolescent consents to such treatment without the parent’s consent.
- when someone other than the parent is authorized by law to consent to the provision of a particular health service to a minor and provides such consent; Example: A court may grant authority to make healthcare decisions for the minor to an adult other than the parent, to the minor, or the court may make the decision(s) itself.
- when a parent agrees to a confidential relationship between the minor and a healthcare provider; Example: A physician asks the parent of a 16-year-old if the physician can talk with the child confidentially about a medical condition and the parent agrees.
Regardless, however, of whether a parent is the personal representative of a minor child, the Privacy Rule defers to State or other applicable laws that expressly address the ability of the parent to obtain health information about the minor child. In doing so, the Privacy Rule permits a CE to disclose to a parent, or provide the parent with access to, a minor child’s PHI when and to the extent it is permitted or required by State or other laws (including relevant case law). Likewise, the Privacy Rule prohibits a CE from disclosing a minor child’s PHI to a parent, or providing a parent with access to such information, when and to the extent it is prohibited under State or other laws (including relevant case law).
In cases in which State or other applicable law is silent concerning parental access to the minor’s PHI, and a parent is not the personal representative of a minor child based on one of the exceptional circumstances described above, a CE has discretion to provide or deny a parent with access under 45 CFR 164.524 to the minor’s health information, if doing so is consistent with State or other applicable law, and provided the decision is made by a licensed health care professional in the exercise of professional judgment.
Abuse, neglect, and endangerment situations
When a physician or other CE reasonably believes that an individual, including an un-emancipated minor, has been or may be subjected to domestic violence, abuse, or neglect by the personal representative, or that treating a person as an individual’s personal representative could endanger the individual, the CE may choose not to treat that person as the individual’s personal representative, if in the exercise of professional judgment, doing so would not be in the best interests of the individual. For example, if a physician reasonably believes that providing the personal representative of an incompetent elderly individual with access to the individual’s health information would endanger that individual, the Privacy Rule permits the physician to decline to provide such access.
- "Summary of the HIPAA Privacy Rule". U.S. Department of Health & Human Services. http://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html. Retrieved 10 June 2016.
- "Electronic Code of Federal Regulations, Title 45, Subtitle A, Subchapter C, Part 164, Subpart E". U.S. Government Publishing Office. http://www.ecfr.gov/cgi-bin/text-idx?SID=064b73f83337b74b8dc8e9c7ed2a508b&mc=true&node=se45.1.164_1514&rgn=div8. Retrieved 9 June 2016.
- "Personal Representatives". U.S. Department of Health & Human Services. http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/personal-representatives/. Retrieved 16 June 2016.