Difference between revisions of "LII:HIPAA Compliance - LII 007 04. Use and Disclosure"

From LIMSWiki
Jump to navigationJump to search
Line 107: Line 107:
There are three instances where use/disclosure of PHI is always authorized - with certain conditions. Those instances are:
There are three instances where use/disclosure of PHI is always authorized - with certain conditions. Those instances are:


# '''Authorization by the Individual'''. A CE must obtain the individual’s written authorization for any use or disclosure of their PHI that is <u>not</u> 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).
1. '''Authorization by the Individual'''. A CE must obtain the individual’s written authorization for any use or disclosure of their PHI that is <u>not</u> 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:
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:
Line 124: Line 124:
The Privacy Rule also contains transition provisions applicable to authorizations and other express legal permissions obtained prior to April 14, 2003.<ref name="45CFR514" />
The Privacy Rule also contains transition provisions applicable to authorizations and other express legal permissions obtained prior to April 14, 2003.<ref name="45CFR514" />


# '''Psychotherapy Notes'''. Using or disclosing PHI is prohibited without the individual's authorization, <u>except</u> in the following cases:
2. '''Psychotherapy Notes'''. Using or disclosing PHI is prohibited without the individual's authorization, <u>except</u> in the following cases:


* The CE who created the notes is allowed to use them for treatment
* The CE who created the notes is allowed to use them for treatment
Line 135: Line 135:
** For the lawful activities of a coroner or medical examiner or as required by law<ref name="45CFR514" />
** For the lawful activities of a coroner or medical examiner or as required by law<ref name="45CFR514" />


# '''Marketing'''.   
3. '''Marketing'''.   
 


===Limiting===
===Limiting===

Revision as of 15:35, 10 June 2016

Now that we understand a) what HIPAA is, b) who it applies to and c) what information is protected, it's time to look at exactly how PHI can and cannot be used.

Permitted Uses and Disclosures

A covered entity ("CE") is permitted - but not required - to use and disclose protected health information, without an individual’s authorization, for the following purposes or situations:

  1. To the Individual who is the subject of the information - unless required for access or accounting of disclosures
  2. Treatment, Payment, and Healthcare Operations
  3. Opportunity to Agree or Object
  4. Incident to an otherwise permitted use and disclosure
  5. Public Interest and Benefit Activities
  6. Limited Data Set for the purposes of research, public health or healthcare operations. Covered entities may rely on professional ethics and best judgments in deciding which of these permissive uses and disclosures to make.[1]

Treatment, Payment, Healthcare Operations

A CE may use and disclose PHI for its own use in treatment, payment, and healthcare operations activities. A covered entity also may disclose protected health information for the treatment activities of any healthcare provider, the payment activities of another covered entity and of any healthcare provider, or the healthcare operations of another covered entity involving either quality or competency assurance activities or fraud and abuse detection and compliance activities, if both covered entities have or had a relationship with the individual and the protected health information pertains to the relationship. See additional guidance on Treatment, Payment, & Healthcare Operations.


  • Treatment is 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.


  • Payment encompasses 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 are 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) conducting or arranging for 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 protected health information, creating a limited data set, and certain fundraising for the benefit of the covered entity.

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 protected health information for treatment, payment, and healthcare operations) is optional under the Privacy Rule for all covered entities.24 The content of a consent form, and the process for obtaining consent, are at the discretion of the covered entity electing to seek consent.

Uses and Disclosures with Opportunity to Agree or Object

Informal permission may be obtained by asking the individual outright, or by circumstances that clearly give the individual the opportunity to agree, acquiesce, or object. Where the individual is incapacitated, in an emergency situation, or not available, covered entities generally may make such uses and disclosures, if in the exercise of their professional judgment, the use or disclosure is determined to be in the best interests of the individual.

  • 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 covered entity 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, protected health information directly relevant to that person’s involvement in the individual’s care or payment for care. 26 This provision, for example, allows a pharmacist to dispense filled prescriptions to a person acting on behalf of the patient. Similarly, a covered entity may rely on an individual’s informal permission to use or disclose protected health information 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, protected health information 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 protected health information 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 covered entity 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 protected health information, 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.

  • Required by Law Covered entities may use and disclose protected health information without individual authorization as required by law (including by statute, regulation, or court orders).
  • Public Health Activities Covered entities may disclose protected health information to: (1) 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; (2) entities subject to FDA regulation regarding FDA regulated products or activities for purposes such as adverse event reporting, tracking of products, product recalls, and post-marketing surveillance; (3) individuals who may have contracted or been exposed to a communicable disease when notification is authorized by law; and (4) 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. See additional guidance on Public Health Activities and CDC's web pages on Public Health and HIPAA Guidance.
  • Victims of Abuse, Neglect or Domestic Violence In certain circumstances, covered entities may disclose protected health information to appropriate government authorities regarding victims of abuse, neglect, or domestic violence.
  • Health Oversight Activities Covered entities may disclose protected health information 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.
  • Judicial and Administrative Proceedings Covered entities may disclose protected health information 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.
  • Law Enforcement Purposes Covered entities may disclose protected health information to law enforcement officials for law enforcement purposes under the following six circumstances, and subject to specified conditions:
  1. As required by law (including court orders, court-ordered warrants, subpoenas) and administrative requests
  2. To identify or locate a suspect, fugitive, material witness, or missing person
  3. In response to a law enforcement official’s request for information about a victim or suspected victim of a crime
  4. To alert law enforcement of a person’s death, if the covered entity suspects that criminal activity caused the death
  5. When a covered entity believes that protected health information is evidence of a crime that occurred on its premises
  6. 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
  • Decedents Covered entities may disclose protected health information 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.
  • Cadaveric Organ, Eye, or Tissue Donation CEs may use or disclose PHI to facilitate the donation and transplantation of cadaveric organs, eyes, and tissue
  • Research “Research” is defined as any systematic investigation designed to develop or contribute to generalizable knowledge.

The Privacy Rule permits a covered entity to use and disclose protected health information for research purposes, without an individual’s authorization, provided the covered entity obtains either:

  1. 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
  2. Representations from the researcher that the use or disclosure of the PHI:
    1. Is solely to prepare a research protocol or for similar purpose preparatory to research
    2. That the researcher will not remove any PHI from the covered entity, and
    3. The PHI for which access is sought is necessary for the research

...OR

  1. 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).

  • Serious Threat to Health or Safety Covered entities may disclose protected health information 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). Covered entities may also disclose to law enforcement if the information is needed to identify or apprehend an escapee or violent criminal.
  • Essential Government Functions An authorization is not required to use or disclose protected health information 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, and determining eligibility for or conducting enrollment in certain government benefit programs.
  • Workers’ Compensation Covered entities may disclose protected health information as authorized by, and to comply with, workers’ compensation laws and other similar programs providing benefits for work-related injuries or illnesses.42 See additional guidance on Workers’ Compensation.

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.

The "certain specified direct identifiers" that must be removed are almost all of the 18 PHI identifiers as listed in Lesson 3 (LII 007 03. What Data Are Protected & General Privacy Principle), but not exactly. They are:

  1. Name
  2. Postal address information, other than town or city, State and zip code (in other words, remove the street address)
  3. Telephone numbers
  4. Fax numbers
  5. Electronic mail (email) addresses
  6. Social security numbers
  7. Medical record numbers (MRN)
  8. Health plan beneficiary numbers
  9. Account numbers
  10. Certificate/license numbers
  11. Vehicle identifiers and serial numbers, including license plate numbers
  12. Device identifiers and serial numbers (medical devices, cell phones, tablets, laptops etc.)
  13. Web Universal Resource Locators (URLs)
  14. Internet Protocol (IP) address numbers
  15. Biometric identifiers, including finger and voice prints
  16. Full face photographic images and any comparable images[2]

Authorized Use & Disclosure

There are three instances where use/disclosure of PHI is always authorized - with certain conditions. Those instances are:

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
  • Expiration
  • 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]

2. Psychotherapy Notes. Using or disclosing PHI is prohibited without the individual's authorization, except in the following cases:

  • The CE who created the notes is allowed to use them for treatment
  • Where 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[2]

3. Marketing.


Limiting

In use and disclosure, even when authorized, it's always important to keep certain conditions and principles in mind.

Patient Notification and Rights

Personal Representatives and Minors

[1]

References