|
Tags: Blanking Manual revert |
| Line 1: |
Line 1: |
| '''Title''': ''HIPAA Compliance: An Introduction''
| |
|
| |
|
| '''Author for citation''': Alan Vaughan, with editorial modifications by Shawn Douglas
| |
|
| |
| '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
| |
|
| |
| '''Publication date''': Originally published June 2016; lightly edited February 2022
| |
|
| |
|
| |
| ==Introduction==
| |
| ===Reason and scope===
| |
| [[File:Leiden University Library, Group Study Room.jpg|right|360px]]In the U.S. healthcare industry, there are two main regulatory laws: the [[Clinical Laboratory Improvement Amendments|Clinical Laboratory Improvement Amendments of 1988]] (CLIA) and the [[Health Insurance Portability and Accountability Act|Health Information Portability and Accountability Act of 1996]] (HIPAA). The first is aimed at [[Clinical laboratory|clinical laboratories]] and the second applies to the vast majority of healthcare settings. This training guide is aimed at providing some accurate and useful training to those required to comply with HIPAA. Indeed, HIPAA training is mandated in the law itself, particularly by the [[United States Department of Health and Human Services]] (HHS), which summarizes that responsibility as such:
| |
|
| |
| <blockquote>Workforce members include employees, volunteers, trainees, and may also include other persons whose conduct is under the direct control of the [covered] entity (whether or not they are paid by the entity). A covered entity must train all workforce members on its privacy policies and procedures, as necessary and appropriate for them to carry out their functions. A covered entity must have and apply appropriate sanctions against workforce members who violate its privacy policies and procedures or the Privacy Rule.<ref name="HHSSummaryHIPAA">{{cite web |url=https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html |title=Summary of the HIPAA Privacy Rule |author=Office for Civil Rights |publisher=United States Department of Health and Human Services |date=26 July 2013 |accessdate=09 February 2022}}</ref></blockquote>
| |
|
| |
| Anyone involved in healthcare has probably already realized that while their own entity's policies and procedures may well be in compliance, there is still a great deal of misunderstanding out there regarding HIPAA, as well as a general lack of knowledge of it beyond those measures that are in place where they happen to work. And it is also a matter of concern that industry professionals have encountered an alarming number of courses and guides purporting to provide an acceptable level of training, yet they prove to be significantly lacking in scope, clarity and in some cases accuracy.
| |
|
| |
| This training guide is designed to provide a substantive, reasonably comprehensive understanding of all of the aspects of HIPAA that have bearing on most healthcare industry professionals. It is based almost completely on first-hand materials from the HHS (which the law charges with administration of HIPAA) and the actual Health Information and Portability Act of 1996 (HIPAA) law itself, rather than relying on secondary and tertiary interpretations and paraphrasing. However, these resources do not and cannot provide every detail for all scenarios. As such, several third-party sources were taken into account to gather and present the fullest comprehension of the materials and their relevance for the covered entities HIPAA affects.
| |
|
| |
| ===Goals of this guide===
| |
| The primary aim of this training guide is to supplement the requirement for HIPAA training as described above. Whether used to fulfill that directive, or as source for your own research, it is designed to provide the most comprehensive, clear and accurate general familiarity with HIPAA possible as it relates to those attempting to be compliant.
| |
|
| |
|
| |
| ==What is HIPAA?==
| |
| [[File:HIPAA Screenshot.png|left|400px]]The healthcare industry must comply with both CLIA and HIPAA. CLIA regulatory standards apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.<ref name="42.5.495">{{cite web |url=https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493 |title=Code of Federal Regulations Title 42, Chapter IV, Subchapter G, Part 493 |publisher=U.S. Government Publishing Office |accessdate=09 February 2022}}</ref> While important, this guide focuses on HIPAA, which was enacted by the United States Congress and signed into law in 1996.<ref name="104-191">{{cite web |url=https://www.govinfo.gov/app/details/PLAW-104publ191 |title=Public Law 104 - 191 - Health Insurance Portability And Accountability Act of 1996 |work=GovInfo |publisher=U.S. Government Publishing Office |date=21 August 1996 |accessdate=09 February 2022}}</ref>
| |
|
| |
| Whereas CLIA involves standards in clinical testing, HIPAA is concerned with rigorously and effectively protecting patients’ personal information. It applies to most any entity that handles a patient's personal information, including contractors and other business associates.
| |
|
| |
| ===Privacy and security===
| |
| There are two main areas of HIPAA regulations and standards: privacy and security. Both apply to all covered entities and are related, but have slightly different emphases.
| |
| {{flowlist |
| |
| * HIPAA privacy (the Privacy Rule): This concentrates on the patient's right to privacy regarding their personal information and health records, and what covered entities must do to support that. It also includes their right to access those data.
| |
|
| |
| * HIPAA security (the Security Rule): This portion of HIPAA focuses on the requirements for covered entities to protect patient data, including administrative, physical and technical ways and means.}}
| |
|
| |
| ===Government oversight===
| |
| When laws are made, the responsibility to make affected parties aware of their obligations and how to meet them—and to monitor, enforce and punish offenders—is often allocated to a particular body. In the case of HIPAA, the HHS is that body. Within the HHS, the Office for Civil Rights (OCR) ensures equal access to certain health and human services and protects the privacy and security of health information. Additionally, the [[Centers for Disease Control and Prevention]] (CDC) and other HHS agencies provide additional guidance and materials.
| |
|
| |
| Further information about HIPAA and its history, etc. can be found on the LIMSwiki [[Health Insurance Portability and Accountability Act]] page.
| |
|
| |
|
| |
| ==Who needs to comply?==
| |
| HIPAA compliance is highly important in the healthcare arena. Non-compliance can result in fines and other serious consequences. But who is actually bound by this law? HIPAA is comprised of two main segments: the Privacy Rule and the Security Rule. Those who must comply are called "covered entities." According to the HHS, these include:
| |
|
| |
| : ▪ health plans;
| |
| : ▪ healthcare clearinghouses; and
| |
| : ▪ any healthcare provider who transmits health information in electronic form in connection with a transaction for which the Secretary of HHS has adopted standards under HIPAA.
| |
|
| |
| Covered entities include doctors, clinics, [[hospital]]s, dentists, nursing homes and pharmacies that transmit data electronically, as well as health plans, insurance plans and healthcare clearinghouses.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| ===Healthcare providers===
| |
| Every healthcare provider (regardless of size) who electronically transmits health [[information]] in connection with certain transactions is a covered entity. These transactions include<ref name="HHSSummaryHIPAA" />:
| |
|
| |
| * claims
| |
| * benefit eligibility inquiries
| |
| * referral authorization requests
| |
| * other transactions for which HHS has established standards under the HIPAA Transactions Rule
| |
|
| |
| It's important to note that using electronic technology (e.g., email) does not mean a healthcare provider is a covered entity. The transmission must be in connection with a "standard transaction."
| |
|
| |
| Transactions are electronic exchanges involving the transfer of information between two parties for specific purposes. For example, a healthcare provider will send a claim to a health plan to request payment for medical services.<ref name="StandardTrans">{{cite web |url=https://www.cms.gov/Regulations-and-Guidance/Administrative-Simplification/HIPAA-ACA/AdoptedStandardsandOperatingRules |title=Adopted Standards and Operating Rules |publisher=U.S. Centers for Medicare and Medicaid Services |date=01 December 2021 |accessdate=09 February 2022}}</ref>
| |
|
| |
| In the HIPAA regulations, the Secretary of Health and Human Services adopted certain standard transactions for [[electronic data interchange]] (EDI) of healthcare data. These transactions include<ref name="StandardTrans" />:
| |
|
| |
| * claims and encounter information
| |
| * payment and remittance advice
| |
| * claims status
| |
| * eligibility, enrollment and disenrollment
| |
| * referrals and authorizations
| |
| * coordination of benefits and premium payment
| |
|
| |
| The standard does not encompass telephone voice response and fax-back systems.<ref name="TexMed">{{cite web |url=https://www.texmed.org/Template.aspx?id=1599 |title=What Are HIPAA Transaction and Code Sets Standards? |publisher=Texas Medical Association |date=29 October 2019 |accessdate=09 February 2022}}</ref>
| |
|
| |
| The Privacy Rule covers a healthcare provider whether it electronically transmits these transactions directly or uses a billing service or other third party to do so on its behalf. Healthcare providers include all “providers of services” (e.g., institutional providers such as hospitals) and “providers of medical or health services” (e.g., non-institutional providers such as physicians, dentists and other practitioners) as defined by Medicare, and any other person or organization that furnishes, bills, or is paid for healthcare.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| ===Business associates===
| |
| [[File:Corporate Woman Shaking Hands With a Corporate Man.svg|right|500px]]Healthcare providers don't always do everything that involves patient information themselves. There are very often other entities contracted for a variety of services. As a result of the [[Health Information Technology for Economic and Clinical Health Act]] (HITECH) that was passed in 2009, HIPAA has also been expanded to include business associates. Business associates are those persons or organizations that function on behalf of a covered entity, such as a doctor, and who either use or receive identifiable health information.<ref name="PrivacyGuide">{{cite web |url=https://www.medscape.org/viewarticle/781892_2 |archiveurl=https://web.archive.org/web/20171004095823/http://www.medscape.org/viewarticle/781892_2 |title=Patient Privacy: A Guide for Providers |work=Medscape |author=Centers for Medicare & Medicaid Services |archivedate=04 October 2017 |accessdate=09 February 2022}}</ref>
| |
|
| |
| According to 45 CFR 160 Part 103, business associate functions or activities on behalf of a covered entity include<ref name="45CFR160">{{cite web |url=https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-160/subpart-A/section-160.103 |title=Code of Federal Regulations Title 45, Subtitle A, Subchapter C, Part 160, Subpart A, 160.103 |publisher=US Government Publishing Office |accessdate=09 February 2022}}</ref>:
| |
|
| |
| * claims processing
| |
| * data analysis
| |
| * utilization review
| |
| * billing
| |
| * legal services
| |
| * actuarial services
| |
| * accounting
| |
| * consulting
| |
| * data aggregation
| |
| * management
| |
| * administrative services
| |
| * accreditation
| |
| * financial services
| |
|
| |
| A business associate is also anyone—not just those in the workforce of the covered entity—who performs any activities for a covered entity that are covered by HIPAA. Consider that an "...and all other related" kind of clause. Subcontractors of business associates who fit these criteria are also subject to HIPAA.<ref name="45CFR160" />
| |
|
| |
| However, persons or organizations are not considered business associates if their functions 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. A covered entity can also be the business associate of another covered entity.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| Here are some examples of business associates, as described by the HHS<ref name="BusinessAssociates">{{cite web |url=https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/business-associates/index.html |title=Business Associates |author=Office of Civil Rights |publisher=U.S. Department of Health & Human Services |date=24 May 2019 |accessdate=09 February 2022}}</ref> :
| |
|
| |
| * third party administrator who assists a health plan with claims processing
| |
| * CPA firm whose accounting services to a healthcare provider involve access to protected health information
| |
| * attorney whose legal services to a health plan involve access to protected health information
| |
| * consultant who performs utilization reviews for a hospital
| |
| * healthcare clearinghouse that translates a claim from a non-standard format into a standard transaction on behalf of a healthcare provider and forwards the processed transaction to a payer
| |
| * independent medical transcriptionist who provides transcription services to a physician
| |
| * pharmacy benefits manager who manages a health plan’s pharmacist network
| |
|
| |
| ====Business associate agreement (BAA)====
| |
| According to the HHS, "A covered entity’s contract or other written arrangement with its business associate must contain the elements specified at 45 CFR 164.504(e)." Provisions need to<ref name="BusinessAssociates" />:
| |
|
| |
| * describe the permitted and required uses of protected health information by the business associate;
| |
| * provide that the business associate will not use or further disclose the protected health information (PHI) other than as permitted or required by the contract or as required by law; and
| |
| * require the business associate to use appropriate safeguards to prevent a use or disclosure of the protected health information other than as provided for by the contract.
| |
|
| |
| Where a covered entity (the party who has contracted the BA) knows of a material breach or violation by the business associate of the contract or agreement, the covered entity is required to take reasonable steps to cure the breach or end the violation, and if such steps are unsuccessful, to terminate the contract or arrangement. If termination of the contract or agreement is not feasible, a covered entity is required to report the problem to the HHS Office for Civil Rights (OCR).
| |
|
| |
| HHS provides a useful [https://www.hhs.gov/hipaa/for-professionals/covered-entities/sample-business-associate-agreement-provisions/index.html sample BAA]] on its website for reference.
| |
|
| |
| ====Exceptions to BAA requirement====
| |
| There are exceptions to the requirement for a covered entity to have a BAA with a business associate before protected health information may be disclosed to the person or entity. Per 45 CFR 164.502(e), the Privacy Rule includes the following exceptions to the business associate standard<ref name="BusinessAssociates" />:
| |
|
| |
| # disclosures by a covered entity to a healthcare provider for treatment of the individual. For example:
| |
| ## A hospital is not required to have a business associate contract with the specialist to whom it refers a patient and transmits the patient’s medical chart for treatment purposes.
| |
| ## A physician is not required to have a business associate contract with a [[laboratory]] as a condition of disclosing protected health information for the treatment of an individual.
| |
| ## A hospital laboratory is not required to have a business associate contract to disclose protected health information to a reference laboratory for treatment of the individual.
| |
| # disclosures to a health plan sponsor, such as an employer, by a group health plan, or by the health insurance issuer or HMO that provides the health insurance benefits or coverage for the group health plan, provided that the group health plan’s documents have been amended to limit the disclosures or one of the exceptions at 45 CFR 164.504(f) have been met.
| |
| # the collection and sharing of protected health information by a health plan that is a public benefits program, such as Medicare, and an agency other than the agency administering the health plan, such as the Social Security Administration, that collects protected health information to determine eligibility or enrollment, or determines eligibility or enrollment, for the government program, where the joint activities are authorized by law.
| |
|
| |
| '''Other situations in which a business associate contract is NOT required'''
| |
|
| |
| Some additional scenarios where a BAA is not necessary include<ref name="BusinessAssociates" />:
| |
|
| |
| * when a healthcare provider discloses protected health information to a health plan for payment purposes, or when the healthcare provider simply accepts a discounted rate to participate in the health plan’s network. A provider that submits a claim to a health plan and a health plan that assesses and pays the claim are each acting on its own behalf as a covered entity, and not as the “business associate” of the other.
| |
| * with persons or organizations (e.g., janitorial service or electrician) whose functions 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.
| |
| * where a person or organization acts merely as a conduit for protected health information, for example the U.S. Postal Service, certain private couriers and their electronic equivalents.
| |
| * covered entities who participate in an Organized Healthcare Arrangement (OHCA) to make disclosures that relate to the joint healthcare activities of the OHCA.
| |
| * when a group health plan purchases insurance from a health insurance issuer or HMO. The relationship between the group health plan and the health insurance issuer or HMO is defined by the Privacy Rule as an OHCA, with respect to the individuals they jointly serve or have served. Thus, these covered entities are permitted to share protected health information that relates to the joint healthcare activities of the OHCA.
| |
| * where one covered entity purchases a health plan product or other insurance, for example, reinsurance, from an insurer. Each entity is acting on its own behalf when the covered entity purchases the insurance benefits, and when the covered entity submits a claim to the insurer and the insurer pays the claim.
| |
| * the disclosure of protected health information to a researcher for research purposes, either with patient authorization, pursuant to a waiver under 45 CFR 164.512(i), or as a limited data set pursuant to 45 CFR 164.514(e). Because the researcher is not conducting a function or activity regulated by the Administrative Simplification Rules, such as payment or healthcare operations, or providing one of the services listed in the definition of “business associate” at 45 CFR 160.103, the researcher is not a business associate of the covered entity, and no business associate agreement is required.
| |
| * when a financial institution processes consumer-conducted financial transactions by debit, credit, or other payment card, clears checks, initiates or processes electronic funds transfers, or conducts any other activity that directly facilitates or effects the transfer of funds for payment for healthcare or health plan premiums. When it conducts these activities, the financial institution is providing its normal banking or other financial transaction services to its customers; it is not performing a function or activity for, or on behalf of, the covered entity.
| |
|
| |
| ===Others (plans, etc.)===
| |
| The other categories of "covered entities" who are subject to the requirements of HIPAA include health plans and healthcare clearinghouses.
| |
|
| |
| ====Health plans====
| |
| [[File:001feknerLeichtINSURANCE.jpg|left|220px]]Whether individual or group, health plans that provide or pay the cost of healthcare, dental care, vision care, and prescription drug costs are covered entities under HIPAA. This includes health maintenance organizations (HMOs); Medicare, Medicaid, Medicare+Choice and Medicare supplement insurers; and long-term care insurers (excluding nursing home fixed-indemnity policies).
| |
|
| |
| Covered entity health plans can be employer-sponsored group health plans, government- and church-sponsored health plans or multi-employer health plans.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| '''Health plan exceptions'''
| |
|
| |
| The exceptions where certain health plans do not constitute covered entities include<ref name="HHSSummaryHIPAA" />:
| |
| {{flowlist|
| |
| # group health plans with less than 50 participants, administered solely by the employer that established and maintains the plan.
| |
| # two types of government-funded programs:
| |
| ## those whose principal purpose is not providing or paying the cost of healthcare, such as the food stamps program (SNAP).
| |
| ## those programs whose principal activity is directly providing healthcare, such as a community health center, or the making of grants to fund the direct provision of healthcare.
| |
| # certain types of insurance entities, particularly those who only provide:
| |
| ## workers’ compensation.
| |
| ## automobile insurance.
| |
| ## property and casualty insurance.}}
| |
|
| |
| However, if an insurance entity has more than one line of business, one of which may be identified separately as a health plan, then HIPAA regulations do apply to the health plan line of business.
| |
|
| |
| ====Healthcare clearinghouses====
| |
| Health care clearinghouses are entities that process nonstandard information they receive from another entity into a standard (i.e., standard format or data content), or vice versa.
| |
|
| |
| In most instances, healthcare clearinghouses will receive individually-identifiable health information only when they are providing these processing services to a health plan or healthcare provider as a [[#Business Associate|Business Associate]]. In those cases, only certain provisions of the Privacy Rule are applicable to uses and disclosures of protected health information.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| Healthcare clearinghouses include<ref name="HHSSummaryHIPAA" />:
| |
|
| |
| * billing services
| |
| * repricing companies
| |
| * community health management information systems
| |
| * value-added networks and switches (if they perform clearinghouse functions)
| |
|
| |
|
| |
| ==Protected health information==
| |
| [[File:Locked Desktop Computer Cartoon.svg|right|300px]]At the center of all of HIPAA and HITECH is a single term and its definition: protected health information or PHI. This is the information that can be linked to a patient and has been identified by the U.S. government as being private to a patient. As such, PH is protected by both the Privacy Rule and Security Rule of HIPAA, as well as HITECH (for electronic PHI). These protections exist so that unauthorized sharing is prevented or at least minimized, and access is controlled, with significant sanctions and measures available to be applied in the even of breaches.
| |
|
| |
| The HHS and the Privacy Rule define PHI in the following way<ref name="HHSSummaryHIPAA" />:
| |
|
| |
| <blockquote>The Privacy Rule protects all "individually identifiable health information" held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral. The Privacy Rule calls this information "protected health information (PHI)."
| |
|
| |
| “Individually identifiable health information” is information, including demographic data, that relates to:
| |
|
| |
| : ▪ the individual’s past, present or future physical or mental health or condition,
| |
| : ▪ the provision of health care to the individual, or
| |
| : ▪ the past, present, or future payment for the provision of health care to the individual,
| |
|
| |
| and that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual.</blockquote>
| |
|
| |
| According to the Privacy Rule, PHI does not include employment records that a covered entity maintains in its capacity as an employer, and education and certain other records subject to, or defined in, the Family Educational Rights and Privacy Act, 20 U.S.C. §1232g.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| HIPAA lists 18 identifiers that qualify as PHI, and as such they must be kept secure and private in the ways that are set down in HIPAA and HITECH. These identifiers are<ref name="45CFR164">{{cite web |url=https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-E/section-164.514 |title=Code of Federal Regulations, Title 45, Subtitle A, Subchapter C, Part 164, Subpart E, 164.514 |publisher=U.S. Government Publishing Office |accessdate=09 February 2022}}</ref>:
| |
|
| |
| # names
| |
| # all geographical subdivisions smaller than a state, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code, if according to the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and (2) The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000
| |
| # all elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older
| |
| # 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)
| |
|
| |
| There are also additional standards and criteria to protect individual's privacy from re-identification. Any code used to replace the identifiers in data sets cannot be derived from any information related to the individual and the master codes, nor can the method to derive the codes be disclosed. For example, a subject's initials cannot be used to code their data because the initials are derived from their name. Additionally, the researcher must not have actual knowledge that the research subject could be re-identified from the remaining identifiers in the PHI used in the research study. In other words, the information would still be considered identifiable if there were a way to identify the individual even though all of the 18 identifiers were removed.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| ===De-identified PHI===
| |
| The government recognizes that there are instances where there is a need to use and/or transmit PHI. Since the key here is whether it can be used to identify the individual, HIPAA provides for two approved "de-identification" methods.
| |
|
| |
| The first is the “Safe Harbor” approach, which permits a covered entity to consider data to be de-identified if it removes the 18 types of identifiers and has no actual knowledge that the remaining information could be used to identify an individual either alone or in combination with other information.<ref name="De-ID">{{cite web |url=https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/2010-de-identification-workshop/index.html |title=Workshop on the HIPAA Privacy Rule's De-Identification Standard |author=Office of Civil Rights |publisher=U.S. Department of Health & Human Services |date=28 March 2017 |accessdate=09 February 2022}}</ref>
| |
|
| |
| The second method is the "Statistical" approach, which allows disclosure of PHI in any form provided that a qualified statistical or scientific expert concludes, through the use of accepted analytic techniques, that the risk the information could be used alone or in combination with other reasonably available information to identify the subject is very small (statistically insignificant).<ref name="De-ID" />
| |
|
| |
| ===Privacy Rule: General principle for use and disclosure===
| |
| In general, to help in deciding when to disclose or not, it is useful to keep the Privacy Rule's purpose in mind: to define and limit the circumstances in which an individual’s protected heath information may be used or disclosed by covered entities.
| |
|
| |
| A covered entity may not use or disclose protected health information, except either:
| |
|
| |
| # as the Privacy Rule permits or requires; or
| |
| # as the individual who is the subject of the information (or the individual’s personal representative) authorizes in writing.
| |
|
| |
| Similarly, there are only two cases where a covered entity is actually required to disclose PHI<ref name="HHSSummaryHIPAA" />:
| |
|
| |
| # when the individual to whom the PHI applies (or authorized representative) requests it in writing; or
| |
| # when the HHS is undertaking a compliance investigation, review or enforcement action and requests it.
| |
|
| |
|
| |
| ==Use and disclosure==
| |
| [[File:Department of Health & Human Services - Sarah Stierch.jpg|right|400px]]Now that we understand what HIPAA is, who it applies to and what information is protected, it's time to look at exactly how PHI can and cannot be used.
| |
|
| |
| According to the HHS, a covered entity is permitted, but not required, to use and disclose PHI, without an individual’s authorization, for any of the following purposes or situations<ref name="HHSSummaryHIPAA" />:
| |
|
| |
| # 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.
| |
|
| |
| ===Permitted uses and disclosures===
| |
| ====To the individual====
| |
| This use and disclosure is straightforward. A covered entity may disclose PHI to the individual who is the subject of the information.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| ====Treatment, payment and healthcare operations====
| |
| A covered entity may use and disclose PHI for its own use in treatment, payment and healthcare operations activities. A covered entity may also disclose PHI 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 PHI pertains to the relationship. The HHS defines treatment, payment and healthcare operations as follows<ref name="HHSSummaryHIPAA" />:
| |
|
| |
| ;Treatment
| |
| : 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
| |
| : 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 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 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 covered entity electing to seek consent.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| ====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. A few common examples are given below<ref name="HHSSummaryHIPAA" />:
| |
|
| |
| '''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, 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 covered entity 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 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.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| ====Public interest and benefit activities====
| |
| [[File:Paramedic dispatch.jpg|right|400px]]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 Privacy 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<ref name="HHSSummaryHIPAA" />:
| |
|
| |
| :'''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''': Covered entities 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, covered entities may disclose PHI to appropriate government authorities regarding victims of abuse, neglect or domestic violence.
| |
|
| |
| :'''4. For health oversight activities''': Covered entities may disclose PHI to health oversight agencies (as defined in the Privacy 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''': Covered entities 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''': Covered entities 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 covered entity suspects that criminal activity caused the death
| |
| ::* when a covered entity 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''': Covered entities 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''': Covered entities 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 covered entity to use and disclose PHI for research purposes, without an individual’s authorization, provided the covered entity 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 covered entity, 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 covered entity, documentation of the death of the individuals about whom information is sought.
| |
| : A covered entity 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''': Covered entities 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). Covered entities 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''': Covered entities 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.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| The "certain specified direct identifiers" that must be removed are almost all of the 18 PHI identifiers previously discussed, but not exactly. Again, they are<ref name="45CFR164" />:
| |
|
| |
| # name
| |
| # 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===
| |
| There are three instances where use and disclosure of PHI is always authorized, with certain conditions.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| '''1. Authorization by the individual''': A covered entity 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 covered entity, or by a third party. Examples of disclosures that would require an individual’s authorization include<ref name="45CFR164" />:
| |
|
| |
| * 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<ref name="45CFR164" />:
| |
|
| |
| * 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. Psychotherapy Notes''': Using or disclosing PHI is prohibited without the individual's authorization, except in the following cases<ref name="45CFR164" />:
| |
|
| |
| * when the covered entity who created the notes is uses them for treatment
| |
| * when the covered entity 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 covered entity’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<ref name="45CFR164" />:
| |
|
| |
| * communications to describe health-related products or services, or payment for them, provided by or included in a benefit plan of the covered entity 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 covered entity and any other entity whereby the covered entity 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 covered entity has to obtain an authorization to use or disclose PHI for marketing, except for face-to-face marketing communications between the covered entity and an individual, and for a covered entity’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 covered entity’s receipt of direct or indirect remuneration from a third party must reveal that fact.
| |
|
| |
| ===Limiting===
| |
| 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.
| |
|
| |
| ====Minimum necessary====
| |
| Basically, HIPAA says that in any case of authorized disclosure, the amount of PHI shared must be the minimum necessary. A covered entity 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 covered entity 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.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| Like most rules, there are exceptions to this principle. They are<ref name="HHSSummaryHIPAA" />:
| |
|
| |
| * 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====
| |
| The tenets of HIPAA, unlike what might be said of many laws, are almost without exception common sense and reasonable measures aimed at protecting people's personally identifiable information. Thus, the idea of restricting and controlling access to that information joins the Minimum Use principle as a sensible idea.
| |
|
| |
| For internal uses, a covered entity 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.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| ====Disclosures and requests for disclosures====
| |
| Covered entities 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, covered entities must develop criteria designed to do the same thing, but with a review of each request individually in accordance with the established criteria.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| ====Reasonable reliance on another covered entity's compliance====
| |
| HIPAA allows you to make the reasonable assumption that a request from another covered entity is in compliance with disclosure rules and principles. The HHS explains it such that if another covered entity makes a request for PHI, a covered entity may rely, if reasonable under the circumstances, on the request as complying with this minimum necessary standard. Similarly, a covered entity 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 covered entity’s business associate, seeking the information to provide services to or for the covered entity; or (c) a researcher who provides the documentation or representation required by the Privacy Rule for research.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| ===Patient notification and rights===
| |
| [[File:Privacy.jpg|left|200px]]Covered entities are required by HIPAA to provide information about how they handle a patient's PHI, and to allow access and the ability to update or amend it. The specifics are as follows.
| |
|
| |
| ====Privacy practices notice====
| |
| Each covered entity, with certain exceptions, must provide a notice of its privacy practices. The Privacy Rule requires that the notice contain certain elements. The notice must<ref name="HHSSummaryHIPAA" />:
| |
| {{flowlist |
| |
| * describe the ways in which the covered entity may use and disclose PHI
| |
| * state the covered entity’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 covered entity if they believe their privacy rights have been violated
| |
| * include a point of contact for further information and for making complaints to the covered entity}}
| |
|
| |
| Covered entities 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 [https://www.hhs.gov/hipaa/index.html HHS site].
| |
|
| |
| '''Notice distribution'''
| |
|
| |
| A covered healthcare provider with a direct treatment relationship with individuals must have delivered a privacy practices notice to patients as follows<ref name="HHSSummaryHIPAA" />:
| |
|
| |
| * 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
| |
|
| |
| Covered entities, whether direct treatment providers or indirect treatment providers (such as laboratories) or health plans, also must supply notice to anyone upon request. A covered entity must also make its notice electronically available on any website it maintains for customer service or benefits information.
| |
|
| |
| The covered entities 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 covered entity 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.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| '''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.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| ====Access====
| |
| Patients have the right to review and obtain a copy of their PHI in a covered entity’s designated record set, with some exceptions. The "designated record set" is that group of records maintained by or for a covered entity 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<ref name="HHSSummaryHIPAA" />:
| |
|
| |
| * psychotherapy notes
| |
| * information compiled for legal proceedings
| |
| * laboratory results to which the CLIA prohibits access
| |
| * information held by certain research laboratories
| |
|
| |
| For information included within the right of access, covered entities 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. Covered entities may impose reasonable, cost-based fees for the cost of copying and postage.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| ====Amendment====
| |
| The rule gives individuals the right to have covered entities amend their PHI in a designated record set when that information is inaccurate or incomplete.
| |
|
| |
| If a covered entity 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 covered entity knows might rely on the information to the individual’s detriment. If the request is denied, covered entities 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 covered entity receives notice to amend from another covered entity, it must amend PHI in its designated record set upon receipt.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| ====Disclosure accounting====
| |
| Under HIPAA, individuals have a right to an accounting of the disclosures of their PHI by a covered entity or the covered entity’s business associates. The maximum disclosure accounting period is the six years immediately preceding the accounting request. However, a covered entity 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<ref name="HHSSummaryHIPAA" />:
| |
|
| |
| # 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.
| |
|
| |
| ====Restriction request====
| |
| Individuals have the right to request that a covered entity restrict use or disclosure of PHI for<ref name="HHSSummaryHIPAA" />:
| |
|
| |
| * 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 covered entity is under no obligation to agree to requests for restrictions. If a covered entity 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, covered healthcare providers and their covered business associates must permit individuals to request an alternative means or location for receiving communications of PHI by means other than those that the covered entity typically employs. For example, an individual may request that the provider communicate with the individual through a designated address or phone number. Similarly, an individual may request that the provider send communications in a closed envelope rather than a postcard.
| |
|
| |
| 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 covered entity 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.<ref name="HHSSummaryHIPAA" />
| |
|
| |
| ===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 Privacy 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.<ref name="45CFR164" />
| |
|
| |
| 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<ref name="HHSPersRep">{{cite web |url=https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/personal-representatives/index.html |title=Personal Representatives |author=Office for Civil Rights |publisher=U.S. Department of Health & Human Services |date=19 September 2013 |accessdate=10 February 2022}}</ref>:
| |
|
| |
| # 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'''
| |
|
| |
| In most cases under the rule, a parent, guardian or other person acting in ''loco parentis'' (collectively, "parent") is the personal representative of the minor child and can exercise the minor’s rights with respect to PHI, because the parent usually has the authority to make healthcare decisions about his or her minor child.
| |
|
| |
| 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 Privacy 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<ref name="HHSPersRep" />:
| |
|
| |
| # 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 covered entity 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 covered entity 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 covered entity 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.<ref name="HHSPersRep" />
| |
|
| |
| '''Abuse, neglect, and endangerment situations'''
| |
| When a physician or other covered entity 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 covered entity 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.<ref name="HHSPersRep" />
| |
|
| |
| ==References==
| |
| {{Reflist|colwidth=30em}}
| |
|
| |
| <!---Place all category tags here-->
| |
