User:Shawndouglas/sandbox/sublevel4

Title: HIPAA Compliance: An Introduction

Author for citation: Alan Vaughan, with editorial modifications by Shawn Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: Originally published June 2016; lightly edited February 2022

Introduction

Reason and scope

In the U.S. healthcare industry, there are two main regulatory laws: the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Information Portability and Accountability Act of 1996 (HIPAA). The first is aimed at 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:

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.

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?

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. While important, this guide focuses on HIPAA, which was enacted by the United States Congress and signed into law in 1996.

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.

• 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, hospitals, dentists, nursing homes and pharmacies that transmit data electronically, as well as health plans, insurance plans and healthcare clearinghouses.

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:

• 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.

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:

• 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.

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.

Business associates

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.

According to 45 CFR 160 Part 103, business associate functions or activities on behalf of a covered entity include:

• 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.

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.

Here are some examples of business associates, as described by the HHS :

• 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:

• 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 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:

1. disclosures by a covered entity to a healthcare provider for treatment of the individual. For example:
   1. 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.
   2. 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.
   3. 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.
2. 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.
3. 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:

• 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

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.

Health plan exceptions

The exceptions where certain health plans do not constitute covered entities include:

1. group health plans with less than 50 participants, administered solely by the employer that established and maintains the plan.
2. two types of government-funded programs:
   1. those whose principal purpose is not providing or paying the cost of healthcare, such as the food stamps program (SNAP).
   2. 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.
3. certain types of insurance entities, particularly those who only provide:
   1. workers’ compensation.
   2. automobile insurance.
   3. 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. In those cases, only certain provisions of the Privacy Rule are applicable to uses and disclosures of protected health information.

Healthcare clearinghouses include:

• billing services
• repricing companies
• community health management information systems
• value-added networks and switches (if they perform clearinghouse functions)

Protected health information

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:

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.

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.

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:

1. names
2. 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
3. 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
4. phone numbers
5. fax numbers
6. electronic mail (email) addresses
7. Social Security numbers
8. medical record numbers (MRNs)
9. health plan beneficiary numbers
10. account numbers
11. certificate/license numbers
12. vehicle identifiers and serial numbers, including license plate numbers
13. device identifiers and serial numbers
14. web addresses or Uniform Resource Locators (URLs)
15. Internet Protocol (IP) address numbers
16. biometric identifiers, including finger and voice prints
17. full face photographic images and any comparable images
18. 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.

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.

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).

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:

1. as the Privacy Rule permits or requires; or
2. 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:

1. when the individual to whom the PHI applies (or authorized representative) requests it in writing; or
2. when the HHS is undertaking a compliance investigation, review or enforcement action and requests it.

Use and disclosure

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:

1. to provide or reveal to the affected individual, unless required for access or accounting of disclosures
2. for treatment, payment, and health care operations
3. as an opportunity to agree or object
4. as incidental to an otherwise permitted use and disclosure
5. in the case of public interest and benefit activities
6. 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.

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:

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.

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:

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.

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 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:

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.