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From a professional perspective, HIPAA (Health Insurance Portability and Accountability Act) is a critical regulatory framework in the healthcare industry. It sets standards for safeguarding protected health information (PHI) to ensure its confidentiality, integrity, and availability. Compliance with HIPAA regulations is paramount for healthcare organizations, as violations can result in severe consequences, including fines and reputational damage.

HIPAA aims to strike a balance between facilitating the efficient exchange of healthcare information and protecting patients' privacy rights. It encompasses various components, including the Privacy Rule, Security Rule, and Breach Notification Rule, each addressing specific aspects of PHI protection.

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The governing agency responsible for overseeing compliance with HIPAA (Health Insurance Portability and Accountability Act) in the United States is the Department of Health and Human Services (HHS), specifically the Office for Civil Rights (OCR). The OCR is tasked with enforcing HIPAA regulations, investigating complaints of HIPAA violations, and conducting audits of covered entities and business associates to ensure compliance with the law. Its primary goal is to protect the privacy and security of individuals' protected health information (PHI) while facilitating the flow of health information necessary for patient care and public health activities.

One of the most important things to learn about governing bodies and accountability at both the federal and state levels for HIPAA is the enforcement mechanisms and penalties for non-compliance. Understanding how the Office for Civil Rights (OCR) at the federal level and state-level agencies handle investigations, audits, and enforcement actions related to HIPAA violations is crucial. This includes being aware of the potential civil monetary penalties, corrective action plans, and other consequences that can result from non-compliance with HIPAA regulations.

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 #3 Federal and state constitutional laws:

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 #3 Federal and state constitutional laws:

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Federal Constitutional Law:

Fourth Amendment of the United States Constitution: Protects against unreasonable searches and seizures. While not directly related to HIPAA, it underpins the notion of privacy rights, which are central to HIPAA's Privacy Rule.

Fifth Amendment of the United States Constitution: Protects against self-incrimination and deprivation of life, liberty, or property without due process of law. This constitutional protection may intersect with HIPAA in certain legal contexts, such as investigations or legal proceedings involving protected health information (PHI).

State Constitutional Law:

Texas Constitution, Article I, Section 9: This section guarantees the right to be secure against unreasonable searches and seizures, similar to the Fourth Amendment of the United States Constitution. While not explicitly focused on healthcare privacy, it establishes a broader framework for protecting individual privacy rights, which can extend to health information.

Texas Constitution, Article I, Section 10: This section protects the right to privacy against governmental intrusion. It states, "All persons shall be at liberty to speak, write or publish their opinions on any subject, being responsible for the abuse of that privilege; and no law shall ever be passed curtailing the liberty of speech or of the press." While not healthcare-specific, it underscores the importance of privacy rights, which are central to HIPAA.

https://constitution.congress.gov/constitution/amendment-4/

https://constitution.congress.gov/constitution/amendment-5/

https://statutes.capitol.texas.gov/Docs/CN/htm/CN.1.htm

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#4 One statue and one administrative law:

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#4 One statue and one administrative law:

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1. Statute: Health Insurance Portability and Accountability Act (HIPAA):

HIPAA is the primary federal statute governing healthcare privacy and security in the United States. Enacted in 1996, HIPAA establishes standards for the protection of sensitive patient health information, known as protected health information (PHI). It includes several regulations, such as the Privacy Rule, Security Rule, and Breach Notification Rule, which healthcare entities must comply with to ensure the confidentiality, integrity, and availability of PHI.

2. Administrative Law: HIPAA Privacy Rule (45 CFR Part 160 and Part 164, Subparts A and E):

The HIPAA Privacy Rule is an administrative regulation issued by the U.S. Department of Health and Human Services (HHS) under the authority of HIPAA. It sets forth national standards for the protection of individuals' medical records and other personal health information. The Privacy Rule governs the permissible uses and disclosures of PHI by covered entities and establishes individuals' rights regarding their health information, such as the right to access and amend their records. It also outlines requirements for covered entities to implement administrative, physical, and technical safeguards to protect PHI.

https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html

https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/introduction/index.html#:~:text=The%20Privacy%20Rule%20(45%20CFR,in%20the%20health%20care%20system.

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This is a summary of key elements of the Privacy Rule including who is covered, what information is protected, and how protected health information can be used and disclosed. Because it is an overview of the Privacy Rule, it does not address every detail of each provision.
Summary of the Privacy Rule
Introduction

The Standards for Privacy of Individually Identifiable Health Information ("Privacy Rule") establishes, for the first time, a set of national standards for the protection of certain health information. The U.S. Department of Health and Human Services ("HHS") issued the Privacy Rule to implement the requirement of the Health Insurance Portability and Accountability Act of 1996 ("HIPAA").¹ The Privacy Rule standards address the use and disclosure of individuals' health information-called "protected health information" by organizations subject to the Privacy Rule - called "covered entities," as well as standards for individuals' privacy rights to understand and control how their health information is used. Within HHS, the Office for Civil Rights ("OCR") has responsibility for implementing and enforcing the Privacy Rule with respect to voluntary compliance activities and civil money penalties.

A major goal of the Privacy Rule is to assure that individuals' health information is properly protected while allowing the flow of health information needed to provide and promote high quality health care and to protect the public's health and well being. The Rule strikes a balance that permits important uses of information, while protecting the privacy of people who seek care and healing. Given that the health care marketplace is diverse, the Rule is designed to be flexible and comprehensive to cover the variety of uses and disclosures that need to be addressed.

This is a summary of key elements of the Privacy Rule and not a complete or comprehensive guide to compliance. Entities regulated by the Rule are obligated to comply with all of its applicable requirements and should not rely on this summary as a source of legal information or advice. To make it easier for entities to review the complete requirements of the Rule, provisions of the Rule referenced in this summary are cited in the end notes. Visit ourPrivacy Rule section to view the entire Rule, and for other additional helpful information about how the Rule applies. In the event of a conflict between this summary and the Rule, the Rule governs.
Statutory and Regulatory Background

The Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, was enacted on August 21, 1996. Sections 261 through 264 of HIPAA require the Secretary of HHS to publicize standards for the electronic exchange, privacy and security of health information. Collectively these are known as the Administrative Simplification provisions.

HIPAA required the Secretary to issue privacy regulations governing individually identifiable health information, if Congress did not enact privacy legislation within three years of the passage of HIPAA. Because Congress did not enact privacy legislation, HHS developed a proposed rule and released it for public comment on November 3, 1999. The Department received over 52,000 public comments. The final regulation, the Privacy Rule, was published December 28, 2000.²
In March 2002, the Department proposed and released for public comment modifications to the Privacy Rule. The Department received over 11,000 comments.The final modifications were published in final form on August 14, 2002. ³ A text combining the final regulation and the modifications can be found at 45 CFR Part 160 and Part 164, Subparts A and E.

Who is Covered by the Privacy Rule
The Privacy Rule, as well as all the Administrative Simplification rules, apply to health plans, health care clearinghouses, and to any health care provider who transmits health information in electronic form in connection with transactions for which the Secretary of HHS has adopted standards under HIPAA (the "covered entities"). For help in determining whether you are covered, use CMS's decision tool.

Health Care Providers. Every health care 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, or other transactions for which HHS has established standards under the HIPAA Transactions Rule. ⁶ Using electronic technology, such as email, does not mean a health care provider is a covered entity; the transmission must be in connection with a standard transaction. The Privacy Rule covers a health care provider whether it electronically transmits these transactions directly or uses a billing service or other third party to do so on its behalf. Health care 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 health care.

Health Care 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. ⁷ In most instances, health care clearinghouses will receive individually identifiable health information only when they are providing these processing services to a health plan or health care provider as a business associate. In such instances, only certain provisions of the Privacy Rule are applicable to the health care clearinghouse's uses and disclosures of protected health information. ⁸ Health care clearinghouses include billing services, repricing companies, community health management information systems, and value-added networks and switches if these entities perform clearinghouse functions.
Business Associates
Business Associate Defined. In general, a business associate is a person or organization, other than a member of a covered entity's workforce, that performs certain functions or activities on behalf of, or provides certain services to, a covered entity that involve the use or disclosure of individually identifiable health information. Business associate functions or activities on behalf of a covered entity include claims processing, data analysis, utilization review, and billing. ⁹ Business associate services to a covered entity are limited to legal, actuarial, accounting, consulting, data aggregation, management, administrative, accreditation, or financial services. 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 be the business associate of another covered entity.

Business Associate Contract. When a covered entity uses a contractor or other non-workforce member to perform "business associate" services or activities, the Rule requires that the covered entity include certain protections for the information in a business associate agreement (in certain circumstances governmental entities may use alternative means to achieve the same protections). In the business associate contract, a covered entity must impose specified written safeguards on the individually identifiable health information used or disclosed by its business associates. ¹⁰ Moreover, a covered entity may not contractually authorize its business associate to make any use or disclosure of protected health information that would violate the Rule. Covered entities that had an existing written contract or agreement with business associates prior to October 15, 2002, which was not renewed or modified prior to April 14, 2003, were permitted to continue to operate under that contract until they renewed the contract or April 14, 2004, whichever was first. ¹¹ See additional guidance on Business Associates and sample business associate contract language.
What Information is Protected
Protected Health Information. 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)." ¹²

"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. ¹³ Individually identifiable health information includes many common identifiers (e.g., name, address, birth date, Social Security Number).

The Privacy Rule excludes from protected health information 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.
General Principle for Uses and Disclosures
Basic Principle. A major purpose of the Privacy Rule is 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. ¹⁶
Permitted Uses and Disclosures
Permitted Uses and Disclosures. A covered entity is permitted, but not required, to use and disclose protected health information, without an individual's authorization, for the following purposes or situations: (1) To the Individual (unless required for access or accounting of disclosures); (2) Treatment, Payment, and Health Care Operations; (3) Opportunity to Agree or Object; (4) Incident to an otherwise permitted use and disclosure; (5) Public Interest and Benefit Activities; and (6) Limited Data Set for the purposes of research, public health or health care operations. ¹⁸ Covered entities may rely on professional ethics and best judgments in deciding which of these permissive uses and disclosures to make.

(1) To the Individual. A covered entity may disclose protected health information to the individual who is the subject of the information.

Most uses and disclosures of psychotherapy notes for treatment, payment, and health care operations purposes require an authorization as described below. ²³ Obtaining "consent" (written permission from individuals to use and disclose their protected health information for treatment, payment, and health care operations) is optional under the Privacy Rule for all covered entities. ²⁴ The content of a consent form, and the process for obtaining consent, are at the discretion of the covered entity electing to seek consent.

(3) 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.

(5) Public Interest and Benefit Activities. The Privacy Rule permits use and disclosure of protected health information, without an individual's authorization or permission, for 12 national priority purposes. ²⁸ These disclosures are permitted, although not required, by the Rule in recognition of the important uses made of health information outside of the health care 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.

Public Health Activities. Covered entities may disclose protected health information to: (1) public health authorities authorized by law to collect or receive such information for preventing or controlling disease, injury, or disability and to public health or other government authorities authorized to receive reports of child abuse and neglect; (2) entities subject to FDA regulation regarding FDA regulated products or activities for purposes such as adverse event reporting, tracking of products, product recalls, and post-marketing surveillance; (3) individuals who may have contracted or been exposed to a communicable disease when notification is authorized by law; and (4) employers, regarding employees, when requested by employers, for information concerning a work-related illness or injury or workplace related medical surveillance, because such information is needed by the employer to comply with the Occupational Safety and Health Administration (OHSA), the Mine Safety and Health Administration (MHSA), or similar state law. ³⁰ See additional guidance on Public Health Activities and CDC's web pages on Public Health and HIPAA Guidance.

Cadaveric Organ, Eye, or Tissue Donation. Covered entities may use or disclose protected health information to facilitate the donation and transplantation of cadaveric organs, eyes, and tissue. ³⁶

Research. "Research" is any systematic investigation designed to develop or contribute to generalizable knowledge. ³⁷ The Privacy Rule permits a covered entity to use and disclose protected health information for research purposes, without an individual's authorization, provided the covered entity obtains either: (1) documentation that an alteration or waiver of individuals' authorization for the use or disclosure of protected health information about them for research purposes has been approved by an Institutional Review Board or Privacy Board; (2) representations from the researcher that the use or disclosure of the protected health information is solely to prepare a research protocol or for similar purpose preparatory to research, that the researcher will not remove any protected health information from the covered entity, and that protected health information for which access is sought is necessary for the research; or (3) representations from the researcher that the use or disclosure sought is solely for research on the protected health information of decedents, that the protected health information 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. ³⁸ A covered entity also may use or disclose, without an individuals' authorization, a limited data set of protected health information for research purposes (see discussion below). ³⁹ See additional guidance on Research and NIH's publication of "Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule."

Workers' Compensation. Covered entities may disclose protected health information as authorized by, and to comply with, workers' compensation laws and other similar programs providing benefits for work-related injuries or illnesses. ⁴² See additional guidance on Workers' Compensation.

(6) Limited Data Set. A limited data set is protected health information from which certain specified direct identifiers of individuals and their relatives, household members, and employers have been removed.43 A limited data set may be used and disclosed for research, health care operations, and public health purposes, provided the recipient enters into a data use agreement promising specified safeguards for the protected health information within the limited data set.
Authorized Uses and Disclosures
An authorization must be written in specific terms. It may allow use and disclosure of protected health information by the covered entity seeking the authorization, or by a third party. Examples of disclosures that would require an individual's authorization include disclosures to a life insurer for coverage purposes, disclosures to an employer of the results of a pre-employment physical or lab test, or disclosures to a pharmaceutical firm for their own marketing purposes.

All authorizations must be in plain language, and contain specific information regarding the information to be disclosed or used, the person(s) disclosing and receiving the information, expiration, right to revoke in writing, and other data. The Privacy Rule contains transition provisions applicable to authorizations and other express legal permissions obtained prior to April 14, 2003. ⁴⁶

The covered entity who originated the notes may use them for treatment.

A covered entity may use or disclose, without an individual's authorization, the psychotherapy notes, for its own training, and 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 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.

Marketing. Marketing is any communication about a product or service that encourages recipients to purchase or use the product or service. ⁴⁹ The Privacy Rule carves out the following health-related activities from this definition of marketing:

Communications to describe health-related products or services, or payment for them, provided by or included in a benefit plan of the 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; and

Communications for case management or care coordination for the individual, or to direct or recommend alternative treatments, therapies, health care 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 protected health information, 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. A covered entity must obtain an authorization to use or disclose protected health information for marketing, except for face-to-face marketing communications between a 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. See additional guidance on Marketing.
Limiting Uses and Disclosures to the Minimum Necessary
The minimum necessary requirement is not imposed in any of the following circumstances: (a) disclosure to or a request by a health care provider for treatment; (b) disclosure to an individual who is the subject of the information, or the individual's personal representative; (c) use or disclosure made pursuant to an authorization; (d) disclosure to HHS for complaint investigation, compliance review or enforcement; (e) use or disclosure that is required by law; or (f) use or disclosure required for compliance with the HIPAA Transactions Rule or other HIPAA Administrative Simplification Rules.

Access and Uses. For internal uses, a covered entity must develop and implement policies and procedures that restrict access and uses of protected health information 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 protected health information to carry out their duties, the categories of protected health information to which access is needed, and any conditions under which they need the information to do their jobs.

Disclosures and Requests for Disclosures. Covered entities must establish and implement policies and procedures (which may be standard protocols) for routine, recurring disclosures, or requests for disclosures, that limits the protected health information disclosed to that which is the minimum amount reasonably necessary to achieve the purpose of the disclosure. Individual review of each disclosure is not required. For non-routine, non-recurring disclosures, or requests for disclosures that it makes, covered entities must develop criteria designed to limit disclosures to the information reasonably necessary to accomplish the purpose of the disclosure and review each of these requests individually in accordance with the established criteria.

Reasonable Reliance. If another covered entity makes a request for protected health information, 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 protected health information 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.
Notice and Other Individual Rights

Notice Distribution. A covered health care provider with a direct treatment relationship with individuals must have delivered a privacy practices notice to patients starting April 14, 2003 as follows:

Not later than the first service encounter by personal delivery (for patient visits), by automatic and contemporaneous electronic response (for electronic service delivery), and by prompt mailing (for telephonic service delivery);

By posting the notice at each service delivery site in a clear and prominent place where people seeking service may reasonably be expected to be able to read the notice; and

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 must supply notice to anyone on request. ⁵² A covered entity must also make its notice electronically available on any web site it maintains for customer service or benefits information.

The covered entities in an organized health care arrangement may use a joint privacy practices notice, as long as each agrees to abide by the notice content with respect to the protected health information created or received in connection with participation in the arrangement. ⁵³ Distribution of a joint notice by any covered entity participating in the organized health care arrangement at the first point that an OHCA member has an obligation to provide notice satisfies the distribution obligation of the other participants in the organized health care arrangement.

A health plan must distribute its privacy practices notice to each of its enrollees by its Privacy Rule compliance date. Thereafter, the health plan must give its notice to each new enrollee at enrollment, and send a reminder to every enrollee at least once every three years that the notice is available upon request. A health plan satisfies its distribution obligation by furnishing the notice to the "named insured," that is, the subscriber for coverage that also applies to spouses and dependents.

Acknowledgement of Notice Receipt. A covered health care 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.⁵⁴ The Privacy Rule does not prescribe any particular content for the acknowledgement. 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.

Access. Except in certain circumstances, individuals have the right to review and obtain a copy of their protected health information in a covered entity's designated record set. ⁵⁵ 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 that 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. ⁵⁶ The Rule excepts from the right of access the following protected health information: psychotherapy notes, information compiled for legal proceedings, laboratory results to which the Clinical Laboratory Improvement Act (CLIA) prohibits access, or 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 health care 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 health care professional for a second opinion. ⁵⁷ Covered entities may impose reasonable, cost-based fees for the cost of copying and postage.

Disclosure Accounting. Individuals have a right to an accounting of the disclosures of their protected health information by a covered entity or the covered entity's business associates. ⁶⁰ The maximum disclosure accounting period is the six years immediately preceding the accounting request, except a covered entity is not obligated to account for any disclosure made before its Privacy Rule compliance date.

The Privacy Rule does not require accounting for disclosures: (a) for treatment, payment, or health care operations; (b) to the individual or the individual's personal representative; (c) for notification of or to persons involved in an individual's health care or payment for health care, for disaster relief, or for facility directories; (d) pursuant to an authorization; (e) of a limited data set; (f) for national security or intelligence purposes; (g) to correctional institutions or law enforcement officials for certain purposes regarding inmates or individuals in lawful custody; or (h) incident to otherwise permitted or required uses or disclosures. Accounting for disclosures to health oversight agencies and law enforcement officials must be temporarily suspended on their written representation that an accounting would likely impede their activities.

Confidential Communications Requirements. Health plans and covered health care providers must permit individuals to request an alternative means or location for receiving communications of protected health information by means other than those that the covered entity typically employs. ⁶³ 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 post card.

Health plans must accommodate reasonable requests if the individual indicates that the disclosure of all or part of the protected health information 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.
Administrative Requirements
HHS recognizes that covered entities range from the smallest provider to the largest, multi-state health plan. Therefore the flexibility and scalability of the Rule are intended to allow covered entities to analyze their own needs and implement solutions appropriate for their own environment. What is appropriate for a particular covered entity will depend on the nature of the covered entity's business, as well as the covered entity's size and resources.

Privacy Policies and Procedures. A covered entity must develop and implement written privacy policies and procedures that are consistent with the Privacy Rule. ⁶⁴

Privacy Personnel. A covered entity must designate a privacy official responsible for developing and implementing its privacy policies and procedures, and a contact person or contact office responsible for receiving complaints and providing individuals with information on the covered entity's privacy practices. ⁶⁵

Workforce Training and Management. Workforce members include employees, volunteers, trainees, and may also include other persons whose conduct is under the direct control of the entity (whether or not they are paid by the entity). ⁶⁶ 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. ⁶⁷ A covered entity must have and apply appropriate sanctions against workforce members who violate its privacy policies and procedures or the Privacy Rule. ⁶⁸

Mitigation. A covered entity must mitigate, to the extent practicable, any harmful effect it learns was caused by use or disclosure of protected health information by its workforce or its business associates in violation of its privacy policies and procedures or the Privacy Rule. ⁶⁹

Among other things, the covered entity must identify to whom individuals can submit complaints to at the covered entity and advise that complaints also can be submitted to the Secretary of HHS.

Documentation and Record Retention. A covered entity must maintain, until six years after the later of the date of their creation or last effective date, its privacy policies and procedures, its privacy practices notices, disposition of complaints, and other actions, activities, and designations that the Privacy Rule requires to be documented. ⁷⁵

Fully-Insured Group Health Plan Exception. The only administrative obligations with which a fully-insured group health plan that has no more than enrollment data and summary health information is required to comply are the (1) ban on retaliatory acts and waiver of individual rights, and (2) documentation requirements with respect to plan documents if such documents are amended to provide for the disclosure of protected health information to the plan sponsor by a health insurance issuer or HMO that services the group health plan. ⁷⁶
Organizational Options
The Rule contains provisions that address a variety of organizational issues that may affect the operation of the privacy protections.

Affiliated Covered Entity. Legally separate covered entities that are affiliated by common ownership or control may designate themselves (including their health care components) as a single covered entity for Privacy Rule compliance. ⁷⁹ The designation must be in writing. An affiliated covered entity that performs multiple covered functions must operate its different covered functions in compliance with the Privacy Rule provisions applicable to those covered functions.

Covered Entities With Multiple Covered Functions. A covered entity that performs multiple covered functions must operate its different covered functions in compliance with the Privacy Rule provisions applicable to those covered functions. ⁸² The covered entity may not use or disclose the protected health information of an individual who receives services from one covered function (e.g., health care provider) for another covered function (e.g., health plan) if the individual is not involved with the other function.

Group Health Plan disclosures to Plan Sponsors. A group health plan and the health insurer or HMO offered by the plan may disclose the following protected health information to the "plan sponsor"-the employer, union, or other employee organization that sponsors and maintains the group health plan: ⁸³

Enrollment or disenrollment information with respect to the group health plan or a health insurer or HMO offered by the plan.

If requested by the plan sponsor, summary health information for the plan sponsor to use to obtain premium bids for providing health insurance coverage through the group health plan, or to modify, amend, or terminate the group health plan. "Summary health information" is information that summarizes claims history, claims expenses, or types of claims experience of the individuals for whom the plan sponsor has provided health benefits through the group health plan, and that is stripped of all individual identifiers other than five digit zip code (though it need not qualify as de-identified protected health information).

Protected health information of the group health plan's enrollees for the plan sponsor to perform plan administration functions. The plan must receive certification from the plan sponsor that the group health plan document has been amended to impose restrictions on the plan sponsor's use and disclosure of the protected health information. These restrictions must include the representation that the plan sponsor will not use or disclose the protected health information for any employment-related action or decision or in connection with any other benefit plan.

Other Provisions: Personal Representatives and Minors
Personal Representatives. The Privacy Rule requires a covered entity to treat a "personal representative" the same as the individual, with respect to uses and disclosures of the individual's protected health information, as well as the individual's rights under the Rule. ⁸⁴ A personal representative is a person legally authorized to make health care decisions on an individual's behalf or to act for a deceased individual or the estate. The Privacy Rule permits an exception when a
covered entity has a reasonable belief that the personal representative may be abusing or neglecting the individual, or that treating the person as the personal representative could otherwise endanger the individual.

Special Case: Minors. In most cases, parents are the personal representatives for their minor children. Therefore, in most cases, parents can exercise individual rights, such as access to the medical record, on behalf of their minor children. In certain exceptional cases, the parent is not considered the personal representative. In these situations, the Privacy Rule defers to State and other law to determine the rights of parents to access and control the protected health information of their minor children. If State and other law is silent concerning parental access to the minor's protected health information, a covered entity has discretion to provide or deny a parent access to the minor's health information, provided the decision is made by a licensed health care professional in the exercise of professional judgment. See additional guidance on Personal Representatives.
State Law
Exception Determination. In addition, preemption of a contrary State law will not occur if HHS determines, in response to a request from a State or other entity or person, that the State law:

Is necessary to prevent fraud and abuse related to the provision of or payment for health care,

Is necessary to ensure appropriate State regulation of insurance and health plans to the extent expressly authorized by statute or regulation,

Is necessary for State reporting on health care delivery or costs,

Is necessary for purposes of serving a compelling public health, safety, or welfare need, and, if a Privacy Rule provision is at issue, if the Secretary determines that the intrusion into privacy is warranted when balanced against the need to be served; or

Has as its principal purpose the regulation of the manufacture, registration, distribution, dispensing, or other control of any controlled substances (as defined in 21 U.S.C. 802), or that is deemed a controlled substance by State law.

Enforcement and Penalties for Noncompliance
Compliance. The Standards for Privacy of Individually Identifiable Health Information (Privacy Rule) establishes a set of national standards for the use and disclosure of an individual's health information - called protected health information - by covered entities, as well as standards for providing individuals with privacy rights to understand and control how their health information is used. The Department of Health and Human Services, Office for Civil Rights (OCR) is responsible for administering and enforcing these standards and may conduct complaint investigations and compliance reviews.

Consistent with the principles for achieving compliance provided in the Privacy Rule, OCR will seek the cooperation of covered entities and may provide technical assistance to help them comply voluntarily with the Privacy Rule. Covered entities that fail to comply voluntarily with the standards may be subject to civil money penalties. In addition, certain violations of the Privacy Rule may be subject to criminal prosecution. These penalty provisions are explained below.

Civil Money Penalties. OCR may impose a penalty on a covered entity for a failure to comply with a requirement of the Privacy Rule. Penalties will vary significantly depending on factors such as the date of the violation, whether the covered entity knew or should have known of the failure to comply, or whether the covered entity's failure to comply was due to willful neglect. Penalties may not exceed a calendar year cap for multiple violations of the same requirement.

Penalty Amount Per Violation

$127 - $63,973* per violation

Calendar Year Cap for Violation of Identical Requirement or Prohibition

$25,000 - $1,919,173**

*The Department of Health and Human Services may make annual adjustments to the CMP amounts pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvement Act of 2015. The annual inflation amounts are found at 45 CFR § 102.3.
**Pursuant to HHS's Notification of Enforcement Discretion, https://www.federalregister.gov/documents/2019/04/30/2019-08530/enforcement-discretion-regarding-hipaa-civil-money-penalties

A penalty will not be imposed for violations in certain circumstances, such as if:

the failure to comply was not due to willful neglect, and was corrected during a 30-day period after the entity knew or should have known the failure to comply had occurred (unless the period is extended at the discretion of OCR); or

the Department of Justice has imposed a criminal penalty for the failure to comply (see below).

In addition, OCR may choose to reduce a penalty if the failure to comply was due to reasonable cause and the penalty would be excessive given the nature and extent of the noncompliance.

Before OCR imposes a penalty, it will notify the covered entity and provide the covered entity with an opportunity to provide written evidence of those circumstances that would reduce or bar a penalty. This evidence must be submitted to OCR within 30 days of receipt of the notice. In addition, if OCR states that it intends to impose a penalty, a covered entity has the right to request an administrative hearing to appeal the proposed penalty.

Criminal Penalties. A person who knowingly obtains or discloses individually identifiable health information in violation of the Privacy Rule may face a criminal penalty of up to $50,000 and up to one-year imprisonment. The criminal penalties increase to $100,000 and up to five years imprisonment if the wrongful conduct involves false pretenses, and to $250,000 and up to 10 years imprisonment if the wrongful conduct involves the intent to sell, transfer, or use identifiable health information for commercial advantage, personal gain or malicious harm. The Department of Justice is responsible for criminal prosecutions under the Priv
Compliance Dates
Compliance Schedule. All covered entities, except "small health plans," must have been compliant with the Privacy Rule by April 14, 2003. ⁹⁰ Small health plans, however, had until April 14, 2004 to comply.
Copies of the Rule & Related Materials
See our Combined Regulation Text of All Rules section of our site for the full suite of HIPAA Administrative Simplification Regulations and Understanding HIPAA for additional guidance material.
End Notes
¹ Pub. L. 104-191.
² 65 FR 82462.
³ 67 FR 53182.
⁴ 45 C.F.R. §§ 160.102, 160.103.
⁵ Even if an entity, such as a community health center, does not meet the definition of a health plan, it may, nonetheless, meet the definition of a health care provider, and, if it transmits health information in electronic form in connection with the transactions for which the Secretary of HHS has adopted standards under HIPAA, may still be a covered entity.
⁶ 45 C.F.R. §§ 160.102, 160.103; see Social Security Act § 1172(a)(3), 42 U.S.C. § 1320d-1(a)(3).
The transaction standards are established by the HIPAA Transactions Rule at 45 C.F.R. Part 162.
⁷ 45 C.F.R. § 160.103.
⁸ 45 C.F.R. § 164.500(b).
⁹ 45 C.F.R. § 160.103.
¹⁰ 45 C.F.R. §§ 164.502(e), 164.504(e).
¹¹ 45 C.F.R. § 164.532
¹² 45 C.F.R. § 160.103.
¹³ 45 C.F.R. § 160.103
¹⁴ 45 C.F.R. §§ 164.502(d)(2), 164.514(a) and (b).
¹⁵ The following identifiers of the individual or of relatives, employers, or household members of the individual must be removed to achieve the "safe harbor" method of de-identification: (A) Names; (B) All geographic 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 Census (1) the geographic units 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; (C) All elements of dates (except year) for dates directly related to the 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; (D) Telephone numbers; (E) Fax numbers; (F) Electronic mail addresses: (G) Social security numbers; (H) Medical record numbers; (I) Health plan beneficiary numbers; (J) Account numbers; (K) Certificate/license numbers; (L) Vehicle identifiers and serial numbers, including license plate numbers; (M) Device identifiers and serial numbers; (N) Web Universal Resource Locators (URLs); (O) Internet Protocol (IP) address numbers; (P) Biometric identifiers, including finger and voice prints; (Q) Full face photographic images and any comparable images; and ® any other unique identifying number, characteristic, or code, except as permitted for re-identification purposes provided certain conditions are met. In addition to the removal of the above-stated identifiers, the covered entity may not have actual knowledge that the remaining information could be used alone or in combination with any other information to identify an individual who is subject of the information. 45 C.F.R. § 164.514(b).
¹⁶ 45 C.F.R. § 164.502(a).
¹⁷ 45 C.F.R. § 164.502(a)(2).
¹⁸ 45 C.F.R. § 164.502(a)(1).
¹⁹ 45 C.F.R. § 164.506(c).
²⁰ 45 C.F.R. § 164.501.
²¹ 45 C.F.R. § 164.501.
²² 45 C.F.R. § 164.501.
²³ 45 C.F.R. § 164.508(a)(2)
²⁴ 45 C.F.R. § 164.506(b).
²⁵ 45 C.F.R. § 164.510(a).
²⁶ 45 C.F.R. § 164.510(b).
²⁷ 45 C.F.R. §§ 164.502(a)(1)(iii).
²⁸ See 45 C.F.R. § 164.512.
²⁹ 45 C.F.R. § 164.512(a).
³⁰ 45 C.F.R. § 164.512(b).
³¹ 45 C.F.R. § 164.512(a), (c).
³² 45 C.F.R. § 164.512(d).
³³ 45 C.F.R. § 164.512(e).
³⁴ 45 C.F.R. § 164.512(f).
³⁵ 45 C.F.R. § 164.512(g).
³⁶ 45 C.F.R. § 164.512(h).
³⁷ The Privacy Rule defines research as, "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." 45 C.F.R. § 164.501.
³⁸ 45 C.F.R. § 164.512(i).
³⁹ 45 CFR § 164.514(e).
⁴⁰ 45 C.F.R. § 164.512(j).
⁴¹ 45 C.F.R. § 164.512(k).
⁴² 45 C.F.R. § 164.512(l).
⁴³ 45 C.F.R. § 164.514(e). A limited data set is protected health information that excludes the
following direct identifiers of the individual or of relatives, employers, or household members of
the individual: (i) Names; (ii) Postal address information, other than town or city, State and zip
code; (iii) Telephone numbers; (iv) Fax numbers; (v) Electronic mail addresses: (vi) Social
security numbers; (vii) Medical record numbers; (viii) Health plan beneficiary numbers; (ix)
Account numbers; (x) Certificate/license numbers; (xi) Vehicle identifiers and serial numbers,
including license plate numbers; (xii) Device identifiers and serial numbers; (xiii) Web Universal
Resource Locators (URLs); (xiv) Internet Protocol (IP) address numbers; (xv) Biometric
identifiers, including finger and voice prints; (xvi) Full face photographic images and any
comparable images. 45 C.F.R. § 164.514(e)(2).
⁴⁴ 45 C.F.R. § 164.508.
⁴⁵ A covered entity may condition the provision of health care solely to generate protected health information for disclosure to a third party on the individual giving authorization to disclose the information to the third party. For example, a covered entity physician may condition the provision of a physical examination to be paid for by a life insurance issuer on an individual's authorization to disclose the results of that examination to the life insurance issuer. A health plan may condition enrollment or benefits eligibility on the individual giving authorization, requested before the individual's enrollment, to obtain protected health information (other than psychotherapy notes) to determine the individual's eligibility or enrollment or for underwriting or risk rating. A covered health care provider may condition treatment related to research (e.g., clinical trials) on the individual giving authorization to use or disclose the individual's protected health information for the research. 45 C.F.R. 508(b)(4).
⁴⁶ 45 CFR § 164.532.
⁴⁷ "Psychotherapy notes" means notes recorded (in any medium) by a health care provider who is a mental health professional documenting or analyzing the contents of conversation during a private counseling session or a group, joint, or family counseling session and that are separated from the rest of the of the individual's medical record. Psychotherapy notes excludes medication prescription and monitoring, counseling session start and stop times, the modalities and frequencies of treatment furnished, results of clinical tests, and any summary of the following items: diagnosis, functional status, the treatment plan, symptoms, prognosis, and progress to date.
⁴⁵ C.F.R. § 164.501.
⁴⁸ 45 C.F.R. § 164.508(a)(2).
⁴⁹ 45 C.F.R. §§ 164.501 and 164.508(a)(3).
⁵⁰ 45 C.F.R. §§ 164.502(b) and 164.514 (d).
⁵¹ 45 C.F.R. §§ 164.520(a) and (b). A group health plan, or a health insurer or HMO with respect to the group health plan, that intends to disclose protected health information (including enrollment data or summary health information) to the plan sponsor, must state that fact in the notice. Special statements are also required in the notice if a covered entity intends to contact individuals about health-related benefits or services, treatment alternatives, or appointment reminders, or for the covered entity's own fundraising.
⁵² 45 C.F.R. § 164.520(c).
⁵³ 45 C.F.R. § 164.520(d).
⁵⁴ 45 C.F.R. § 164.520(c).
⁵⁵ 45 C.F.R. § 164.524.
⁵⁶ 45 C.F.R. § 164.501.
⁵⁷ A covered entity may deny an individual access, provided that the individual is given a right to have such denials reviewed by a licensed health care professional (who is designated by the covered entity and who did not participate in the original decision to deny), when a licensed health care professional has determined, in the exercise of professional judgment, that: (a) the access requested is reasonably likely to endanger the life or physical safety of the individual or another person; (b) the protected health information makes reference to another person (unless such other person is a health care provider) and the access requested is reasonably likely to cause substantial harm to such other person; or (c) the request for access is made by the individual's personal representative and the provision of access to such personal representative is reasonably likely to cause substantial harm to the individual or another person.

A covered entity may deny access to individuals, without providing the individual an opportunity for review, in the following protected situations: (a) the protected health information falls under an exception to the right of access; (b) an inmate request for protected health information under certain circumstances; (c) information that a provider creates or obtains in the course of research that includes treatment for which the individual has agreed not to have access as part of consenting to participate in the research (as long as access to the information is restored upon completion of the research); (d) for records subject to the Privacy Act, information to which access may be denied under the Privacy Act, 5 U.S.C. § 552a; and (e) information obtained under a promise of confidentiality from a source other than a health care provider, if granting access would likely reveal the source. 45 C.F.R. § 164.524.
⁵⁸ 45 C.F.R. § 164.526.
⁵⁹ Covered entities may deny an individual's request for amendment only under specified circumstances. A covered entity may deny the request if it: (a) may exclude the information from access by the individual; (b) did not create the information (unless the individual provides a reasonable basis to believe the originator is no longer available); (c) determines that the information is accurate and complete; or (d) does not hold the information in its designated record set. 164.526(a)(2).
⁶⁰ 45 C.F.R. § 164.528.
⁶¹ 45 C.F.R. § 164.522(a).
⁶² 45 C.F.R. § 164.522(a). In addition, a restriction agreed to by a covered entity is not effective under this subpart to prevent uses or disclosures permitted or required under §§ 164.502(a)(2)(ii), 164.510(a) or 164.512.
⁶³ 45 C.F.R. § 164.522(b).
⁶⁴ 45 C.F.R. § 164.530(i).
⁶⁵ 45 C.F.R. § 164.530(a).
⁶⁶ 45 C.F.R. §160.103.
⁶⁷ 45 C.F.R. § 164.530(b).
⁶⁸ 45 C.F.R. § 164.530(e).
⁶⁹ 45 C.F.R. § 164.530(f).
⁷⁰ 45 C.F.R. § 164.530(c).
⁷¹ 45 C.F.R. § 164.530(d).
⁷² 45 C.F.R. § 164.520(b)(1)(vi).
⁷³ 45 C.F.R. § 164.530(g).
⁷⁴ 45 C.F.R. § 164.530(h).
⁷⁵ 45 C.F.R. § 164.530(j).
⁷⁶ 45 C.F.R. § 164.530(k).
⁷⁷ 45 C.F.R. §§ 164.103, 164.105.
⁷⁸ 45 C.F.R. § 164.103.
⁷⁹ 45 C.F.R. §164.105. Common ownership exists if an entity possesses an ownership or equity interest of five percent or more in another entity; common control exists if an entity has the direct or indirect power significantly to influence or direct the actions or policies of another entity. 45 C.F.R. §§ 164.103.
⁸⁰ The Privacy Rule at 45 C.F.R. § 160.103 identifies five types of organized health care arrangements:

A clinically-integrated setting where individuals typically receive health care from more
than one provider.

An organized system of health care in which the participating covered entities hold themselves out to the public as part of a joint arrangement and jointly engage in utilization review, quality assessment and improvement activities, or risk-sharing payment activities.

A group health plan and the health insurer or HMO that insures the plan's benefits, with respect to protected health information created or received by the insurer or HMO that relates to individuals who are or have been participants or beneficiaries of the group health plan.

All group health plans maintained by the same plan sponsor.

All group health plans maintained by the same plan sponsor and all health insurers and HMOs that insure the plans' benefits, with respect to protected health information created or received by the insurers or HMOs that relates to individuals who are or have been participants or beneficiaries in the group health plans.

⁸¹ 45 C.F.R. § 164.506(c)(5).
⁸² 45 C.F.R. § 164.504(g).
⁸³ 45 C.F.R. § 164.504(f).
⁸⁴ 45 C.F.R. § 164.502(g).
⁸⁵ 45 C.F.R. §160.203.
⁸⁶ 45 C.F.R. § 160.202.
⁸⁷ 45 C.F.R.§ 160.304
⁸⁸ Pub. L. 104-191; 42 U.S.C. §1320d-5.
⁸⁹ Pub. L. 104-191; 42 U.S.C. §1320d-6.
⁹⁰ 45 C.F.R. § 164.534.
⁹¹ 45 C.F.R. § 160.103.
⁹² Fully insured health plans should use the amount of total premiums that they paid for health insurance benefits during the plan's last full fiscal year. Self-insured plans, both funded and unfunded, should use the total amount paid for health care claims by the employer, plan sponsor or benefit fund, as applicable to their circumstances, on behalf of the plan during the plan's last full fiscal year. Those plans that provide health benefits through a mix of purchased insurance and self-insurance should combine proxy measures to determine their total annual receipts.

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1. Common Law Right to Privacy: The common law recognizes an individual's right to privacy, which forms the basis for many privacy protections under HIPAA. Legal precedents related to privacy rights, such as those established in tort law cases involving intrusion upon seclusion or public disclosure of private facts, may align with HIPAA's privacy protections.

2. State Laws on Privacy and Confidentiality: Many states have enacted laws that provide additional privacy and confidentiality protections for healthcare information beyond HIPAA requirements. Legal precedents arising from cases interpreting these state laws may align with HIPAA's goals and principles.

3. Breach of Confidentiality Cases: Cases involving breaches of confidentiality in healthcare settings, whether through unauthorized access to medical records or improper disclosure of PHI, often involve legal principles that are consistent with HIPAA's requirements for protecting patient privacy and confidentiality.

4. Data Security Breach Cases: Legal precedents related to data security breaches, including cases involving the unauthorized access or disclosure of sensitive personal information, may align with HIPAA's Security Rule requirements for safeguarding electronic PHI (ePHI) and preventing data breaches.

5. Enforcement Actions by Regulatory Agencies: While not traditional case law, enforcement actions and settlements by regulatory agencies such as the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) can establish legal precedents and interpretations of HIPAA requirements through consent decrees or administrative decisions.

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1. Permissible Uses and Disclosures: The Privacy Rule outlines when covered entities are permitted to use or disclose PHI without individual authorization. It also specifies the circumstances under which PHI may be disclosed for treatment, payment, healthcare operations, and other purposes.

2. Individual Rights: The Privacy Rule grants individuals certain rights regarding their PHI, including the right to access and obtain copies of their medical records, request amendments to their records, and receive an accounting of disclosures of their PHI.

3. Minimum Necessary Standard: Covered entities are required to limit the use or disclosure of PHI to the minimum necessary to accomplish the intended purpose. This standard helps protect patient privacy by restricting unnecessary access to PHI.

4. Administrative Safeguards: The Privacy Rule requires covered entities to implement administrative safeguards to protect the privacy and security of PHI, such as designating a privacy officer, conducting workforce training, and developing policies and procedures.

5. Breach Notification: In the event of a breach of unsecured PHI, covered entities are required to notify affected individuals, the Secretary of HHS, and, in some cases, the media. The Privacy Rule sets forth the requirements for breach notification, including the timing and content of notifications.

https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/permitted-uses/index.html

https://constitution.congress.gov/browse/essay/intro.7-4/ALDE_00000033/

https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/minimum-necessary-requirement/index.html

https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/administrative/securityrule/adminsafeguards.pdf

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Information is essential fuel for the engine of health care. Physicians, medical professionals, hospitals and other clinical institutions generate, use and share it to provide good care to individuals, to evaluate the quality of care they are providing, and to assure they receive proper payment from health plans. Health plans generate, use and share it to pay for care, to assure care for their members is well coordinated and that populations of individuals with chronic conditions are receiving appropriate care. The capability for relevant players in the health care system - including the patient - to be able to quickly and easily access needed information to make decisions, and to provide the right care at the right time, is fundamental to achieving the goals of health reform.

The Privacy, Security, and Breach Notification Rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) were intended to support information sharing by providing assurance to the public that sensitive health data would be maintained securely and shared only for appropriate purposes or with express authorization of the individual. For more than a decade, the HIPAA regulations have provided a strong privacy and security foundation for the health care system.

Although the regulations have been in effect for quite some time, health care providers frequently still question whether the sharing of health information, even for routine purposes like treatment or care coordination, is permissible under HIPAA. Confusion about the rules has been cited by many as a potential obstacle to interoperability of digital health information.

To address this confusion, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) and the Office for Civil Rights (OCR) have worked collaboratively to develop a series of topical fact sheets on HIPAA Permitted Uses and Disclosures that provide examples of when PHI can be exchanged under HIPAA without first requiring a specific authorization from the patient, so long as other protections or conditions are met.

One fact sheet addresses Permitted Uses and Disclosures for Health Care Operations, and clarifies that an entity covered by HIPAA ("covered entity"), such as a physician or hospital, can disclose identifiable health information (referred to in HIPAA as protected health information or PHI) to another covered entity (or a contractor (i.e., "business associate") working for that covered entity), for activities that fall within HIPAA's definition of "health care operations." The fact sheet includes illustrations of how HIPAA supports sharing of PHI by providers to enable case management by a health plan; for quality assessment and/or quality improvement; and for population health. The other fact sheet, Permitted Uses and Disclosures: Exchange for Treatment, illustrates how HIPAA supports sharing of PHI between and among health care providers in order to treat or coordinate care for their patients.

Both fact sheets also provide information on what health care providers should do to help assure that sharing PHI for either treatment or operations is in compliance with the HIPAA Privacy and Security Rules.

As a reminder, permitted uses and disclosures must be addressed in a covered entity's Notice of Privacy Practices. HHS offers model notices of privacy practices for both health care providers and health plans. These model notices are available for free download, in English and in Spanish, at http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/model-notices-privacy-practices

It is our hope that the fact sheets will be helpful tools that help clarify HIPAA and support the goals of interoperability of health information.

Read the fact sheets

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Understanding Some of HIPAA's Permitted Uses and Disclosures

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Topical fact sheets that provide examples of when PHI can be exchanged under HIPAA without first requiring a specific authorization from the patient, so long as other protections or conditions are met.

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A local policy or rule that illustrates how local institutions are approaching HIPAA (Health Insurance Portability and Accountability Act) compliance may be found within healthcare facilities or organizations such as hospitals, clinics, or medical practices. Let's consider an example:

Local Healthcare Facility Privacy Policy:

Policy Name: Patient Privacy and Confidentiality Policy

Objective: To ensure compliance with HIPAA regulations and protect the privacy and confidentiality of patient health information.

Key Components:

1. Patient Rights: The policy outlines patients' rights regarding their protected health information (PHI), including the right to access their medical records, request amendments to their records, and receive an accounting of disclosures.

2. Authorized Uses and Disclosures: It specifies the circumstances under which PHI may be used or disclosed without patient authorization, such as for treatment, payment, or healthcare operations.

3. Minimum Necessary Standard: The policy emphasizes the importance of limiting access to PHI to only those individuals who require it to perform their job duties, in accordance with the minimum necessary standard.

4. Confidentiality Safeguards: It outlines administrative, physical, and technical safeguards implemented to protect the confidentiality and security of PHI, including encryption of electronic PHI, secure storage of paper records, and access controls.

5. Breach Notification Procedures: The policy provides procedures for responding to and reporting breaches of PHI, including notifying affected individuals, the Department of Health and Human Services (HHS), and other relevant parties as required by HIPAA regulations.

Training and Compliance: The policy requires ongoing staff training on HIPAA regulations and compliance with the facility's privacy and security policies. It also designates a privacy officer responsible for overseeing HIPAA compliance and investigating any potential breaches or violations.

Enforcement and Consequences: The policy outlines the consequences of non-compliance with HIPAA regulations, including disciplinary actions for staff members who fail to adhere to privacy and confidentiality requirements.

https://www.ncbi.nlm.nih.gov/books/NBK519540/

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Introduction

Ensuring the security, privacy, and protection of patients' healthcare data is critical for all healthcare personnel and institutions. In this age of fast-evolving information technology, this is truer than ever before. In the past, healthcare workers often collected patient data for research and usually only omitted the patients' names. This is no longer permitted, now any protected health information (PHI) that can identify a patient or the patient's relatives, employers, or household members, must be omitted before being used for research. The health insurance portability and accountability act (HIPAA) public law 104-191, was enacted into federal law to ensure that that patient medical data remains private and secure.[1][2][3][4][5] There are two main sections of the law, the privacy rule which addresses the use and disclosure of individuals' health information, and the security rule which sets national standards for protecting the confidentiality, integrity, and availability of electronically protected health information.[6] The privacy rule specifies 18 elements that constitute PHI.[7] These identifiers include demographic and other information relating to the past, present, or future physical or mental health or condition of an individual, or the provision or payment of health care to an individual.

HIPAA was enacted to encompass three areas of patient care:

1. Portability of insurance or the ability of a patient/worker to move to another place of work and be certain that insurance coverage is not denied

2. Detection and enforcement of fraud and accountability

3. Simplify administrative procedures in health care and other professions (this is an area where communication and transmission of records are done electronically). With improved technology, the role of wearable technology and androids to disclose PHI is now under scrutiny.[8][9]

The penalties for failing to comply with HIPAA can be severe.

To Whom Does HIPAA Apply?

HIPAA applies to all healthcare institutions and healthcare workers, who submit claims electronically. For example, if you are a healthcare worker and transmit or even discuss PHI with others who are not involved with that patient's care, then you violate HIPAA. However, there is a HIPAA rule that permits disclosure of PHI without prior obtained consent for healthcare operations, treatment, and payment. This includes consultation between providers regarding a patient, referring a patient, and information required by law for public health safety and reporting. These exceptions cover the majority of clinical uses of PHI. Other disclosures demand explicit patient consent and apply to everyone in a healthcare facility, including:

The HIPAA policies also apply to any interns and volunteers who work under supervision at a health clinic or hospital, third-party contractors, or business associates, including:

Definition of PHI

HIPAA broadly defines PHI as any health information that is transmitted or maintained in electronic media. It is also important to know that PHI is not only restricted to transmission on electronic media but also any oral communications of individually identifiable health information that constitutes PHI. For example, if a surgery resident speaks about a surgical procedure in an elevator full of people, that can be a HIPAA violation if any PHI is mentioned. The majority of medical records in healthcare institutions and clinics meet the definition of PHI, some of which include:

Hence all healthcare institutions and clinics must satisfy HIPAA standards for security and privacy.

Function

Where is the HIPAA Privacy Rule Applicable?

The HIPAA privacy rule applies to almost every department in a medical facility, even when walking to the parking lot with a colleague or on your home internet, the confidentiality of PHI must be preserved. Only the bare minimum health information that is necessary should be disclosed during any health care service, and this also includes human resources or ancillary services. For example, when a pharmacist is about to dispense medication to a patient, he or she should only ask the patient if they know how to take the pill when to take the pill, and to follow up with their healthcare provider. No in-depth discussion with the patient in full view of other people is permitted. This rule also applies to other healthcare providers who may be exchanging information with other healthcare workers who are also actively involved in patient care. For example, it is permitted for a radiologist to ask the ordering medical resident a few questions about why the patient is having the test to ensure that the procedure is necessary and the best choice for the situation, but he or she is not at liberty to discuss this with a third party who is not actively treating the patient. In all such matters, one must first obtain consent from the patient to determine if he or she is willing to permit the doctor to divulge medical information to others. This rule not only applies to verbal communication but all written and electronic text.[10][11][12]

In addition to HIPAA, many states have their own restrictive rules on the privacy of PHI, which may be far more stringent than HIPAA, particularly when the information concerns patients with infectious diseases like HIV, mental health problems, certain genetic disorders, and substance abuse. Further, there are also federal rules that are more stringent than HIPAA, such as those pertaining to substance abuse and drug addiction records. However, this does not mean that HIPAA is void when other more stringent rules are in place. In situations where a more stringent rule regarding privacy is in place, the more stringent rule will take precedence over HIPAA for that jurisdiction. All healthcare workers must be aware of both HIPAA and the state and federal rules that govern PHI.

Contents and Authorizations

When a patient is admitted to a healthcare institution, he or she must be provided with the information on rights to privacy, what type of PHI will be shared, and for what reason. This notice of privacy practice is now a requirement of HIPAA for all patients, regardless of age or gender. The patient must sign this document, and one copy must be kept in the hospital files. This also indicates that the patient did receive the privacy notice. If for any reason, the patient cannot sign, the reason must be documented and witnessed. If another person signs the document, the reason why the individual is signing must be documented. Once a notice of privacy practices is signed, the healthcare institution does not need to ask the patient repeatedly for disclosure of PHI in the course of normal care. If the patient's health situation changes or the patient has additional privacy concerns, this should be documented in the note. The patient may ask that no family member or friend is permitted to pick up his or her medications or that none of the medical staff discuss the health condition with family or friends.

Security With Flexibility

The HIPAA security rule does provide all healthcare institutions with a practical and flexible format for implementing security measures. Some of these are mandatory requirements but others are flexible and allow the institution to implement security and privacy measures that are consistent with the organization's resources, infrastructure, and functionality.

What are Some Exclusions to a Patient's PHI?

There are several scenarios where disclosure of PHI may be violating HIPAA, and they include the following:

1. Mental health notes, which under HIPAA are not allowed to be shared even for purposes of treatment, without explicit authorization

2. Any legal document that pertains to medical records

3. Laboratory results, especially the results of sexually transmitted diseases

When Can PHI be Disclosed Without Consent?

If the patient cannot provide consent or is unavailable when disclosure is necessary for public health, by law, or regarding child abuse[13]

Anytime there is an investigation of fraud by the US department of health and human services

When a healthcare worker is trying to obtain consent over the phone when the patient is not able to provide one

Images and Videos

It is important to understand that HIPAA violations not only occur after vocal or written disclosure of PHI but even after posting images. For example, cosmetic surgeons who routinely post preoperative and post-operative photos of patients, or surgeons who videotape surgical procedures must obtain consent from the patient. In addition, when not necessary, the face should be blanked. Professionals are also prohibited from using the names of patients in case reports. Anything that can identify a patient is not permitted.

Specific HIPAA Rules That Pertain to PHI Security

1. Ensure that there is integrity, confidentiality, and security of all electronic PHI that the healthcare institution creates, maintains, receives, or transmits

2. Develop protection against any reasonably anticipated hazards or threats to the integrity of the security of such data

3. Protect against any reasonably anticipated use or disclosure of information that is not permitted or required

4. Ensure compliance among the workforce

5. Have flexibility in the system, so patient care is not compromised

6. Covered entities may use any security that meets the minimal standards

7. The type of security depends on the size, complexity, and capabilities of the covered entity

Issues of Concern

Risk Analysis

The HIPAA security requirements place significant emphasis on risk analysis, especially now that electronic healthcare technology is the norm. All hospitals not only have to work with their healthcare workers, but also third-party contractors, vendors, and solo practitioners; and they must identify and address the appropriate security options to ensure the security of data. The use of the internet is perhaps the biggest threat to data leaks. When transmitting data over the internet, the hospital IT must encrypt the data to ensure that it remains private. For example, a provider who is an independent contractor and has a patient admitted to the hospital will transmit over the internet the patient's medical history to the hospital. However, this information must be encrypted to prevent leaks and eavesdropping. Today, encryption of healthcare records is standard, and there are many software programs that one may use.[14][15][16][17][18][10]

Use of Wireless Networks

These days many healthcare workers use wireless networks to access medical records. However, if many computers connect through a wireless network, then the encryption function of the wireless network must be activated. Furthermore, healthcare workers must be asked to stop using the unencrypted wireless network for communication because of the risk of interception.

Storage of PHI Data

Another area of great concern is the storage of PHI on hard drives, especially portable devices like laptop computers and flash drives. Over the years, many privacy breaches have occurred as a result of stolen laptops and flash drives. To address this problem, healthcare workers should refrain from storing any patient data on their laptops, flash drives, or CDs. If the data is stored, it must be encrypted. Another option is to use the laptop only to view the data, but never to store the information. This has become possible with cloud technology and storage systems.

Passwords

All healthcare workers who use the computer to access patient records must have a secure password. The password should be unique and changed every 3 to 4 months. No one should share their password with other individuals. The information technology (IT) department must determine the quality of the password before access is granted to the system. The password must be sufficiently strong so that it cannot be guessed or even predicted with the available computer programs. The password must contain a combination of numerical and alpha characters with symbols to increase their complexity. Further, no worker should paste the password anywhere near the PC or leave a sticker with the password on a desk, as this defeats the purpose of security. However, passwords alone are not adequate for security measures and offer a very weak method of protection.

Unique User Identification

There have been many instances when both the healthcare worker and non-healthcare workers who were not involved in the care of the patient have accessed the medical records of celebrities and other important people. The purpose was to pass the documents to the tabloid magazines. Thus, HIPAA enhancements under the health information technology for economic and clinical health (HITECH) act now require a system that will track all users the moment they sign on and off. The tracking system will show who signed on, when, what data they accessed, and if they downloaded any information. Thus the importance of assigning unique names and passwords that are never shared with anyone, otherwise tracking is not possible in the event of a data breach.

Stronger Authentication

Today many healthcare institutions have started to implement stronger authentication requirements. Besides the password, some systems also require a specific biometric feature to enter the system. Some hospitals have started to use fingerprints to identify the individual entering the system and others have started to incorporate facial recognition.

Selective Access

To ensure privacy and authenticate the computer used, some organizations have started to limit access to individuals based on their role in healthcare. For example, a laboratory technologist would only need access to the patient's laboratory record, so there is no need to provide that worker access to the patient's medical history. Similarly, a pharmacist may only have access to the patient's medications or pertinent parts of the medical history regarding drug reactions; whereas, an internist would have access to most of the medical information. Customized access is the new wave of the future, and so far, limited studies do show that it works in maintaining the security of patient data.

Electronic Health Records

HITECH was enacted to promote the widespread adoption and meaningful use of electronic health records (EHRs) and related technologies. Among other things, HITECH requires covered entities that implement an EHR to provide an audit trail accounting for all disclosures of information. When a patient asks for an electronic copy of their records, HITECH also stipulates that healthcare organizations provide the PHI maintained in an EHR. Therefore, an EHR is very broadly defined in the proposed rule as "any electronic data." Furthermore, healthcare entities must acknowledge and fulfill a patient's request that the healthcare provider not share PHI with a health insurance plan if the individual pays for the care out of pocket and in full.

Audits and Risk Assessment

Once a security system is in place, risk management should audit the system to look for any flaws and identify any gaps in maintaining the integrity, confidentiality, and security of PHI. All risks identified must go through a HIPAA-compliant risk management process and the flaws rectified. Risk analysis is not a one-shot deal but must be conducted regularly because new technology is constantly introduced. This is also repeated whenever there is a change in clinical practice.

Dedicated IT Staff

All healthcare institutions should employ persons who are dedicated to maintaining the security and privacy of PHI. In most cases, a team of IT professionals should ensure that everyone follows the established procedures and policies. Moreover, this team must ensure that all healthcare workers use the system appropriately. It is the job of the IT staff to conduct audits to ensure that everyone is HIPAA compliant regularly.

Obtain Authorizations

While HIPAA does permit the use of PHI for many hospital-based services like treatments, pharmacy operations, rehabilitation and outpatient care, any other use or disclosure of PHI must be authorized by the patient in writing before any PHI is disclosed. For example, there are protocols to follow when a patient is enrolled in a clinical trial. Plus, when patients want their medical records transferred to another unrelated provider or out of state, then written consent must be obtained from the patient.

Third-Party Agreements

Ensure third-party business agreements are in place. Sometimes a third party may need access to PHI to perform a service on behalf of the hospital. For example, the patient may be entering an outpatient rehabilitation unit, and the therapist requires medical records or the patient may be going for radiation therapy at another center. The rehabilitation center and the radiation clinic also need to comply with HIPAA rules. These third-party entities must provide the hospital with a business associate agreement that the requirements of HIPAA are understood and are being followed.

Inadvertent Disclosure

In the past, it was routine for healthcare workers to share patient information between family and friends sometimes out of concern or in an attempt to help. Now, this is not acceptable, and a provider can violate the law. HIPAA does not permit deliberate or accidental disclosure of PHI for any reason. For example, a disgruntled healthcare worker can be held liable if he or she steals PHI and then shares the data for monetary gain or revenge purposes. Sometimes the PHI disclosure may occur accidentally when the patient's chart is left unattended in the lobby or the radiology suite. When a patient's chart is taken along with the patient on the trolley, it is important to make sure that the transporter knows not to leave the chart lying where the information may be inadvertently or purposefully looked at by persons not directly involved in that patient's care.

Personal PHI

Under HIPAA, all patients are legally permitted to obtain copies of their PHI which includes billing and medical records over the past 6 years. Some exclusions cover legal documents, mental health notes, or laboratory results. The healthcare provider may deny access to PHI if he or she believes that such access may harm the patient or others. A patient has to request, in writing, to obtain his or her medical chart.

Inform Patients of Privacy Practices

All healthcare facilities that are covered by HIPAA must document their private practice and share that information with patients. When patients ask for HIPAA information, they should be provided with the information and asked to sign a form to ensure that they have received the booklet.

Clinical Significance

Patient Rights under HIPAA

HIPAA rules give patients rights, some of which they may not be not aware of. The most important rights of patients under HIPAA include the following:

Right to receive a notice of privacy practices

Right to restrict PHI disclosures

Right to state how they want PHI to be handled and communicated to others. For example, the patient may want any message from the pharmacist or the hospital to be sent by mail to his private home and not left on his home phone number

Right to inspect and review their PHI. If the patient perceives there to be anything erroneous in the PHI, they do have the right to request a change. The provider may accept or deny this request. For example, a nurse may have been diagnosed with bipolar disorder and after treatment may want this diagnosis to be deleted from the medical chart. This is not a request that can be accepted.

Right to obtain a copy of their PHI

Right to receive an accounting of where PHI disclosures have been made

The right to report to the office of civil rights if the patient believes there has been any violation of disclosure

HIPAA and Communication With Patients

HIPAA recommends disclosing a minimal amount of information to ensure the privacy of patients. When speaking to a patient in a room with other patients, it is important not to divulge specific information other than greetings. If one has to communicate the results of a biopsy or surgery, then one may ask the patient to come to a private room for discussion. Even then, only disclose what is relevant. If the healthcare provider is faced with a situation where there are other patients, for example, in the recovery room or intensive care unit (ICU), the discussion should be broad and not detail any specific procedure or diagnosis. Similarly, in outpatient clinics, one should never discuss PHI in the hallway but wait until the patient is seated in a private room.

HIPAA permits disclosure of PHI to a spouse, parents, legal guardians, and other caregivers who are involved in the patient's care without having a formal agreement from the patients. If there is ever a need to discuss something specific regarding the patient when other individuals are present, ask the patient if he or she has any objections.

When Can Information Be Shared?

Healthcare workers need to be aware that all PHI for clinical purposes is covered under HIPAA and includes the following:

Discussing diagnosis, workup, and treatment with other healthcare providers

Performing imaging and laboratory test and disclosing this information to other providers

Providing results of imaging test, or discuss the patient history when submitting surgical samples to those who perform further diagnostic tests

When referring a patient to another facility or obtaining a consult

When calling the pharmacist over the phone to dispense medication to a patient

As long healthcare providers are offering treatment, they are not restricted by HIPAA, as long as the patient has not made a request not to disclose data to any particular healthcare provider. However, caution must still be used. For example, when asking a phlebotomist to start an intravenous line on a patient needing chemotherapy medication, a provider does not have to divulge why the patient needs an intravenous line to the technologist.

1. Similarly, when healthcare providers consult with other providers, the HIPAA privacy rule does not prohibit them from engaging in such conversations. However, these conversations should be held away from the public and in private rooms. One should not obtain a telephone consult from a phone line in the cafeteria where others can hear the conversation.

2. Healthcare staff may communicate verbally at the nurse desk to coordinate activities.

3. Also, a healthcare provider may discuss a patient's medical status over the phone with a provider, patient, or other family members.

4. Healthcare workers may discuss a patient's medical condition in an academic institution, or during rounds.

5. In emergency situations, the law does permit entities to engage in communication as required to ensure the proper delivery of healthcare.

Email Communications

All healthcare institutions should establish specific guidelines on email communication from patients. Some of the recommendations include the following:

The patient name should not be inserted in the subject guideline

Make sure that the patient email is correct

Only transmit the bare minimal information in an email

Have a standard disclaimer at the end of every email

All emails must be encrypted

Do not use your non-work email to communicate with a patient. For example, you should never use commercial email accounts, but use the email system set up by the institution

Faxes

Like emails, there should be specific policies and guidelines regarding the use of faxes to transmit medical information. Some of the recommendations include the following:

All fax machines must be located in a secure area away from the public, patients, and most healthcare workers

The first page of the fax should always be a disclaimer indicating what to do if the fax is sent to a wrong number

Unless an emergency, faxes should only be sent during working hours. The reason is that if any faxes arrive, they can be picked up and not left lying on the fax machine container

When sending faxes, it is important to correspond to the other party to ensure that they have picked up the fax

Computers

Today, computers play a critical role in healthcare and store a vast amount of PHI. Hence, these devices must be secure. Some of the recommendations for computer use include the following:

The computers should be kept in a place where they are not accessible to the public or patients

The screen should not be visible to the patients or public

Each time, a healthcare provider should log in and log off, even if they are only gone for a few minutes

All healthcare workers should have a unique password

The password should never be shared with anyone else

Clergy and Other Religious Figures

The HIPAA privacy rule permits religious figures and clergy to be informed of individuals belonging to their denomination that are in a hospital, as long as the patient has first been informed and has no objection. Patients should be asked about these preferences when they are first admitted to the hospital and asked to sign a paper regarding who they want as a visitor and who should be notified.

During an emergency, or when the patient is incapacitated and has not been able to provide consent, disclosures can still occur. However, the disclosure has to be consistent with the individual's best interest in mind. One has to use not only good judgment but also involve administration and risk management in decision making. Everything should be documented as to why a particular course of action was undertaken.

Other Issues

Disposing of PHI

When disposing of the medical records, labels, prescription labels, the documents should be shredded or incinerated so that there is no chance that they will be reconstructed. Any PHI on a computer must be completely erased before disposing of the PC. The same applies to any CD or zip drive. The people who are in charge of shredding or disposing of the PHI must be properly selected to make sure that the records are destroyed and not just taken home.

Signed Consent

During a visit or medical encounter, pharmacies and hospitals may get signed authorization from patients before service, allowing that entity to access the patient's PHI during care. However, this form has to contain the initiation and expiration date for the disclosure. The authorization only remains valid until the expiration date and can be renewed. So if a patient has signed an authorization for the release of his medical records to a psychiatrist, then one can send the records during that time. But one is not allowed to send PHI to other healthcare entities without additional consent nor can PHI be sent continuously outside of the specified time frame. If the patient is not available or is not able, then the risk analysis committee may disclose PHI without authorization, if it is a matter of life or death. Other cases where PHI may be disclosed are in cases of child abuse, elderly neglect, public health law, or where there appears to be fraudulent activity.

Training Employees

It is imperative that the entire staff know about HIPAA. Thus, regular education seminars must be conducted. The teaching not only applies to regular staff but all interns and volunteers who come into contact with PHI. The staff must be fully trained, updated regularly, and made aware of HIPAA rules that apply to them.

Reporting HIPAA Violations

In general, HIPAA violations must be self-reported to the department of health and human services (HHS). If a violation has affected more than 500 patients, the department must be notified in writing within 60 days. If less than 500 patients have been affected then HHS has to be notified no later than 60 days after the calendar year ends. Penalties may increase if self-reporting is not done and the violation is discovered through the media.

Who Monitors Hospitals and Healthcare Workers for HIPAA Compliance?

The office for civil rights (OCR) under health and human services (HHS) is the entity responsible for enforcing HIPAA privacy and security rules. The agency enforces rules in the following ways:

1. Performs an investigation after receiving complaints from patients

2. Will perform an audit to ensure compliance is maintained. OCR may select an institution at random for an audit

3. Conduct education seminars and outreach to boost compliances. During these sessions, they may also perform an audit and catch everyone by surprise

4. May have read or heard in the media about PHI being discovered or disposed of improperly

The Investigation Protocol

Once OCR receives a complaint of HIPAA violation, it gathers the information and tries to determine if the privacy and security rules were violated. If the problem is a minor case of noncompliance, OCR will initially try and resolve the matter with the respective institution in the following ways:

For those institutions that fail to comply with HIPAA, there may be criminal and civil penalties. If the complaint received indicates a violation of the criminal provision of HIPAA, then the matter may be referred to the department of justice (DOJ) for further investigation.

Civil and Criminal Violations

When the healthcare institution fails to comply with the matter satisfactorily, OCR may impose civil monetary penalties that are based on the seriousness of the non-compliance. The amount of monetary fine is usually up to the discretion of the secretary of HHS and depends on the extent and nature of the harm that occurred as a result of the violation. In almost all cases, the secretary is not permitted to impose any civil penalty for a violation that is corrected within 4 to 6 weeks. All criminal violations of HIPAA are handled by the DOJ, who in addition to civil penalties may add other fines depending on the severity of the violation.

Criminal Violation of HIPAA Rules

Criminal penalties for HIPAA violations apply to the following entities:

All health coverage plans

Health care clearinghouses

All health care providers who transmit claims electronically

Medicare prescription drug card sponsors

Besides institutions, individuals can also be charged with criminal violations of HIPAA and this includes employees, directors, officers, nurses, secretaries, and telephone operators. Even individuals not directly liable under HIPAA may be charged with abetting or conspiring. Finally, the HHS has the authority to exclude any individual or healthcare institution from participation in medicare as either temporary or permanent.

It is critical to understand that no matter how big or small the institution or how many or few healthcare workers work in a clinic, each entity can be penalized for HIPAA violations. While the monetary penalties can be dramatic, all such violations are published in cyberspace and this can quickly ruin the reputation of the facility or the healthcare provider.

Can Patients Sue a Healthcare Facility or a Healthcare Worker for Violating HIPAA?

For example, a pharmacist calls up the home of a patient, but no one answers the phone. Then he leaves a message asking when you will be coming up to pick up your HIV medications. The patient can claim that no one in the home knew about his HIV status and now the pharmacist has disclosed his private health condition to everyone in the home. Can the patient sue the pharmacist?

When a healthcare worker or the facility has violated HIPAA rules, patients generally have no recourse except to report the matter to the OCR. In fact, HIPAA has created a right to privacy and does not allow for most patients to file lawsuits. However, if the HIPAA violation is due to gross negligence and professional malpractice, then such a case may be brought to court.

Avoiding HIPAA Violations

Preventing HIPAA violations is not difficult. First, get professional help from a HIPAA expert.

1. Develop a code of conduct booklet and write down all the policies and procedures that everyone must follow.

2. Do not let anyone get away with violations of policies because, in the end, it is the healthcare provider who will have to face the legal system.

3. If healthcare providers or institutions already have HIPAA policies in effect and have suffered a HIPAA violation, consult with a HIPAA specialist to determine any deficiencies and corrective solutions. These individuals provide comprehensive education, tips, and offer seminars to the staff about HIPAA rules and regulations. It is money worth spent because violation of HIPAA is a very expensive ordeal.

Violation Amount/Violations of an Identical Provision in a C alendar Year

Did not know: $100 to $50,000; $1.5 million

Reasonable cause: $1,000 to $50,000; $1.5 million

Willful neglect (corrected): $10,000 to $50,000; $1.5 million

Willful Neglect (uncorrected): $50,000; $1.5 million

Pearls

HIPAA has been enacted to ensure the privacy and security of PHI.

Each healthcare institution may set up unique policies and procedures, but they must conform to HIPAA guidelines.

With evolving technology, one must keep updated with HIPAA and ensure that PHI remains protected.

Ensure that all the workers in the organization know the HIPAA policies and procedures.

Be stringent with workers who break HIPAA rules because eventually, there will be a cost.

References

Disclosure: Rayhan Tariq declares no relevant financial relationships with ineligible companies.

Disclosure: Pamela Hackert declares no relevant financial relationships with ineligible companies.

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Ensuring the security, privacy, and protection of patients' healthcare data is critical for all healthcare personnel and institutions. In this age of fast-evolving information technology, this is truer than ever before. In the past, healthcare workers often collected patient data for research and usually only omitted the patients' names.

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Regular Security Risk Assessments: Conducting periodic security risk assessments to identify vulnerabilities in systems and processes related to protected health information (PHI). This involves examining potential risks to the confidentiality, integrity, and availability of PHI and implementing measures to mitigate these risks.

Employee Training and Awareness Programs: Providing comprehensive training and awareness programs for employees to educate them about HIPAA regulations, privacy policies, and security best practices. This includes training on handling PHI securely, recognizing potential security threats, and understanding their roles and responsibilities in safeguarding patient information.

Robust Incident Response Plan: Developing and implementing an incident response plan to effectively respond to security incidents and breaches involving PHI. This plan should outline procedures for detecting, reporting, and responding to breaches, as well as coordinating with appropriate authorities and stakeholders. Regular testing and drills of the incident response plan can help ensure readiness to handle security incidents effectively.

https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/administrative/securityrule/riskassessment.pdf

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In the ACM Code of Ethics and Professional Conduct, which governs computer professionals, there's an item directly related to HIPAA or similar ethical dilemmas in the context of handling sensitive information:

ACM Code of Ethics and Professional Conduct - Section 1.7: Respect the privacy of others.

This item emphasizes the importance of respecting individuals' privacy rights and maintaining the confidentiality of sensitive information, which aligns with the principles of HIPAA. It requires professionals to ensure that they handle personal and health information responsibly, protecting it from unauthorized access or disclosure. Violations of privacy, such as unauthorized access to patient records or sharing sensitive information without consent, would contravene this ethical principle. Therefore, computer professionals must adhere to this code item when dealing with scenarios involving the handling of health information or other sensitive data to uphold the trust and confidentiality expected in their professional roles.

https://www.acm.org/code-of-ethics#:~:text=1.7%20Honor%20confidentiality.&text=Computing%20professionals%20should%20protect%20confidentiality,disclosed%20except%20to%20appropriate%20authorities.

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Preamble

Computing professionals' actions change the world. To act responsibly, they should reflect upon the wider impacts of their work, consistently supporting the public good. The ACM Code of Ethics and Professional Conduct ("the Code") expresses the conscience of the profession.

The Code is designed to inspire and guide the ethical conduct of all computing professionals, including current and aspiring practitioners, instructors, students, influencers, and anyone who uses computing technology in an impactful way. Additionally, the Code serves as a basis for remediation when violations occur. The Code includes principles formulated as statements of responsibility, based on the understanding that the public good is always the primary consideration. Each principle is supplemented by guidelines, which provide explanations to assist computing professionals in understanding and applying the principle.

Section 1 outlines fundamental ethical principles that form the basis for the remainder of the Code. Section 2 addresses additional, more specific considerations of professional responsibility. Section 3 guides individuals who have a leadership role, whether in the workplace or in a volunteer professional capacity. Commitment to ethical conduct is required of every ACM member, ACM SIG member, ACM award recipient, and ACM SIG award recipient. Principles involving compliance with the Code are given in Section 4.

The Code as a whole is concerned with how fundamental ethical principles apply to a computing professional's conduct. The Code is not an algorithm for solving ethical problems; rather it serves as a basis for ethical decision-making. When thinking through a particular issue, a computing professional may find that multiple principles should be taken into account, and that different principles will have different relevance to the issue. Questions related to these kinds of issues can best be answered by thoughtful consideration of the fundamental ethical principles, understanding that the public good is the paramount consideration. The entire computing profession benefits when the ethical decision-making process is accountable to and transparent to all stakeholders. Open discussions about ethical issues promote this accountability and transparency.

1. GENERAL ETHICAL PRINCIPLES.
A computing professional should...
1.1 Contribute to society and to human well-being, acknowledging that all people are stakeholders in computing.

This principle, which concerns the quality of life of all people, affirms an obligation of computing professionals, both individually and collectively, to use their skills for the benefit of society, its members, and the environment surrounding them. This obligation includes promoting fundamental human rights and protecting each individual's right to autonomy. An essential aim of computing professionals is to minimize negative consequences of computing, including threats to health, safety, personal security, and privacy. When the interests of multiple groups conflict, the needs of those less advantaged should be given increased attention and priority.

Computing professionals should consider whether the results of their efforts will respect diversity, will be used in socially responsible ways, will meet social needs, and will be broadly accessible. They are encouraged to actively contribute to society by engaging in pro bono or volunteer work that benefits the public good.

In addition to a safe social environment, human well-being requires a safe natural environment. Therefore, computing professionals should promote environmental sustainability both locally and globally.

1.2 Avoid harm.

In this document, "harm" means negative consequences, especially when those consequences are significant and unjust. Examples of harm include unjustified physical or mental injury, unjustified destruction or disclosure of information, and unjustified damage to property, reputation, and the environment. This list is not exhaustive.

Well-intended actions, including those that accomplish assigned duties, may lead to harm. When that harm is unintended, those responsible are obliged to undo or mitigate the harm as much as possible. Avoiding harm begins with careful consideration of potential impacts on all those affected by decisions. When harm is an intentional part of the system, those responsible are obligated to ensure that the harm is ethically justified. In either case, ensure that all harm is minimized.

To minimize the possibility of indirectly or unintentionally harming others, computing professionals should follow generally accepted best practices unless there is a compelling ethical reason to do otherwise. Additionally, the consequences of data aggregation and emergent properties of systems should be carefully analyzed. Those involved with pervasive or infrastructure systems should also consider Principle 3.7.

A computing professional has an additional obligation to report any signs of system risks that might result in harm. If leaders do not act to curtail or mitigate such risks, it may be necessary to "blow the whistle" to reduce potential harm. However, capricious or misguided reporting of risks can itself be harmful. Before reporting risks, a computing professional should carefully assess relevant aspects of the situation.

1.3 Be honest and trustworthy.

Honesty is an essential component of trustworthiness. A computing professional should be transparent and provide full disclosure of all pertinent system capabilities, limitations, and potential problems to the appropriate parties. Making deliberately false or misleading claims, fabricating or falsifying data, offering or accepting bribes, and other dishonest conduct are violations of the Code.

Computing professionals should be honest about their qualifications, and about any limitations in their competence to complete a task. Computing professionals should be forthright about any circumstances that might lead to either real or perceived conflicts of interest or otherwise tend to undermine the independence of their judgment. Furthermore, commitments should be honored.

Computing professionals should not misrepresent an organization's policies or procedures, and should not speak on behalf of an organization unless authorized to do so.

1.4 Be fair and take action not to discriminate.

The values of equality, tolerance, respect for others, and justice govern this principle. Fairness requires that even careful decision processes provide some avenue for redress of grievances.

Computing professionals should foster fair participation of all people, including those of underrepresented groups. Prejudicial discrimination on the basis of age, color, disability, ethnicity, family status, gender identity, labor union membership, military status, nationality, race, religion or belief, sex, sexual orientation, or any other inappropriate factor is an explicit violation of the Code. Harassment, including sexual harassment, bullying, and other abuses of power and authority, is a form of discrimination that, amongst other harms, limits fair access to the virtual and physical spaces where such harassment takes place.

The use of information and technology may cause new, or enhance existing, inequities. Technologies and practices should be as inclusive and accessible as possible and computing professionals should take action to avoid creating systems or technologies that disenfranchise or oppress people. Failure to design for inclusiveness and accessibility may constitute unfair discrimination.

1.5 Respect the work required to produce new ideas, inventions, creative works, and computing artifacts.

Developing new ideas, inventions, creative works, and computing artifacts creates value for society, and those who expend this effort should expect to gain value from their work. Computing professionals should therefore credit the creators of ideas, inventions, work, and artifacts, and respect copyrights, patents, trade secrets, license agreements, and other methods of protecting authors' works.

Both custom and the law recognize that some exceptions to a creator's control of a work are necessary for the public good. Computing professionals should not unduly oppose reasonable uses of their intellectual works. Efforts to help others by contributing time and energy to projects that help society illustrate a positive aspect of this principle. Such efforts include free and open source software and work put into the public domain. Computing professionals should not claim private ownership of work that they or others have shared as public resources.

1.6 Respect privacy.

The responsibility of respecting privacy applies to computing professionals in a particularly profound way. Technology enables the collection, monitoring, and exchange of personal information quickly, inexpensively, and often without the knowledge of the people affected. Therefore, a computing professional should become conversant in the various definitions and forms of privacy and should understand the rights and responsibilities associated with the collection and use of personal information.

Computing professionals should only use personal information for legitimate ends and without violating the rights of individuals and groups. This requires taking precautions to prevent re-identification of anonymized data or unauthorized data collection, ensuring the accuracy of data, understanding the provenance of the data, and protecting it from unauthorized access and accidental disclosure. Computing professionals should establish transparent policies and procedures that allow individuals to understand what data is being collected and how it is being used, to give informed consent for automatic data collection, and to review, obtain, correct inaccuracies in, and delete their personal data.

Only the minimum amount of personal information necessary should be collected in a system. The retention and disposal periods for that information should be clearly defined, enforced, and communicated to data subjects. Personal information gathered for a specific purpose should not be used for other purposes without the person's consent. Merged data collections can compromise privacy features present in the original collections. Therefore, computing professionals should take special care for privacy when merging data collections.

1.7 Honor confidentiality.

Computing professionals are often entrusted with confidential information such as trade secrets, client data, nonpublic business strategies, financial information, research data, pre-publication scholarly articles, and patent applications. Computing professionals should protect confidentiality except in cases where it is evidence of the violation of law, of organizational regulations, or of the Code. In these cases, the nature or contents of that information should not be disclosed except to appropriate authorities. A computing professional should consider thoughtfully whether such disclosures are consistent with the Code.

2. PROFESSIONAL RESPONSIBILITIES.
A computing professional should...
2.1 Strive to achieve high quality in both the processes and products of professional work.

Computing professionals should insist on and support high quality work from themselves and from colleagues. The dignity of employers, employees, colleagues, clients, users, and anyone else affected either directly or indirectly by the work should be respected throughout the process. Computing professionals should respect the right of those involved to transparent communication about the project. Professionals should be cognizant of any serious negative consequences affecting any stakeholder that may result from poor quality work and should resist inducements to neglect this responsibility.

2.2 Maintain high standards of professional competence, conduct, and ethical practice.

High quality computing depends on individuals and teams who take personal and group responsibility for acquiring and maintaining professional competence. Professional competence starts with technical knowledge and with awareness of the social context in which their work may be deployed. Professional competence also requires skill in communication, in reflective analysis, and in recognizing and navigating ethical challenges. Upgrading skills should be an ongoing process and might include independent study, attending conferences or seminars, and other informal or formal education. Professional organizations and employers should encourage and facilitate these activities.

2.3 Know and respect existing rules pertaining to professional work.

"Rules" here include local, regional, national, and international laws and regulations, as well as any policies and procedures of the organizations to which the professional belongs. Computing professionals must abide by these rules unless there is a compelling ethical justification to do otherwise. Rules that are judged unethical should be challenged. A rule may be unethical when it has an inadequate moral basis or causes recognizable harm. A computing professional should consider challenging the rule through existing channels before violating the rule. A computing professional who decides to violate a rule because it is unethical, or for any other reason, must consider potential consequences and accept responsibility for that action.

2.4 Accept and provide appropriate professional review.

High quality professional work in computing depends on professional review at all stages. Whenever appropriate, computing professionals should seek and utilize peer and stakeholder review. Computing professionals should also provide constructive, critical reviews of others' work.

2.5 Give comprehensive and thorough evaluations of computer systems and their impacts, including analysis of possible risks.

Computing professionals are in a position of trust, and therefore have a special responsibility to provide objective, credible evaluations and testimony to employers, employees, clients, users, and the public. Computing professionals should strive to be perceptive, thorough, and objective when evaluating, recommending, and presenting system descriptions and alternatives. Extraordinary care should be taken to identify and mitigate potential risks in machine learning systems. A system for which future risks cannot be reliably predicted requires frequent reassessment of risk as the system evolves in use, or it should not be deployed. Any issues that might result in major risk must be reported to appropriate parties.

2.6 Perform work only in areas of competence.

A computing professional is responsible for evaluating potential work assignments. This includes evaluating the work's feasibility and advisability, and making a judgment about whether the work assignment is within the professional's areas of competence. If at any time before or during the work assignment the professional identifies a lack of a necessary expertise, they must disclose this to the employer or client. The client or employer may decide to pursue the assignment with the professional after additional time to acquire the necessary competencies, to pursue the assignment with someone else who has the required expertise, or to forgo the assignment. A computing professional's ethical judgment should be the final guide in deciding whether to work on the assignment.

As appropriate to the context and one's abilities, computing professionals should share technical knowledge with the public, foster awareness of computing, and encourage understanding of computing. These communications with the public should be clear, respectful, and welcoming. Important issues include the impacts of computer systems, their limitations, their vulnerabilities, and the opportunities that they present. Additionally, a computing professional should respectfully address inaccurate or misleading information related to computing.

2.8 Access computing and communication resources only when authorized or when compelled by the public good.

Individuals and organizations have the right to restrict access to their systems and data so long as the restrictions are consistent with other principles in the Code. Consequently, computing professionals should not access another's computer system, software, or data without a reasonable belief that such an action would be authorized or a compelling belief that it is consistent with the public good. A system being publicly accessible is not sufficient grounds on its own to imply authorization. Under exceptional circumstances a computing professional may use unauthorized access to disrupt or inhibit the functioning of malicious systems; extraordinary precautions must be taken in these instances to avoid harm to others.

2.9 Design and implement systems that are robustly and usably secure.

Breaches of computer security cause harm. Robust security should be a primary consideration when designing and implementing systems. Computing professionals should perform due diligence to ensure the system functions as intended, and take appropriate action to secure resources against accidental and intentional misuse, modification, and denial of service. As threats can arise and change after a system is deployed, computing professionals should integrate mitigation techniques and policies, such as monitoring, patching, and vulnerability reporting. Computing professionals should also take steps to ensure parties affected by data breaches are notified in a timely and clear manner, providing appropriate guidance and remediation.

To ensure the system achieves its intended purpose, security features should be designed to be as intuitive and easy to use as possible. Computing professionals should discourage security precautions that are too confusing, are situationally inappropriate, or otherwise inhibit legitimate use.

In cases where misuse or harm are predictable or unavoidable, the best option may be to not implement the system.

3. PROFESSIONAL LEADERSHIP PRINCIPLES.

Leadership may either be a formal designation or arise informally from influence over others. In this section, "leader" means any member of an organization or group who has influence, educational responsibilities, or managerial responsibilities. While these principles apply to all computing professionals, leaders bear a heightened responsibility to uphold and promote them, both within and through their organizations.
A computing professional, especially one acting as a leader, should...
3.1 Ensure that the public good is the central concern during all professional computing work.

People-including users, customers, colleagues, and others affected directly or indirectly-should always be the central concern in computing. The public good should always be an explicit consideration when evaluating tasks associated with research, requirements analysis, design, implementation, testing, validation, deployment, maintenance, retirement, and disposal. Computing professionals should keep this focus no matter which methodologies or techniques they use in their practice.

3.2 Articulate, encourage acceptance of, and evaluate fulfillment of social responsibilities by members of the organization or group.

Technical organizations and groups affect broader society, and their leaders should accept the associated responsibilities. Organizations-through procedures and attitudes oriented toward quality, transparency, and the welfare of society-reduce harm to the public and raise awareness of the influence of technology in our lives. Therefore, leaders should encourage full participation of computing professionals in meeting relevant social responsibilities and discourage tendencies to do otherwise.

3.3 Manage personnel and resources to enhance the quality of working life.

Leaders should ensure that they enhance, not degrade, the quality of working life. Leaders should consider the personal and professional development, accessibility requirements, physical safety, psychological well-being, and human dignity of all workers. Appropriate human-computer ergonomic standards should be used in the workplace.

3.4 Articulate, apply, and support policies and processes that reflect the principles of the Code.

Leaders should pursue clearly defined organizational policies that are consistent with the Code and effectively communicate them to relevant stakeholders. In addition, leaders should encourage and reward compliance with those policies, and take appropriate action when policies are violated. Designing or implementing processes that deliberately or negligently violate, or tend to enable the violation of, the Code's principles is ethically unacceptable.

3.5 Create opportunities for members of the organization or group to grow as professionals.

Educational opportunities are essential for all organization and group members. Leaders should ensure that opportunities are available to computing professionals to help them improve their knowledge and skills in professionalism, in the practice of ethics, and in their technical specialties. These opportunities should include experiences that familiarize computing professionals with the consequences and limitations of particular types of systems. Computing professionals should be fully aware of the dangers of oversimplified approaches, the improbability of anticipating every possible operating condition, the inevitability of software errors, the interactions of systems and their contexts, and other issues related to the complexity of their profession-and thus be confident in taking on responsibilities for the work that they do.

3.6 Use care when modifying or retiring systems.

Interface changes, the removal of features, and even software updates have an impact on the productivity of users and the quality of their work. Leaders should take care when changing or discontinuing support for system features on which people still depend. Leaders should thoroughly investigate viable alternatives to removing support for a legacy system. If these alternatives are unacceptably risky or impractical, the developer should assist stakeholders' graceful migration from the system to an alternative. Users should be notified of the risks of continued use of the unsupported system long before support ends. Computing professionals should assist system users in monitoring the operational viability of their computing systems, and help them understand that timely replacement of inappropriate or outdated features or entire systems may be needed.

3.7 Recognize and take special care of systems that become integrated into the infrastructure of society.

Even the simplest computer systems have the potential to impact all aspects of society when integrated with everyday activities such as commerce, travel, government, healthcare, and education. When organizations and groups develop systems that become an important part of the infrastructure of society, their leaders have an added responsibility to be good stewards of these systems. Part of that stewardship requires establishing policies for fair system access, including for those who may have been excluded. That stewardship also requires that computing professionals monitor the level of integration of their systems into the infrastructure of society. As the level of adoption changes, the ethical responsibilities of the organization or group are likely to change as well. Continual monitoring of how society is using a system will allow the organization or group to remain consistent with their ethical obligations outlined in the Code. When appropriate standards of care do not exist, computing professionals have a duty to ensure they are developed.

4. COMPLIANCE WITH THE CODE.
A computing professional should...
The future of computing depends on both technical and ethical excellence. Computing professionals should adhere to the principles of the Code and contribute to improving them. Computing professionals who recognize breaches of the Code should take actions to resolve the ethical issues they recognize, including, when reasonable, expressing their concern to the person or persons thought to be violating the Code.

4.2 Treat violations of the Code as inconsistent with membership in the ACM.

Each ACM member should encourage and support adherence by all computing professionals regardless of ACM membership. ACM members who recognize a breach of the Code should consider reporting the violation to the ACM, which may result in remedial action as specified in the ACM's Code of Ethics and Professional Conduct Enforcement Policy.
The Code and guidelines were developed by the ACM Code 2018 Task Force: Executive Committee Don Gotterbarn (Chair), Bo Brinkman, Catherine Flick, Michael S Kirkpatrick, Keith Miller, Kate Varansky, and Marty J Wolf. Members: Eve Anderson, Ron Anderson, Amy Bruckman, Karla Carter, Michael Davis, Penny Duquenoy, Jeremy Epstein, Kai Kimppa, Lorraine Kisselburgh, Shrawan Kumar, Andrew McGettrick, Natasa Milic-Frayling, Denise Oram, Simon Rogerson, David Shamma, Janice Sipior, Eugene Spafford, and Les Waguespack. The Task Force was organized by the ACM Committee on Professional Ethics. Significant contributions to the Code were also made by the broader international ACM membership. This Code and its guidelines were adopted by the ACM Council on June 22nd, 2018. This Code may be published without permission as long as it is not changed in any way and it carries the copyright notice. Copyright (c) 2018 by the Association for Computing Machinery.

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The Code affirms an obligation of computing professionals to use their skills for the benefit of society.

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Ethical and social computing are embodied in the ACM Code of Ethics. The core values expressed in the ACM Code inspire and guide computing professionals. The actions of computing professionals change the world, and the Code is the conscience of the field.

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#10 Personal Connection to the Legal and Ethical Standards:

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#10 Personal Connection to the Legal and Ethical Standards:

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In my job as a healthcare administrator, I encountered numerous situations where understanding legal and ethical standards was crucial. Navigating issues such as patient privacy, consent, and compliance with HIPAA regulations highlighted the real-world implications of these laws on patient care and organizational operations. This experience ignited my passion for studying healthcare law and ethics, driving me to pursue further education in health law to better understand and address these complex issues in healthcare settings.

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#11  Bulleted list of Recommendations / Best Practices for Compliance:

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#11  Bulleted list of Recommendations / Best Practices for Compliance:

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Provide comprehensive training: Ensure that all staff members, including healthcare providers, administrators, and support staff, receive regular training on HIPAA regulations, privacy policies, and security best practices.

Implement strong access controls: Restrict access to protected health information (PHI) to only authorized personnel through user authentication, role-based access controls, and encryption.

Conduct regular risk assessments: Perform periodic assessments of security risks and vulnerabilities to identify areas for improvement and ensure compliance with HIPAA requirements.

Develop clear policies and procedures: Establish and document policies and procedures for handling PHI, including guidelines for data access, storage, transmission, and disposal.

Monitor and audit compliance: Implement monitoring mechanisms and conduct regular audits to track access to PHI, detect unauthorized activity, and ensure adherence to HIPAA regulations.

Respond promptly to breaches: Develop and implement a breach response plan outlining steps to take in the event of a security breach, including notifying affected individuals and regulatory authorities as required by HIPAA.

Stay informed about updates: Stay abreast of changes to HIPAA regulations, guidance, and enforcement actions by regulatory agencies to ensure ongoing compliance and update policies and practices accordingly.

Document compliance efforts: Maintain thorough documentation of compliance efforts, including training records, risk assessments, policies, procedures, and audit findings, to demonstrate adherence to HIPAA regulations.