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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. The U. 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 our Privacy 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. 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, The Department received over 52, public comments. The final regulation, the Privacy Rule, was published December 28, In March , the Department proposed and released for public comment modifications to the Privacy Rule.
The Department received over 11, comments. The final modifications were published in final form on August 14, For help in determining whether you are covered, use CMS's decision tool.
Health Plans. Individual and group plans that provide or pay the cost of medical care are covered entities. Health plans also include employer-sponsored group health plans, government and church-sponsored health plans, and multi-employer health plans.
There are exceptions—a group health plan with less than 50 participants that is administered solely by the employer that established and maintains the plan is not a covered entity. Two types of government-funded programs are not health plans: 1 those whose principal purpose is not providing or paying the cost of health care, such as the food stamps program; and 2 those programs whose principal activity is directly providing health care, such as a community health center, 5 or the making of grants to fund the direct provision of health care.
If an insurance entity has separable lines of business, one of which is a health plan, the HIPAA regulations apply to the entity with respect to the health plan line of business. 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.
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 Clearinghouses. Health care clearinghouses are entities that process nonstandard information they receive from another entity into a standard i. 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. 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.
Covered entities that had an existing written contract or agreement with business associates prior to October 15, , which was not renewed or modified prior to April 14, , were permitted to continue to operate under that contract until they renewed the contract or April 14, , whichever was first. 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 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. De-Identified Health Information. There are no restrictions on the use or disclosure of de-identified health information.
Basic Principle. Required Disclosures. A covered entity must disclose protected health information in only two situations: a to individuals or their personal representatives specifically when they request access to, or an accounting of disclosures of, their protected health information; and b to HHS when it is undertaking a compliance investigation or review or enforcement action.
A covered entity may disclose protected health information to the individual who is the subject of the information. A covered entity may use and disclose protected health information for its own treatment, payment, and health care operations activities. Treatment is the provision, coordination, or management of health care and related services for an individual by one or more health care providers, including consultation between providers regarding a patient and referral of a patient by one provider to another.
Payment encompasses activities of a health plan to obtain premiums, determine or fulfill responsibilities for coverage and provision of benefits, and furnish or obtain reimbursement for health care delivered to an individual 21 and activities of a health care provider to obtain payment or be reimbursed for the provision of health care to an individual.
Health care operations are any of the following activities: a quality assessment and improvement activities, including case management and care coordination; b competency assurance activities, including provider or health plan performance evaluation, credentialing, and accreditation; c conducting or arranging for medical reviews, audits, or legal services, including fraud and abuse detection and compliance programs; d specified insurance functions, such as underwriting, risk rating, and reinsuring risk; e business planning, development, management, and administration; and f business management and general administrative activities of the entity, including but not limited to: de-identifying protected health information, creating a limited data set, and certain fundraising for the benefit of the covered entity.
Most uses and disclosures of psychotherapy notes for treatment, payment, and health care operations purposes require an authorization as described below. Informal permission may be obtained by asking the individual outright, or by circumstances that clearly give the individual the opportunity to agree, acquiesce, or object.
Where the individual is incapacitated, in an emergency situation, or not available, covered entities generally may make such uses and disclosures, if in the exercise of their professional judgment, the use or disclosure is determined to be in the best interests of the individual. Facility Directories. It is a common practice in many health care facilities, such as hospitals, to maintain a directory of patient contact information.
Members of the clergy are not required to ask for the individual by name when inquiring about patient religious affiliation. For Notification and Other Purposes. In addition, protected health information may be disclosed for notification purposes to public or private entities authorized by law or charter to assist in disaster relief efforts. The Privacy Rule does not require that every risk of an incidental use or disclosure of protected health information be eliminated.
Specific conditions or limitations apply to each public interest purpose, striking the balance between the individual privacy interest and the public interest need for this information. Required by Law. Covered entities may use and disclose protected health information without individual authorization as required by law including by statute, regulation, or court orders.
Public Health Activities. Victims of Abuse, Neglect or Domestic Violence. In certain circumstances, covered entities may disclose protected health information to appropriate government authorities regarding victims of abuse, neglect, or domestic violence. Health Oversight Activities. Covered entities may disclose protected health information to health oversight agencies as defined in the Rule for purposes of legally authorized health oversight activities, such as audits and investigations necessary for oversight of the health care system and government benefit programs.
Judicial and Administrative Proceedings. Covered entities may disclose protected health information in a judicial or administrative proceeding if the request for the information is through an order from a court or administrative tribunal.
Such information may also be disclosed in response to a subpoena or other lawful process if certain assurances regarding notice to the individual or a protective order are provided. Law Enforcement Purposes. Covered entities may disclose protected health information to funeral directors as needed, and to coroners or medical examiners to identify a deceased person, determine the cause of death, and perform other functions authorized by law.
Cadaveric Organ, Eye, or Tissue Donation. Covered entities may use or disclose protected health information to facilitate the donation and transplantation of cadaveric organs, eyes, and tissue. Serious Threat to Health or Safety. Covered entities may disclose protected health information that they believe is necessary to prevent or lessen a serious and imminent threat to a person or the public, when such disclosure is made to someone they believe can prevent or lessen the threat including the target of the threat.
Covered entities may also disclose to law enforcement if the information is needed to identify or apprehend an escapee or violent criminal. Essential Government Functions. An authorization is not required to use or disclose protected health information for certain essential government functions.
Such functions include: assuring proper execution of a military mission, conducting intelligence and national security activities that are authorized by law, providing protective services to the President, making medical suitability determinations for U. State Department employees, protecting the health and safety of inmates or employees in a correctional institution, and determining eligibility for or conducting enrollment in certain government benefit programs.
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.
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. 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, Psychotherapy Notes Marketing is any communication about a product or service that encourages recipients to purchase or use the product or service. 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.
No authorization is needed, however, to make a communication that falls within one of the exceptions to the marketing definition. See additional guidance on Marketing. Minimum Necessary. A covered entity must make reasonable efforts to use, disclose, and request only the minimum amount of protected health information needed to accomplish the intended purpose of the use, disclosure, or request.
When the minimum necessary standard applies to a use or disclosure, a covered entity may not use, disclose, or request the entire medical record for a particular purpose, unless it can specifically justify the whole record as the amount reasonably needed for the purpose.
See additional guidance on Minimum Necessary. Access and Uses.
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