These standards are intended to protect the privacy of patients. 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. (1) To the Individual. Protected Health Information. Organized Health Care Arrangement. 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. 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. 164.522(a).62 45 C.F.R. Privacy Practices Notice. 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." The Department of Justice is responsible for criminal prosecutions under the Priv. 1320d-6.90 45 C.F.R. 3 de julho de 2022 . 160.10314 45 C.F.R. 164.530(f).70 45 C.F.R. 164.528.61 45 C.F.R. According to the Health Insurance Portability and Accountability Act (HIPAA), protected health information (PHI) is any health information that can identify an individual that is in possession of or transmitted by a "covered entity" or its business associates that relates to a patient's past, present, or future health. 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.33, Law Enforcement Purposes. 164.501.21 45 C.F.R. A covered entity is allowed under the privacy rule to disclose protected health information to the patient or authorized representative without prior written approval. Amendment. 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 covered entity may not retaliate against a person for exercising rights provided by the Privacy Rule, for assisting in an investigation by HHS or another appropriate authority, or for opposing an act or practice that the person believes in good faith violates the Privacy Rule.73 A covered entity may not require an individual to waive any right under the Privacy Rule as a condition for obtaining treatment, payment, and enrollment or benefits eligibility.74, Documentation and Record Retention. Compliance Schedule. 164.502(a).17 45 C.F.R. 164.512(b).31 45 C.F.R. In March 2002, the Department proposed and released for public comment modifications to the Privacy Rule. De-Identified Health Information. 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. 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.22. Michael Fielding Allen. 164.501.48 45 C.F.R. 45 C.F.R. The Rule also contains specific distribution requirements for direct treatment providers, all other health care providers, and health plans. (i) A public health authority that is authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health 164.526(a)(2).60 45 C.F.R. 164.502(g).85 45 C.F.R. HIPAA stands for Health Insurance Portability and Accountability Act of 1996 (HIPAA) goal of HIPAA improving efficiency in healthcare by improving portability and continuity of healthcare coverage, addressing the problem of pre-existing conditions, and regulating privacy and security of health information Department of Health and Human Services Covered entities may use or disclose protected health information to facilitate the donation and transplantation of cadaveric organs, eyes, and tissue.36, Research. A covered health care provider may rely on an individual's informal permission to list in its facility directory the individual's name, general condition, religious affiliation, and location in the provider's facility.25 The provider may then disclose the individual's condition and location in the facility to anyone asking for the individual by name, and also may disclose religious affiliation to clergy. 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. Preemption. It may allow use and disclosure of protected health information by the covered entity seeking the authorization, or by a third party. Similarly, a covered entity may rely on an individual's informal permission to use or disclose protected health information for the purpose of notifying (including identifying or locating) family members, personal representatives, or others responsible for the individual's care of the individual's location, general condition, or death. 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. 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. Limiting Uses and Disclosures to the Minimum Necessary. Business Associate Defined. A covered entity must obtain the individual's written authorization for any use or disclosure of protected health information that is not for treatment, payment or health care operations or otherwise permitted or required by the Privacy Rule.44 A covered entity may not condition treatment, payment, enrollment, or benefits eligibility on an individual granting an authorization, except in limited circumstances.45. 45 C.F.R. The Privacy Rule permits a covered entity that is a single legal entity and that conducts both covered and non-covered functions to elect to be a "hybrid entity. To sign up for updates or to access your subscriber preferences, please enter your contact information below. 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. A covered entity must develop and implement written privacy policies and procedures that are consistent with the Privacy Rule.64, Privacy Personnel. Complaints. 164.512(g).36 45 C.F.R. 164.501.23 45 C.F.R. Criminal Penalties. Business Associate Contract. 164.510(b).27 45 C.F.R. 164.534.91 45 C.F.R. 45 C.F.R. 45 C.F.R. 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. > HIPAA Home 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. This includes civil laws which permit the removal of a child from the home and other protective interventions. In most cases, parents are the personal representatives for their minor children. 164.508(a)(2)24 45 C.F.R. An authorization must be written in specific terms. 164.103.80 The Privacy Rule at 45 C.F.R. by . L. 104-191; 42 U.S.C. 164.520(d).54 45 C.F.R. comparable images. Definition. 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. Covered Entities With Multiple Covered Functions. 164.512(e).34 45 C.F.R. Required by Law. 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. 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. Penalties may not exceed a calendar year cap for multiple violations of the same requirement. After making this designation, most of the requirements of the Privacy Rule will apply only to the health care components. 164.506(c)(5).82 45 C.F.R. 164.502(a)(1)(iii).28 See 45 C.F.R. Every health care provider, regardless of size, who electronically transmits health information in connection with certain transactions, is a covered entity. 164.524.56 45 C.F.R. HHS recognizes that covered entities range from the smallest provider to the largest, multi-state health plan. A covered entity also may rely on an individual's informal permission to disclose to the individual's family, relatives, or friends, or to other persons whom the individual identifies, protected health information directly relevant to that person's involvement in the individual's care or payment for care.26 This provision, for example, allows a pharmacist to dispense filled prescriptions to a person acting on behalf of the patient. Health Care Clearinghouses. ", https://www.federalregister.gov/documents/2019/04/30/2019-08530/enforcement-discretion-regarding-hipaa-civil-money-penalties, Frequently Asked Questions for Professionals, The Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, was enacted on August 21, 1996. A clinically-integrated setting where individuals typically receive health care from more. sample business associate contract language. 164.512(f).35 45 C.F.R. Access and Uses. Reasonable Reliance. 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. Is necessary to prevent fraud and abuse related to the provision of or payment for health care. It becomes individually identifiable health information when identifiers are included in the same record set, and it becomes protected when . > Summary of the HIPAA Privacy Rule. 164.526.59 Covered entities may deny an individual's request for amendment only under specified circumstances. 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. 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. 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. PHI is essentially any . 164.500(b).9 45 C.F.R. 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. In general, State laws that are contrary to the Privacy Rule are preempted by the federal requirements, which means that the federal requirements will apply.85 "Contrary" means that it would be impossible for a covered entity to comply with both the State and federal requirements, or that the provision of State law is an obstacle to accomplishing the full purposes and objectives of the Administrative Simplification provisions of HIPAA.86 The Privacy Rule provides exceptions to the general rule of federal preemption for contrary State laws that (1) relate to the privacy of individually identifiable health information and provide greater privacy protections or privacy rights with respect to such information, (2) provide for the reporting of disease or injury, child abuse, birth, or death, or for public health surveillance, investigation, or intervention, or (3) require certain health plan reporting, such as for management or financial audits. There are no restrictions on the use or disclosure of de-identified health information.14 De-identified health information neither identifies nor provides a reasonable basis to identify an individual.

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