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. It is a common practice in many health care facilities, such as hospitals, to maintain a directory of patient contact information. 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. 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. 164.524.58 45 C.F.R. a notable exclusion of protected health information is quizlet 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. Breach Reporting | HHS.gov This is interpreted rather broadly and includes any part of a patient's medical record or payment history. Therefore, in most cases, parents can exercise individual rights, such as access to the medical record, on behalf of their minor children. Minimum Necessary. 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. 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. Account numbers; (x) Certificate/license numbers; (xi) Vehicle identifiers and serial numbers, Covered entities may use and disclose protected health information without individual authorization as required by law (including by statute, regulation, or court orders).29. 58 If a covered entity accepts an amendment request, it must make reasonable efforts to provide the amendment to persons that the individual has identified as needing it, and to persons that the covered entity knows might rely on the information to the individual's detriment.59 If the request is denied, covered entities must provide the individual with a written denial and allow the individual to submit a statement of disagreement for inclusion in the record. 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. 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. 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. (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 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. The Privacy Rule contains transition provisions applicable to authorizations and other express legal permissions obtained prior to April 14, 2003.46, Psychotherapy Notes.47 A covered entity must obtain an individual's authorization to use or disclose psychotherapy notes with the following exceptions:48. a notable exclusion of protected health information is: 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 entity must develop and implement written privacy policies and procedures that are consistent with the Privacy Rule.64, Privacy Personnel. In emergency treatment situations, the provider must furnish its notice as soon as practicable after the emergency abates. Each covered entity, with certain exceptions, must provide a notice of its privacy practices.51 The Privacy Rule requires that the notice contain certain elements. 160.10314 45 C.F.R. Usamos cookies para asegurar que te damos la mejor experiencia en nuestra web. 164.500(b).9 45 C.F.R. 1320d-6.90 45 C.F.R. The Vaccine Education Center staff regularly reviews materials for accuracy. 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. 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. Exceptions to the HIPAA Privacy Policy - UniversalClass.com No authorization is needed, however, to make a communication that falls within one of the exceptions to the marketing definition. 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. "Notable is much more than a vendor. 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. (5) Public Interest and Benefit Activities. Access. Frequently Asked Questions for Professionals- Please see the HIPAA FAQs for additional guidance on health information privacy topics. the individual: (i) Names; (ii) Postal address information, other than town or city, State and zip In addition, certain violations of the Privacy Rule may be subject to criminal prosecution. The Rule also contains specific distribution requirements for direct treatment providers, all other health care providers, and health plans. The Privacy Rule calls this information "protected health information (PHI)."12. 164.512(e).34 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." 164.520(c).53 45 C.F.R. 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). The best way to protect yourself against this possibility is to make sure you verify the source before sharing your personal or medical information. Is necessary to ensure appropriate State regulation of insurance and health plans to the extent expressly authorized by statute or regulation. 9. Covered Entities With Multiple Covered Functions. 160.103.10 45 C.F.R. Permitted Uses and Disclosures. The Department of Justice is responsible for criminal prosecutions under the Priv. The Rule specifies processes for requesting and responding to a request for amendment. 164.501.38 45 C.F.R. Restriction Request. 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. There are exceptionsa 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. 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. 164.501.23 45 C.F.R. In the Journals: Impact of CA SB277 Removing Non-medical Exemptions Data Safeguards. 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. 164.512(k).42 45 C.F.R. 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. 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. A covered entity must have procedures for individuals to complain about its compliance with its privacy policies and procedures and the Privacy Rule.71 The covered entity must explain those procedures in its privacy practices notice.72. 164.530(h).75 45 C.F.R. Collectively these are known as the. A use or disclosure of this information that occurs as a result of, or as "incident to," an otherwise permitted use or disclosure is permitted as long as the covered entity has adopted reasonable safeguards as required by the Privacy Rule, and the information being shared was limited to the "minimum necessary," as required by the Privacy Rule.27 See additional guidance on Incidental Uses and Disclosures. 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. Covered entities that fail to comply voluntarily with the standards may be subject to civil money penalties. Guidance: Treatment, Payment, and Health Care Operations 164.512(f).35 45 C.F.R. Individuals have the right to request that a covered entity restrict use or disclosure of protected health information for treatment, payment or health care operations, disclosure to persons involved in the individual's health care or payment for health care, or disclosure to notify family members or others about the individual's general condition, location, or death.61 A covered entity is under no obligation to agree to requests for restrictions. (1) To the Individual. Tier 3: Obtaining PHI for personal gain or with malicious intent - Up to 10 years in jail. 164.504(f).84 45 C.F.R. Covered entities may also disclose to law enforcement if the information is needed to identify or apprehend an escapee or violent criminal.40, Essential Government Functions. Organized Health Care Arrangement. HIPAA applies to physicians and other individual and institutional health care providers (e.g., dentists, psychologists, hospitals, clinics, pharmacies, etc.). 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. The Privacy Rule permits an exception when a 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. 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, Other Provisions: Personal Representatives and Minors.
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