by . Individual and group plans that provide or pay the cost of medical care are covered entities.4 Health plans include health, dental, vision, and prescription drug insurers, health maintenance organizations ("HMOs"), Medicare, Medicaid, Medicare+Choice and Medicare supplement insurers, and long-term care insurers (excluding nursing home fixed-indemnity policies). 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. Protected Health Information. The health plan may not question the individual's statement of Because it is an overview of the Privacy Rule, it does not address every detail of each provision. GINA covers employers with 15 or more employees, including state and local governments. Safeguard your medical and health insurance information and shred any insurance forms, prescriptions, or physician statements. 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. A penalty will not be imposed for violations in certain circumstances, such as if: 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. 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. 164.502(g).85 45 C.F.R. Extended Health Care Plan The Employer shall pay the monthly premium for regular employees entitled to coverage under a mutually acceptable extended health care plan.. Medical Examination Where the Employer requires an employee to submit to a medical examination or medical interview, it shall be at the Employer's expense and on the Employer's time, other than . 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." Is necessary to prevent fraud and abuse related to the provision of or payment for health care. (6) Limited Data Set. 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. 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. 164.512(f).35 45 C.F.R. 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. A covered entity may use and disclose protected health information for its own treatment, payment, and health care operations activities.19 A covered entity also may disclose protected health information for the treatment activities of any health care provider, the payment activities of another covered entity and of any health care provider, or the health care operations of another covered entity involving either quality or competency assurance activities or fraud and abuse detection and compliance activities, if both covered entities have or had a relationship with the individual and the protected health information pertains to the relationship. Toll Free Call Center: 1-800-368-1019 160.103.13 45 C.F.R. Group Health Plan disclosures to Plan Sponsors. The Privacy Rule permits an exception when a 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. 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. 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 Department of Justice has imposed a criminal penalty for the failure to comply (see below). 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. 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. An authorization must be written in specific terms. 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. 164.522(a). 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. 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. 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. A covered entity may also disclose PHI to aid in TPO, which is the acronym for "Treatment, Payment and Health Care Operations". the individual: (i) Names; (ii) Postal address information, other than town or city, State and zip In emergency treatment situations, the provider must furnish its notice as soon as practicable after the emergency abates. TTD Number: 1-800-537-7697, Content created by Office for Civil Rights (OCR), U.S. Department of Health & Human Services, has sub items, about Compliance & Enforcement, has sub items, about Covered Entities & Business Associates, Other Administrative Simplification Rules, For help in determining whether you are covered, use CMS's decision tool. 164.520(c).53 45 C.F.R. "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). 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. 45 C.F.R. 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. 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. ", Serious Threat to Health or Safety. Is necessary to ensure appropriate State regulation of insurance and health plans to the extent expressly authorized by statute or regulation. "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 HIPAAPrivacy Rule. 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. 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. Kenneth Stoller. Disclosure Accounting. The Privacy Rule does not require that every risk of an incidental use or disclosure of protected health information be eliminated. 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. 164.528.61 45 C.F.R. 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. 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. 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: 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. 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. 164.526(a)(2).60 45 C.F.R. 164.530(f).70 45 C.F.R. 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. This is interpreted rather broadly and includes any part of a patient's medical record or payment history. 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. 164.530(k).77 45 C.F.R. 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. 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. 164.501.48 45 C.F.R. Washington, D.C. 20201 Business Associate Defined. 45 C.F.R. 164.512(a), (c).32 45 C.F.R. 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. 200 Independence Avenue, S.W. The Department of Justice is responsible for criminal prosecutions under the Priv. The notice must state the covered entity's duties to protect privacy, provide a notice of privacy practices, and abide by the terms of the current notice. Compliance Schedule. comparable images. Special Case: Minors. 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. 164.504(f).84 45 C.F.R. 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. Certain types of insurance entities are also not health plans, including entities providing only workers' compensation, automobile insurance, and property and casualty insurance. A covered entity can be the business associate of another covered entity. 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.