What is HIPAA?
The Health Insurance Portability and Accountability Act (HIPAA) is a United States federal statute enacted by the 104th United States Congress which was signed into law by President Bill Clinton on August 21, 1996. The law required the creation of national standards to protect sensitive patient health information and gave the US Department of Health and Human Services (HHS) rulemaking authority.
HHS has issued the following rules:
- HHS published a final Privacy Rule in December 2000, which was later modified in August 2002. This Rule set national standards for the protection of individually identifiable health information by three types of covered entities: health plans, health care clearinghouses, and health care providers who conduct the standard health care transactions electronically. Compliance with the Privacy Rule was required as of April 14, 2003 (April 14, 2004, for small health plans). 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. As part of HHS’s Regulatory Sprint to Coordinated Care, OCR has issued a Notice of Proposed Rulemaking (NPRM) to modify HIPAA’s Privacy Rule to support individuals’ engagement in their health care, remove barriers to coordinated care, and decrease regulatory burdens on the health care industry, while continuing to protect individuals’ health information privacy interests. You can learn more about this regulatory initiative by visiting this page.
- HHS published a final Security Rule in February 2003. This Rule sets national standards for protecting the confidentiality, integrity, and availability of electronic protected health information. Compliance with the Security Rule was required as of April 20, 2005 (April 20, 2006 for small health plans).
- The Enforcement Rule provides standards for the enforcement of all the Administrative Simplification Rules.
- HHS enacted a final Omnibus rule that implements a number of provisions of the HITECH Act to strengthen the privacy and security protections for health information established under HIPAA, finalizing the Breach Notification Rule.
You can view the Combined Regulation Text — PDF (as of March 2013). This is an unofficial version that presents all the HIPAA regulatory standards in one document.
The HIPAA Privacy Rule
Through the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) HHS established a set of national standards for the protection of certain health information.
The Privacy Rule standards address the use and disclosure of individuals’ health information (called “protected health information” or PHI) 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.
Preemption of State Laws:
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. See, 45 C.F.R. §160.203. “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. See, 45 C.F.R. § 160.202.
- 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.
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.
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. See, 45 C.F.R. § 164.502(g).
- 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.
Additional resources: See additional HHS guidance on Personal Representatives.
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.
Compliance Schedule. All covered entities, except “small health plans,” must have been compliant with the Privacy Rule by April 14, 2003. Small health plans, however, had until April 14, 2004 to comply. See, 45 C.F.R. § 164.534.
- Small Health Plans. A health plan with annual receipts of not more than $5 million is a small health plan. See, 45 C.F.R. § 160.103. Health plans that file certain federal tax returns and report receipts on those returns should use the guidance provided by the Small Business Administration at 13 Code of Federal Regulations (CFR) 121.104 to calculate annual receipts. Health plans that do not report receipts to the Internal Revenue Service (IRS), for example, group health plans regulated by the Employee Retirement Income Security Act 1974 (ERISA) that are exempt from filing income tax returns, should use proxy measures to determine their annual receipts.
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”). [See 45 C.F.R. §§ 160.102]
- Health Plans. Individual and group plans that provide or pay the cost of medical care are covered entities. 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). 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, or the making of grants to fund the direct provision of 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. 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. [See 45 C.F.R. §§ 160.102, and 160.103.]
- 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. 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. [See, 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.]
- 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. 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.8Health care clearinghouses include billing services, repricing companies, community health management information systems, and value-added networks and switches if these entities perform clearinghouse functions. [See 45 C.F.R. § 160.103. and 45 C.F.R. § 164.500(b)]
For help determining whether an organization is covered, HHS has made available a CMS’s decision tool.
What is a “business associate”?
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.
- 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.
Additional resources: You can find additional helpful guidance on on business associates here
Are business associates directly responsible for HIPAA compliance? Yes. In 2009, Congress enacted the Health Information Technology for Economic and Clinical Health (HITECH) Act, making business associates of covered entities directly liable for compliance with certain requirements of the HIPAA Rules. Business associates are directly liable for HIPAA violations as follows:
- Failure to provide the Secretary with records and compliance reports; cooperate with complaint investigations and compliance reviews; and permit access by the Secretary to information, including protected health information (PHI), pertinent to determining compliance. [See 45 CFR 160.310, 164.502(a)(4)(i).]
- Taking any retaliatory action against any individual or other person for filing a HIPAA complaint, participating in an investigation or other enforcement process, or opposing an act or practice that is unlawful under the HIPAA Rules. [See 45 CFR 160.316.]
- Failure to comply with the requirements of the Security Rule. [See HITECH Act 13401, 42 U.S.C. 17931 (making 45 CFR 164.308, 160.310, 164.312, and 164.316 directly applicable to business associates, as well as any other security provision that the HITECH Act made applicable to covered entities); 45 CFR 164.306, 164.308, 160.310, 164.312, 164.314, 164.316.]
- Failure to provide breach notification to a covered entity or another business associate. [See 45 CFR 164.410, 164.412.]
- Impermissible uses and disclosures of PHI. [See 45 CFR 164.502(a)(3).]
- Failure to disclose a copy of electronic PHI (ePHI) to either (a) the covered entity or (b) the individual or the individual’s designee (whichever is specified in the business associate agreement) to satisfy a covered entity’s obligations under 45 CFR 164.524(c)(2)(ii) and 3(ii), respectively, with respect to an individual’s request for an electronic copy of PHI. [See 45 CFR 164.502(a)(4)(ii).]
- Failure to make reasonable efforts to limit PHI to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request. [See 45 CFR 164.502(b).]
- Failure, in certain circumstances, to provide an accounting of disclosures. [See HITECH Act 13405(c)(3), 42 U.S.C. 17935(c)(3) (“A business associate included on a list under subparagraph (b) shall provide an accounting of disclosures (as required under paragraph (1) for a covered entity) made by the business associate upon a request made by an individual directly to the business associate for such an accounting.”). OCR plans to issue rulemaking on the accounting of disclosures as required by HITECH Act 13405(c)(2).]
- Failure to enter into business associate agreements with subcontractors that create or receive PHI on their behalf, and failure to comply with the implementation specifications for such agreements. [See 45 CFR 164.502(e)(1)(ii), 164.504(e)(5).]
- Failure to take reasonable steps to address a material breach or violation of the subcontractor’s business associate agreement. [See 45 CFR 164.504(e)(1)(iii) (“A business associate is not in compliance with the standards in 164.502(e) and this paragraph, if the business associate knew of a pattern of activity or practice of a subcontractor that constituted a material breach or violation of the subcontractor’s obligation under the contract or other arrangement, unless the business associate took reasonable steps to cure the breach or end the violation, as applicable, and, if such steps were unsuccessful, terminated the contract or arrangement, if feasible.”).]
Additional resources: See New HHS Fact Sheet On Direct Liability of Business Associates under HIPAA
Are there contractual requirements for business associate contracts? Yes. When a “covered entity: uses a contractor or other non-workforce member to perform “business associate” services or activities, the Privacy 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.
- 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
HHS publishes sample business associate contract language here.
What information is protected by the HIPAA Privacy Rule?
The HIPPA 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).” [See, 45 C.F.R. § 160.103.]
“Individually identifiable health information” is information, including demographic data, that relates to: (i) the individual’s past, present or future physical or mental health or condition, (ii) the provision of health care to the individual, OR (iii) 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. [See, 45 C.F.R. § 160.103.]
- 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.
- De-identified health information is information that neither identifies nor provides a reasonable basis to identify an individual.
There are two ways to de-identify information:
- a formal determination by a qualified statistician; or
- the removal of specified identifiers of the individual and of the individual’s relatives, household members, and employers is required, and is adequate only if the covered entity has no actual knowledge that the remaining information could be used to identify the individual.
[See 45 C.F.R. § 164.514(b)]
NOTE: 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 (R) 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. [See 45 C.F.R. § 164.514(b)]
Use and disclosure of PHI under the Privacy Rule
As a general rule, a covered entity may not use or disclose protected health information, except either:
- as the Privacy Rule permits or requires; or
- as the individual who is the subject of the information (or the individual’s personal representative) authorizes in writing.
See, 45 C.F.R. § 164.502(a).
A covered entity must disclose protected health information in only two situations:
- to individuals (or their personal representatives) specifically when they request access to, or an accounting of disclosures of, their protected health information; and
- to HHS when it is undertaking a compliance investigation or review or enforcement action.
Additional resource: HHS provides additional guidance on govermental access to information here.
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 certain purposes. Covered entities may rely on professional ethics and best judgments in deciding which of these permissive uses and disclosures to make.
The permitted uses and disclosures under the Privacy Rule are as follows:
- To the Individual: A covered entity may disclose protected health information to the individual who is the subject of the information.
- Treatment, Payment, and Health Care Operations: A covered entity may use and disclose protected health information for its own treatment, payment, and health care operations activities. See, 45 C.F.R. § 164.506(c). 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. See, 45 C.F.R. § 164.501. Most uses and disclosures of psychotherapy notes for treatment, payment, and health care operations purposes require an authorization. See, 45 C.F.R. § 164.508(a)(2). Obtaining “consent” (written permission from individuals to use and disclose their protected health information for treatment, payment, and health care operations) is optional for these types of disclosures and (if they choose to seek it) the consent form and process are at the discretion of the covered entity electing to seek consent. See, 45 C.F.R. § 164.506(b).
Additional resources: You can see additional HSS guidance on Treatment, Payment, & Health Care Operations.
- 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.
Practice tip: Informal consent:
Directories: It is a common practice in many health care facilities, such as hospitals, to maintain a directory of patient contact information. Entities typically 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. See, 45 C.F.R. § 164.510(a). 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. Members of the clergy are not required to ask for the individual by name when inquiring about patient religious affiliation.
Notification and other purposes: Covered entity also typically rely on 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. See, 45 C.F.R. § 164.510(b). This allows a pharmacist to dispense filled prescriptions to a person acting on behalf of the patient. Similarly, a covered entity may rely on informal permission 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. 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.
- Incident to an otherwise permitted use and disclosure: Uses or disclosures that occur 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, and the information being shared was limited to the “minimum necessary” . See, 45 C.F.R. §§ 164.502(a)(1)(iii)
Additional resources: HHS provides additional guidance on Incidental Uses and Disclosures.
- Public Interest and Benefit Activities: Use and disclosure of protected health information, without an individual’s authorization or permission, is permitted for 12 purposes: (1) required by law [see, 45 C.F.R. § 164.512(a)]; (2) public health ativites [see, 45 C.F.R. § 164.512(b)]; (3) victims of abuse, neglect or domestic violence [see, 45 C.F.R. § 164.512 (c)]; (4) health oversight activities [see, 45 C.F.R. § 164.512(d)]; (5) judicial and administrative proceedings [see, 45 C.F.R. § 164.512(e)]; (6) law enforcement purposes [see, 45 C.F.R. § 164.512(f)]; (7) decedents [see, 45 C.F.R. § 164.512(g)]; (8) cadaveric organ, eye, or tissue donation [see, 45 C.F.R. § 164.512(h)]; (9) research defined to mean “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” [see, 45 C.F.R. § 164.501 + 45 C.F.R. § 164.512(i) and 45 CFR § 164.514(e)]; (10) serious threat to health or safety [see, 45 C.F.R. § 164.512(j)]; (11) essential government functions [see, 45 C.F.R. § 164.512(k)]; and (12) workers comp [see, 45 C.F.R. § 164.512(l)]. Specific conditions or limitations apply to each public interest purpose.
Additional resources: HHS website provides additional guidance on Public Health Activities. You can also consult CDC’s web pages on Public Health and HIPAA Guidance. See also additional guidance on Research and NIH’s publication of “Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule.” — PDF. Finally, see additional guidance on Workers’ Compensation.
- Limited Data Sets: 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. 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. See, 45 C.F.R. § 164.514(e). and
Authorized Uses and Disclosures
AUTHORIZATION: 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. See, 45 C.F.R. § 164.508.
- 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.
Practice Tip: The Privacy Rule contains transition provisions applicable to authorizations and other express legal permissions obtained prior to April 14, 2003. 45 CFR § 164.532.
As a general rule, a covered entity may not condition treatment, payment, enrollment, or benefits eligibility on an individual granting an authorization, except in limited circumstances
- However, 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).
PSYCHOTHERAPY NOTES: “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.
See, 45 C.F.R. § 164.501.
A covered entity must obtain an individual’s authorization to use or disclose psychotherapy notes with the following exceptions:
- 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 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. The Privacy Rule carves out the following health-related activities from the 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.
An authorization for marketing that involves the covered entity’s receipt of direct or indirect remuneration from a third party must reveal that fact.
Additional resources: See HHS additional guidance on Marketing.
Limiting Uses and Disclosures to the Minimum Necessary
Minimum Necessary. The principle of “minimum necessary” use and disclosure is core to the Privacy Rule. 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. See, 45 C.F.R. §§ 164.502(b) and 164.514 (d).
- A covered entity must develop and implement policies and procedures to reasonably limit uses and disclosures to the minimum necessary.
- 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.
The minimum necessary requirement is not imposed in any of the following circumstances:
- disclosure to or a request by a health care provider for treatment;
- disclosure to an individual who is the subject of the information, or the individual’s personal representative;
- use or disclosure made pursuant to an authorization;
- disclosure to HHS for complaint investigation, compliance review or enforcement;
- use or disclosure that is required by law; or
- use or disclosure required for compliance with the HIPAA Transactions Rule or other HIPAA Administrative Simplification Rules.
Additional resources: See HHS additional guidance on Minimum Necessary.
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.
Individual Rights under the Privacy Rule
Under HIPAA’s Privacy Rule, individuals have the following rights:
- Right to notice of privacy practices
- Right to access information
- Right to amend information
- Right to accounting of disclosures
- Right to request restrictions
- Confidential communications request
(1) Right to Notice of Privacy Practices
Each covered entity, with certain exceptions, must provide a notice of its privacy practices.
See, 45 C.F.R. §§ 164.520(a) and (b).
Note: 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.
The notice must contain certain elements.
- The notice must describe the ways in which the covered entity may use and disclose protected health information.
- 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.
- The notice must describe individuals’ rights, including the right to complain to HHS and to the covered entity if they believe their privacy rights have been violated.
- The notice must include a point of contact for further information and for making complaints to the covered entity. Covered entities must act in accordance with their notices.
In addition, there are specific distribution requirements for direct treatment providers, all other health care providers, and health plans.
- 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.
Notice distribution: Covered entities, whether direct treatment providers or indirect treatment providers (such as laboratories) or health plans must supply notice to anyone on request. See, 45 C.F.R. § 164.520(c). 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. See, 45 C.F.R. § 164.520(d) 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. See, 45 C.F.R. § 164.520(c).
- 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.
Additional resources: See HHS additional guidance on Notice.
(2) Right to Access Information
As a general rule, individuals have the right to review and obtain a copy of their protected health information in a covered entity’s designated record set. See, 45 C.F.R. § 164.524.
- 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. See, 45 C.F.R. § 164.501.
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.
Note: 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.
See, 45 C.F.R. § 164.524.
Covered entities may impose reasonable, cost-based fees for the cost of copying and postage.
(3) Right to Amend Information
The Rule gives individuals the right to have covered entities amend their protected health information in a designated record set when that information is inaccurate or incomplete. See, 45 C.F.R. § 164.526.
- 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.
- 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. See, 45 C.F.R. 164.526(a)(2).
- 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.
- The Rule specifies processes for requesting and responding to a request for amendment.
- A covered entity must amend protected health information in its designated record set upon receipt of notice to amend from another covered entity.
(4) Right to accounting of disclosures
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. See, 45 C.F.R. § 164.528.
- 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:
- for treatment, payment, or health care operations;
- to the individual or the individual’s personal representative;
- 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;
- pursuant to an authorization;
- of a limited data set;
- for national security or intelligence purposes;
- to correctional institutions or law enforcement officials for certain purposes regarding inmates or individuals in lawful custody; or
- 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.
(5) Restriction Request.
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. See, 45 C.F.R. § 164.522(a).
- A covered entity is under no obligation to agree to requests for restrictions.
- A covered entity that does agree must comply with the agreed restrictions, except for purposes of treating the individual in a medical emergency. See, 45 C.F.R. § 164.522(a)[Note that 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.]
(6) 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. See, 45 C.F.R. § 164.522(b).
- 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 under the Privacy Rule
Because covered entities range from the smallest provider to the largest, multi-state health plan, the Privacy Rule provides flexibility and scalability to allow covered entities to analyze their own needs and implement solutions appropriate for their own environment.
- Privacy Policies and Procedures. A covered entity must develop and implement written privacy policies and procedures that are consistent with the Privacy Rule. See, 45 C.F.R. § 164.530(i).
- 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. See, 45 C.F.R. § 164.530(a).
- 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). See, 45 C.F.R. §160.103 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. See, 45 C.F.R. § 164.530(b) A covered entity must have and apply appropriate sanctions against workforce members who violate its privacy policies and procedures or the Privacy Rule. See, 45 C.F.R. § 164.530(e).
- 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. See, 45 C.F.R. § 164.530(f).
- Data Safeguards. A covered entity must maintain reasonable and appropriate administrative, technical, and physical safeguards to prevent intentional or unintentional use or disclosure of protected health information in violation of the Privacy Rule and to limit its incidental use and disclosure pursuant to otherwise permitted or required use or disclosure. See, 45 C.F.R. § 164.530(c) For example, such safeguards might include shredding documents containing protected health information before discarding them, securing medical records with lock and key or pass code, and limiting access to keys or pass codes.
Additional resources: See HHS additional guidance on Incidental Uses and Disclosures.
- Complaints. A covered entity must have procedures for individuals to complain about its compliance with its privacy policies and procedures and the Privacy Rule. See, 45 C.F.R. § 164.530(d). The covered entity must explain those procedures in its privacy practices notice. See, 45 C.F.R. § 164.520(b)(1)(vi). 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.
- Retaliation and Waiver. 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. See, 45 C.F.R. § 164.530(g). 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. See, 45 C.F.R. § 164.530(h).
- 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. See, 45 C.F.R. § 164.530(j).
- 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. See, 45 C.F.R. § 164.530(k)
The Privacy Rule contains provisions that address a variety of organizational issues that may affect the operation of the privacy protections.
- Hybrid Entity. 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.” See, 45 C.F.R. §§ 164.103, 164.105. (The activities that make a person or organization a covered entity are its “covered functions.” See, 45 C.F.R. §§ 164.103) To be a hybrid entity, the covered entity must designate in writing its operations that perform covered functions as one or more “health care components.” After making this designation, most of the requirements of the Privacy Rule will apply only to the health care components. A covered entity that does not make this designation is subject in its entirety to the Privacy Rule.
- 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. See, 45 C.F.R. §164.105. 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.
- Organized Health Care Arrangement. The Privacy Rule identifies relationships in which participating covered entities share protected health information to manage and benefit their common enterprise as “organized health care arrangements.” Covered entities in an organized health care arrangement can share protected health information with each other for the arrangement’s joint health care operations. See, 45 C.F.R. § 164.506(c)(5).
Practice tip: The Privacy Rule at 45 C.F.R. § 160.103 identifies five types of organized health care arrangements:
(1) A clinically-integrated setting where individuals typically receive health care from more than one provider.
(2) 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.
(3) 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.
(4) All group health plans maintained by the same plan sponsor.
(5) 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.
- 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. See, 45 C.F.R. § 164.504(g). 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 certain protected health information to the “plan sponsor” — the employer, union, or other employee organization that sponsors and maintains the group health plan. See, 45 C.F.R. § 164.504(f). :
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. 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.
Civil monetary 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.
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.
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 Privacy Rule.
THE HIPAA SECURITY RULE
Prior to HIPAA, no generally accepted set of security standards or general requirements for protecting health information existed in the health care industry. At the same time, new technologies were evolving, and the health care industry began to move away from paper processes and rely more heavily on the use of electronic information systems to pay claims, answer eligibility questions, provide health information and conduct a host of other administrative and clinically based functions.
The HIPAA Security Rule establishes national standards to protect individuals’ electronic personal health information that is created, received, used, or maintained by a covered entity. The Security Rule requires appropriate administrative, physical and technical safeguards to ensure the confidentiality, integrity, and security of electronic protected health information.
Preemption. In general, State laws that are contrary to the HIPAA regulations are preempted by the federal requirements, which means that the federal requirements will apply. See, 45 C.F.R. § 160.203.
- “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. See, 45 C.F.R. § 160.202.
Compliance Schedule. All covered entities, except “small health plans,” must have been compliant with the Security Rule by April 20, 2005. Small health plans had until April 20, 2006 to comply.
Who is covered by the HIPAA Security Rule?
The Security Rule applied initially only to health plans, health care clearinghouses, and to any health care provider who transmits health information in electronic form in connection with a transaction for which the Secretary of HHS has adopted standards under HIPAA (the “covered entities”) and to their business associates.
The HITECH Act of 2009 expanded the responsibilities of business associates under the HIPAA Security Rule. HHS developed regulations to implement and clarify these changes. See additional guidance on business associates.
Additional resources: You can use HSS tool for help in determining whether you are covered, use CMS’s decision tool. You can read more about covered entities in the Summary of the HIPAA Privacy Rule — PDF — PDF.
What information is covered by the HIPAA Security Rule?
The HIPAA Privacy Rule protects the privacy of individually identifiable health information, called protected health information (PHI.) The Security Rule protects a subset of information covered by the Privacy Rule, which is all individually identifiable health information a covered entity creates, receives, maintains or transmits in electronic form. The Security Rule calls this information “electronic protected health information” (e-PHI).
See, 45 C.F.R. § 160.103.
Practice Tip: The Security Rule does not apply to PHI transmitted orally or in writing.
The Security Rule requires covered entities to maintain reasonable and appropriate administrative, technical, and physical safeguards for protecting e-PHI.
Specifically, covered entities must:
- Ensure the confidentiality, integrity, and availability of all e-PHI they create, receive, maintain or transmit;
- Identify and protect against reasonably anticipated threats to the security or integrity of the information;
- Protect against reasonably anticipated, impermissible uses or disclosures; and
- Ensure compliance by their workforce.
See, 45 C.F.R. § 164.306(a).
The Security Rule defines “confidentiality” to mean that e-PHI is not available or disclosed to unauthorized persons.
- The Security Rule’s confidentiality requirements support the Privacy Rule’s prohibitions against improper uses and disclosures of PHI.
The Security rule also promotes the two additional goals of maintaining the integrity and availability of e-PHI. Under the Security Rule, “integrity” means that e-PHI is not altered or destroyed in an unauthorized manner. “Availability” means that e-PHI is accessible and usable on demand by an authorized person.
See, 45 C.F.R. § 164.304.
Therefore the Security Rule is flexible and scalable to allow covered entities to analyze their own needs and implement solutions appropriate for their specific environments. Therefore, when a covered entity is deciding which security measures to use, the Rule does not dictate those measures but requires the covered entity to consider:
- Its size, complexity, and capabilities,
- Its technical, hardware, and software infrastructure,
- The costs of security measures, and
- The likelihood and possible impact of potential risks to e-PHI.
Covered entities must review and modify their security measures to continue protecting e-PHI in a changing environment.
Risk Analysis and Management
The Administrative Safeguards provisions in the Security Rule require covered entities to perform risk analysis as part of their security management processes. The risk analysis and management provisions of the Security Rule are addressed separately here because, by helping to determine which security measures are reasonable and appropriate for a particular covered entity, risk analysis affects the implementation of all of the safeguards contained in the Security Rule.
- A risk analysis process includes, but is not limited to, the following activities:
- Evaluate the likelihood and impact of potential risks to e-PHI [See, 45 C.F.R. § 164.306(b)(iv)];
- Implement appropriate security measures to address the risks identified in the risk analysis [See, 45 C.F.R. § 164.308(a)(1)(ii)(B)];
- Document the chosen security measures and, where required, the rationale for adopting those measures; [45 C.F.R. § 164.306(d)(3)(ii)(B)(1); 45 C.F.R. § 164.316(b)(1).] and
- Maintain continuous, reasonable, and appropriate security protections.[See, 45 C.F.R. § 164.306(e)]
Risk analysis should be an ongoing process, in which a covered entity regularly reviews its records to track access to e-PHI and detect security incidents, [see, 45 C.F.R. § 164.308(a)(1)(ii)(D)] periodically evaluates the effectiveness of security measures put in place,[see, 45 C.F.R. § 164.306(e); 45 C.F.R. § 164.308(a)(8)] and regularly reevaluates potential risks to e-PHI. See, 45 C.F.R. § 164.306(b)(2)(iv); 45 C.F.R. § 164.306(e).
- Security Management Process. A covered entity must identify and analyze potential risks to e-PHI, and it must implement security measures that reduce risks and vulnerabilities to a reasonable and appropriate level.
- Security Personnel. A covered entity must designate a security official who is responsible for developing and implementing its security policies and procedures. See, 45 C.F.R. § 164.308(a)(2).
- Information Access Management. Consistent with the Privacy Rule standard limiting uses and disclosures of PHI to the “minimum necessary,” the Security Rule requires a covered entity to implement policies and procedures for authorizing access to e-PHI only when such access is appropriate based on the user or recipient’s role (role-based access). See, 45 C.F.R. § 164.308(a)(4)(i).
- Workforce Training and Management. A covered entity must provide for appropriate authorization and supervision of workforce members who work with e-PHI. See, 45 C.F.R. § 164.308(a)(3) & (4). A covered entity must train all workforce members regarding its security policies and procedures,[see, 45 C.F.R. § 164.308(a)(5)(i)] and must have and apply appropriate sanctions against workforce members who violate its policies and procedures. See, 45 C.F.R. § 164..308(a)(1)(ii)(c)
- Evaluation. A covered entity must perform a periodic assessment of how well its security policies and procedures meet the requirements of the Security Rule. See, 45 C.F.R. § 164.308(a)(8).
- Facility Access and Control. A covered entity must limit physical access to its facilities while ensuring that authorized access is allowed. See, 45 C.F.R. § 164.310(a).
- Workstation and Device Security. A covered entity must implement policies and procedures to specify proper use of and access to workstations and electronic media. See, 45 C.F.R. §§ 164.310(b) & (c). A covered entity also must have in place policies and procedures regarding the transfer, removal, disposal, and re-use of electronic media, to ensure appropriate protection of electronic protected health information (e-PHI). See, 45 C.F.R. § 164.310(d).
- Access Control. A covered entity must implement technical policies and procedures that allow only authorized persons to access electronic protected health information (e-PHI). See, 45 C.F.R. § 164.312(a).
- Audit Controls. A covered entity must implement hardware, software, and/or procedural mechanisms to record and examine access and other activity in information systems that contain or use e-PHI. See, 45 C.F.R. § 164.312(b).
- Integrity Controls. A covered entity must implement policies and procedures to ensure that e-PHI is not improperly altered or destroyed. Electronic measures must be put in place to confirm that e-PHI has not been improperly altered or destroyed. See, 45 C.F.R. § 164.312(c).
- Transmission Security. A covered entity must implement technical security measures that guard against unauthorized access to e-PHI that is being transmitted over an electronic network. See, 45 C.F.R. § 164.312(e).
Required and Addressable Implementation Specifications
Covered entities are required to comply with every Security Rule “Standard.” However, the Security Rule categorizes certain implementation specifications within those standards as “addressable,” while others are “required.”
- The “required” implementation specifications must be implemented.
- The “addressable” designation does not mean that an implementation specification is optional.
- However, it permits covered entities to determine whether the addressable implementation specification is reasonable and appropriate for that covered entity.
- If it is not, the Security Rule allows the covered entity to adopt an alternative measure that achieves the purpose of the standard, if the alternative measure is reasonable and appropriate.
See, 45 C.F.R. § 164.306(d).
- Covered Entity Responsibilities. If a covered entity knows of an activity or practice of the business associate that constitutes a material breach or violation of the business associate’s obligation, the covered entity must take reasonable steps to cure the breach or end the violation. See, 45 C.F.R. § 164.314(a)(1). Violations include the failure to implement safeguards that reasonably and appropriately protect e-PHI.
- Business Associate Contracts. HHS developed regulations relating to business associate obligations and business associate contracts under the HITECH Act of 2009.
Policies and Procedures and Documentation Requirements
- A covered entity must adopt reasonable and appropriate policies and procedures to comply with the provisions of the Security Rule. A covered entity must maintain, until six years after the later of the date of their creation or last effective date, written security policies and procedures and written records of required actions, activities or assessments. See, 45 C.F.R. § 164.316.
- Updates. A covered entity must periodically review and update its documentation in response to environmental or organizational changes that affect the security of electronic protected health information (e-PHI). See, 45 C.F.R. § 164.316(b)(2)(iii).
BREACH NOTIFICATION RULE
The HIPAA Breach Notification Rule, 45 CFR §§ 164.400–414, requires HIPAA covered entities and their business associates to provide notification following a breach of unsecured protected health information.
Similar breach notification provisions implemented and enforced by the Federal Trade Commission (FTC), apply to vendors of personal health records and their third party service providers, pursuant to section 13407 of the HITECH Act.
Acknowledgment, Resources and Citations
This resource was created using the summaries provided in the hhs.gov pages.
Some Reminders on How HIPAA Works | WilmerHal