However, experts have recognized that technology, social conditions, and the availability of information changes over time. This means that a covered entity has actual knowledge if it concludes that the remaining information could be used to identify the individual. Since she was a participant, she can disclose anything she wants to anyone she wants if it does not violated spousal privilege. Regardless of the method by which de-identification is achieved, the Privacy Rule does not restrict the use or disclosure of de-identified health information, as it is no longer considered protected health information. Although PHI is the more commonly used acronym in HIPAA, both PHI and IIHI are protected by the Privacy and Security Rules because they mean exactly the same thing. HIPAA violation: potentially yes if someone can identify it is them and prove it. Simply put, each one is built by aggregating the Census 2000 blocks, whose addresses use a given ZIP code, into a ZCTA which gets that ZIP code assigned as its ZCTA code. As a rule of thumb, any information relating to a person's health becomes PHI as soon as the individual can be identified. Covered entities are allowed to disclose PHI for treatment, payment, and health care operations. Even though most people couldn't identify a client from just their initials, some people can. A person or entity that performs certain functions or activities that involve the use or disclosure of protected health information on behalf of, or provides services to, a covered entity. However, nothing prevents a covered entity from asking a recipient of de-identified information to enter into a data use agreement, such as is required for release of a limited data set under the Privacy Rule. 2.1 Have expert determinations been applied outside of the health field? Get our HIPAA Compliance Checklist to see everything you need to be compliant. For further information, go to: https://www.census.gov/programs-surveys/geography/guidance/geo-areas/zctas.html. Further details can be found at http://csrc.nist.gov/groups/ST/hash/. This means that, although entities related to personal health devices do not have to comply with the Privacy and Security Rules, it is necessary for these entities to know what is considered PHI under HIPAA in order to comply with the Breach Notification Rule. The 18 HIPAA identifiers that make health information PHI are: 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 can be used to identify the individual. These provisions allow the entity to use and disclose information that neither identifies nor provides a reasonable basis to identify an individual.4 As discussed below, the Privacy Rule provides two de-identification methods: 1) a formal determination by a qualified expert; or 2) the removal of specified individual identifiers as well as absence of actual knowledge by the covered entity that the remaining information could be used alone or in combination with other information to identify the individual. Health information is also not PHI when it is created, received, maintained, or transmitted by an entity not subject to the HIPAA Rules. Brown from New York. In this case, the expert may determine that public records, such as birth, death, and marriage registries, are the most likely data sources to be leveraged for identification. The application of a method from one class does not necessarily preclude the application of a method from another class. The use of initials to try to disguise a name is ineffective and does not constitute any level of identity protection. Additionally, PHI is only considered PHI when an individual could be identified from the information in the record set. No. Are initials protected health information? Health information maintained by employers as part of an employees employment record is not considered PHI under HIPAA. Example 3: Publicized Clinical Event All elements of dates (except year) for dates directly related to an individual. This includes names, addresses, dates of birth, social security numbers, and medical records containing any of these items. Regulatory Changes Search Search Recent Posts Given an array of numbers, return array of products of all other numbers (no division) The HIPAA Security Rule requires covered entities to protect against reasonably anticipated threats to the security of PHI. The standards can be found in Subparts I to S of the HIPAA Administrative Data Standards. Linkage between the records in the tables is possible through the demographics. Patient records should always be kept in a locked space so they can't be stumbled upon by others. Under HIPAA, health information such as diagnoses, treatment information, medical test results, and prescription information, as well as national To help individuals get a better understanding of who PHI can be shared with under the permissible uses and disclosures of PHI, patients and health plan members must be given a Notice of Privacy Practices by the covered entity, be given the right to object to PHI being disclosed to third parties, and be told how to request an accounting of disclosures to check their wishes are being upheld. Therefore, an internal patient identifier on its own is not considered PHI. ADA, FCRA, etc.). The Bureau of the Census provides information regarding population density in the United States. > For Professionals 2.3 What is an acceptable level of identification risk for an expert determination? 3.5 What constitutes any other unique identifying number, characteristic, or code with respect to the Safe Harbor method of the Privacy Rule? (i) That identifies the individual; or A general workflow for expert determination is depicted in Figure 2. Regardless of the process or methods employed, the information must meet the very small risk specification requirement. HIPAA has several criteria for data to be considered PHI: The information must relate to the past, current, or future health status of the patient. There is no specific professional degree or certification program for designating who is an expert at rendering health information de-identified. The Privacy Rule was designed to protect individually identifiable health information through permitting only certain uses and disclosures of PHI provided by the Rule, or as authorized by the individual subject of the information. A client's initials are considered to be identifying for the purposes of determining if a given piece of information is PHI under HIPAA, because they are derived from names. The ability of a recipient of information to identify an individual (i.e., subject of the information) is dependent on many factors, which an expert will need to take into account while assessing the risk from a data set. Thus, by relying on the statistics derived from the data set, the expert will make a conservative estimate regarding the uniqueness of records. In line with this guidance from NIST, a covered entity may disclose codes derived from PHI as part of a de-identified data set if an expert determines that the data meets the de-identification requirements at 164.514(b)(1). The covered entity, in other words, is aware that the information is not actually de-identified information. The Census Bureau will not be producing data files containing U.S. Before explaining these terms, it is useful to first explain what is meant by health information, of which protected health information is a subset. Several broad classes of methods can be applied to protect data. If a covered entity records Mr. The determination of which method is most appropriate for the information will be assessed by the expert on a case-by-case basis and will be guided by input of the covered entity. : Madhu Gupta should be written as MG. PHI is health information in any form, including physical records, electronic records, or spoken information. OCR does not expect a covered entity to presume such capacities of all potential recipients of de-identified data. Zip codes can cross State, place, county, census tract, block group, and census block boundaries. not within earshot of the general public) and the Minimum Necessary Standard applies the rule that limits the sharing of PHI to the minimum necessary to accomplish the intended purpose. A characteristic may be anything that distinguishes an individual and allows for identification. It notes that derivations of one of the 18 data elements, such as a patients initials or last four digits of a Social Security number, are considered PHI. The average number of breaches per day for 2020 was 1.76. PHI refers to physical records, while ePHI is any PHI that is created, stored, transmitted, or received digitally. 67 FR 53182, 53233-53234 (Aug. 14, 2002)). PII is Personally Identifiable Information that is used outside a healthcare context, while PHI (Protected Health Information) and IIHA (Individually Identifiable Health Information) is the same information used within a healthcare context. Patient names (first and last name or last name and initial) are one of the 18 identifiers classed as protected health information (PHI) in the HIPAA Privacy Rule. Copyright 2014-2022 HIPAA Journal. Are patient initials considered protected health information? PHI identifiers are any note, image, or file maintained in a record set that could be used to identify the subject of the health information. If you work in healthcare or health insurance, or are considering doing business with clients in these industries that involves the disclosure of health information, you will need to know what is considered protected health information under HIPAA law because under HIPAA law only certain uses and disclosures of protected health information are permitted, while it is also necessary to implement safeguards to ensure the confidentiality, integrity, and availability of protected health information while it is in your possession. According to this section, health information means any information, including genetic information, whether oral or recorded in any form or medium, that: Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual., From here, we need to progress to the definition of individually identifiable health information which states individually identifiable health information [] is a subset of health information, including demographic information collected from an individual [that] is created or received by a health care provider, health plan, employer, or health care clearinghouse [] and that identifies the individual or [] can be used to identify the individual.. Beyond this data, there exists a voter registration data source, which contains personal names, as well as demographics (i.e., Birthdate, ZIP Code, and Gender), which are also distinguishing. The first two rows (i.e., shaded light gray) and last two rows (i.e., shaded dark gray) correspond to patient records with the same combination of generalized and suppressed values for Age, Gender, and ZIP Code. Therefore, PHI includes health records, health histories, lab test results, and medical bills. It notes that derivations of one of the 18 data elements, such as a patients initials or last four digits of a Social Security number, are considered PHI. In the previous example, the expert provided a solution (i.e., removing a record from a dataset) to achieve de-identification, but this is one of many possible solutions that an expert could offer. De-identified health information created following these methods is no longer protected by the Privacy Rule because it does not fall within the definition of PHI. Unprotected storage of private health information can be an issue. Covered entities can include limited patient details in a hospital directory and provide limited information to friends and family with the patients informal consent unless the patient is unable to give their consent, in which case professional judgement should be used to determine whether or not the disclosures are in the patients best interests. The following are examples of such features: Identifying Number The guidance explains and answers questions regarding the two methods that can be used to satisfy the Privacy Rules de-identification standard: Expert Determination and Safe Harbor1. This agreement may prohibit re-identification. (2)(i) The following identifiers of the individual or of relatives, employers, or household members of the individual, are removed: (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 the ZIP code if, according to the current publicly available data from the Bureau of the Census: HHS If a covered entity or business associate successfully undertook an effort to identify the subject of de-identified information it maintained, the health information now related to a specific individual would again be protected by the Privacy Rule, as it would meet the definition of PHI. Read the Full Guidance. Guidance on Satisfying the Safe Harbor Method. HIPAA Advice, Email Never Shared Figure 3. The answer is yes! Your Privacy Respected Please see HIPAA Journal privacy policy. In the following two sections, we address questions regarding the Expert Determination method (Section 2) and the Safe Harbor method (Section 3). Data managers and administrators working with an expert to consider the risk of identification of a particular set of health information can look to the principles summarized in Table 1 for assistance.6 These principles build on those defined by the Federal Committee on Statistical Methodology (which was referenced in the original publication of the Privacy Rule).7 The table describes principles for considering the identification risk of health information. Covered entities must implement safeguards to ensure the confidentiality, integrity, and availability of PHI, although HIPAA is not technology specific and the exact safeguards that should be implemented are left to the discretion of the covered entity. In truth, there are five 25 year old males in the geographic region in question (i.e., the population). The following information is meant to provide covered entities with a general understanding of the de-identification process applied by an expert. Gmail can be used as part of a HIPAA-compliant organization. Avail of a complimentary session with a HIPAA compliance risk assessment expert. This could occur, for instance, if the data set includes patients over one year-old but the population to which it is compared includes data on people over 18 years old (e.g., registered voters). Can an expert derive multiple solutions from the same data set for a recipient? Get our HIPAA Compliance Checklist to see everything you need to do to be fully compliant. Based on this observation, the expert recommends removing this record from the data set. This standard consists of 18 specific identifiers: The acronym PHI stands for Protected Health Information, while the acronym ePHI stands for electronic Protected Health Information a subset of PHI that is subject to the safeguards of the HIPAA Security Rule as well as the HIPAA Privacy Rule. Learn the rules and HIPAA exceptions now. is a subject to the HIPAA privacy rule. An overarching common goal of such approaches is to balance disclosure risk against data utility.17 If one approach results in very small identity disclosure risk but also a set of data with little utility, another approach can be considered. To clarify what must be removed under (R), the implementation specifications at 164.514(c) provide an exception with respect to re-identification by the covered entity. 3.10 Must a covered entity remove protected health information from free text fields to satisfy the Safe Harbor Method? For instance, the details of a complicated series of procedures, such as a primary surgery followed by a set of follow-up surgeries and examinations, for a person of a certain age and gender, might permit the recipient to comprehend that the data pertains to his or her relatives case. Steve has developed a deep understanding of regulatory issues surrounding the use of information technology in the healthcare industry and has written hundreds of articles on HIPAA-related topics. From an enforcement perspective, OCR would review the relevant professional experience and academic or other training of the expert used by the covered entity, as well as actual experience of the expert using health information de-identification methodologies. Glossary of terms used in Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. Protected health information is information, including demographic information, which relates to: For example, a medical record, laboratory report, or hospital bill would be PHI because each document would contain a patients name and/or other identifying information associated with the health data content. Is a patient name alone considered PHI? HIPAA regulations apply to healthcare facilities of all sizes and purposes. There has been confusion about what constitutes a code and how it relates to PHI. A clients initials are considered to be identifying for the purposes of determining if a given piece of information is PHI under HIPAA, because they are derived from names. . Steve is responsible for editorial policy regarding the topics covered on HIPAA Journal. There are even criminal penalties for HIPAA violations; and claiming ignorance of the Rules is not a valid defense if you are found to have failed to protect health information under HIPAA law. FACT: HIPAA applies to any and all healthcare providers who transmit, store or handle protected health information. Stakeholder input suggests that the determination of identification risk can be a process that consists of a series of steps. The short answer to this is no. The Department notes that these three-digit ZIP codes are based on the five-digit ZIP Code Tabulation Areas created by the Census Bureau for the 2000 Census. For example, if the patients year of birth is 1910 and the year of healthcare service is reported as 2010, then in the de-identified data set the year of birth should be reported as on or before 1920. Otherwise, a recipient of the data set would learn that the age of the patient is approximately 100. For example, when ESPN reported on a football player losing fingers in a fireworks incident people thought they violated HIPAA. Though G Suite, email can be made HIPAA compliant provided the service is used alongside a business domain. 2.4 How long is an expert determination valid for a given data set? Troubleshooting a software problem is a part of patient care, even if the patent isn't directly involved with it. Example Scenario 2 The identifiers that make health information PHI are: Patient Name (full or last name and initial) Date of birth To safeguard against this, any device containing PHI should be password protected. Even if social media or a reverse lookup tool does not give you the individuals name, you will still be able to find enough information about the individual for that information with the email address to be considered PHI. The information in this table is distinguishing, such that each row is unique on the combination of demographics (i.e., Age, ZIP Code, and Gender). For instance, the date January 1, 2009 could not be reported at this level of detail. The following provides a survey of potential approaches. 3. The key word here is "identify": If a snippet of data or a data set . The expert may certify a covered entity to share both data sets after determining that the two data sets could not be merged to individually identify a patient. For instance, imagine the information in a patient record revealed that a patient gave birth to an unusually large number of children at the same time. However, while not PHI, the employer may be required to keep the nature of the discussion confidential under other federal or state laws (i.e. Is using initials A Hipaa violation? The HIPAA Privacy Rule provides federal protections for personal health information held by covered entities and gives patients an array of rights with respect to that information. A third class of methods that can be applied for risk mitigation corresponds to perturbation. . Similarly, the final digit in each ZIP Code is within +/- 3 of the original ZIP Code. This certification may be based on a technical proof regarding the inability to merge such data sets. Covered entities will need to have an expert examine whether future releases of the data to the same recipient (e.g., monthly reporting) should be subject to additional or different de-identification processes consistent with current conditions to reach the very low risk requirement. However, entities related to personal health devices are required to comply with the Breach Notification Rule under Section 5 of the Federal Trade Commission Act if a breach of unsecured PHI occurs. 1.2 Covered Entities, Business Associates, and PHI Omit These 18 Identifiers When Blogging About Patient Care 1. Alternatively, suppression of specific values within a record may be performed, such as when a particular value is deemed too risky (e.g., President of the local university, or ages or ZIP codes that may be unique). What are PHI Identifiers? A strict interpretation and an "on-the-face-of-it" reading would classify the patient name alone as PHI if it is in any way associated with the hospital. The principles should serve as a starting point for reasoning and are not meant to serve as a definitive list. This standard consists of 18 specific identifiers: Names All geographic subdivisions smaller than a State All elements of dates (except year) for dates directly related to an individual. What is mandatory and discretionary spending. Some of the methods described below have been reviewed by the Federal Committee on Statistical Methodology16, which was referenced in the original preamble guidance to the Privacy Rule de-identification standard and recently revised. The objective of the paragraph is to permit covered entities to assign certain types of codes or other record identification to the de-identified information so that it may be re-identified by the covered entity at some later date. Due to the language used in the original Health Insurance Portability and Accountability Act, there is a misconception that HIPAA only applies to electronic health records.
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