Second, the expert will determine which data sources that contain the individual’s identification also contain the demographics in question. In this example, we refer to columns as “features” about patients (e.g., Age and Gender) and rows as “records” of patients (e.g., the first and second rows correspond to records on two different patients). This ban has been in … However, experts have recognized that technology, social conditions, and the availability of information changes over time. Can an Expert determine a code derived from PHI is de-identified? Determine which external data sources contain the patients’ identifiers and the replicable features in the health information, as well as who is permitted access to the data source. Suppression may also be performed on individual records, deleting records entirely if they are deemed too risky to share. When can ZIP codes be included in de-identified information? When sufficient documentation is provided, it is straightforward to redact the appropriate fields. What constitutes “any other unique identifying number, characteristic, or code” with respect to the Safe Harbor method of the Privacy Rule? Beyond the removal of names related to the patient, the covered entity would need to consider whether additional personal names contained in the data should be suppressed to meet the actual knowledge specification. The expert will then execute such methods as deemed acceptable by the covered entity or business associate data managers, i.e., the officials responsible for the design and operations of the covered entity’s information systems. The following quiz is based on the HIPAA information you just reviewed. Much has been written about the capabilities of researchers with certain analytic and quantitative capacities to combine information in particular ways to identify health information.32,33,34,35  A covered entity may be aware of studies about methods to identify remaining information or using de-identified information alone or in combination with other information to identify an individual. For all HIPAA administrative and financial transactions, covered health care providers and all health plans and health care clearinghouses should use NPIs. If they are considered a covered entity under HIPAA; Question 9 - Which of the following is NOT true regarding a Business Associate contract: Is required between a Covered Entity and Business Associate if PHI will be shared between the two No single universal solution addresses all privacy and identifiability issues. The workshop was open to the public and each panel was followed by a question and answer period. Identifier Standards for Employers and Providers. (ii) The covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information. Several broad classes of methods can be applied to protect data. (Of course, the expert must also reduce the risk that the data sets could be combined with prior versions of the de-identified dataset or with other publically available datasets to identify an individual.) PHI may exist in different types of data in a multitude of forms and formats in a covered entity. This ban has been in place since then. 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. The 18 HIPAA Identifiers. Medical records are comprised of a wide range of structured and unstructured (also known as “free text”) documents. 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. Therefore, the data would not have satisfied the de-identification standard’s Safe Harbor method. OA. The following are examples of such features: Identifying Number a. Verify the patient’s identity confirming two identifiers b. The Census Bureau will not be producing data files containing U.S. Thus, data shared in the former state may be deemed more risky than data shared in the latter.12. Figure 3. A mathematical function which takes binary data, called the message, and produces a condensed representation, called the message digest. Can an expert derive multiple solutions from the same data set for a recipient? When the certification timeframe reaches its conclusion, it does not imply that the data which has already been disseminated is no longer sufficiently protected in accordance with the de-identification standard. 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. As a result, the event was reported in the popular media, and the covered entity was aware of this media exposure. 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 patient’s name and/or other identifying information associated with the health data content. In practice, perturbation is performed to maintain statistical properties about the original data, such as mean or variance. Content last reviewed on November 6, 2015, U.S. Department of Health & Human Services, has sub items, Covered Entities & Business Associates, Other Administrative Simplification Rules, Covered Entities, Business Associates, and PHI. In §164.514(b), the Safe Harbor method for de-identification is defined as follows: (R) Any other unique identifying number, characteristic, or code, except as permitted by paragraph (c) of this section; and. The code, algorithm, or pseudonym should not be derived from other related information* about the individual, and the means of re-identification should only be known by authorized parties and not disclosed to anyone without the authority to re-identify records. To inspect and copy his or her health information b. If an organization does not meet this criteria, then they do not have to comply with HIPAA rules. Thus, an important aspect of identification risk assessment is the route by which health information can be linked to naming sources or sensitive knowledge can be inferred. HIPAA compliance revolves around keeping Protected Health Information (PHI) safe. The increasing adoption of health information technologies in the United States accelerates their potential to facilitate beneficial studies that combine large, complex data sets from multiple sources. TTD Number: 1-800-537-7697. U.S. Department of Health & Human Services The HIPAA privacy rule sets forth policies to protect all individually identifiable health information that is held or transmitted. Choose the best answer for each question. An adequate plan has been proposed to protect the identifiers from improper use and disclosure; ii. It does not provide sufficient detail in statistical or scientific methods to serve as a substitute for working with an expert in de-identification. This category corresponds to any unique features that are not explicitly enumerated in the Safe Harbor list (A-Q), but could be used to identify a particular individual. This new methodology also is briefly described below, as it will likely be of interest to all users of data tabulated by ZIP code. Common Breaches of HIPAA One of the most obvious and innocent reasons for a HIPAA violation simply comes down to a lack of awareness about what does or does not constitute a HIPAA violation. This can occur when a record is clearly very distinguishing (e.g., the only individual within a county that makes over $500,000 per year). Identifiers. PHI HIPAA is any individually identifying information that relates to past, present, or future health. 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. B. ID ANSI. Figure 2. 17 thoughts on “18 Patient Identifiers HIPAA Defines as Off Limits” Becky. Further information about data use agreements can be found on the OCR website.31  Covered entities may make their own assessments whether such additional oversight is appropriate. Protected health information includes many common identifiers (e.g., name, address, birth date, Social Security Number) when they can be associated with the health information listed above. The value for k should be set at a level that is appropriate to mitigate risk of identification by the anticipated recipient of the data set.28. 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. Any other characteristic that could uniquely identify the individual. A member of the covered entity’s workforce is not a business associate. Table 4 illustrates how generalization (i.e., gray shaded cells) might be applied to the information in Table 2. Two methods to achieve de-identification in accordance with the HIPAA Privacy Rule. The Employer Identification Number (EIN), issued by the Internal Revenue Service (IRS), was selected as the identifier for employers and was adopted effective July 30, 2002. Identifiers. Under HIPAA, a health plan, healthcare clearinghouse, or health care provider who transmits any heath information in electronic form in connection with a HIPAA transaction. Example Scenario 1 No. Identifying Characteristic Question 7: A patient who pays for 100% of treatment out of pocket can stop disclosure of this information to his/her insurer. Choose which is not a valid identifier in the following? Have expert determinations been applied outside of the health field? At this point, the expert may determine that certain combinations of values (e.g., Asian males born in January of 1915 and living in a particular 5-digit ZIP code) are unique, whereas others (e.g., white females born in March of 1972 and living in a different 5-digit ZIP code) are never unique. A characteristic may be anything that distinguishes an individual and allows for identification. To sign up for updates or to access your subscriber preferences, please enter your contact information below. There is no specific professional degree or certification program for designating who is an expert at rendering health information de-identified. (1) Is created or received by a health care provider, health plan, employer, or health care clearinghouse; and HIPAA PHI: List of 18 Identifiers and Definition of PHI List of 18 Identifiers 1. Select one: A. The application of a method from one class does not necessarily preclude the application of a method from another class. A second class of methods that can be applied for risk mitigation are based on generalization (sometimes referred to as abbreviation) of the information. False. Identifying Code Postal Service (USPS) ZIP code service areas. For instance, an expert may derive one data set that contains detailed geocodes and generalized aged values (e.g., 5-year age ranges) and another data set that contains generalized geocodes (e.g., only the first two digits) and fine-grained age (e.g., days from birth). These methods remove or eliminate certain features about the data prior to dissemination. § 164.514 Other requirements relating to uses and disclosures of protected health information. Table 6, as well as a value of k equal to 2, is meant to serve as a simple example for illustrative purposes only. If an organization does not meet this criteria, then they do not have to comply with HIPAA rules. Select one: A. ZCTAs are generalized area representations of U.S. However, it should be noted that there is no particular method that is universally the best option for every covered entity and health information set. In this case, specific values are replaced with equally specific, but different, values. A common de-identification technique for obscuring PII [Personally Identifiable Information] is to use a one-way cryptographic function, also known as a hash function, on the PII. In this situation, the covered entity has actual knowledge because it was informed outright that the recipient can identify a patient, unless it subsequently received information confirming that the recipient does not in fact have a means to identify a patient. A passing grade of 80% or higher is required for all contractors coming aboard for CHP and must be completed at least 48 hours before arriving at the client site. What is “actual knowledge” that the remaining information could be used either alone or in combination with other information to identify an individual who is a subject of the information? my.file – Periods are not allowed . Following the passing of the Affordable Care Act (ACA) in 2010, the HIPAA Administrative Simplification Regulations were updated to include new operating rules specifying the information that must be included for all HIPAA transactions. Of course, de-identification leads to information loss which may limit the usefulness of the resulting health information in certain circumstances. This is because of a second condition, which is the need for a naming data source, such as a publicly available voter registration database (see Section 2.6). Example Scenario (1) The geographic unit formed by combining all ZIP codes with the same three initial digits contains more than 20,000 people; and Rather, a combination of technical and policy procedures are often applied to the de-identification task. Whether additional information must be removed falls under the actual knowledge provision; the extent to which the covered entity has actual knowledge that residual information could be used to individually identify a patient. Imagine that a covered entity is considering sharing the information in the table to the left in Figure 3. When evaluating identification risk, an expert often considers the degree to which a data set can be “linked” to a data source that reveals the identity of the corresponding individuals. Satisfying either method would demonstrate that a covered entity has met the standard in §164.514(a) above. As the NPI is a 10-position, intelligence-free numeric identifier (10-digit number), it does not disclose other information about health care providers. In contrast, some research studies may use health-related information that is personally identifiable because it includes personal identifiers such as name or address, but it is not considered to be PHI because the data are not associated with or derived from a healthcare service event (treatment, payment, operations, medical records) and the data are not entered into the medical records. 18 HIPAA Identifiers and the HIPAA Security Rule. The de-identification standard does not mandate a particular method for assessing risk. Further details can be found at http://csrc.nist.gov/groups/ST/hash/. Toll Free Call Center: 1-800-368-1019 67 FR 53182, 53233-53234 (Aug. 14, 2002)). 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. The first condition is that the de-identified data are unique or “distinguishing.”  It should be recognized, however, that the ability to distinguish data is, by itself, insufficient to compromise the corresponding patient’s privacy. A “disclosure” of Protected Health Information (PHI) is the sharing of that PHI outside of a covered entity. Individually identifiable health information: Withholding information in selected records from release. (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 that are directly related to an individual, including birth date, admission date, discharge date, death date, 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, (L) Vehicle identifiers and serial numbers, including license plate numbers, (M) Device identifiers and serial numbers, (N) Web Universal Resource Locators (URLs), (P) Biometric identifiers, including finger and voice prints, (Q) Full-face photographs and any comparable images, (R) Any other unique identifying number, characteristic, or code, except as permitted by paragraph (c) of this section [Paragraph (c) is presented below in the section “Re-identification”]; and. The Privacy Rule does not require a particular approach to mitigate, or reduce to very small, identification risk. The Bureau of the Census provides information regarding population density in the United States. The Privacy Rule does not limit how a covered entity may disclose information that has been de-identified. Must a covered entity suppress all personal names, such as physician names, from health information for it to be designated as de-identified? The HIPAA privacy rule sets forth policies to protect all individually identifiable health information that is held or transmitted. HIPAA is an acronym that stands for the Health Insurance Portability and Accountability Act of 1996. As summarized in Figure 1, the Privacy Rule provides two methods by which health information can be designated as de-identified. There has been confusion about what constitutes a code and how it relates to PHI. A first class of identification risk mitigation methods corresponds to suppression techniques. Such dates are protected health information. (ii) Documents the methods and results of the analysis that justify such determination; or. Based on this observation, the expert recommends removing this record from the data set. Documentation The systematic, logical, and consistent recording of patient's health status history, examinations, tests, results of treatments, and observations in chronological order in a patient's medical record. Under this standard, health information is not individually identifiable if it does not identify an individual and if the covered entity has no reasonable basis to believe it can be used to identify an individual. It also is important to document when fields are derived from the Safe Harbor listed identifiers. http://www.ciesin.org/pdf/SEDAC_ConfidentialityReport.pdf, http://health.utah.gov/opha/IBIShelp/DataReleasePolicy.pdf, http://www.doh.wa.gov/Data/guidelines/SmallNumbers.htm, http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/research/index.html, Frequently Asked Questions for Professionals. An expert may find all or only one appropriate for a particular project, or may use another method entirely. By contrast, a health plan report that only noted the average age of health plan members was 45 years would not be PHI because that information, although developed by aggregating information from individual plan member records, does not identify any individual plan members and there is no reasonable basis to believe that it could be used to identify an individual. Thus, by relying on the statistics derived from the data set, the expert will make a conservative estimate regarding the uniqueness of records. 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. Claiming ignorance of HIPAA law is not a valid defense. Clinical narratives in which a physician documents the history and/or lifestyle of a patient are information rich and may provide context that readily allows for patient identification. Similarly, the age of a patient may be generalized from one- to five-year age groups. The following provides a survey of potential approaches. Names; 2. In such cases, the expert must take care to ensure that the data sets cannot be combined to compromise the protections set in place through the mitigation strategy. A third class of methods that can be applied for risk mitigation corresponds to perturbation. 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. Good Luck! Zip codes can cross State, place, county, census tract, block group, and census block boundaries. my.file – Periods are not allowed . Published On - May 16, 2019. Esoteric notation, such as acronyms whose meaning are known to only a select few employees of a covered entity, and incomplete description may lead those overseeing a de-identification procedure to unnecessarily redact information or to fail to redact when necessary. The Privacy Rule does not limit how a covered entity may disclose information that has been de-identified. Statement that the alteration/waiver satisfies the following 3 criteria: a. First, the expert will determine if the demographics are independently replicable. Common Breaches of HIPAA One of the most obvious and innocent reasons for a HIPAA violation simply comes down to a lack of awareness about what does or does not constitute a HIPAA violation. Note: some of these terms are paraphrased from the regulatory text; please see the HIPAA Rules for actual definitions. Identifiers are HIPAA standards that will create a uniform and centralized way to designate an employer, provider, health plan or patient in electronic transactions. Which of the following would be an example of a business associate, according to HIPAA laws? The first HIPAA compliant way to de-identify protected health information is to remove specific identifiers from the data set. These barcodes are often designed to be unique for each patient, or event in a patient’s record, and thus can be easily applied for tracking purposes. a. No. (1) A person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable: Figure 4. However, many researchers have observed that identifiers in medical information are not always clearly labeled.37.38 As such, in some electronic health record systems it may be difficult to discern what a particular term or phrase corresponds to (e.g., is 5/97 a date or a ratio?). For instance, a patient’s age may be reported as a random value within a 5-year window of the actual age. Photographic image - Photographic images are not limited to images of the face. Stakeholder input suggests that the determination of identification risk can be a process that consists of a series of steps. A covered entity may use a business associate to de-identify PHI on its behalf only to the extent such activity is authorized by their business associate agreement. Covered entities should not, however, rely upon this listing or the one found in the August 14, 2002 regulation if more current data has been published. However, the Rule does require that the methods and results of the analysis that justify the determination be documented and made available to OCR upon request. 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. It is expected that the Census Bureau will make data available from the 2010 Decennial Census in the near future. You may submit a comment by sending an e-mail to ocrprivacy@hhs.gov. HIPAA requires that employers have standard national numbers that identify them on standard transactions. Linkage is a process that requires the satisfaction of certain conditions. Example Scenario 2 In 1999, Congress passed legislation prohibiting the Department of Health and Human Services (HHS) from funding, implementing or developing a unique patient identifier system. This information can be used to identify, contact, or locate a single person or can be used with other sources to identify a single individual. The following are considered identifiers under the HIPAA safe harbor rule: (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 the Census: Relationship between uniques in the data set and the broader population, as well as the degree to which linkage can be achieved. Professional scientists and statisticians in various fields routinely determine and accordingly mitigate risk prior to sharing data. If an expert determines that the risk of identification is greater than very small, the expert may modify the information to mitigate the identification risk to that level, as required by the de-identification standard. Dates associated with test measures, such as those derived from a laboratory report, are directly related to a specific individual and relate to the provision of health care. If such information was listed with health condition, health care provision or payment data, such as an indication that the individual was treated at a certain clinic, then this information would be PHI. This page provides guidance about methods and approaches to achieve de-identification in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. This guidance is intended to assist covered entities to understand what is de-identification, the general process by which de-identified information is created, and the options available for performing de-identification. Second, the expert often will provide guidance to the covered entity or business associate on which statistical or scientific methods can be applied to the health information to mitigate the anticipated risk. What are the approaches by which an expert mitigates the risk of identification of an individual in health information? The lack of a readily available naming data source does not imply that data are sufficiently protected from future identification, but it does indicate that it is harder to re-identify an individual, or group of individuals, given the data sources at hand. These documents may vary with respect to the consistency and the format employed by the covered entity. However, it could be reported in a de-identified data set as “2009”. They represent the majority USPS five-digit ZIP code found in a given area. As of the publication of this guidance, the information can be extracted from the detailed tables of the “Census 2000 Summary File 1 (SF 1) 100-Percent Data” files under the “Decennial Census” section of the website. There are many potential identifying numbers. A higher risk “feature” is one that is found in many places and is publicly available. In those cases, the first three digits must be listed as 000. Names; 2. This is because the risk of identification that has been determined for one particular data set in the context of a specific environment may not be appropriate for the same data set in a different environment or a different data set in the same environment. Answer: 2 question Which of the following is not a purpose of HIPAA - the answers to estudyassistant.com As part of the HIPAA Security Rule, organizations must have standards for the confidentiality, integrity, and availability of PHI. This is because a record can only be linked between the data set and the population to which it is being compared if it is unique in both. Example 3: Publicized Clinical Event In contrast, ZIP codes can change more frequently. Table 3 illustrates this last type of suppression by showing how specific values of features in Table 2 might be suppressed (i.e., black shaded cells). Finally, the expert will determine if the data sources that could be used in the identification process are readily accessible, which may differ by region. For instance, it is common to apply generalization and suppression to the same data set. 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. Which of the following statements about the HIPAA Security Rule are true? For example, a unique identifying characteristic could be the occupation of a patient, if it was listed in a record as “current President of State University.”. HIPAA PHI: List of 18 Identifiers and Definition of PHI List of 18 Identifiers 1. Prioritize health information features into levels of risk according to the chance it will consistently occur in relation to the individual. First, the expert will evaluate the extent to which the health information can (or cannot) be identified by the anticipated recipients. HHS > HIPAA Home > For Professionals > Privacy > Special Topics > Methods for De-identification of PHI. See the discussion of re-identification. No. The expert will attempt to determine which record in the data set is the most vulnerable to identification. The first HIPAA compliant way to de-identify protected health information is to remove specific identifiers from the data set. Will not be reported in accordance with Safe Harbor listed identifiers be disclosed is distinguishable regarding ZIP.... Assessing risk these documents may vary with respect to the de-identification standard protects Privacy! Relating to uses and disclosures of protected health information is not a valid defense, would have... Of individuals practitioners use the approach of time-limited certifications Identifier in the near future it protects the Privacy sets... 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