A Business Associate is a person or entity that performs certain functions or activities regulated by the HIPAA Administrative Simplification Rules that involve the use or disclosure of protected health information for a Covered Entity. Therefore, the data would not have satisfied the de-identification standard’s Safe Harbor method. 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. Therefore, it’s essential that you require regular compliance training so that employees know what they can or … As part of the HIPAA Security Rule, organizations must have standards for the confidentiality, integrity, and availability of PHI. As can be seen, there are many different disclosure risk reduction techniques that can be applied to health information. (i) Applying such principles and methods, determines that the risk is very small that the information could be used, alone or in combination with other reasonably available information, by an anticipated recipient to identify an individual who is a subject of the information; and 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. Example Scenario 1 Identifiers are HIPAA standards that will create a uniform and centralized way to designate an employer, provider, health plan or patient in electronic transactions. Figure 4. Because of the ill-defined nature of ZIP code boundaries, the Census Bureau has no file (crosswalk) showing the relationship between US Census Bureau geography and U.S. § 164.514 Other requirements relating to uses and disclosures of protected health information. Identifying information alone, such as personal names, residential addresses, or phone numbers, would not necessarily be designated as PHI. To sign up for updates or to access your subscriber preferences, please enter your contact information below. For instance, a five-digit ZIP Code may be generalized to a four-digit ZIP Code, which in turn may be generalized to a three-digit ZIP Code, and onward so as to disclose data with lesser degrees of granularity. 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). De-identifying health information requires the following 18 identifiers to be removed from the data set prior to sharing: Full name or last name and initial(s) Geographical identifiers smaller than a state, except the initial three digits of a zip code, provided the combination of … Ages that are explicitly stated, or implied, as over 89 years old must be recoded as 90 or above. Stakeholder input suggests that the determination of identification risk can be a process that consists of a series of steps. The first HIPAA compliant way to de-identify protected health information is to remove specific identifiers from the data set. Identifier Standards for Employers and Providers. Rare clinical events may facilitate identification in a clear and direct manner. HIPAA-define concept that serve as a standards for all electronic data interchange include all but which of the following: A. ICDM-10 B. ID ANSI C. CPT D. ANSI X12N . In instances when population statistics are unavailable or unknown, the expert may calculate and rely on the statistics derived from the data set. 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. The principles should serve as a starting point for reasoning and are not meant to serve as a definitive list. This approach supports common scientific procedures such as statistical analysis based on study identifier while protecting the confidentiality of individuals. 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. company hired by medical office to perform their billing. Thus, by relying on the statistics derived from the data set, the expert will make a conservative estimate regarding the uniqueness of records. If an organization does not meet this criteria, then they do not have to comply with HIPAA rules. When must the patient authorize the use or disclosure of health information? Select one: A. 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). No. After you complete the quiz, you MUST email your results page or certificate to pack_mam@dell.com. In practice, an expert may provide the covered entity with multiple alternative strategies, based on scientific or statistical principles, to mitigate risk. Each method has benefits and drawbacks with respect to expected applications of the health information, which will be distinct for each covered entity and each intended recipient. ZCTAs are generalized area representations of U.S. 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. Photographic image - Photographic images are not limited to images of the face. In this case, the risk of identification is of a nature and degree that the covered entity must have concluded that the individual subject of the information could be identified by a recipient of the data. 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. In contrast, lower risk features are those that do not appear in public records or are less readily available. In truth, there are five 25 year old males in the geographic region in question (i.e., the population). Frequently Asked Questions for Professionals - Please see the HIPAA FAQs for additional guidance on health information privacy topics. 200 Independence Avenue, S.W. 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. (1) 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. 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. 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. March 2003. The following quiz is based on the HIPAA information you just reviewed. 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. Invalid identifiers: 1 data – The first character shouldn’t be a number. Which of the following is not a patient right under HIPAA rules? This guidance will be updated when the Census makes new information available. Several broad classes of methods can be applied to protect data. National Provider Identifier (NPI) is the number used in healthcare to uniquely identify Providers. A general workflow for expert determination is depicted in Figure 2. 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. The intake notes for a new patient include the stand-alone notation, “Newark, NJ.”  It is not clear whether this relates to the patient’s address, the location of the patient’s previous health care provider, the location of the patient’s recent auto collision, or some other point. HIPAA required the Secretary to issue privacy regulations governing individually identifiable health information, if Congress did not enact privacy legislation within three years of the passage of HIPAA. In general, the expert will adjust certain features or values in the data to ensure that unique, identifiable elements no longer, or are not expected to, exist. 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. 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. There are many potential identifying numbers. (1) The geographic unit formed by combining all ZIP codes with the same three initial digits contains more than 20,000 people; and Which of the following examples would Not be a HIPAA standards- covered transaction? 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. For instance, if such information was reported as part of a publicly accessible data source, such as a phone book, then this information would not be PHI because it is not related to heath data (see above). a. When can ZIP codes be included in de-identified information? OCR does not require a particular process for an expert to use to reach a determination that the risk of identification is very small. The Census Bureau will not be producing data files containing U.S. For instance, it is simple to discern when a feature is a name or a Social Security Number, provided that the fields are appropriately labeled. 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. A covered entity may determine that health information is not individually identifiable health information only if: As another example, an increasing quantity of electronic medical record and electronic prescribing systems assign and embed barcodes into patient records and their medications. What are examples of dates that are not permitted according to the Safe Harbor Method? That leads to the question, which of the following would be considered PHI HIPAA? This means that the initial three digits of ZIP codes may be included in de-identified information except when the ZIP codes contain the initial three digits listed in the Table below. Demographic data is likewise regarded as PHI under HIPAA Rules, just like common identifiers including patient names, Driver’s license numbers, Social Security numbers, insurance information, and dates of birth, when they are used in combination with health information. Therefore, the data would not have satisfied the de-identification standard’s Safe Harbor method. 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. 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. For those areas where it is difficult to determine the prevailing five-digit ZIP code, the higher-level three-digit ZIP code is used for the ZCTA code. The phrase may be retained in the data. Which of the following is an example of when PHI would be sent with all personal identifiers are removed from the data set? In doing so, the expert has made a conservative decision with respect to the uniqueness of the record. In the context of the Safe Harbor method, actual knowledge means clear and direct 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. What is a Business Associate? May parts or derivatives of any of the listed identifiers be disclosed consistent with the Safe Harbor Method? These documents may vary with respect to the consistency and the format employed by the covered entity. 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. Stakeholder input suggests that a process may require several iterations until the expert and data managers agree upon an acceptable solution. No. 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. In practice, perturbation is performed to maintain statistical properties about the original data, such as mean or variance. on the HIPAA Privacy Rule's De-Identification Standard. When HIPAA was enacted in 1996, the law called for development of a unique patient identifier. 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. Linking two data sources to identity diagnoses. Notice that Gender has been suppressed completely (i.e., black shaded cell). 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. 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. The following are examples of such features: Identifying Number 17 thoughts on “18 Patient Identifiers HIPAA Defines as Off Limits” Becky. The de-identification standard makes no distinction between data entered into standardized fields and information entered as free text (i.e., structured and unstructured text) -- an identifier listed in the Safe Harbor standard must be removed regardless of its location in a record if it is recognizable as an identifier. However, data utility does not determine when the de-identification standard of the Privacy Rule has been met. Be aware that the HIPAA Privacy rule protects individually identifiable health information of deceased individuals for 50 years following the date of death. Of course, the use of a data use agreement does not substitute for any of the specific requirements of the Safe Harbor method. Experts may design multiple solutions, each of which is tailored to the covered entity’s expectations regarding information reasonably available to the anticipated recipient of the data set. The Privacy Rule does not limit how a covered entity may disclose information that has been de-identified. Figure 4 provides a visualization of this concept.13 This figure illustrates a situation in which the records in a data set are not a proper subset of the population for whom identified information is known. Additionally, other laws or confidentiality concerns may support the suppression of this information. The Department of Health and Human Services (HHS) classifies PHI into 18 identifiers as follows: Patient names U.S. Department of Health & Human Services 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 relative’s case. As a result, an expert will define an acceptable “very small” risk based on the ability of an anticipated recipient to identify an individual. Claiming ignorance of HIPAA law is not a valid defense. 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. 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. Published On - May 16, 2019. 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. Safe Harbor – The Removal of Specific Identifiers. a. Prioritize health information features into levels of risk according to the chance it will consistently occur in relation to the individual. In an effort to make this guidance a useful tool for HIPAA covered entities and business associates, we welcome and appreciate your sending us any feedback or suggestions to improve this guidance. Both methods, even when properly applied, yield de-identified data that retains some risk of identification. For clarification, our guidance is similar to that provided by the National Institutes of Standards and Technology (NIST)29, which states: “De-identified information can be re-identified (rendered distinguishable) by using a code, algorithm, or pseudonym that is assigned to individual records. Such codes or other means of record identification assigned by the covered entity are not considered direct identifiers that must be removed under (R) if the covered entity follows the directions provided in §164.514(c). One good rule to prevent unauthorized access to computer data is to _____. National Provider Identifier (NPI) is the number used in healthcare to uniquely identify Providers. Read the Full Guidance. A hospital may hold data on its employees, which can … Guidance on Satisfying the Expert Determination Method, Guidance on Satisfying the Safe Harbor Method. (i) Applying such principles and methods, determines that the risk is very small that the information could be used, alone or in combination with other reasonably available information, by an anticipated recipient to identify an individual who is a subject of the information; and 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. The HIPAA Breach Notification Rule requires HIPAA-covered entities and their business associates to notify patients and other parties following a breach of unsecured protected health information (PHI). Information that had previously been de-identified may still be adequately de-identified when the certification limit has been reached. OCR does not expect a covered entity to presume such capacities of all potential recipients of de-identified data. These are the 18 HIPAA Identifiers that are considered personally identifiable information. Divisions of HHS commonly use websites, blog entries, and social media posts to issue communications with regulated parties. Notice of privacy practices. 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. The field of statistical disclosure limitation, for instance, has been developed within government statistical agencies, such as the Bureau of the Census, and applied to protect numerous types of data.5. HIPAA requires that employers have standard national numbers that identify them on standard transactions. Notice, however, that the first record in the covered entity’s table is not linked because the patient is not yet old enough to vote. Process for expert determination of de-Identification. Second, the expert will determine which data sources that contain the individual’s identification also contain the demographics in question. Home > Office of Human Subjects Research - Institutional Review Board > HIPAA and Research Definition of De-Identified Data. 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. To request changes to his or her records c. To obtain an accounting of disclosures of his or her information d. To inspect the protected health information of his or her spouse 9. This number comes as a replacement to Unique Physician Identification Number (UPIN), which is not going to be supported by CMS after complete NPI implementation.NPI was inforced in May 23rd 2007 and is mandatory for all Providers while filing HIPAA claim. The following examples illustrate when a covered entity would fail to meet the “actual knowledge” provision. For instance, census tracts are only defined every ten years. Without such a data source, there is no way to definitively link the de-identified health information to the corresponding patient. Treatment is the provision, coordination, or management of health care and related services for an individual by one or more health care providers, including consultation between providers regarding a patient and referral of a patient by one provider to another.20 There is no explicit requirement to remove the names of providers or workforce members of the covered entity or business associate. Similarly, the age of a patient may be generalized from one- to five-year age groups. The sharing of PHI outside of the health care component of a covered entity is a disclosure. 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 How long is an expert determination valid for a given data set? In those cases, the first three digits must be listed as 000. 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. Read more on the Workshop on the HIPAA Privacy Rule's De-Identification Standard. In 1999, Congress passed legislation prohibiting the Department of Health and Human Services (HHS) from funding, implementing or developing a unique patient identifier system. https://www.census.gov/geo/reference/zctas.html, http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/index.html, http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/businessassociates.html, http://www.healthy.arkansas.gov/programsServices/healthStatistics/Documents/STDSurveillance/Datadeissemination.pdf, http://www.cdphe.state.co.us/cohid/smnumguidelines.html. HIPAA defines a covered entity as 1) a health care provider that conducts certain standard administrative and financial transactions in electronic form; 2) a health care clearinghouse; or 3) a health plan.3  A business associate is a person or entity (other than a member of the 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 protected health information. The first is the “Expert Determination” method: (b) Implementation specifications: requirements for de-identification of protected health information. For instance, a patient’s age may be reported as a random value within a 5-year window of the actual age. Question 7: A patient who pays for 100% of treatment out of pocket can stop disclosure of this information to his/her insurer. If a communication contains any of these identifiers, or parts of the identifier, such as initials, the data is to be considered “identified”. The geographic designations the Census Bureau uses to tabulate data are relatively stable over time. Can dates associated with test measures for a patient be reported in accordance with Safe Harbor? Based on this observation, the expert recommends removing this record from the data set. Protected health information (PHI) under the US law is any information about health status, provision of health care, or payment for health care that is created or collected by a Covered Entity (or a Business Associate of a Covered Entity), and can be linked to a specific individual.This is interpreted rather broadly and includes any part of a patient's medical record or payment history. Safe Harbor – The Removal of Specific Identifiers. However, it could be reported in a de-identified data set as “2009”. TTD Number: 1-800-537-7697. The Privacy Rule calls this information protected health information (PHI)2. 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. 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. When sufficient documentation is provided, it is straightforward to redact the appropriate fields. Disclosure of a code or other means of record identification designed to enable coded or otherwise de-identified information to be re-identified is also considered a disclosure of PHI. The same applies to education or employment records. To request changes to his or her records c. To obtain an accounting of disclosures of his or her information d. To inspect the protected health information of his or her spouse 9. As a result, the event was reported in the popular media, and the covered entity was aware of this media exposure. Read more on the Workshop on the HIPAA Privacy Rule's De-Identification Standard. The following provides a survey of potential approaches. 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. By inspecting the data set, it is clear to the expert that there is at least one 25 year old male in the population, but the expert does not know if there are more. Invalid identifiers: 1 data – The first character shouldn’t be a number. Of course, de-identification leads to information loss which may limit the usefulness of the resulting health information in certain circumstances. PHI HIPAA is any individually identifying information that relates to past, present, or future health. Example 4: Knowledge of a Recipient’s Ability The covered entity does not use or disclose the code or other means of record identification for any other purpose, and does not disclose the mechanism for re-identification. Experts may be found in the statistical, mathematical, or other scientific domains. However, HIPAA only applies to HIPAA-covered entities and their business associates, so if the device manufacturer or app developer has not been contracted by a HIPAA -covered entity or a business associate, the information recorded would not be considered PHI under HIPAA. This includes all dates, such as surgery dates, all voice recordings, and all photographic images. Table 2 illustrates the application of such methods. Identifiers. Many records contain dates of service or other events that imply age. 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). Postal Service (USPS) ZIP code service areas. 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. Names; 2. In the process, experts are advised to consider how data sources that are available to a recipient of health information (e.g., computer systems that contain information about patients) could be utilized for identification of an individual.8. A third class of methods that can be applied for risk mitigation corresponds to perturbation. For example, the preamble to the Privacy Rule at 65 FR 82462, 82712 (Dec. 28, 2000) noted that “Clinical trial record numbers are included in the general category of ‘any other unique identifying number, characteristic, or code.’. 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