Which of the following examples would Not be a HIPAA standards- covered transaction? Identifiers. For instance, one example of a data protection model that has been applied to health information is the k-anonymity principle.18,19  In this model, “k” refers to the number of people to which each disclosed record must correspond. No. The phrase may be retained in the data. Process for expert determination of de-Identification. Consequently, certain de-identification practitioners use the approach of time-limited certifications. 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. Example 2: Clear Familial Relation Alternatively, the expert also could require additional safeguards through a data use agreement. Identifying information alone, such as personal names, residential addresses, or phone numbers, would not necessarily be designated as PHI. Guidance on Satisfying the Expert Determination Method, Guidance on Satisfying the Safe Harbor Method. However, it could be reported in a de-identified data set as “2009”. Identifiers. HIPAA compliance revolves around keeping Protected Health Information (PHI) safe. This means that a covered entity has actual knowledge if it concludes that the remaining information could be used to identify the individual. Many records contain dates of service or other events that imply age. The following information is meant to provide covered entities with a general understanding of the de-identification process applied by an expert. 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. Invalid identifiers: 1 data – The first character shouldn’t be a number. Question 7: A patient who pays for 100% of treatment out of pocket can stop disclosure of this information to his/her insurer. This data may reside in highly structured database tables, such as billing records. 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. 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. In practice, perturbation is performed to maintain statistical properties about the original data, such as mean or variance. Health information that does not identify an individual and with respect to which there is no reasonable basis to believe that the information can be used to identify an individual is not individually identifiable health information. Second, the expert will determine which data sources that contain the individual’s identification also contain the demographics in question. See section 3.10 for a more complete discussion. The expert may consider different measures of “risk,” depending on the concern of the organization looking to disclose information. Satisfying either method would demonstrate that a covered entity has met the standard in §164.514(a) above. A hospital may hold data on its employees, which can … A second class of methods that can be applied for risk mitigation are based on generalization (sometimes referred to as abbreviation) of the information. They represent the majority USPS five-digit ZIP code found in a given area. Identifiers are HIPAA standards that will create a uniform and centralized way to designate an employer, provider, health plan or patient in electronic transactions. What is Considered a HIPAA Breach? HIPAA PHI: List of 18 Identifiers and Definition of PHI List of 18 Identifiers 1. 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. 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. However, a covered entity may require the recipient of de-identified information to enter into a data use agreement to access files with known disclosure risk, such as is required for release of a limited data set under the Privacy Rule. Therefore, the data would not have satisfied the de-identification standard’s Safe Harbor method unless the covered entity made a sufficient good faith effort to remove the ‘‘occupation’’ field from the patient record. PythonCSIP CS IP sa 11 cs chapter 6, sa 11 ip chapter 3. As part of the HIPAA Security Rule, organizations must have standards for the confidentiality, integrity, and availability of PHI. (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.) A member of the covered entity’s workforce is not a business associate. a. Read the Full Guidance. OCR does not expect a covered entity to presume such capacities of all potential recipients of de-identified data. What constitutes “any other unique identifying number, characteristic, or code” with respect to the Safe Harbor method of the Privacy Rule? 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. Stakeholder input suggests that the determination of identification risk can be a process that consists of a series of steps. At the same time, there is also no requirement to retain such information in a de-identified data set. To inspect and copy his or her health information b. What are examples of dates that are not permitted according to the Safe Harbor Method? However, due to the public’s interest in having statistics tabulated by ZIP code, the Census Bureau has created a new statistical area called the Zip Code Tabulation Area (ZCTA) for Census 2000. Figure 3. (c) Implementation specifications: re-identification. 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 The same applies to education or employment records. 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 If the research will include any identifiers linked to living persons or involves accessing death records maintained by the State Registrar, local registrars, or county recorders, the project must be approved in advance. Example 3: Publicized Clinical Event Covered entities may include the first three digits of the ZIP code if, according to the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combining all ZIP codes with the same three initial digits contains more than 20,000 people; or (2) the initial three digits of a ZIP code for all such geographic units containing 20,000 or fewer people is changed to 000. The process of de-identification, by which identifiers are removed from the health information, mitigates privacy risks to individuals and thereby supports the secondary use of data for comparative effectiveness studies, policy assessment, life sciences research, and other endeavors. OCR also thanks the 2010 workshop panelists for generously providing their expertise and recommendations to the Department. (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. If an organization does not meet this criteria, then they do not have to comply with HIPAA rules. 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. Any information, whether oral or recorded in any form or medium, that: Information that is a subset of health information, including demographic information collected from an individual, and: (1) A person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable: No. Choose which is not a valid identifier in the following? (i) That identifies the individual; or Names; 2. 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). Of course, the use of a data use agreement does not substitute for any of the specific requirements of the Safe Harbor method. Rather, a combination of technical and policy procedures are often applied to the de-identification task. The covered entity, in other words, is aware that the information is not actually de-identified information. The implementation specifications further provide direction with respect to re-identification, specifically the assignment of a unique code to the set of de-identified health information to permit re-identification by the covered entity. However, experts have recognized that technology, social conditions, and the availability of information changes over time. Question: QUESTION 3 Which Of The Following Is Not A Purpose Of HIPAA? This certification may be based on a technical proof regarding the inability to merge such data sets. The guidance explains and answers questions regarding the two methods that can be used to satisfy the Privacy Rule’s de-identification standard: Expert Determination and Safe Harbor1. 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. This agreement may prohibit re-identification. 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. Understanding how to secure protected health information (PHI) and what constitutes PHI is a large portion of what it means to be HIPAA compliant. When HIPAA was enacted in 1996, the law called for development of a unique patient identifier. (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 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. A general workflow for expert determination is depicted in Figure 2. True Covered entities who violate HIPAA law are only punished with civil, monetary penalties. It also is important to document when fields are derived from the Safe Harbor listed identifiers. For instance, clinical features, such as blood pressure, or temporal dependencies between events within a hospital (e.g., minutes between dispensation of pharmaceuticals) may uniquely characterize a patient in a hospital population, but the data sources to which such information could be linked to identify a patient are accessible to a much smaller set of people. Example Scenario 2 Sections 164.514(b) and(c) of the Privacy Rule contain the implementation specifications that a covered entity must follow to meet the de-identification standard. No single universal solution addresses all privacy and identifiability issues. Thus, by relying on the statistics derived from the data set, the expert will make a conservative estimate regarding the uniqueness of records. 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. 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. § 164.514 Other requirements relating to uses and disclosures of protected health information. In this situation, the risk of identification is of a nature and degree that the covered entity must have concluded that the recipient could clearly and directly identify the individual in the data. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) required the Secretary of Health and Human Services (HHS) to adopt standards for the following identifiers: Employer Identification Number (EIN) Health Plan Identifier (HPID) National Provider Identifier (NPI) Unique Patient Identifier … 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. Washington, D.C. 20201 When HIPAA was enacted in 1996, the law called for development of a unique patient identifier. The importance of documentation for which values in health data correspond to PHI, as well as the systems that manage PHI, for the de-identification process cannot be overstated. These are features that could be exploited by anyone who receives the information. HIPAA requires that employers have standard national numbers that identify them on standard transactions. Expert Answer … The first HIPAA compliant way to de-identify protected health information is to remove specific identifiers from the data set. As can be seen, there are many different disclosure risk reduction techniques that can be applied to health information. 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. 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. (2) 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 the individual; and Must a covered entity use a data use agreement when sharing de-identified data to satisfy the Expert Determination Method? The use/disclosure of PHI involves no more than minimal risk to the privacy of individuals, based on at least the following elements: i. The first HIPAA compliant way to de-identify protected health information is to remove specific identifiers from the data set. Can an expert derive multiple solutions from the same data set for a recipient? Which of the following is not a patient right under HIPAA rules? However, a covered entity’s mere knowledge of these studies and methods, by itself, does not mean it has “actual knowledge” that these methods would be used with the data it is disclosing. A covered entity may assign a code or other means of record identification to allow information de-identified under this section to be re-identified by the covered entity, provided that: For instance, a code derived from a secure hash function without a secret key (e.g., “salt”) would be considered an identifying element. The Privacy Rule does not limit how a covered entity may disclose information that has been de-identified. 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. In general, the protections of the Privacy Rule apply to information held by covered entities and their business associates. 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. The HIPAA privacy rule sets forth policies to protect all individually identifiable health information that is held or transmitted. Determine the extent to which the subject’s data can be distinguished in the health information. 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. 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. After you complete the quiz, you MUST email your results page or certificate to pack_mam@dell.com. Imagine that a covered entity is considering sharing the information in the table to the left in Figure 3. These methods remove or eliminate certain features about the data prior to dissemination. 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. 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. Experts may be found in the statistical, mathematical, or other scientific domains. 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. Imagine a covered entity was told that the anticipated recipient of the data has a table or algorithm that can be used to identify the information, or a readily available mechanism to determine a patient’s identity. the individual’s past, present, or future physical or mental health or condition, the provision of health care to the individual, or. Identifier Standards for Employers and Providers. 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. The notion of expert certification is not unique to the health care field. Finally, the expert will evaluate the identifiability of the resulting health information to confirm that the risk is no more than very small when disclosed to the anticipated recipients. I posted in a forum about a case I had recently saying “45 year old male with history of substance abuse” being treated with dialysis. Although the risk is very small, it is not zero, and there is a possibility that de-identified data could be linked back to the identity of the patient to which it corresponds. 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). Identifying Code The relationship with health information is fundamental. 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.’. 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. As a result, an expert will define an acceptable “very small” risk based on the ability of an anticipated recipient to identify an individual. No. To be considered “de-identified”, ALL of the 18 HIPAA Identifiers must be removed from the data set. False. In contrast, ZIP codes can change more frequently. Imagine a covered entity was aware that the anticipated recipient, a researcher who is an employee of the covered entity, had a family member in the data (e.g., spouse, parent, child, or sibling). The following examples illustrate when a covered entity would fail to meet the “actual knowledge” provision. 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. Good Luck! Identifying Characteristic What are the approaches by which an expert mitigates the risk of identification of an individual in health information? There is no specific professional degree or certification program for designating who is an expert at rendering health information de-identified. The ZCTAs were designed to overcome the operational difficulties of creating a well-defined ZIP code area by using Census blocks (and the addresses found in them) as the basis for the ZCTAs. If a covered entity knows of specific studies about methods to re-identify health information or use de-identified health information alone or in combination with other information to identify an individual, does this necessarily mean a covered entity has actual knowledge under the Safe Harbor method? 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. 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. Identifiers. No. In 1999, Congress passed legislation prohibiting the Department of Health and Human Services (HHS) from funding, implementing or developing a unique patient identifier system. 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. These documents may vary with respect to the consistency and the format employed by the covered entity. 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. 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). In practice, an expert may provide the covered entity with multiple alternative strategies, based on scientific or statistical principles, to mitigate risk. How do experts assess the risk of identification of information? November 27, 2018. 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