3.9 Must a covered entity use a data use agreement when sharing de-identified data to satisfy the Safe Harbor Method? The list is based on 5-digit zip codes from the 2000 census. Although the privacy Rule does not specify an expiration date for de-identified data, the Department for Health & Human Services recognizes that technology, social conditions, and the availability of information changes over time and has suggested that covered entities periodically review the chosen de-identification method to ensure it maintains the very low risk requirement. Figure 3. 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. Medical records are comprised of a wide range of structured and unstructured (also known as free text) documents. Ages that are explicitly stated, or implied, as over 89 years old must be recoded as 90 or above. A third class of methods that can be applied for risk mitigation corresponds to perturbation. When personally identifiable information is used in conjunction with one's physical or mental health or . Example Scenario 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. Safe Harbor requires 18 data types that must to be removed or modified. Imagine a covered entity has a data set in which there is one 25 year old male from a certain geographic region in the United States. (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. HIPAA-compliant de-identification of protected health information is possible using two methods: Safe Harbor and Expert Determination. (i) That identifies the individual; or However, it could be reported in a de-identified data set as 2009. The Office of Civil Rights gives this clarification: There are no restrictions on the use or disclosure of de-identified health information. Read more on the Workshop on the HIPAA Privacy Rule's De-Identification Standard. -kOe\7XIumBvpH/"(x0t(';17CcU\O)7,,'Pj[sB/203 According to the Bureau of the Census, that means 17 zip codes must have the first three digits changed to zero: 036, 692, 878, 059, 790, 879, 063, 821, 884, 102, 823, 890, 203, 830, 893, 556, 831. 2.7 What are the approaches by which an expert assesses the risk that health information can be identified? The first is Safe Harbor whereby all 18 identifiers are explicitly and implicitly removed. Study: HIPAA Data De-identification Improvements Are Needed. The expert determination method carries a small risk that an individual could be identified, although the risk is so low that it meets HIPAA Privacy Rule requirements. For example, a data set that contained patient initials, or the last four digits of a Social Security number, would not meet the requirement of the Safe Harbor method for de-identification. A code corresponds to a value that is derived from a non-secure encoding mechanism. 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 Professionals Finally, for the third condition, we need a mechanism to relate the de-identified and identified data sources. 1.3 De-identification and its Rationale HIPAA Journal provides the most comprehensive coverage of HIPAA news anywhere online, in addition to independent advice about HIPAA compliance and the best practices to adopt to avoid data breaches, HIPAA violations and regulatory fines. It also is important to document when fields are derived from the Safe Harbor listed identifiers. The De-identified Patient Health information (PHI) is used for various research, census and other activities. The geographic designations the Census Bureau uses to tabulate data are relatively stable over time. >EN$s A+y6'~P+_@V,w7h)f2,1/14| Iod}lwKp{?cz,`OKLxF"U8648:Tv t[%Ve* R)[sY+9jH}~]yosg JArl[Yh8rMd! The HIPAA Privacy Rule uses the term "de-identified" to refer to data that is not protected health information (PHI) for purposes of HIPAA. 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. He works as a driver, and long hours of work reported. In practice, perturbation is performed to maintain statistical properties about the original data, such as mean or variance. This is because the Privacy Rule defines Protected Health Information as individually identifiable health information, with the only further guidance about what individually identifiable health information consists of being a subset of health information, including demographic information collected from an individual when it is created or received by a Covered Entity and when it relates a past, present, or future condition, treatment, or payment for treatment. Experts may come from a number of different fields and do not require any specific qualifications. Of course, the use of a data use agreement does not substitute for any of the specific requirements of the Safe Harbor method. 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. The workshop was open to the public and each panel was followed by a question-answer period. 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. As the Safe Harbor method of de-identification lists what identifiers need to be removed from a designated data set before the data set is no longer subject to Privacy Rule protections, many compliance experts use this list as an example to answer the question what is PHI? The final item on the list (unique identifying numbers, characteristics, and codes) is open to interpretation, but generally includes (for example) occupations, familial relationships, and social media usernames. An expert may find all or only one appropriate for a particular project, or may use another method entirely. De-identification The removal of any individually identifiable data that may allow someone to connect the data in question with a specific person. The code or other means of record identification is not derived from or related to information about the individual and is not otherwise capable of being translated so as to identify the individual; and This guidance will be updated when the Census makes new information available. He reports dizziness, drowsiness, head ache in the frontotemporal region with skin lacerations on his right occipital . 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. Finally, as noted in the preamble to the Privacy Rule, the expert may also consider the technique of limiting distribution of records through a data use agreement or restricted access agreement in which the recipient agrees to limits on who can use or receive the data, or agrees not to attempt identification of the subjects. Issued by: Office for Civil Rights (OCR). Standard: de-identification of protected health information. There is no explicit numerical level of identification risk that is deemed to universally meet the very small level indicated by the method. Get our HIPAA Compliance Checklist to see everything you need to be compliant. Health Level 7 (HL7) and the International Standards Organization (ISO) publish best practices in documentation and standards that covered entities may consult in this process. The Safe Harbor technique involves the removal of 18 personal identifiers, including the name, zip code, dates, telephone, email, URL, IP address, health plan id, bank . 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. 2.10 Must a covered entity use a data use agreement when sharing de-identified data to satisfy the Expert Determination Method? 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). (1) The geographic unit formed by combining all ZIP codes with the same three initial digits contains more than 20,000 people; and If there is very little chance of a patient being identified by a doctors name, then the name can remain in the de-identified data set subject to any state laws or confidentiality concerns. 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. There is no specific professional degree or certification program for designating who is an expert at rendering health information de-identified. endstream endobj 1378 0 obj <>/Metadata 101 0 R/Pages 1375 0 R/StructTreeRoot 212 0 R/Type/Catalog>> endobj 1379 0 obj <>/MediaBox[0 0 612 792]/Parent 1375 0 R/Resources<>/ProcSet[/PDF/Text]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 1380 0 obj <>stream 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. 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. If this were patient data being used for analytics, it would need to be de-identified per the section on uses and disclosures of PHI, 45 CFR 164.514 (a)- (b) such as names, geographic subdivisions smaller than a state, dates that are directly related to an individual, phone numbers, and email. In this case, specific values are replaced with equally specific, but different, values. Experts may be found in the statistical, mathematical, or other scientific domains. 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.. Postal Service ZIP codes either as part of the Census 2000 product series or as a post Census 2000 product. https://www.census.gov/programs-surveys/geography/guidance/geo-areas/zctas.html, https://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/index.html, https://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/businessassociates.html. 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. HIPAA Journal is the leading provider of news, updates, and independent advice for HIPAA compliance. (1) Is created or received by a health care provider, health plan, employer, or health care clearinghouse; and De-identification is also a blanket term referring to the anonymization or masking of PII in many other industries. HIPAA TRAINING DE-IDENTIFICATION Our short HIPAA training course, De-Identification (5.5 minutes), explains the two methods under HIPAA for de-identifying data - the statistician method and the safe harbor method. You may submit a comment by sending an e-mail to ocrprivacy@hhs.gov. 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. So, without any additional knowledge, the expert assumes there are no more, such that the record in the data set is unique. (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. 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. 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. Safe Harbor The Safe Harbor method of de-identification requires removing 18 types of identifiers, like those listed below, so that residual information cannot be used for identification: Names Dates, except the year Telephone numbers Geographic data To sign up for updates or to access your subscriber preferences, please enter your contact information below. 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. Areas Covered in the Session. This depends on the relationship between the doctor and the patient. 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. De-identification of PHI. The first is the Expert Determination method: (b) Implementation specifications: requirements for de-identification of protected health information. Breach News Copyright 2014-2022 HIPAA Journal. To produce a de-identified data set utilizing the safe harbor method, all records with three-digit ZIP codes corresponding to these three-digit ZCTAs must have the ZIP code changed to 000. Complete P.T. For further information on de-identification of protected health information using the safe harbor method see 45 CFR 164.514(b)(2). Such dates are protected health information. Accordingly, the context in which such vendors provide data analytics services must satisfy the HIPAA rules governing business associates. 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). 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. However, covered entities can, if they wish, enter into a Data Use Agreement with the recipient of the data to specify how the recipient can use the data and prohibit its re-identification. Key points for de-identification include: 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.. 200 Independence Avenue, S.W. 3.6 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? De-identification of PHI to HIPAA standards can be achieved in one of two ways: Expert Determination and Safe Harbor. 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. In this case, the expert may attempt to compute risk from several different perspectives. 3.5 What constitutes any other unique identifying number, characteristic, or code with respect to the Safe Harbor method of the Privacy Rule? Read the Full Guidance. HHS There has been confusion about what constitutes a code and how it relates to PHI. A qualified expert may apply generally accepted statistical or scientific principles to compute the likelihood that a record in a data set is expected to be unique, or linkable to only one person, within the population to which it is being compared. Rare clinical events may facilitate identification in a clear and direct manner. 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. 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 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. HIPAA recognizes two ways of establishing that a study is using de-identified information, and therefore outside the requirements of HIPAA: Through removal of the 18 identifiers listed on the Declaration: Section I, Safe Harbor De-identification or Through a documented statistical analysis: Section II, Statistical Analysis De-identification. 2.3 What is an acceptable level of identification risk for an expert determination? OCR gratefully acknowledges the significant contributions made by Bradley Malin, PhD, to the development of this guidance, through both organizing the 2010 workshop and synthesizing the concepts and perspectives in the document itself. For instance, the date January 1, 2009 could not be reported at this level of detail. The following provides a survey of potential approaches. 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. In instances when population statistics are unavailable or unknown, the expert may calculate and rely on the statistics derived from the data set. OCR does not require a particular process for an expert to use to reach a determination that the risk of identification is very small. a health care provider that conducts certain transactions in electronic form (called here a "covered health care provider"). However, due to the publics 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. 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. When researchers remove PHI from a dataset they do so in an attempt to preserve privacy for research participants. Must a covered entity suppress all personal names, such as physician names, from health information for it to be designated as de-identified? The most recent Security Rule in HIPAA regulations (45 CFR Parts 160 and 164) spell out the compliance requirements for those entities managing PHI. Get our HIPAA Compliance Checklist to see everything you need to do to be fully compliant. If for example a doctor attends only one patient, and the patient could be identified by disclosing the name of the doctor, then the doctors name must be removed. 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. 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. 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.
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