1.4 The De-identification Standard Notice that Gender has been suppressed completely (i.e., black shaded cell). As a result, an expert will define an acceptable very small risk based on the ability of an anticipated recipient to identify an individual. In this example, a covered entity would not satisfy the de-identification standard by simply removing the enumerated identifiers in 164.514(b)(2)(i) because the risk of identification is of a nature and degree that a covered entity must have concluded that the information could identify the patient. Covered entities will need to have an expert examine whether future releases of the data to the same recipient (e.g., monthly reporting) should be subject to additional or different de-identification processes consistent with current conditions to reach the very low risk requirement. However, depending on the nature of service being provided, business associates may also need to comply with parts of the Administrative Requirements and the Privacy Rule depending on the content of the Business Associate Agreement. The Census Bureau will not be producing data files containing U.S. Medical records are comprised of a wide range of structured and unstructured (also known as free text) documents. If identifiers are removed, the health information is referred to as de-identified PHI. In the past, there has been no correlation between ZIP codes and Census Bureau geography. It does not provide sufficient detail in statistical or scientific methods to serve as a substitute for working with an expert in de-identification. 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. The use of initials to try to disguise a name is ineffective and does not constitute any level of identity protection. This data may reside in highly structured database tables, such as billing records. Usually a patient will have to give their consent for a medical professional to discuss their treatment with an employer; and unless the discussion concerns payment for treatment or the employer is acting as an intermediary between the patient and a health plan, it is not a HIPAA-covered transaction. Cancel Any Time. Regulatory Changes Names; 2. 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. Despite this, accidental HIPAA violations do occur which may result in the exposure or impermissible disclosure of the protected health information (PHI) of certain individuals. Further information about individuals rights under HIPAA can be found in our HIPAA Rights article. 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.. However, nothing prevents a covered entity from asking a recipient of de-identified information to enter into a data use agreement, such as is required for release of a limited data set under the Privacy Rule. HHS only gives a general definition of PHI in its Summary of the HIPAA Privacy Rule The Privacy Rule protects all individually identifiable health information held or transmitted by a covered entity or its business associate. Protected health information is individually identifiable health information that is created, maintained, used, or obtained by a HIPAA-covered entity or a business associate of a HIPAA covered entity. Additionally, PHI is only considered PHI when an individual could be identified from the information in the record set. Encryption ensures that sensitive information remains secure. 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? When personally identifiable information is used in conjunction with one's physical or mental health or . Consequently, compliance experts refer to the safe harbor standard for the de-identification of PHI (164.514) to determine what is consider PHI. 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). HHS Yes. With respect to the safe harbor method, the guidance clarifies whether specific data need to be removed from a given data set before it can be de-identified. That said, the EHR vendor should have a BAA signed for this very purpose. The phrase may be retained in the data. It can also consist of a single item under the definition of a designated record set in 164.501. If not, the form is invalid and any information released to a third party would be in violation of HIPAA regulations. No. First, are you covered by HIPAA in some way to protect patient information? 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. Before explaining these terms, it is useful to first explain what is meant by health information, of which protected health information is a subset. The Bureau of the Census provides information regarding population density in the United States. 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. In structured documents, it is relatively clear which fields contain the identifiers that must be removed following the Safe Harbor method. Linkage between the records in the tables is possible through the demographics. In this case, specific values are replaced with equally specific, but different, values. HITECH News The expert may consider different measures of risk, depending on the concern of the organization looking to disclose information. For instance, a code derived from a secure hash function without a secret key (e.g., salt) would be considered an identifying element. Is a patient name alone considered PHI? The HIPAA Privacy Rule details the permissible uses and disclosures of PHI. Your Privacy Respected Please see HIPAA Journal privacy policy. You can see patients' lab test results with their names and dates of birth. 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). It also is important to document when fields are derived from the Safe Harbor listed identifiers. 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. 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. In this sense, the expert will assess the expected change of computational capability, as well as access to various data sources, and then determine an appropriate timeframe within which the health information will be considered reasonably protected from identification of an individual. Providertechs CareMessenger is a HIPAA-compliant text messaging platform that allows providers and healthcare practices to securely message patients and other health professionals by sending HIPAA-compliant texts, photos, and documents. In instances when population statistics are unavailable or unknown, the expert may calculate and rely on the statistics derived from the data set. What is marketing intermediaries and why they are used? 2.6 How do experts assess the risk of identification of information? For example, permitted disclosures (i.e., for treatment, payment, or health care operations) do not have to been included, nor do disclosures to health oversight agencies or law enforcement officials if inclusion in the accounting of disclosures would impede their activities. Get our HIPAA Compliance Checklist to see everything you need to do to be fully compliant. Author: Steve Alder is the editor-in-chief of HIPAA Journal. Entities related to personal health devices are not covered entities or business associates under HIPAA unless they are contracted to provide a service for or on behalf of a covered entity or business associate. 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. (i) That identifies the individual; or Are initials alone considered PHI? In doing so, the expert has made a conservative decision with respect to the uniqueness of the record. (a) Standard: de-identification of protected health information. There is a common misconception that all health information is considered PHI under HIPAA, but this is not the case. HIPAA Advice, Email Never Shared Can dates associated with test measures for a patient be reported in accordance with Safe Harbor? Therefore, the data would not have satisfied the de-identification standards Safe Harbor method. One of the 18 protected health information (PHI) identifiers in the HIPAA Privacy Rule is patient names (first and last name, or last name and initial). Patient records should always be kept in a locked space so they can't be stumbled upon by others. Basically, all health data is regarded as PHI if it includes personal identifiers. How long is an expert determination valid for a given data set? All elements of dates (except year) for dates directly related to an individual. Are patient initials PHI? A first class of identification risk mitigation methods corresponds to suppression techniques. Delivered via email so please ensure you enter your email address correctly. Several broad classes of methods can be applied to protect data. Mr. See the OCR website https://www.hhs.gov/ocr/privacy/ for detailed information about the Privacy Rule and how it protects the privacy of health information. Search Search Recent Posts Given an array of numbers, return array of products of all other numbers (no division) 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 patients privacy. 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. Further information about when consent or authorization is required, and the permissible disclosures for public benefit activities can be found in HHS Summary of the HIPAA Privacy Rule. Your Privacy Respected Please see HIPAA Journal privacy policy. 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. I have also heard from others, that it the initials are not considered "de-identified" enough to be permissible. HIPAA does not prohibit the electronic transmission of PHI. This agreement may prohibit re-identification. The information I'm talking about sending is . > Privacy Both the warning and the consent must be documented. 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. Linking two data sources to identity diagnoses. However, it could be reported in a de-identified data set as 2009. Can an Expert determine a code derived from PHI is de-identified? Sending a PHI-encrypted email to an incorrect recipient would be both an unauthorized and a HIPAA violation. For example, if the patients year of birth is 1910 and the year of healthcare service is reported as 2010, then in the de-identified data set the year of birth should be reported as on or before 1920. Otherwise, a recipient of the data set would learn that the age of the patient is approximately 100. 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. During the year of this event, it is highly possible that this occurred for only one individual in the hospital (and perhaps the country). The other woman training me says never use their last name in public, use their first name (ie: calling out for Jill or Jim). Here are some recommendations to consider when implementing HIPAA regulations and requirements in your office and establishing your patient electronic communication protocol: Patient identifiers to avoid when communicating with patients via email and SMS. The 18 HIPAA identifiers that make health information PHI are: If the data set contains any limited identifiers, but none of the direct identifiers, it is considered a limited data set under HIPAA. 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. In general, the protections of the Privacy Rule apply to information held by covered entities and their business associates. It does not include information contained in educational and employment records. Administrative safeguards include access controls to limit who can view PHI information. The information must be individually-identifiable (i.e. Postal Service ZIP codes. Of course, de-identification leads to information loss which may limit the usefulness of the resulting health information in certain circumstances. Patients "ideally" need to authenticate who they are before gaining access to PHI. The HIPAA Privacy Rule protects most individually identifiable health information held or transmitted by a covered entity or its business associate, in any form or medium, whether electronic, on paper, or oral. A client's initials are considered to be identifying for the purposes of determining if a given piece of information is PHI under HIPAA, because they are derived from . To determine payment amounts for: an office appointment, please 214-351-8450 option 2; surgery, please contact (000-000-0000 option 5 ). Consequently, certain de-identification practitioners use the approach of time-limited certifications. PHI refers to physical records, while ePHI is any PHI that is created, stored, transmitted, or received digitally. The principles should serve as a starting point for reasoning and are not meant to serve as a definitive list. The computation of population uniques can be achieved in numerous ways, such as through the approaches outlined in published literature.14,15 For instance, if an expert is attempting to assess if the combination of a patients race, age, and geographic region of residence is unique, the expert may use population statistics published by the U.S. Census Bureau to assist in this estimation. The information is derived from the Decennial Census and was last updated in 2000. Other than when required or permitted, all other uses and disclosures of PHI require formal, written patient authorization except limited disclosures in facility directories and limited notifications to friends and family when they enquire about the wellbeing of a patient. 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). Cancel Any Time. 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. Thus, data shared in the former state may be deemed more risky than data shared in the latter.12. Patient names (first and last name or last name and initial) are one of the 18 identifiers classed as protected health information (PHI) in the HIPAA Privacy Rule. This standard consists of 18 specific identifiers: Names All geographic subdivisions smaller than a State All elements of dates (except year) for dates directly related to an individual. 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. Toll Free Call Center: 1-800-368-1019 Table 2 illustrates the application of such methods. A characteristic may be anything that distinguishes an individual and allows for identification. This standard consists of 18 specific identifiers: The acronym PHI stands for Protected Health Information, while the acronym ePHI stands for electronic Protected Health Information a subset of PHI that is subject to the safeguards of the HIPAA Security Rule as well as the HIPAA Privacy Rule. The covered entity must remove this information. According to this section, health information means any information, including genetic information, whether oral or recorded in any form or medium, that: Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual., From here, we need to progress to the definition of individually identifiable health information which states individually identifiable health information [] is a subset of health information, including demographic information collected from an individual [that] is created or received by a health care provider, health plan, employer, or health care clearinghouse [] and that identifies the individual or [] can be used to identify the individual.. No. These barcodes are often designed to be unique for each patient, or event in a patients record, and thus can be easily applied for tracking purposes. This information can be downloaded from, or queried at, the American Fact Finder website (http://factfinder.census.gov). Washington, D.C. 20201 This document was brought to the world more than 20 years ago in 1996 when it wasn't even possible to imagine all of the modern technologies that are now involved in healthcare. A general workflow for expert determination is depicted in Figure 2. PHI stands for Protected Health Information and is any data that was degenerated, used, or disclosed during a patient's medical care. 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. 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. Covered entities can include limited patient details in a hospital directory and provide limited information to friends and family with the patients informal consent unless the patient is unable to give their consent, in which case professional judgement should be used to determine whether or not the disclosures are in the patients best interests. Get our HIPAA Compliance Checklist to see everything you need to be compliant. ADA, FCRA, etc.). At the same time, the Privacy Rule is balanced so that it permits the disclosure of personal health information needed for patient care and other important purposes. For example, if the proprietary ID is a primary key . chaosink 4 yr. ago http://www.ciesin.org/pdf/SEDAC_ConfidentialityReport.pdf, https://doh.wa.gov/sites/default/files/legacy/Documents/1500//SmallNumbers.pdf, https://www.hhs.gov/ocr/privacy/hipaa/understanding/special/research/index.html. PII is Personally Identifiable Information that is used outside a healthcare context, while PHI (Protected Health Information) and IIHA (Individually Identifiable Health Information) is the same information used within a healthcare context. 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. Health information such as diagnoses, treatment information, medical test results, and prescription information are considered protected health information under HIPAA, as are national identification numbers and demographic information such as birth dates, gender, ethnicity, and contact and emergency contact. The re-identification provision in 164.514(c) does not preclude the transformation of PHI into values derived by cryptographic hash functions using the expert determination method, provided the keys associated with such functions are not disclosed, including to the recipients of the de-identified information. He is a specialist on healthcare industry legal and regulatory affairs, and has several years of experience writing about HIPAA and other related legal topics. 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, 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. 2.2 Who is an expert? Figure 1. To safeguard against this, any device containing PHI should be password protected. 3.9 Must a covered entity use a data use agreement when sharing de-identified data to satisfy the Safe Harbor Method? Your Privacy Respected Please see HIPAA Journal privacy policy. It notes that derivations of one of the 18 data elements, such as a patients initials or last four digits of a Social Security number, are considered PHI. Example Scenario 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 Example Scenario The free text field of a patients medical record notes that the patient is the Executive Vice President of the state university. Each panel addressed a specific topic related to the Privacy Rules de-identification methodologies and policies. A covered health care provider, health plan, or health care clearinghouse can be a business associate of another covered entity. The Privacy Rule calls this information protected health information (PHI)2. If an item containing PHI, such as a laptop or smartphone, is lost or stolen, that's also considered a HIPAA violation and can result in a hefty fine. Technologies such as encryption software and firewalls are covered under technical safeguards. To sign up for updates or to access your subscriber preferences, please enter your contact information below. 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. Get our HIPAA Compliance Checklist to see everything you need to be compliant. 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 The key word here is "identify": If a snippet of data or a data set . Terms such as PHI and PII are commonly referred to in healthcare, but what do they mean and what information do they include? The covered entity, in other words, is aware that the information is not actually de-identified information. Even though most people couldn't identify a client from just their initials, some people can. 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. However, while not PHI, the employer may be required to keep the nature of the discussion confidential under other federal or state laws (i.e. 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 Privacy Rule does not require a particular approach to mitigate, or reduce to very small, identification risk. (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 an individual. The de-identification standard does not mandate a particular method for assessing risk. Of course, the specific details of such an agreement are left to the discretion of the expert and covered entity. 2.1 Have expert determinations been applied outside of the health field? 3. PHI may exist in different types of data in a multitude of forms and formats in a covered entity. For instance, voter registration registries are free in the state of North Carolina, but cost over $15,000 in the state of Wisconsin. This means making sure you have appropriate notices visible, both online and in the real world, warning patients about the potential security risks of transmitting protected health information (PHI) using non-secure email over the Internet. One says that when I go to the waiting room and announce for a patient to come back I should use their last name because of HIPPA (ie: Ms. Smith or Mr. Jones). It is a requirement that staff are provided HIPAA security awareness training. PHI is an acronym of Protected Health Information, while PII is an acronym of Personally Identifiable Information. Similarly, the final digit in each ZIP Code is within +/- 3 of the original ZIP Code. However, even without mentioning names one must keep in mind if a patient can identify themselves in what you write about this may be a violation of HIPAA. What are the approaches by which an expert assesses the risk that health information can be identified? 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? However, combined with a unique identifier that can be used to link to health information, the data set could be classified as protected health information (PHI).
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