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It also summarizes HIPAA Authorization requirements, including core elements and required 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does HIPAA apply to a research submission?","Question",{"text":62,"@type":63},"HIPAA criteria may apply when the research involves Protected Health Information (PHI), and the researcher must address how the study meets HIPAA requirements in the submission.","Answer",{"name":65,"@type":60,"acceptedAnswer":66},"What qualifies as Protected Health Information (PHI)?",{"text":67,"@type":63},"PHI is individually identifiable health information transmitted or maintained in any form or medium by a covered entity or business associate, including information tied to health status, care provision, or payment that identifies the individual or can reasonably be used to identify them.",{"name":69,"@type":60,"acceptedAnswer":70},"How can researchers use PHI without identifying participants?",{"text":71,"@type":63},"Researchers may use de-identified health information, which neither identifies individuals nor provides a reasonable basis for identification, using either Expert Determination by a qualified statistician or the Safe Harbor method removing 18 specified identifiers.","https://schema.org",{"og:url":32,"og:type":74,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":76,"canonical":32},"index,follow",{"doc_id":78,"site_id":7},283691,1790155510,{"code":4,"msg":81,"data":82},"success",[83,88,93,98,103,108,113,118,123],{"id":84,"doc_module":22,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},11,"Presentations",90,"presentations",{"id":89,"doc_module":22,"doc_module_name":25,"category_name":90,"show_sort_weight":91,"slug":92},12,"Resumes",80,"resumes",{"id":94,"doc_module":22,"doc_module_name":25,"category_name":95,"show_sort_weight":96,"slug":97},14,"Invoices",70,"invoices",{"id":99,"doc_module":22,"doc_module_name":25,"category_name":100,"show_sort_weight":101,"slug":102},15,"Posters",60,"posters",{"id":104,"doc_module":22,"doc_module_name":25,"category_name":105,"show_sort_weight":106,"slug":107},16,"Social 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Templates",5,"papers-templates",{"id":124,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":4,"slug":125},158,"general-158",{"code":4,"msg":81,"data":127},{"doc_id":78,"user_id":128,"nickname":42,"user_avatar":129,"doc_module":22,"category_id":124,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":30,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":33,"language":135,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":12,"update_tm":139,"read_time":26},687208528416,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","| | IRB Guidance: HIPAA and Human Subjects Research |\n| --- | --- |\n\nWhen research will involve the use of Protected Health Information (PHI), criteria under the Health Insurance Portability and Accountability Act (HIPAA) may apply and the researcher will need to address how their research meets HIPAA requirements in the research submission.  \nHIPAA Covered Entities  \nCampbell University researchers planning to work with HIPAA-covered entities, e.g. , hospitals, medical centers, universities, clinics, etc. , may need to comply with use and disclosure requirements under HIPAA for use of protected health information in their research. Researchers working at or obtaining data from HIPAA covered of components of Campbell University will have to comply with HIPAA use and disclosure requirements if their research involves protected health information.  \nProtected Health Information  \nProtected Health Information (PHI) includes any individually identifiable health information transmitted or maintained in any form or medium (e.g. , electronic, paper, oral) by a covered entity or its business associate.  \nIndividually identifiable health information is information, including demographic data, that relates to:  \n• The individual’s past, present or future physical or mental health or condition,  \n• The provision of health care to the individual, or  \n• The past, present, or future payment for the provision of health care to the individual, and  \no That identifies the individual, or  \no For which there is a reasonable basis to believe it can be used to identify the individual.  \nList of Protected Health Information (PHI) Identifiers  \n1. Names.  \n2. All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census:  \na. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people.  \nb. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000.  \n3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older.  \n4. Telephone numbers.  \n\n| | IRB Guidance: HIPAA and Human Subjects Research |\n| --- | --- |\n\n5. Facsimile numbers.  \n6. Electronic mail addresses.  \n7. Social security numbers.  \n8. Medical record numbers.  \n9. Health plan beneficiary numbers.  \n10. Account numbers.  \n11. Certificate/license numbers.  \n12. Vehicle identifiers and serial numbers, including license plate numbers.  \n13. Device identifiers and serial numbers.  \n14. Web universal resource locators (URLs) .  \n15. Internet protocol (IP) address numbers.  \n16. Biometric identifiers, including fingerprints and voiceprints.  \n17. Full-face photographic images and any comparable images.  \n18. Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re-identification.  \nDe-Identified Health Information  \nResearchers should note that are no restrictions under HIPAA for the use or disclosure of deidentified health information. De-identified health information neither identifies nor provides a reasonable basis to identify an individual. HIPAA provides only two ways to de-identify information, either:  \n1. Expert Determination: A formal determination by a qualified statistician; or  \n2. Safe Harbor: The removal of 18 specified identifiers of the individual and of the individual’s relatives, household members, and employers is required, and is adequate only if the covered entity has no actual knowledge that the remaining i","cbCaitt2K9W1ANFq","https://ap.wps.com/l/cbCaitt2K9W1ANFq","pdf",66019,"English","# HIPAA applicability in human subjects research\n## HIPAA Covered Entities\n## Protected Health Information (PHI)\n## List of PHI identifiers\n## De-Identified Health Information\n## HIPAA Authorization\n## Authorization core elements\n## Authorization required statements","[{\"question\":\"When does HIPAA apply to a research submission?\",\"answer\":\"HIPAA criteria may apply when the research involves Protected Health Information (PHI), and the researcher must address how the study meets HIPAA requirements in the submission.\"},{\"question\":\"What qualifies as Protected Health Information (PHI)?\",\"answer\":\"PHI is individually identifiable health information transmitted or maintained in any form or medium by a covered entity or business associate, including information tied to health status, care provision, or payment that identifies the individual or can reasonably be used to identify them.\"},{\"question\":\"How can researchers use PHI without identifying participants?\",\"answer\":\"Researchers may use de-identified health information, which neither identifies individuals nor provides a reasonable basis for identification, using either Expert Determination by a qualified statistician or the Safe Harbor method removing 18 specified identifiers.\"}]","IRB Guidance: HIPAA and Human Subjects Research | PDF",1789617364]