Research is defined in the Privacy Rule as, “ a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge .” See 45 CFR 164.501.
Can PHI be used for research?
PHI may be used and disclosed for research without an Authorization in limited circumstances: Under a waiver of the Authorization requirement, as a limited data set with a data use agreement, preparatory to research, and for research on decedents’ information.
Answer: Informed consent is required under federal research regulations for the protection of human subjects. The HIPAA Privacy rule, a different regulation, separately requires that patients give written Authorization before a covered entity may use or disclose patients’ protected health information for research.
What is research health information?
Research Health Information (RHI) is defined as data used in research that would be personally identifiable but not considered PHI and is therefore not subject to the HIPAA Privacy and security Rules.
What constitutes PHI research?
PHI is defined as a subset of individually identifiable health information (IIHI) that is maintained or transmitted in any form, including oral communications that is created or received by a health care provider, relates to the past, present or future physical or mental condition of an individual; provision of health ...
Why is HIPAA important in research?
The HIPAA Privacy Rule establishes the conditions under which protected health information may be used or disclosed by covered entities for research purposes . The Privacy Rule builds upon these existing Federal protections. ...
What are the six patient rights under the Privacy Rule?
Right of access, right to request amendment of PHI, right to accounting of disclosures, right to request restrictions of PHI , right to request confidential communications, and right to complain of Privacy Rule violations.
When can you use or disclose PHI?
Generally speaking, covered entities may disclose PHI to anyone a patient wants . They may also use or disclose PHI to notify a family member, personal representative, or someone responsible for the patient’s care of the patient’s location, general condition, or death.
What is limited data set under Hipaa?
‘A “limited data set” is a limited set of identifiable patient information as defined in the Privacy Regulations issued under the Health Insurance Portability and Accountability Act, better known as “HIPAA”. ... A “limited data set” is information from which “facial” identifiers have been removed.
HIPAA Requirements: Any research that involved collecting identifiable health information is subject to HIPAA requirements. As a result records must be retained for a minimum of 6 years after each subject signed an authorization .
What health information is not protected by HIPAA?
PHI only relates to information on patients or health plan members. It does not include information contained in educational and employment records , that includes health information maintained by a HIPAA covered entity in its capacity as an employer.
What is included in protected health information?
Protected health information includes all individually identifiable health information , including demographic data, medical histories, test results, insurance information, and other information used to identify a patient or provide healthcare services or healthcare coverage.
Which of the following is the best definition of electronic protected health information ePHI )?
Electronic protected health information or ePHI is defined in HIPAA regulation as any protected health information (PHI) that is created, stored, transmitted, or received in any electronic format or media . HIPAA regulation states that ePHI includes any of 18 distinct demographics that can be used to identify a patient.
What is not considered as PHI?
Examples of health data that is not considered PHI: Number of steps in a pedometer . Number of calories burned . Blood sugar readings w/out personally identifiable user information (PII) (such as an account or user name) Heart rate readings w/out PII.
Is patient ID considered PHI?
Demographic information is also considered PHI under HIPAA Rules, as are many common identifiers such as patient names, Social Security numbers, Driver’s license numbers, insurance details, and birth dates, when they are linked with health information. The 18 identifiers that make health information PHI are: Names.
Is patient age considered PHI?
PHI is any individually identifying health information, categorized into 18 patient identifiers under HIPAA. ... Dates related to the health or identity of individuals (including birthdates, date of admission, date of discharge, date of death, or exact age of a patient older than 89) Telephone numbers.
