Can protected health information be used for research? Under the Privacy Rule, covered entities are permitted to use and disclose protected health information for research with individual authorization, or without individual authorization under limited circumstances set forth in the Privacy Rule.
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.
What is protected health information in research?
The Privacy Rule regulates the way certain health care groups, organizations, or businesses, called covered entities under the Rule, handle the
individually identifiable health information
known as protected health information (PHI).
Is a BAA needed for research?
Answer:
No. Disclosures from a covered entity to a researcher for research purposes do not require a business associate contract
, even in those instances where the covered entity has hired the researcher to perform research on the covered entity’s own behalf.
Does HIPAA apply to research data?
A: Yes. Under the HIPAA Privacy Rule, covered entities may use or disclose protected health information from existing databases or repositories for research purposes either with individual authorization as required at 45 CFR 164.508, or with a waiver of individual authorization as permitted at 45 CFR 164.512(i).
What types of Protected Health Information may be used in research without specific authorization from patients?
Limited Data Set if the identity of the patient is protected and De-Identified Data
. Accounting of Disclosures of PHI is NOT required under HIPAA when…
What is not considered PHI under HIPAA?
Employee and education records
: Any records concerning employee or student health, such as known allergies, blood type, or disabilities, are not considered PHI. Wearable devices: Data collected by wearable devices such as heart rate monitors or smartwatches is not PHI.
How does HIPAA affect research?
The Privacy Rule permits health care provider organizations (“covered entities”) to disclose individually identifiable health information (called protected health information) for research purposes only if the researcher has obtained from each patient written authorization to access his or her medical record or, if …
How do you research health information?
- MedlinePlus. NIH National Library of Medicine. www.medlineplus.gov.
- Centers for Medicare & Medicaid Services. 800-633-4227. …
- Centers for Disease Control and Prevention (CDC) 800-232-4636. …
- healthfinder.gov. www.healthfinder.gov.
- U.S. Food and Drug Administration. 888-463-6332.
The HIPAA Privacy Rule
establishes the conditions under which protected health information may be used or disclosed by covered entities for research purposes.
What patient protections are covered in a research study?
Office of Human Research Protections (OHRP)
The OHRP is the government’s main protector of people’s safety in clinical trials. The OHRP makes sure that the rules of
informed consent, IRBs, and participation of people with special needs
are followed. OHRP can stop clinical trials when problems are found.
Are researchers covered entities under HIPAA?
Covered entities can be institutions, organizations, or persons. Researchers are covered entities if they are also health care providers who electronically transmit health information in connection with any transaction for which HHS has adopted a standard.
Do I need a BAA to be HIPAA compliant?
The HIPAA Privacy Rule requires all Covered Entities to have a signed Business Associate Agreement (BAA) with any Business Associate (BA) they hire that may come in contact with PHI
. The HIPAA Omnibus Rule changed how BAs and Business Associate Subcontractors (BAS) can be held liable for potential HIPAA violations.
What does the HIPAA privacy rule say about a research participant’s right of access to research records or results?
With few exceptions, the Privacy Rule
gives patients the right to inspect and obtain a copy of health information about themselves that is maintained by a covered entity or its business associate in a “designated record set.”
A designated record set is basically a group of records which a covered entity uses to make …
Which of the following are permitted uses of protected health information?
A covered entity may use and disclose protected health information for its own
treatment, payment, and health care operations activities
.
Which of the following would not be considered protected health information?
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.
Under which of the following circumstances may PHI be disclosed?
A covered entity must disclose protected health information in only two situations: (a)
to individuals (or their personal representatives) specifically when they request access to, or an accounting of disclosures of, their protected health information
; and (b) to HHS when it is undertaking a compliance investigation or …
Which of the following would not be considered an example of 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)
What would be a violation of HIPAA?
Further HIPAA Violation Examples
Improper disposal of PHI
. Failure to conduct a risk analysis. Failure to manage risks to the confidentiality, integrity, and availability of PHI. Failure to implement safeguards to ensure the confidentiality, integrity, and availability of PHI.
Which of the following is an example of a prohibited disclosure of PHI?
Personal Use or Disclosure of PHI
Use and disclosure for personal purposes, or to benefit someone other than the patient and the BU Covered Component, is prohibited. For example:
Workforce members may not post any information, photos, videos or anything else about a patient on social media
; and.
What is research privacy?
Privacy for research participants is
a concept in research ethics which states that a person in human subject research has a right to privacy when participating in research
.
What must be done when using patient information for the purpose of research?
What must I do in order to use or disclose PHI for research purposes? Prior to using or disclosing PHI for research purposes, you must
obtain prior approval from the Research Privacy Board (RPB) or the Institutional Review Board (IRB)
.
When health data is needed for research the entire medical record is disclosed to the researchers?
When health data is needed for research, the entire medical record is disclosed to the researchers.
False
. According to HIPAA, a health insurance company can deny coverage to a person with pre-existing health conditions.
How do I know if health information is credible?
- You can find reliable health information at your doctor’s surgery, pharmacies and community health centres.
- Beware of medical information provided by organisations trying to sell a particular product or service – information written to sell products or services is not medical advice.
What entities are exempt from HIPAA and not considered to be covered entities?
What entities are exempt from HIPAA and not considered to be covered entities? HIPAA allows exemption for entities providing only
worker’s compensation plans, employers with less than 50 employees as well as government funded programs such as food stamps and community health centers
.
What is included in protected health information?
Protected health information (PHI), also referred to as personal health information, is the demographic information, medical histories, test and laboratory results, mental health conditions, insurance information and other data that a healthcare professional collects to identify an individual and determine appropriate …
Can you have a Baa without a contract?
For vendors that create, receive, maintain, or transmit PHI on your organization’s behalf (called business associates)
you must have a business associate agreement
. The BAA contract is unique to HIPAA.
Is PHI in written or verbal form is considered secure?
PHI in written or verbal form is considered secure
. Workforce members must notify the Privacy Officer upon becoming aware of any privacy incident that, upon further investigation, may be considered a breach of unsecured PHI.
Is a limited data set human subjects research?
Not Human Subject
, may be used in any manner, not regulated under HIPAA. May not be used alone. Not required. Limited data sets are only for purposes of research, public health, or health care operations.
Is PHI a specimen ID?
PHI is
anything that can be used to identify an individual such as private information, facial images, fingerprints, and voiceprints
. These can be associated with medical records, biological specimens, biometrics, data sets, as well as direct identifiers of the research subjects in clinical trials.
What are examples of PHI?
Covered entities may disclose protected health information to funeral directors as needed, and to coroners or medical examiners to identify a deceased person, determine the cause of death, and perform other functions authorized by law.
