Does Hipaa apply to research? 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).
Does HIPAA apply to exempt research?
Although
the HIPAA Exemption applies only to secondary research uses of identifiable private information
, the exemption is not limited to data that have been collected in the past, before the secondary research project at issue begins.
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.
In what ways does the HIPAA privacy rule apply to researchers?
Can PHI be disclosed 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.
How does HIPAA define research?
Research means
a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge
.
What is not subject to 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.
Is a researcher a business associate under HIPAA?
Research is not a covered function under HIPAA
and research is not listed under the definition of business associate as one of the functions that a business associate may perform.
What is considered PHI in research?
What is PHI? Protected health information (PHI) is any information in the medical record or designated record set that can be used to identify an individual and that was created, used, or disclosed in the course of providing a health care service such as diagnosis or treatment.
Who would not be considered a covered entity under HIPAA?
Even if an entity is a healthcare provider, health plan or healthcare clearinghouse, they are not considered a HIPAA covered entity
if they do not transmit any information electronically for transactions that HHS has adopted standards
. In such cases, the entity would not be required to comply with HIPAA Rules.
Is a researcher a covered entity?
Researchers are not themselves covered entities
, unless they are also health care providers and engage in any of the covered electronic transactions.
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 …
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)
.
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 is not considered protected health information?
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)
Under HIPAA, your health care provider may share
your information face-to-face, over the phone, or in writing
. A health care provider or health plan may share relevant information if: You give your provider or plan permission to share the information. You are present and do not object to sharing the information.
Who is covered by HIPAA privacy Rule?
The Privacy Rule, a Federal law, gives you rights over your health information and sets rules and limits on who can look at and receive your health information. The Privacy Rule applies to
all forms of individuals’ protected health information, whether electronic, written, or oral
.
Who is not covered by the privacy Rule?
Is research considered healthcare?
A researcher is a covered health care provider if he or she furnishes health care services to individuals, including the subjects of research, and transmits any health information in electronic form in connection with a transaction covered by the Transactions Rule.
Is clinical research considered healthcare?
Clinical research is
a branch of healthcare science
that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use.
Generally not
. Most retrospective chart reviews involve a large number of records, and therefore the IRB would consider it impracticable (not possible) to do the study if informed consent and authorization were required. However, the investigator must answer the waiver of consent/authorization questions (section IV.
Can I use patient data for research?
When can you reveal information needed for medical research?
You can reveal information needed for medical research if: Answer:
The patient authorizes it
. 10 if the patient wants to request a restriction on the disclosure of his/her protected health information (phi): answer: It must be in writing.
When can a researcher break confidentiality?
In contrast, some Anglophone professional codes of ethics in the social sciences allow the researcher (in exceptional cases) to break confidentiality, for example
in “health- or life-threatening” situations
(ASA 2018) or child abuse (BSA 2017).
What are the limits of confidentiality in research?
There are
ethical or legal limits
to confidentiality, for example when a researcher obtains information subject to mandatory reporting, such as evidence of child abuse.
Under which circumstances must a researcher break confidentiality?
Could the research practicably be conducted without a waiver of HIPAA Authorization?
The research could not practicably be carried out without the waiver or alteration
. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
When can HIPAA Authorization be waived?
Is a limited data set human subjects research?
Which uses of patient health information do not require the patient’s Authorization?
A covered entity is permitted, but not required, to use and disclose protected health information, without an individual’s authorization, for the following purposes or situations: (1)
To the Individual (unless required for access or accounting of disclosures); (2) Treatment, Payment, and Health Care Operations
; (3) …
