Part 9: Summary of main points
Privacy rules define two new rights for research participants.
Privacy rules define two new rights for research participants.
Participants have the right to ask researchers to explain the protected health information (PHI) they obtained according to the exemption or exception of HIPAA privacy rules. Accounts of such disclosures for the previous six years may be required.
Participants have the right to ask researchers to explain the protected health information (PHI) obtained under the exemption or exception of HIPAA privacy rules. It may be necessary to explain such disclosures in the past six years.
The researcher is not required to explain the following disclosure:
I authorization of participants;
Ⅱ, included in a limited data set; or
Iii. release as non-identification data.
Researchers need not explain the following disclosures:
1, participant authorization;
2, contained in a limited data set; or
3. Release as de-identification data.
Other situations that do not require accounting include national security or intelligence purposes, and disclosure to correctional institutions or law enforcement officials.
Other situations where accounting is not required include national security or intelligence purposes, and disclosure of information to correctional institutions or law enforcement officials.
Participants have the right to revoke their authorization to use or disclose protected health information (PHI). However, if the researcher has made disclosure according to the original authorization of the participant, the revocation is invalid.
Participants have the right to revoke their authorization to use or disclose protected health information (PHI). However, if the researcher has made disclosure according to the original authorization of the participant, the revocation is invalid.
DHHS Civil Rights Office is responsible for enforcing HIPAA privacy rules and investigating complaints about non-compliance. Failure to observe privacy rules may result in civil or criminal penalties. For more information about the implementation of privacy rules, please visit the newsletter.
Breach of confidentiality is usually defined as disclosure of protected information of participants to third parties without court order or consent of participants. Violations of confidentiality can be oral or written, and can also occur by telephone, fax or electronic means (such as email or other Internet-based communication methods).
Five situations are described below. According to the situation, classify whether confidentiality is violated by selecting "Violation" or whether confidentiality is not violated by selecting "No Violation". ?
Five situations are described below. According to the scenario, whether there is a violation of confidentiality is classified by selecting "violation", or whether there is a violation of confidentiality is classified by selecting "no violation".
A researcher completed a clinical trial and then published the results. A researcher of another study read the publication and contacted the researcher of this study to request data sets, including data of unidentified participants, for secondary analysis. The investigators of this study shared the de-identified data set with the researchers.
A researcher completed a clinical trial and then published the results. Researchers in another study read the publication and contacted the researchers in this study, asking for data sets and uncertain participant data for secondary analysis. The researchers in this study shared unidentified data sets with researchers.
The research clinician shares the test results of the participants with the research doctor to confirm the qualifications of the participants to participate in clinical trials.
Research clinicians and research doctors share the test results of the subjects to confirm that the subjects are qualified to participate in clinical trials.
Mary, a 25-year-old woman, is currently receiving outpatient treatment at the Research Center of Charity Hospital, where she participated in a clinical trial. When asked to fill out the HIPAA form, Mary authorized the release of medical records only to her general practitioner. Mary's mother wants to know more about her daughter's treatment, but she doesn't want to confront Mary head-on. When Mary's mother contacted the research center directly, the front desk staff immediately transferred the call to the study consultant. After confirming Mary's birth date and social security number to her mother, the research consultant explained that she understood the situation and revealed that Mary had participated in an HIV clinical trial in the center. However, she can't disclose the details of Mary's treatment.
Mary, a 25-year-old woman, is currently receiving outpatient treatment at Macy's Hospital Research Center, where she participated in a clinical trial. When asked to fill in the HIPAA form, Mary authorized the release of medical records only to her general practitioner. Mary's mother is interested in learning more about her daughter's treatment, but she doesn't want to confront Mary. When Mary's mother contacted the research center directly, the front desk staff immediately transferred the call to the research consultant. After confirming Mary's birth date and social security number with her mother, the research consultant explained that she knew this situation and revealed that Mary had participated in the HIV clinical trial in the center. However, she can't disclose the details of Mary's treatment.
A study on opioid use disorders is being carried out in the local research institution General Hospital of Physicians. The researcher has obtained the confidentiality certificate of the research. Jim, a parolee, took part in the study at the General Hospital of Physicians. Parole officer bridges visited the research site and asked for a copy of Jim's drug test results with a court order. The research doctor informed Officer Bridges of Jim's drug test results.
The local research institute, the Medical Association, is conducting a study on opioid use disorders. The researcher has obtained a confidentiality certificate for this research. Jim, a parolee, took part in the study in the general hospital of internal medicine. Parole officer bridges visited the research site and asked for a copy of Jim's drug test results by court order. The research doctor announced the results of Jim's drug test to police officer bridges.
After taking the study drug, the subjects immediately developed allergic reactions at the study site. When the ambulance arrived, the study clinician provided the emergency medical conditions of the participants to the nursing staff before sending them to the hospital.
After taking the study drug, the participants immediately developed allergic reactions at the study site. When the ambulance arrived, the research clinician provided the emergency medical condition of the subject to the nursing staff, and then took the subject to the hospital.
Feedback 1: How do you classify this situation: violation or no violation? The correct answer is no violation. As long as the shared data is confidential, research data can be disclosed for research purposes.
Feedback 1: How to classify this situation: default or non-default? The correct answer is not to default. As long as the data enjoyed by * * * is not recognized, the research data may be disclosed for research purposes.
Feedback 2: How do you classify this situation: violation or no violation? The correct answer is no violation. The information in the participants' medical records can be disclosed to those who need the information to perform the duties related to the diagnosis and treatment of the participants.
Feedback 2: How do you classify this situation: default or non-default? The correct answer is not to default. The information in the medical records of participants can be disclosed to those who need this information to perform their duties related to the diagnosis and treatment of participants.
Feedback 3: How do you classify this situation: violation or no violation? The correct answer is breach of contract. Clinical researchers shall not disclose the participants' participation in the study without the consent of the participants, court orders, subpoenas or other legal authorization.
Feedback 3: How do you classify this situation: default or non-default? The correct answer is breach of contract. Clinical researchers shall not disclose the participants' participation in the study without the consent of the participants or the authorization of court orders, subpoenas or other laws.
Feedback 4: How do you classify this situation: violation or no violation? The correct answer is breach of contract. Court orders alone cannot force the disclosure of confidential information. A subpoena or other statutory order must be issued to force disclosure.
Feedback 4: How do you classify this situation: default or non-default? The correct answer is breach of contract. The court order itself does not force the disclosure of confidential information. A subpoena or other legal authorization must be issued to force disclosure.
Feedback 5: How do you classify this situation: violation or no violation? The correct answer is no violation. The information in the participants' medical records can be disclosed to those who need the information to perform the duties related to the diagnosis and treatment of the participants.
Feedback 5: How do you classify this situation: default or non-default? The correct answer is not to default. The information in the medical records of participants can be disclosed to those who need this information to perform their duties related to the diagnosis and treatment of participants.
1. Federal laws and regulations protect the confidentiality of participants' records. In addition, federal laws protect the confidentiality of identifiable health information of all research participants.
1. Federal laws and regulations protect the confidentiality of participants' records. In addition, federal laws protect the confidentiality of identifiable health information of all research participants.
Ii. generally speaking, all records of anyone's identity, diagnosis, prognosis or treatment related to the prevention, education, training, treatment, rehabilitation or research of alcohol or drug abuse must be kept confidential.
2. Generally speaking, the identity, diagnosis, prognosis or treatment records of anyone related to the prevention, education, training, treatment, rehabilitation or research of alcoholism or drug abuse must be kept confidential.
Ⅲ. The regulations determine some exceptions to confidentiality requirements. Information in a participant's medical record can be disclosed:
I. Personnel who perform duties related to diagnosis, treatment or referral of alcohol or drug abuse treatment of participants.
Ii. When the participants commit or threaten to commit crimes at the project site or against the project staff, report to the law enforcement personnel.
Iii. When reporting suspected child abuse or neglect to state or local authorities.
Iv. Provide it to medical personnel in case of medical emergency.
Five, for the purpose of research, there are certain conditions.
Vi. Used for management audit, financial audit or project evaluation.
Vii. If the participant is found to be in danger of suicide, or he or she threatens to hurt another person.
Viii. When the participant suffers from an infectious disease that poses a threat to public health.
When the court orders authorization.
X when required by state laws.
3. The regulations define some exceptions to confidentiality requirements. Information in a participant's medical record can be disclosed:
(1) is applicable to personnel who perform duties related to the diagnosis, treatment or referral of participants' alcoholism or drug abuse.
(2) When participants threaten or commit crimes at the project site or against project personnel, report to law enforcement personnel.
(3) Report the suspected child abuse or neglect to the state or local authorities.
(4) Medical personnel in medical emergencies.
(5) For research purposes, there are certain conditions.
(6) Used for management audit, financial audit or project evaluation.
(7) If it is found that the participant is in danger of suicide, or he or she makes a credible threat to hurt others.
(8) Participants suffer from infectious diseases that pose a threat to public health.
(9) Authorized by a court order.
(10) When required by state laws.
Ⅳ. If a project stops operating or is acquired by another project, as far as clinical records are concerned, certain medical record responsibilities must be followed. The main researcher of each experimental site must understand the procedures and retention requirements of medical and research-related records established by the organizers and regulatory agencies with supervisory power.
4. If a project stops operating or is acquired by another project, it must fulfill certain medical record responsibilities for clinical records. Every major researcher on site must understand the procedures and retention period requirements of medical and research-related records formulated by the applicant and regulatory agencies.
ⅴ. The confidentiality certificate provides additional protection for the privacy of the participants in the study.
5. The confidentiality certificate provides additional protection for the privacy of research participants.
ⅵ. Unless under certain conditions, researchers who have obtained confidentiality certificates shall not be forced to disclose the identity of research participants in any federal, state or local civil, criminal, administrative, legislative or other proceedings.
6. Unless under certain conditions, researchers who have obtained confidentiality certificates shall not be forced to determine the identity of research participants in any federal, state or local civil, criminal, administrative, legislative or other procedures.
ⅶ. Participants must be informed that a research project has been granted a confidentiality certificate.
7. Participants must be informed that a research project has obtained a confidentiality certificate.
Ⅷ. HIPAA privacy rules protect all personally identifiable health information held or transmitted by related entities and their business associations. Information can be in any form (for example, paper, electronic, oral). Privacy rules refer to this information as protected health information (PHI). Unless permitted or required by privacy rules, PHI shall not be used or disclosed by relevant entities.
8.HIPAA privacy rules protect all personally identifiable health information held or transmitted by the insured entity and its business partners. Information can be in any form (for example, paper, electronic, oral). Privacy rules refer to this information as Protected Health Information (PHI). Unless permitted or required by privacy rules, the insured entity shall not use or disclose PHI.
IX. Covered entities can use or disclose the "minimum necessary" amount of PHI to themselves or between them for the purpose of treatment, payment and medical care business without personal authorization.
9. Covered entities can use or disclose "minimum necessary" PHI to individuals or each other for the purposes of treatment, payment and medical care operation without personal authorization.
ⅹ. PHI may be disclosed for research purposes with the authorization of research participants. In the process of informed consent, disclosure authorization is usually obtained from the participants. The treatment plan does not need to track the disclosure of participants' authorization.
10. PHI can be disclosed for research purposes when research participants authorize disclosure. In the process of informed consent, the disclosure authorization is usually obtained from the participants. The treatment plan does not need to track the disclosure of participants' authorization.
Health information that has been revoked by deleting all elements that may identify individuals is no longer regarded as PHI and is not subject to privacy rules.
1 1. Health information whose identity has been revoked by deleting all elements that may identify individuals is no longer regarded as PHI and is not subject to privacy rules.