XingImaging's Privacy Policy

Effective date September 25, 2024 

XingImaging, LLC is committed to safeguarding your privacy and personal data. This policy is provided to describe what information we collect about you, what we do with it, what we do to keep it secure, as well as how it might be disclosed and your rights in relation to your personal information. This Privacy Policy applies to all information received by XingImaging, any electronic, written communication you share with us, and any information you provide to us to while at our clinical research site.  XingImaging handles your personal information as part of clinical research studies for which you have provided your consent to participate. 

For further questions, XingImaging’s Regulatory and Compliance Team can be contacted:

• By  email: dpo@xingimaging.com 
• By post: XingImaging, LLC, 55 Church Street, New Haven, CT 

Understanding your health record 

A record is made each time you agree to participate in a clinical research trial being conducted at our site. Information about your examination and test results is recorded. These records provide information about your research visit pertaining to the applicable clinical study in which you have consented to participate.  

Understanding what information is retained in your record, collected and how that information may be used or shared is defined in the associated clinical study informed consent document. 

XingImaging is not considered a covered entity, i.e., waived under the Health Insurance Portability and Accountability Act (HIPAA). XingImaging is a research organization. XingImaging is not a health care provider. It will not charge you or your healthcare insurance program, nor does it exchange personal health information electronically for the purpose of securing health care/medical coverage or payments (e.g., disability).  Although we do not provide health care (HIPAA waived) we remain committed to the protection and security of your information and strive to put all safeguards in place to protect PHI as if it is a covered entity as defined in the HIPAA.

What data we collect

The data we collect includes the personal information you directly submit to us as part of the study enrollment, including your name, date of birth, email address, address, phone number, residency, primary neurologist or medical doctor’s name and your medical history.

Once you have signed an informed consent form to participate in a study you give permission for your health information and any data gathered from study procedures to be used as part of the specific study to which you consented, your health record will then be processed as part of that study. 

You are under no legal or contractual obligation to provide us with your personal information. However, failure to do so will mean that you are unable to be enrolled or take part in potential research studies conducted at our site. 

Understanding your privacy rights

Under data protection law, you have a number of rights over your personal data:  

The right to be informed

You have the right to be informed about the collection and use of your personal information. We respect this right by providing you with this Privacy Notice which outlines how your data will be handled. The informed consent form also has information about how your personal information will be used.  

The right of access

You have the right to request a copy of the information that we hold about you, sometimes termed a Data Subject Access Request.   

The right to erasure

If you wish to have your personal information removed from our system, please contact us at dpo@xingimaging.com and your information will be removed.  However, please be aware that the right to erasure is not absolute, and once you sign the informed consent to participate in a specific research study, the data collected during your time in the study may not be removed.  

The right to rectification

If any of the personal information we hold about you is inaccurate, incomplete or out of date, you may ask us to correct it.  

Withdrawing from the study

Your clinical research data record is the physical property of the clinical research study site or sponsor, as defined in the informed consent.  

You may request to withdraw from the study at any time by sending written notice to the study investigator. Upon receiving the written notice, the study team will no longer access your personal health information and you will not be able to stay in the study. Information that has already been gathered (and de-identified) may need to be used and given to others for the validity of the study. 

Data security

To protect your personal information, XingImaging has put in place suitable physical, electronic and managerial procedures to secure the information we process. This includes: 

• Restricting access to the computing environment by a minimum necessary standard so that only those employees who are deemed to require access to sensitive data for their job function will have access to the data.
• Robust access logs and monitoring of network activity, when applicable 
• Implementation of multi-factor authentication (MFA) 
• Implementing a comprehensive information security policy    
• Pseudonymization or de-identification of your personal health information 

The XingImaging data are located in a locked, secure environment, and computer systems are maintained in accordance with industry standards to secure information. Consistent with regulations of the United States and European Union, XingImaging takes many technical precautions to keep identifiable data secure against security breaches. However, if there is a breach, XingImaging will comply with its regulatory obligations. 

XingImaging’s Privacy Practices

We understand that health information about you is personal, and we are committed to protecting that information.  In meeting legal requirements and the organization’s efforts to protect your health information we: 

• Keep your medical information private. Other than for reasons described in this notice, this organization agrees not to use or disclose your identifiable health information to individuals without your authorization. 
• Provide you with this notice of your rights and our legal commitment and privacy practices with respect to the information we collect and maintain about you. 
• Abide by the terms of this notice and notify you if we are unable to grant your requested restrictions or reasonable desires to communicate your health information by alternative means or to alternative locations. 
• Take all possible steps to safeguard your health information. 
• Ensure that all healthcare professionals and individuals with privileges, including staff members, abide by our privacy policy and practices. 

Understanding our policy for specific disclosures

• Authorization – As a research participant, your health information will be disclosed to those      you have specifically authorized to receive this information and wherever possible the information will be pseudonymized or de-identified.    
• Study Partners – Some or all of your health information may be subject to disclosure through      contracts for services to assist the study in conducting the clinical research study.  To protect your health information, we require these Business Associates to follow the same standards held by this office through terms detailed in a written and signed confidentiality agreement. 
• Additional Research – We may share your personal data with our Study Partners for the purpose of enabling you to take part in separate research studies. We will only do this where you have consented to take part in another study, and where this is the case, you will be provided with a      separate informed consent form outlining the sharing in more detail. 
• Limited  Data Set – We may use or disclose information about you without your authorization as      part of a “limited data set” which includes limited information (such as a city, but not personally identifying information such as your name or address) for research purposes. The recipient of this information must sign a data use agreement to restrict the use of this information. 
• Food and Drug Administration (FDA) – This office is required by law to disclose health information to the FDA related to the data collected in a clinical research trial conducted with      investigational drugs or related to any adverse events or compliance violations occurring in the study. 
• Public Health – This office is required by law to disclose information to The Office of Research Integrity (ORI) as required, which is charged with tracking mandatory reports of research integrity,  
• Law  Enforcement – (1) Your health information will be disclosed for law enforcement purposes as required under state law or in response to a valid subpoena. (2) Provisions of federal law permit the disclosure of your health information to appropriate health oversight agencies and authorities when a report is made in good faith that there has been unlawful conduct or violations of professional clinical standards. 
• Service providers - We may share your personal information (limited to minimum necessary for the suited purpose) with third parties that provide services, e.g., reimbursement processing, travel accommodations, imaging and other study required services, database management services. 

If we have a change in policy

The clinical study sponsor or XingImaging reserves the right to change its practices and affect new policy to enhance the privacy standards of research participant records. You will be informed of changes at your research visits.  

For additional information or to report a problem

For further explanation of this notice, you may contact XingImaging’s Privacy Officer at (475) 318-8200. If you believe your privacy rights have been violated, you have the right to file a complaint with this office by contacting the individual above.