Metastatic Breast Cancer Insight Study
We are working to transform the research process by bringing together clinical health data and real world evidence.
When you share your clinical data (the data found in your medical records) and your real world experiences with us, you contribute to deepening our collective understanding of the needs and characteristics of the metastatic breast cancer patient community.
Together, we will lead truly patient-powered research.
Join us by getting started on your Ciitizen profile.
Breastcancer.org and Ciitizen invite you to be part of a patient-powered research initiative that will collectively analyze the health records of approximately 100 people in the United States with metastatic breast cancer. The goal of this study is to analyze which treatments metastatic breast cancer patients are receiving to find patterns of care. The data will help you – and patients like you – gain a better understanding of treatment and care options.
What’s in it for you? In addition to knowing that your health data will inform future research and metastatic breast cancer treatments, you will get a complete digital record of all your health information. By having all of your health information in one secure place, you can control where it is shared for second opinions, and apply it to clinical trial matching.
A promise made
Ciitizen founder Anil Sethi made a promise to his sister Tania, who died of metastatic breast cancer in 2017. That promise is to help patients explore all of their options by providing them with control over their complete health data and the choice to share it with whomever they choose.
How The Study Works
1. You sign-up and request your records
After you create your Ciitizen account we will request your records from all of the medical institutions where you’ve received care. You can also upload your health documents on your own if you choose.
2. You consent to share your records for research
Provide consent to share your anonymous clinical health data with researchers. If you already have a Ciitizen account, go to My Info in your profile and select to share your information for cancer research.
3. We’ll analyze the collective health data
A team of researchers at Ciitizen will analyze the anonymous health data from the metastatic community participating in the study.
4. Breastcancer.org and Ciitizen will share our findings with you
We’ll share our discoveries directly with you and publish our findings in a report on Breastcancer.org.
Spread the Word
To invite others from the metastatic breast cancer community to participate in the study, share this link:
Frequently Asked Questions
Q: Who is eligible for the private beta?
A: Currently Ciitizen is open to individuals with a diagnosis or history of breast cancer and a few other indications in the United States. Additionally, there are a few initiatives where Ciitizen is working directly with rare disease advocacy groups outside of cancer. The platform will be offered more broadly at some point in the future as Ciitizen develops support for additional therapeutic areas.
Q: Why is it so important to have your health information?
A: When you have access to your health information, you have the power to seek additional treatment options, to determine if you are eligible for clinical trials, and to share your data for research. When it resides only with your medical providers, you are dependent on them to keep it (and most providers do not keep records for more than 10 years); you’re also dependent on them to send it where you need it to go. By law health care providers are required to give you copies of your medical records – but they are not required to do this immediately (they can take up to 30 days or more in some cases), and they can charge you a reasonable fee to do so. Having your health information helps you be more informed and more prepared, and allows you to participate in research to help others.
Q: Why was Ciitizen formed?
A: Ciitizen was founded by Anil Sethi in honor of his sister Tania, who was killed by metastatic breast cancer in 2017. Tania saw 17 oncologists, and went to 23 institutions during the course of her treatment, and while she was able to get some of the best care, her caretakers were always acting on limited information because her health history was so fragmented – and she didn’t have control over it. Our mission is to help patients explore all of their options by providing them with control of their comprehensive health information (including clinical, genomic, and imaging data) and the choice to share it with whomever they choose.
Q: What if I don’t want to use Ciitizen anymore – what happens to my health data?
A: If you decide you no longer want to use Ciitizen, you can let us know that you wish to close your account – and we will take care of it within 30 business days. We will also work with you to make arrangements for how to get copies of all of the health information that is uploaded to your Ciitizen account (or if you’d prefer, we will securely destroy it). Please email firstname.lastname@example.org.
Q: How do I participate in research?
A: When you sign up for Ciitizen, you have the option (it’s always up to you to decide) to share your medical record data for research purposes. All you need to do is sign up for the platform, follow the steps to authorize us to get your medical records, and we will take it from there!
Q: Which study am I eligible for?
A: Ciitizen and Breastcancer.org are starting with this study to understand treatment patterns in metastatic breast cancer – it is open to any person who has been diagnosed with metastatic breast cancer at any time. As we start new studies we may be interested in looking at different patient groups, and we will inform you of any future research opportunities that may be a good match for you, if you are interested.
Q: Do I need to fill out a survey?
A: There is no survey or questionnaire for this study, your medical records data speaks for itself! Researchers are able to gather a lot of information by looking at medical records data to understand things like treatment patterns and outcomes of certain treatments. This is called “Real World Evidence” and it’s a way from researchers, drug developers, and regulators to understand how diseases and drugs perform in the “real world,” meaning outside of clinical trials. By sharing your data with us, you are letting your experience be your voice. In the future, we may have additional studies which do involve surveys and questionnaires – we will keep you updated on these future research opportunities if you are interested.
Q: I created an account already, but where do I log in?
A: Click “Log In” on the ciitizen.com website and log in with your username and password, or go to http://app.ciitizen.com and log in directly.
Q: Can I bring health records that are already in my possession onto the Ciitizen platform?
A: Yes, when you are requesting records, you will have the option to upload records that you have in your possession already.
Q: What type of technology do I need to use Ciitizen?
A: All you need is an internet connection and an internet browser such as Firefox, Google Chrome, or Safari. You can then access your Ciitizen account using a desktop computer, a laptop, a tablet, or a phone. When you sign up, you will need access to your mobile phone so that you can easily upload a copy of your driver’s license and an electronic signature, which are required to obtain records on your behalf from the providers you identify. If you don’t have a mobile phone, we’ll work directly with you to complete your onboarding.
Q: How do I reset my password?
A: If you ever need to reset your password, simply click “Forgot Password?” on the login page located at app.ciitizen.com and we will email you a link to reset your password; for security reasons, this link expires in 24 hours. If you have trouble resetting your password or do not receive a link, you can also reach out to email@example.com.
Q: How do you get my health data?
Q: What do you do with my health data?
Q: Who can see my data – who has access?
A: The people who have access to your data are those that you share with specifically through your Ciitizen profile. In addition, select individuals who work for Ciitizen will have access to your health information on an as needed basis and only for purposes of maintaining your account, for improving our services, and for determining which opportunities may be of interest to you. We will not commercialize or share your data with any third parties without your explicit consent. Only those individuals working for Ciitizen who have a need to access your information will be granted permission to do so.
Q: How do I share my health information?
A: You share your health information by granting someone access to your Ciitizen profile through the “Care Team” or “Share” features. You can grant access to anyone you choose simply by providing an email address for the person with whom you want to share your data. You can designate how long that person should have access to your account and you may revoke access at any time. Ciitizen will also notify you of opportunities for you to share your health data – and you can decide, either in advance or at the time you receive notice of each opportunity, whether or not you want to share your data.
Q: Is it safe to keep my information on your platform?
A: Ciitizen uses HIPAA-compliant Amazon Web Services (AWS) to maintain your data. AWS is an encrypted platform in widespread use by companies worldwide, and their product reputation depends on keeping data secure. For more, visit Amazon’s website. Additionally, we encrypt data locally and have stringent policies for staff regarding access to data aimed at ensuring your data is protected at all times. We train staff and contractors regularly on our company security policies and requirements. Although we take standard industry precautions to prevent breaches – we are also prepared if they happen. We are required by federal and state law to notify you (and in some cases, regulatory authorities) promptly if there has been a breach of your health information, and we act promptly to investigate breaches to determine the cause and do our best to ensure to mitigate and resolve. Subject to relevant laws and regulations, we never share your data with any third parties or access it for any other commercial purpose without your explicit consent.
Q: What happens to my data if Ciitizen is sold or ceases to exist?
Q: How much does it cost to join Ciitizen?
A: Ciitizen currently does not charge users for use of the platform and the service is free for cancer patients. Should this ever change in the future, and a user no longer wants to maintain their Ciitizen account, that user can close their account and take their medical records with them.
Q: I have received a bill from my provider for the records Ciitizen requested. What should I do next?
A: Ciitizen uses the HIPAA right for individuals to be able to get copies of their health information in order to populate your Ciitizen account. Because this is your right of access, and the requests are submitted on your behalf, occasionally a health care provider may send you a bill for your records. (HIPAA places limits on what fees can be charged to patients – and many providers give patients copies of their records for free; however, the law does permit a reasonable, cost-based fee to be charged.) Please promptly send the bill to firstname.lastname@example.org so we can make sure it is compliant with HIPAA and then Ciitizen will pay the bill on your behalf. Your Ciitizen profile is free for your use, and Ciitizen pays any HIPAA-compliant fees related to the release of your records from a provider.
Q: What is your business model – how do you make money?
A: Ciitizen is currently free to patients; we believe patients should never have to pay to access their own health information. If you consent to share your records for research, Ciitizen uses our patent-pending machine learning (ML) engine to translate the thousands of pages of your health records and creates a research-ready summary of your data. We call this the Ciitizen Research Summary. When you consent to allow researchers to access your summary, Ciitizen will receive a fee from that research organization. The Ciitizen Research Summary creates efficiency for researchers, reducing their cost and labor to make patient data research-ready. Ciitizen will only ever grant researchers access to summaries of Ciitizen users who have consented to share their data.
We also are committed to returning to Ciitizen users a portion of value gained from sharing their data with researchers, to the extent permitted by law (for example, in the form of direct payment, services, discounts, donations, or other value).
Most importantly – it will always be your choice of whether or not to share your health data with anyone. You can always change your mind and choose not to share with researchers if that is your preference. Your profile is yours to use even if you decide not to share it with anyone else.
Q: What is a Ciitizen Research Summary?
A: Ciitizen uses our patent pending machine learning (ML) engine to take the thousands of pages of documents found in a patient’s history and summarizes the most important elements in a patient’s disease. The elements in this summary are then matched with clinical terminology codes so that researchers can immediately make use of this data, such as in clinical trials or observational studies.
Q: Who will my data be shared with if I decide to share my records for research? Who are your partners?
A: Ciitizen works with partners that have a vision aligned to advance research for cancer and rare disease. These partners include physicians, academic institutions, drug companies and independent research organizations that support them. We will never disclose your data for insurance, advertising, or to 3rd parties not related to research.
Q: Why should I share my records for research? Will my information be identifiable?
A: By agreeing to share your health information for research, you can help drug companies and research physicians to better understand the experience of patients like you, which can help lead to new treatments in the future. If you agree to your data being shared for observational research, we will share a summary of your profile with our research partners, for research purposes only. The information about you that we share with researchers will not contain data like your name, date of birth, phone number, address or other information that can be easily used to identify you. In addition, we will contractually prohibit vetted partners from attempting to re-identify the information.
Q: What does it mean that Ciitizen shares “value with patients when their data is used in research”?
A: Should a patient’s data be included in a study, Ciitizen is committed to returning a portion of the value gained from this study with users to the extent permitted by law (for example, in the form of direct payment, services, discounts, donations, or other value) or to donate this value to an advocacy or research non-profit as directed by the patient.
Q: What is the record access process?
A: You have the right under federal law (HIPAA) to get copies of all of your medical records. Ciitizen helps you leverage this right by submitting your medical records requests to your health care providers – and by educating providers about HIPAA compliance if necessary to help get these requests fulfilled.
Q: How quickly will I get my records?
A: HIPAA requires that providers send records to patients within 30 days of receiving the request except in a few select cases. Individual cases will vary on how quickly records will arrive. After a request is made, we follow-up and urge providers to get them to us as soon as possible. In rare cases, providers won’t send records in a timely fashion. After 45 days and multiple follow-up communications we will stop trying to collect these records and share next steps on how you can approach getting these records into your profile.
Q: How far back can you get my medical records?
A: Ciitizen will ask for records going back ten years from the current date. Health care providers do not have to keep your records indefinitely – and how long they are required to keep them varies by state law. In general, we have found it difficult to get records that are older than 10 years and, in some cases, providers may destroy them earlier than that.
Q: Why do I need to provide my signature?
A: The HIPAA right to copies of your records is YOUR right – so requests for your records need to come from you. We place your signature on a form letter we send to request your records. We only use your signature to sign records request letters, and these letters are ONLY sent to your medical providers.
Q: Why do I need to provide a clear (not blurry) copy of my photo ID?
A: Your medical requests are submitted to your medical providers by fax or by email – so the provider needs some way to prove identity, and that you authorized the request letters to be sent. A clear copy of your photo ID is a way to remotely show that you are making the request.
Q: Why does my signature and my signature on my ID need to match?
A: Your medical provider needs some assurance that it is you who authorized the request for records. They will look for a decent match between your signature and the signature on the ID in order to prove identity and make sure that the request for records is coming from you.
Q: My provider has contacted me directly about my request – what should I do?
A: Many providers, as a matter of company policy, will contact a patient about a records request just to confirm that the patient submitted the request. If your provider contacts you to confirm that you want your records to be sent to Ciitizen, you should confirm that you want your records sent to Ciitizen, unless you have changed your mind. (After all, it is YOUR right to your records that Ciitizen is helping you to exercise—so it is not surprising that providers may want to make sure that you authorized the records request.) However, if the provider calls and wants to send your records directly to you instead of Ciitizen – or if they call to tell you they won’t honor the request, or if they send you a bill for the records, or push back in any way – please contact us at email@example.com so we can help successfully resolve this.
Q: Will my records be complete?
A: Your right under HIPAA is to ALL of your medical records maintained by your healthcare provider, and the request to your provider states this clearly. We review your records when they come in to make sure they contain information that is customary for a patient with your medical history – however, we cannot know for sure whether your provider has sent us all of the medical record information that they have about you. Please check your records and let us know if you think something is missing.
Q: What if a provider is refusing to honor a records request or is charging too much for the records?
A: On occasions, providers refuse to comply with the HIPAA right of access by refusing to send records or by charging too high a fee. This could happen for a variety of reasons, but we are seeing higher compliance. For example, see Ciitizen’s Patient Record Scorecard. We escalate your requests to higher level officials at the provider in order to do all that we can to make sure your provider complies with HIPAA – but we don’t have the power to enforce the law against them. If we are unable to get one of your providers to comply with HIPAA after 45 days, we will cease following up on that record and let you know next steps on how you can pursue it with your provider directly. It’s possible in some cases that the records may need to be sent to you first – and then to us for population in your Ciitizen account; if that’s the case, we will provide you with assistance, including covering any costs involved in getting these records to you and then on to us. We can also advise you about how to file a complaint with federal regulators if you want to do that.
Q: Will the records sent to Ciitizen per my request include sensitive data?
A: Your HIPAA rights extend to all information in the medical record except for notes from psychotherapy sessions that are kept separate from other medical records (which is not all mental health information – just the notes of a psychotherapy provider during a psychotherapy session, frequently maintained separately from other medical records). However, state laws often require additional consent before sensitive information like HIV test results, mental health or genetic information can be released, even to the patient. As a result, when you put in your medical records requests as part of onboarding to Ciitizen, you will need to specify whether you are comfortable with having this sensitive information shared with Ciitizen. Once this information is in your profile, you have the right to decide whether or not to share any of your medical record data with any third parties. If you have any questions, please reach out to firstname.lastname@example.org.
Q: I want to make sure the information in my Ciitizen profile is current – do I have to submit a new request every time I go back to my medical provider?
A: To check the status of a pending records request or request an update to your existing records, sign in to your Ciitizen profile, select the provider you would like to view to see the status, and then, if you’ve been to that provider recently, you can choose “Yes, update my records” to request a records update.