Your Information. Your Rights. Our Responsibilities.
This notice describes how medical information about you may be used and disclosed and how you can get access to this information. Please review it carefully.
You have the right to:
- Get a copy of your paper or electronic medical record
- Correct your paper or electronic medical record
- Request confidential communication
- Ask us to limit the information we share
- Get a list of those with whom we’ve shared your information
- Get a copy of this privacy notice
- Choose someone to act for you
- File a complaint if you believe your privacy rights have been violated
You have some choices in the way that we use and share information as we:
- Tell family and friends about your condition
- Provide disaster relief
- Include you in a hospital directory
- Provide mental health care
- Market our services and sell your information
- Raise funds
Our Uses and Disclosures
We may use and share your information as we:
- Treat you
- Run our organization
- Bill for your services
- Help with public health and safety issues
- Do research
- Comply with the law
- Respond to organ and tissue donation requests
- Work with a medical examiner or funeral director
- Address workers’ compensation, law enforcement, and other government requests
- Respond to lawsuits and legal actions
When it comes to your health information, you have certain rights. This section explains your rights and some of our responsibilities to help you.
Get an electronic or paper copy of your medical record
- You can ask to see or get an electronic or paper copy of your medical record and other health information we have about you. Ask us how to do this.
- We will provide a copy or a summary of your health information, usually within 30 days of your request. We may charge a reasonable, cost-based fee.
Ask us to correct your medical record
- You can ask us to correct health information about you that you think is incorrect or incomplete. Ask us how to do this.
- We may say “no” to your request, but we’ll tell you why in writing within 60 days.
Request confidential communications
- You can ask us to contact you in a specific way (for example, home or office phone) or to send mail to a different address.
- We will say “yes” to all reasonable requests.
Ask us to limit what we use or share
- You can ask us not to use or share certain health information for treatment, payment, or our operations. We are not required to agree to your request, and we may say “no” if it would affect your care.
- If you pay for a service or health care item out-of-pocket in full, you can ask us not to share that information for the purpose of payment or our operations with your health insurer. We will say “yes” unless a law requires us to share that information.
Get a list of those with whom we’ve shared information
- You can ask for a list (accounting) of the times we’ve shared your health information for six years prior to the date you ask, who we shared it with, and why.
- We will include all the disclosures except for those about treatment, payment, and health care operations, and certain other disclosures (such as any you asked us to make). We’ll provide one accounting a year for free but will charge a reasonable, cost-based fee if you ask for another one within 12 months.
Get a copy of this privacy notice
You can ask for a paper copy of this notice at any time, even if you have agreed to receive the notice electronically. We will provide you with a paper copy promptly.
Choose someone to act for you
- If you have given someone medical power of attorney or if someone is your legal guardian, that person can exercise your rights and make choices about your health information.
- We will make sure the person has this authority and can act for you before we take any action.
File a complaint if you feel your rights are violated
- You can complain if you feel we have violated your rights by contacting us using the information on page 1.
- You can file a complaint with the U.S. Department of Health and Human Services Office for Civil Rights by sending a letter to 200 Independence Avenue, S.W., Washington, D.C. 20201, calling 1-877-696-6775, or visiting https://www.hhs.gov/hipaa/filing-a-complaint/what-to-expect/index.html.
- We will not retaliate against you for filing a complaint.
For certain health information, you can tell us your choices about what we share. If you have a clear preference for how we share your information in the situations described below, talk to us. Tell us what you want us to do, and we will follow your instructions.
In these cases, you have both the right and choice to tell us to:
- Share information with your family, close friends, or others involved in your care
- Share information in a disaster relief situation
- Include your information in a hospital directory
If you are not able to tell us your preference, for example if you are unconscious, we may go ahead and share your information if we believe it is in your best interest. We may also share your information when needed to lessen a serious and imminent threat to health or safety.
In these cases we never share your information unless you give us written permission:
- Marketing purposes
- Sale of your information
- Most sharing of psychotherapy notes
In the case of fundraising:
- We may contact you for fundraising efforts, but you can tell us not to contact you again.
Our Uses and Disclosures
How do we typically use or share your health information?
We typically use or share your health information in the following ways.
We can use your health information and share it with other professionals who are treating you.
Example: A doctor treating you for an injury asks another doctor about your overall health condition.
Run our organization
We can use and share your health information to run our practice, improve your care, and contact you when necessary.
Example: We use health information about you to manage your treatment and services.
Bill for your services
We can use and share your health information to bill and get payment from health plans or other entities.
Example: We give information about you to your health insurance plan so it will pay for your services.
How else can we use or share your health information?
We are allowed or required to share your information in other ways – usually in ways that contribute to the public good, such as public health and research. We have to meet many conditions in the law before we can share your information for these purposes. For more information see: www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/index.html.
Help with public health and safety issues
We can share health information about you for certain situations such as:
- Preventing disease
- Helping with product recalls
- Reporting adverse reactions to medications
- Reporting suspected abuse, neglect, or domestic violence
- Preventing or reducing a serious threat to anyone’s health or safety
We can use or share your information for health research.
Comply with the law
We will share information about you if state or federal laws require it, including with the Department of Health and Human Services if it wants to see that we’re complying with federal privacy law.
Respond to organ and tissue donation requests
We can share health information about you with organ procurement organizations.
Work with a medical examiner or funeral director
We can share health information with a coroner, medical examiner, or funeral director when an individual dies.
Address workers’ compensation, law enforcement, and other government requests
We can use or share health information about you:
- For workers’ compensation claims
- For law enforcement purposes or with a law enforcement official
- With health oversight agencies for activities authorized by law
- For special government functions such as military, national security, and presidential protective services
Respond to lawsuits and legal actions
We can share health information about you in response to a court or administrative order, or in response to a subpoena.
Sale of information
We never market or sell your personal information.
What Information Do We Collect?
Information That You Give Us: We collect Personal Data such as your name, title, date of birth, company name, camera images, work contact information, e-mail, COVID-19 Symptom Assessment Details(as per the CDC https://www.cdc.gov/screening/index.html), or mailing address from you when you voluntarily choose to register for or use certain SDI Labs Services. We use the Personal Data that we collect in an effort to provide you with a superior customer experience on the Site/Mobile App and to improve and market SDI Labs Services or to comply with legal obligations, including mandatory reporting obligations to public health authorities if applicable.
We may combine your information with data gathered from other sources. For instance, if incorrect postal codes are received, insurance details are rightly received, we may use third party software to correct them. We also may collect e-mail or other addresses from prospect lists of other companies, for example, may occasionally ask you to complete surveys for sales and research purposes.
Information That You Give Us When You Sign Up for and Use a SDI Labs Mobile Application or SDI Labs Web Portal Application: In addition to the Personal Data collection described above, We will use this data to do data science research for COVID19 or diseases. This Personal Data may include your personal username and password, individual health-related information including diagnostic test results, medications taken, and information from other applications or devices or x Testing kits that you consent to link to the SDI Labs Web or mobile application. In the case of SDI mobile applications, we also provide additional and more specific information to users at the point each user signs up for use of a mobile application. In the case of SDI Labs COVID-19 mobile applications, storing documents on devices, your data may also be collected and used by the SDI Labs Research & Diagnostic Lab team as described.
Information That You Give Us in the Context of Participating in a SDI Labs patient-support or other patient-specific Program: If you sign up for a SDI Labs patient support or other patient-specific program, in addition to the Personal Data collection described above, we collect other Personal Data, including username and password, health-related information, medication taken, reactions to medication, financial insurance information and other related information used to determine your eligibility for the program, as well as any other information you may choose to provide.
Information That We Get from the Following Other Sources:
- Publicly available sources
- Customers, including healthcare providers and insurance providers
- Kit Manufacturing Service Provider
COVID-19 Testing Device and Other Information: When you interact with SDI Labs through this Website or SDI Labs mobile applications, we may receive and store certain “User Data.” That User Data is collected passively using various technologies, SDI Labs may store that User Data itself or it may be stored in databases owned and maintained by SDI Labs Team. To be compliant as CLIA laboratory SDI Labs will share data as requested by state governments to support the government’s ongoing effort to track, trace and control infectious diseases and current COVID-19 pandemic.
This Site will use de-identified User Data together with data provided by other parties and pool it with other information to track, for example, the total number of visitors to our Site, the number of visitors to each page of our Site, the keywords visitors used to find our Site and the domain names of our visitors’ Internet service providers. We also may disclose de-identified User Data in order to describe our services to current and prospective business partners, and to other third parties for other lawful purposes. It is important to note that no Personal Data is available or used in this process.
App Permission: In an ongoing effort to better understand and serve our users, SDI Labs often requests to access camera permission for taking photos, scanning QRcode/Barcode, and sending necessary documents. Additionally, the app needs the access to external file storage of the device to download and share the result PDF and video camera.
Aggregated Data: In an ongoing effort to better understand and serve our users, SDI Labs often conducts research on Aggregated Data. SDI Labs may share this Aggregated Data with government agencies, its affiliates, agents and business partners. This aggregated information does not identify you personally. SDI Labs also may disclose Aggregated Data in order to describe our services to current and prospective business partners, and to other third parties for other lawful purposes.
FDA EUA Letter: https://www.fda.gov/media/136878/download
This product has not been FDA cleared or approved, but has been submitted to review to get authorized by FDA under an Emergency Use Authorization Study Purpose Only. Service has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3), unless the declaration is terminated or authorization is revoked sooner.
HIPAA Notice of Privacy Practices and Patient Consent
By visiting sdilabsinc.com, you are agreeing to participate in our health survey and consenting to the use of your data in a manner which protects your privacy from third parties but which also allows SDI Laboratories to conduct research and address evolving healthcare circumstances in our communities. The information you provide including your demographic information, symptoms, pre-existing conditions, current medications and other data will be used to improve the care you receive. SDI Labs research division exists alongside but separate from SDI Labs testing division. All studies are open-ended and exist to improve medical treatment outcomes. New features and surveys may be added on a continuing basis and we may invite you to participate in these activities as they arise. We may also invite you to participate in specific studies if your self-reported information matches an area of interest for improving outcomes. Such invitations will be sent using routine communication methods such as email. SDI Labs would like to thank you for your voluntary participation in this health survey
Specialty Diagnostics, Inc.
Clinical Genetics Center, 12634 Hoover Street
Garden Grove, CA 92841
T: 877 509-0376
F: 714 891-8697
- We are required by law to maintain the privacy and security of your protected health information.
- We will let you know promptly if a breach occurs that may have compromised the privacy or security of your information.
- We must follow the duties and privacy practices described in this notice and give you a copy of it.
- We will not use or share your information other than as described here unless you tell us we can in writing. If you tell us we can, you may change your mind at any time. Let us know in writing if you change your mind.
For more information see: www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/noticepp.html.
Changes to the Terms of this Notice
We can change the terms of this notice, and the changes will apply to all information we have about you. The new notice will be available upon request, in our office, and on our web site.
Effective Date of Notice