HIPAA privacy notice

Effective date - 05/04/2023

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.

A.1 Our Commitment to You

Diagnose Early Inc. ("we", "our", or "us") is committed to maintaining the privacy of your health information. As part of our services or during your treatment with us, physicians, nurses, and other personnel may collect information about your health history and current health status. This Notice explains how that information, called “Protected Health Information” (PHI), may be used and disclosed to others. The terms of this Notice apply to health information produced or obtained by Diagnose Early.

A.2 Our Legal Duties

The HIPAA Privacy Law requires us to provide this Notice to you regarding our privacy practices, our legal duties to protect your health information and your rights concerning health information about you. We are required to follow the privacy practices described in this Notice whenever we use or disclose your protected health information (PHI). Other companies or persons that perform services on our behalf, called Business Associates, must also protect the privacy of your information. Business Associates are not allowed to release your information to anyone else unless specifically permitted by law.

A.3 Uses and Disclosures of Protected Health Information

A.3.1 What Health Information We Collect

As part of our services or during your treatment with us, physicians, nurses, and other personnel may collect information about your health history and current health status. The information we collect is generally personal information as defined under privacy statutory regulations and protected health information as defined under HIPAA. We collectively refer to this information as personal information or health information in this Notice.

We may directly collect all or some of the following personal information from you, as well as additional information relevant to your care:

Name, email and contact details;
Health Number;
Medical History;
Breath analysis results

We use and disclose the information to provide health services and access to our cloud health data platform, and as otherwise described in this Notice

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A.3.2 How We Use and Disclose Your Health Information

The HIPAA Privacy Law permits Diagnose Early to make uses and disclosures of your health information for purposes of treatment, payment and health care operations. We may use or disclose your health information for the purposes outlined in this Notice.

Treatment: We will use and may share health information about you for your health care and treatments or to coordinate/manage your treatment. For example, a nurse or medical assistant will obtain treatment information about you and record it in a medical record. As an additional example, we may disclose information to a physician for a consultation with or a referral to the physician to diagnose your illness and determine which treatment option, such as surgery or medication, will best address your health needs.
Payments: We may use and disclose health information about you to obtain payment for the care and services we have provided. We may use and disclose health information about your treatment and services to bill and collect payment from you, your insurance company or a third-party payer. For example, we may need to give your insurance company information before it approves or pays for the health care services we recommend for you. The insurance company may use that information to determine eligibility or coverage for insurance benefits, review services provided to you for health necessity, and undertake utilization review activities.
Healthcare Operations: We may use and share health information about you for Diagnose Early’s health care operations, which include planning, management, quality assessment, and improvement activities for the treatments that we deliver. For example, we may use your health information to evaluate the skills of our health care providers in caring for you. We also may use and disclose your information to review quality and health outcomes.
Health-Related Benefits, Services and Treatment Alternatives: We may use and disclose information to tell you about new or alternative treatments or other health care services. For example, we may offer to mail you newsletters, coupons, or announcements.
Appointment Reminders: We may use and disclose health information to contact you for appointment reminders and to communicate necessary information about your appointment.
Law Enforcement: In certain circumstances, we may be legally required to share certain personal information held by us, which may include your health information. We may disclose your health information to a law enforcement official if required or allowed by law, such as gunshot wounds and some burns. We may also disclose information about you to law enforcement for the following reasons:
- To identify or locate a suspect, material witness, victim of a crime, or missing person
- About a death we believe may be the result of criminal conduct
- About criminal conduct at our location
- In emergency circumstances to report a crime; the location of the crime or victims; or the identity, description or location of the person who committed the crime.

People Assisting in Your Care: In certain limited situations, Diagnose Early may disclose essential health information to people such as family members, relatives, or close friends who are helping care for you or helping you pay your health care bills. We may also use and disclose information about you to notify, or to assist in notifying, a family member or friend of your location or condition. Except in emergency circumstances, you will generally be given an opportunity to object before we make these disclosures. If you are unable to make health-related decisions or it is an emergency, Diagnose Early will determine if it would be in your best interest to disclose pertinent health information about you to the people assisting in your care.
Research: Under certain circumstances, we may use and disclose health information about you for research purposes. For example, a research project may involve comparing the health and recovery of all patients who were exposed to certain chemicals. Where consistent with the research goals and purposes, we will use or disclose only de-identified information, so that your identity cannot be ascertained from the information disclosed.
When research cannot be conducted with such de-identified information, we will usually ask for your authorization for such use or disclosure. However, some research projects that involve information gathering may be adversely affected by requiring prior patient authorization before otherwise confidential information can be used or disclosed for research purposes. In those circumstances, research projects are subject to a specific and comprehensive approval process. This process evaluates the proposed research project and its use of health information, trying to balance research needs with patients’ rights to privacy of health information. Before we use or disclose health information for research under such circumstances, the project will have been approved by an Institutional Review Board (IRB) or a specially designated privacy board, which will be required to determine whether the nature of the research is such that it could not be conducted if prior patient authorization was required and will be required to determine that adequate protections are in place to protect patient information from unauthorized use or disclosure. However, as part of the research process we may disclose health information about you to individuals preparing to conduct the research project, for example, to help them look for patients with specific medical needs, but any such health information will not be allowed to leave our offices.

Health Oversight Activities: We may use and disclose health information to a health oversight agency for activities that are required by federal, state or local law. Oversight activities include investigations, inspections, industry licensures, and government audits. These activities are necessary to enable government agencies to monitor various health care systems, government programs, and industry compliance with civil rights laws.
Public Health Risks: As authorized by law, we may disclose health information about you to public health or legal authorities whose official responsibilities generally include the following:
- To prevent or control disease, injury or disability;
- To report births and deaths;
- To report child abuse or neglect;
- To report reactions to medications or problems with products;
- To notify people of recalls of products they may be using;
- To notify a person who may have been exposed to a disease or may be at risk for contracting or spreading a disease or condition; and
- To notify the appropriate government authority if we believe a patient has been the victim of abuse, neglect or domestic violence. We will only make this disclosure if you agree or when required or authorized by law.

Serious Threat to Health or Safety: Consistent with applicable laws, we may disclose your health information if the disclosure is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public. We also may disclose your health information if it is necessary for law enforcement authorities to identify or apprehend an individual.
Specialized Government Functions: If you are a member of the military or a veteran, we will disclose health information about you as required by command authorities; or if you give us your written permission. We may also disclose your health information for other specialized government functions such as national security or intelligence activities.
Workers Compensation: If you are seeking compensation due to a work-related injury, we may release health information about you to the extent necessary to comply with laws relating to Workers Compensation claims.
Employers: We may release health information to your employer for public health activities if we provide health treatment to you at the request of your employer, and the health care services are provided either to conduct an evaluation relating to medical surveillance of the workplace or to evaluate whether you have a work-related illness or injury. In such circumstances, we will provide you with written notice of such information disclosure. Any other disclosures to your employer will generally be made only if you sign a specific authorization to release that information.
Lawsuits and Disputes: If you are involved in a lawsuit, dispute, or other judicial proceedings, we may disclose health information about you in response to a court order or subpoena, or other lawful processes. We may also disclose health information about you in response to a subpoena, discovery request, or other lawful process by someone else involved in the dispute, but only if efforts have been made to tell you about the request or to obtain an order protecting the information requested.
Coroners, Medical Examiners, and Funeral Directors: We may release your health information to a coroner or medical examiner. This may be necessary, for example, to identify a deceased person or to determine the cause of death. We may also release your health information to a funeral director, as necessary, to carry out his/her duties.
Correctional Facilities: If you are an inmate of a correctional institution or under the custody of a law enforcement official, we may disclose health information about you to the correctional institution or law enforcement official only as required by law or with your written permission. We may release your health information for your health and safety, for the health and safety of others, or for the safety and security of the correctional institution.
Required by HIPAA Law: The Secretary of the Department of Health and Human Services (HHS) may investigate privacy violations. If your health information is requested as part of an investigation, we are required to share your information with HHS.

A.3.3 Circumstances Which Require Your Written Consent Prior to Disclosure

For any purpose other than the ones described in this Notice, we may only use or share your health information when you give us your written authorization to do so. For example, you will need to sign an authorization form before sending your health information to your life insurance company. You may revoke your authorization, at any time, in writing, except to the extent that we have taken action in reliance on the authorization.

Marketing: We must also obtain your written authorization before using your health information for marketing purposes, as described under HIPAA. The only exceptions to this requirement are that:
- We can provide you with marketing materials in a face-to-face encounter or a promotional gift of minimal value if we so choose
- We may communicate with you about products or services relating to your treatment, to coordinate or manage your care, or provide you with information about different treatments, providers or care settings.

Sale: Your written authorization will typically be required for most arrangements involving the sale of protected health information.
Highly Confidential Information: Your written authorization will typically be required for most uses and disclosures of psychotherapy notes. Additional federal and state law standards sometimes apply to certain “Highly Confidential Information” such as:
- Child abuse and neglect
- Domestic abuse of an adult with a disability
- Mental illness or developmental disability treatment or services
- Alcohol or drug dependency diagnosis, treatment, or referral
- HIV/AIDS testing, diagnosis, or treatment
- Sexually transmitted disease
- Sexual assault
- Genetic testing
- In Vitro Fertilization (IVF)

Before we disclose your Highly Confidential Information for a purpose other than those permitted by law, we must obtain your written permission.

Other Uses: Other uses and disclosures of your health information not described in this Notice will be made only with your written authorization.

A.3.4 Your Rights Regarding Your Health Information

You have certain rights regarding your health information, which are explained below. You may exercise these rights by submitting a request in writing to privacy@DiagnoseEarly.com

Right to inspect and copy: If you would like to inspect or receive a copy of your PHI that is contained in a designated record set (e.g., health and billing records), we are required to provide you access to such information. We may charge you a reasonable fee to cover duplication, mailing and other costs incurred by us in complying with your request.

We may deny your request for access to your personal information as permitted by HIPAA. For example, we may deny your request if we believe the disclosure will endanger your life or that of another person. Depending on the circumstances of the denial, you may have a right to have this decision reviewed.

Right to Request Restrictions on Use and Disclosure: You have the right to request a restriction or limitation on certain uses and disclosures of your health information. To request restrictions, you must make your request in writing to privacy@DiagnoseEarly.com. In your request, you must tell us:
- What information you wish to limit
- Whether you wish to limit our use, disclosure, or both
- To whom you want the limits to apply – for example, if you want to prohibit disclosures for insurance payment, health care operations, for disaster relief purposes, to persons involved in your care, or to your spouse.

You or your personal representative must sign it.

We are not required to agree to your request, other than a request that we not disclose information to a health plan for payment or health care operations where the request relates only to a health care item or service for which we have been paid in full. We retain the right to terminate an agreed-to restriction if we believe such termination is appropriate. In the event of a termination by us, we will notify you of such termination. You also have the right to terminate, in writing or orally, any agreed-to restriction. If we agree to the requested restriction, we may not use or disclose your personal information in violation of that restriction unless it is needed to provide emergency treatment.

Right to Request Amendment: If you believe that any health information we have about you is incorrect or incomplete, you have the right to ask us to change the information for as long as Diagnose Early maintains the information. To request an amendment to your health information, your request must be in writing, signed, and submitted to Diagnose Early.

If we deny your request, if we deny your request for amendment, we will provide you with information regarding your right to respond to that decision.

Right to Receive Confidential Communications: You have the right to request that we communicate with you about your health information in a confidential manner or at a specific location. For example, you may ask that we only contact you via mail to a post office box. You must submit your request in writing to Diagnose Early. We will not ask you the reason for your request. Your request must specify how or where you wish to be contacted. We will accommodate all reasonable requests.
Right to Receive an Accounting of Certain Disclosures: With some exceptions, you have the right to receive an accounting of certain disclosures we have made, if any, of your health information. Your accounting request must be in writing and signed by you or your personal representative and submitted to Diagnose Early. Your request must specify the time in which the disclosures were made. You may receive one free accounting in any 12-month period. We will charge you for additional requests.

In most cases, this list will not include disclosures made for purposes of treatment, payment, or health care operations and disclosures that were made in response to a specific authorization from you. The right to receive this information is subject to certain other exceptions, restrictions and limitations as allowed by HIPAA.

Right to Obtain a Copy of this Notice: You have the right to receive a paper copy of this Notice upon request, even if you have agreed to receive the Notice electronically. You may ask us to give you a copy of this Notice at any time.
Right to Cancel Authorization to Use or Disclose: Other uses and disclosures of your health information not covered by this Notice or the laws that govern us will be made only with your written authorization. You have the right to revoke your authorization in writing at any time, and we will discontinue future uses and disclosures of your health information for the reasons covered by your authorization. We are unable to take back any disclosures that were already made with your authorization, and we are required to retain the records of the care that we provided to you.

In addition, you have the right to be notified if you are affected by a breach of unsecured personal information.

A.4 CHANGES TO THIS NOTICE

We reserve the right to change this notice. We reserve the right to make the revised or changed notice effective for health information we already have about you as well as any information we receive in the future. We will post a copy of the current notice at our offices. The notice will contain the effective date. You may also obtain a copy of any current notice by submitting a written request to the Privacy Official at the address set forth below.

A.5 COMPLAINTS/CONTACT US

If you believe that we have violated your privacy rights, you may file a complaint with us by notifying us at privacy@DiagnoseEarly.com. You may also file a complaint with the Secretary of the U.S. Department of Health and Human Services if you feel that your rights have been violated. There will be no retaliation from Diagnose Early for making a complaint.

Privacy Officer: Email privacy@diagnoseearly.com