HIPAA Notice of Privacy Practices

Effective date: September 20, 2026
Last updated: September 20, 2026

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.

This Notice of Privacy Practices (this “Notice”) describes how BioMark Diagnostics Inc. and its U.S. affiliates and workforce members that are covered by the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (“HIPAA”) (together, “BioMark,” “we,” “us,” or “our”) may use and disclose your protected health information (“PHI”), and your rights with respect to that information.

This Notice applies only when we create or receive PHI in our role as a HIPAA covered entity or business associate — for example, in connection with a laboratory test, clinical service, or health-plan or provider arrangement in the United States. It does not replace our Privacy Policy, Cookie Notice, or Consumer Health Data Privacy Policy, which cover Website and consumer information that is not PHI under HIPAA.

If we are not acting as a covered entity or business associate with respect to your information, HIPAA may not apply, and the other BioMark notices control.

1. Who we are

BioMark Diagnostics Inc.
145 – 10541 Shellbridge Way
Richmond, BC V6X 2W8
Canada
Tel: 1 604 370 0779
Email: info@biomarkdiagnostics.com

BioMark develops liquid-biopsy tests that use metabolomics and machine learning for cancer detection and related purposes. A U.S. laboratory, clinic, or affiliate may provide testing or related services that involve PHI. This Notice covers those HIPAA-covered activities.

This Notice also applies to members of our designated affiliated covered entity or organized health care arrangement, if we participate in one, and to our business associates when they handle PHI on our behalf, to the extent HIPAA requires.

2. What is PHI?

PHI is individually identifiable health information that we create or receive that relates to your past, present, or future physical or mental health or condition, the provision of health care, or payment for health care, and that identifies you or could reasonably be used to identify you. Examples may include:

  • name, address, date of birth, phone number, and other identifiers;
  • test orders, specimen information, and laboratory results;
  • diagnoses, treatment, and insurance or billing information; and
  • information in our records that is linked to the above.

De-identified information is not PHI. We may use or share de-identified data without this Notice applying.

3. How we may use and disclose PHI without your written authorization

HIPAA allows us to use and disclose PHI for the following purposes without your written authorization, unless a more protective law applies.

3.1 Treatment

We may use and disclose PHI to provide, coordinate, or manage your testing and related care. Examples: communicating with the ordering clinician, a referring laboratory, or a consulting specialist about a test we perform.

3.2 Payment

We may use and disclose PHI to obtain payment for services. Examples: billing you, your health plan, or Medicare/Medicaid; determining eligibility or coverage; and collections.

3.3 Health care operations

We may use and disclose PHI for our laboratory and business operations. Examples: quality assessment, proficiency testing, accreditation, licensing, training, customer service, compliance, auditing, and arranging for legal or accounting services.

3.4 Business associates

We may share PHI with vendors that perform services for us (for example, billing, IT hosting, courier, or accreditation support) if they have signed a HIPAA business associate agreement and are required to protect the PHI.

3.5 Required by law

We may use or disclose PHI when federal, state, or other law requires it, including to the U.S. Department of Health and Human Services in connection with a HIPAA investigation or review.

3.6 Public health and safety

We may disclose PHI for public-health activities (for example, to a public-health authority for disease reporting), to prevent or lessen a serious and imminent threat to health or safety, and for certain FDA-related purposes concerning products we test or that are regulated.

3.7 Health oversight

We may disclose PHI to health-oversight agencies for audits, inspections, licensure, and disciplinary proceedings.

3.8 Legal proceedings and law enforcement

We may disclose PHI in response to a court or administrative order, a subpoena or discovery request that meets HIPAA conditions, and for certain limited law-enforcement purposes permitted by HIPAA.

3.9 Coroners, funeral directors, and organ donation

We may disclose PHI to a coroner, medical examiner, or funeral director, and for organ, eye, or tissue donation, as permitted by law.

3.10 Research

We may use or disclose PHI for research when an institutional review board or privacy board has approved a waiver, when you authorize it, or when only a limited data set is used under a data-use agreement, as HIPAA allows.

3.11 Workers’ compensation and specialized government functions

We may disclose PHI as authorized by workers’ compensation laws and for certain military, national-security, or correctional-institution functions as HIPAA permits.

3.12 Appointment reminders and service communications

We may use PHI to contact you about a specimen, result availability, or a related operational matter. We will follow any stricter rules that apply to sensitive results.

4. Uses and disclosures that require your authorization

We will not use or disclose PHI for purposes not described in this Notice unless you sign a written authorization that meets HIPAA requirements. You may revoke an authorization in writing at any time, except to the extent we have already relied on it.

In particular, we will obtain your authorization before:

  • most uses or disclosures of PHI for marketing;
  • disclosures that constitute a sale of PHI; and
  • most uses and disclosures of psychotherapy notes, if we ever maintain them (BioMark does not typically create psychotherapy notes).

Other uses not listed in Section 3 also require authorization.

5. Your rights

You have the following rights, subject to HIPAA limits and verification of your identity.

5.1 Right to inspect and copy

You may ask to inspect or obtain a copy of PHI we maintain in a designated record set (for example, test reports and billing records we keep about you). We may charge a reasonable, cost-based fee. We may deny the request in limited situations; if we do, you may ask for a review where HIPAA provides one.

5.2 Right to request amendment

You may ask us to amend PHI you believe is incorrect or incomplete. We may deny the request if we did not create the information, it is not part of our designated record set, or we determine it is accurate and complete. If we deny the request, you may submit a written statement of disagreement.

5.3 Right to an accounting of disclosures

You may ask for a list of certain disclosures of your PHI that we made in the six years before your request. The accounting does not include disclosures for treatment, payment, and health care operations, or certain other disclosures HIPAA excludes. The first accounting in a 12-month period is free; we may charge for additional accountings.

5.4 Right to request restrictions

You may ask us to restrict uses or disclosures of PHI for treatment, payment, or operations, or to persons involved in your care. We are not required to agree, except that if you pay in full out of pocket for a service, you may require us not to disclose PHI about that service to a health plan for payment or operations, unless the disclosure is required by law.

5.5 Right to request confidential communications

You may ask us to contact you in a specific way (for example, only at a certain phone number or address). We will accommodate reasonable requests.

5.6 Right to a paper copy of this Notice

You may ask for a paper copy of this Notice at any time, even if you agreed to receive it electronically. Contact us using Section 9.

5.7 Right to notification of a breach

You have the right to be notified if a breach of your unsecured PHI occurs, as required by HIPAA.

5.8 Right to choose someone to act for you

If you have a legal representative (for example, a health-care proxy or guardian), that person may exercise your rights. We will verify authority before we act.

6. Our duties

We are required by law to:

  • maintain the privacy and security of your PHI;
  • provide you with this Notice of our legal duties and privacy practices;
  • abide by the terms of the Notice that is currently in effect;
  • notify you if a breach of unsecured PHI occurs; and
  • not use or disclose PHI in ways not described here without your authorization, except as the law allows.

We will not retaliate against you for filing a complaint or exercising your rights.

7. Changes to this Notice

We may change this Notice at any time. The revised Notice will apply to PHI we already have as well as PHI we receive in the future. We will post the current Notice on our Website and make a copy available on request. The effective date is at the top of this page.

8. Complaints

If you believe your privacy rights have been violated, you may file a complaint with BioMark or with the U.S. Department of Health and Human Services, Office for Civil Rights:

https://www.hhs.gov/hipaa/filing-a-complaint/index.html

You will not be penalized for filing a complaint.

9. How to contact us or exercise your rights

To exercise HIPAA rights, request a paper copy of this Notice, ask a question, or file a complaint with BioMark:

BioMark Diagnostics Inc.
Attention: Privacy / HIPAA
145 – 10541 Shellbridge Way
Richmond, BC V6X 2W8
Canada
Email: info@biomarkdiagnostics.com
Tel: 1 604 370 0779

Please put “HIPAA Request” in the subject line. We may need to verify your identity before we fulfill a request.

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