THIS NOTICE DESCRIBES HOW PROTECTED HEALTH INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED. PLEASE REVIEW IT CAREFULLY.
This Notice of Privacy Practices applies to iMDx, Inc and all of its subsidiaries and business units (collectively, “iMDx”), except to the extent that a subsidiary, division, or business unit of iMDx performs, if applicable, certain occupational screening, forensic tests, paternity/identity tests, or other services that may not be subject to HIPAA under this notice.
iMDx’s Protection of Protected Health Information
Under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), iMDx is required by law to maintain the privacy of health information that identifies you, called protected health information (“PHI”), and to provide you with notice of our legal duties and privacy practices regarding PHI. iMDx is committed to the protection of your PHI and will make reasonable efforts to ensure the confidentiality of your PHI, as required by statute and regulation. We take this commitment seriously and will work with you to comply with your right to receive certain information under HIPAA.
iMDx’s Use and Disclosure of PHI
As permitted under HIPAA, the following categories explain the types of uses and disclosures of PHI by iMDx. Some of the uses and disclosures described may be limited or restricted by state laws or other legal requirements, for example, the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Please contact us, using the contact information provided at the end of this notice, for specific information regarding your state.
For treatment – iMDx may use or disclose PHI for treatment purposes, including disclosure to physicians, nurses, medical students, pharmacies, and other health care professionals who provide you with health care services and/or are involved in the coordination of your care, such as providing your physician with your laboratory test results.
For payment – iMDx may use or disclose PHI to bill and collect payment for laboratory services and other services. For example, iMDx may provide PHI to your health plan to receive payment for the health care services provided to you.
For health care operations – iMDx may use or disclose PHI for health care operations purposes. These uses and disclosures are necessary, for example, to evaluate the quality of our laboratory testing, accuracy of results, accreditation functions and for iMDx’s operation and management purposes. iMDx may also disclose PHI to other health care providers or health plans that are involved in your care for their health care operations. For example, iMDx may provide PHI to manage disease, or to coordinate health care or health benefits.
Appointment reminders and health-related benefits and services – iMDx may use and disclose PHI to contact you as a reminder that you have an appointment with us and may use and disclose PHI to tell you about health-related benefits and services that may be of interest to you. For example, iMDx may contact you about new testing services available at iMDx based on services ordered by your physician.
Individuals involved in your care or payment for your care – iMDx may disclose PHI to a person who is involved in your care or helps pay for your care, such as a family member or friend. We also may notify your family about your location or general condition or disclose such information to an entity assisting in a disaster relief effort. You may tell us whether you want us to share such information and, if so, with whom. As allowed by federal and state law, we may disclose the PHI of minors to their parents or legal guardians.
Business associates – iMDx may disclose PHI to its business associates to perform certain business functions or provide certain business services to iMDx. For example, we may use another company to perform billing services on our behalf. All of our business associates are required to maintain the privacy and confidentiality of your PHI. In addition, at the request of your health care providers or health plan, iMDx may disclose PHI to their business associates for purposes of performing certain business functions or health care services on their behalf. For example, we may disclose PHI to a business associate of Medicare for purposes of medical necessity review and audit.
Disclosure for judicial and administrative proceedings – Under certain circumstances, iMDx may disclose your PHI in the course of a judicial or administrative proceeding, including in response to a court or administrative order, subpoena, discovery request, or other lawful process.
Law enforcement – iMDx may disclose PHI for law enforcement purposes, including reporting of certain types of wounds or physical injuries or in response to a court order, warrant, subpoena or summons, or similar process authorized by law. We may also disclose PHI when the information is needed: 1) for identification or location of a suspect, fugitive, material witness or missing person, 2) about a victim of a crime, 3) about an individual who has died, 4) in relation to criminal conduct on iMDx premises or involving iMDx assets, or 5) 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.
As required by law – iMDx must disclose your PHI if required to do so by federal, state, or local law.
Public Health – iMDx may disclose PHI for public health activities. These activities generally include: 1) disclosures to a public health authority to report, prevent or control disease, injury, or disability; 2) disclosures to report births and deaths, or to report child abuse or neglect; 3) disclosures to a person subject to the jurisdiction of the Food and Drug Administration (“FDA”) for purposes related to the quality, safety or effectiveness of an FDA-regulated product or activity, including reporting reactions to medications or problems with products or notifying people of recalls of products they may be using; 4) disclosures 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 5) disclosures to an employer about an employee to conduct medical surveillance in certain limited circumstances concerning work-place illness or injury.
Disclosure about victims of abuse, neglect, or domestic violence – iMDx may disclose PHI about an individual to a government authority, including social services, if we reasonably believe that an individual is a victim of abuse, neglect, or domestic violence.
Health oversight activities – iMDx may disclose PHI to a health care oversight agency for activities authorized by law such as audits, civil, administrative, or criminal investigations and proceedings/actions, inspections, licensure/disciplinary actions, or other activities necessary for appropriate oversight of the health care system, government benefit programs, and compliance with regulatory requirements and civil rights laws.
Coroners, medical examiners, and funeral directors – iMDx may disclose PHI to a coroner, medical examiner, or funeral director for the purpose of identifying a deceased person, determining cause of death, or for performing some other duty authorized by law.
Organ Procurement and tissue donations requests – We can share health information about you with organ procurement organizations.
Personal Representative – iMDx may disclose PHI to your personal representative, as established under applicable law, or to an administrator, executor, or other authorized individual associated with your estate.
Correctional Institution – iMDx may disclose the PHI of an inmate or other individual when requested by a correctional institution or law enforcement official for health, safety, and security purposes.
Serious threat to health or safety – iMDx may disclose PHI if necessary to prevent or lessen a serious and/or imminent threat to health or safety to a person or the public or for law enforcement authorities to identify or apprehend an individual.
Research – iMDx may use and disclose PHI for research purposes. Subject to certain procedures, limited sets of data or records may be viewed by researchers to identify patients who may qualify for their research project or for other research purposes.
Before we use or disclose PHI for any other research activity, one of the following will happen, in accordance with applicable law: 1) a special committee will determine that the research activity poses minimal risk to privacy and that there is an adequate plan to safeguard PHI; 2) if the PHI relates to deceased individuals, the researchers give us assurances that the PHI is necessary for the research and will be used only as part of the research; or 3) the researcher will be provided only with information that does not identify you directly.
Government functions – In certain situations, iMDx may disclose the PHI of military personnel and veterans, including Armed Forces personnel, as required by military command authorities. Additionally, we may disclose PHI to authorized officials for U.S. national security purposes, such as protecting the President of the United States, conducting intelligence, counter-intelligence, and other national security activities.
Workers’ compensation – As authorized by applicable laws, iMDx may use or disclose PHI to comply with workers’ compensation or other similar programs established to provide work-related injury or illness benefits.
De-identified Information – iMDx may use and disclose health information that has been “de-identified” by removing certain identifiers making it unlikely that you could be identified, which can then be used for certain health care purposes.
Other Uses and Disclosures of PHI
For purposes not described above, including uses and disclosures of PHI for marketing purposes and disclosures that would constitute a sale of PHI, iMDx will ask for patient authorization before using or disclosing PHI. If you signed an authorization form, you may revoke it, in writing, at any time, except to the extent that action has been taken in reliance on the authorization.
Information Breach Notification
iMDx is required to provide patient notification if it discovers a breach of unsecured PHI unless there is a demonstration, based on a risk assessment, that there is a low probability that the PHI has been compromised. You will be notified without unreasonable delay and no later than 60 days after discovery of the breach (or sooner if other applicable law applies). Such notification will include information about what happened and what can be done to mitigate any harm.
Patient Rights Regarding PHI
Subject to certain exceptions, HIPAA establishes the following patient rights with respect to PHI:
Right to Receive a Copy of the iMDx Notice of Privacy Practices – You have a right to receive a copy of the iMDx Notice of Privacy Practices at any time by contacting us at [email protected], calling us at (615) 255-8880, or by sending a written request to: iMDx, HIPAA, 2 International Plaza Dr. Suite 510, Nashville, TN 37217. This Notice will also be posted on the iMDx website at www.imdxinc.com.
Right to Request Limits on Uses and Disclosures of your PHI – You have the right to request that we limit: 1) how we use and disclose your PHI for treatment, payment, and health care operations activities; or 2) our disclosure of PHI to individuals involved in your care or payment for your care. iMDx will consider your request, but is not required to agree to it unless the requested restriction involves a disclosure that is not required by law to a health plan for payment or health care operations purposes and not for treatment, and you have paid for the service in full out of pocket. If we agree to a restriction on other types of disclosures, we will state the agreed restrictions in writing and will abide by them, except in emergency situations when the disclosure is for purposes of treatment.
Right to Request Confidential Communications – You have the right to request that iMDx communicate with you about your PHI at an alternative address or by an alternative means. iMDx will accommodate reasonable requests.
Right to See and Receive Copies of Your PHI – You and your personal representative have the right to access PHI consisting of your laboratory test results or reports ordered by your physician. Within 30 days after our receipt of your request, you will receive a copy of the completed laboratory report from iMDx unless an exception applies. Exceptions include a determination by a licensed health care professional that the access requested is reasonably likely to endanger the life or safety of you or another person, and our inability to provide access to the PHI within 30 days, in which case we may extend the response time for an additional 30 days if we provide you with a written statement of the reasons for the delay and the date by which access will be provided. You have the right to access and receive your PHI in an electronic format if it is readily producible in such a format. You also have the right to direct iMDx to transmit a copy to another person you designate, provided that such request is made in writing, signed by you, and clearly identifies the designated person and where to send the copy of your PHI. To request a copy of your PHI: Contact us at [email protected], or call us at (949) 409-7600.
Right to Receive an Accounting of Disclosures – You have a right to receive a list of certain instances in which iMDx disclosed your PHI. This list will not include certain disclosures of PHI, such as (but not limited to) those made based on your written authorization or those made prior to the date on which iMDx was required to comply. If you request an accounting of disclosures of PHI that were made for purposes other than treatment, payment, or health care operations, the list will include disclosures made in the past six (6) years, unless you request a shorter period of disclosures. If you request an accounting of disclosures of PHI that were made for purposes of treatment, payment, or health care operations, the list will include only those disclosures made in the past three (3) years for which an accounting is required by law, unless you request a shorter period of disclosures.
Right to Correct or Update your PHI – If you believe that your PHI contains a mistake, you may request, in writing, that iMDx correct the information. If your request is denied, we will provide an explanation of the reasoning for our denial.
How to Exercise Your Rights – To exercise any of your rights described in this notice, you must send a written request to: iMDx, HIPAA, 15 Cushing Irvine, CA 92618.
How to Contact Us or File a Complaint
If you have questions or comments regarding the iMDx Notice of Privacy Practices, or have a complaint about our use or disclosure of your PHI or our privacy practices, please contact us at: [email protected], call us at (949) 409-7600, or write us at iMDx, HIPAA, 15 Cushing Irvine, CA 92618. You also may file a complaint with the Secretary of the U.S. Department of Health and Human Services by sending a letter to 200 Independence Avenue, S.W., Washington, D.C. 20201, calling 1-877-696-6775, or visiting
www.hhs.gov/ocr/privacy/hipaa/complaints/
iMDx will not take retaliatory action against you for filing a complaint about our privacy practices.
Changes to the iMDx Notice of Privacy Practices
iMDx reserves the right to make changes to this notice and to our privacy policies from time to time. Changes adopted will apply to any PHI we maintain about you. iMDx is required to abide by the terms of our notice currently in effect. When changes are made, we will promptly update this notice and post the information on the iMDx website at imdxinc.com. Please review this site periodically to ensure that you are aware of any such updates.
©2025 Insight Molecular Diagnostics Inc. All rights reserved. iMDx, GraftAssureCore, GraftAssureIQ, GraftAssureDx, DetermaIO, DetermaCNI, and OncoTIME are trademarks of Insight Molecular Diagnostics Inc. All other trademarks are the property of their respective owners. For the intended uses of all products, please refer to www.imdxinc.com.
WEBSITE BY: LEFT HAND DESIGN
James Liu joined iMDx in July 2021 and was appointed Vice President of Accounting, Controller, Treasurer, and Principal Accounting Officer in March 2025. He has held several key roles at iMDx, including Senior Director, Controller & Principal Accounting Officer and Manager of SEC Reporting & Compliance. James also served as interim Principal Financial Officer from August 2023 to June 2024, overseeing financial operations and public company reporting.
Before iMDx, James served as Accounting Manager at Acacia Research Corporation, where he led the SEC reporting and compliance, accounting close, and all other financial reporting requirements of an opportunistic capital platform that identifies and acquires other. He also worked as Senior Accountant at Gatekeeper Systems, Inc. and as Senior Assurance Associate at BDO USA, LLP, gaining deep expertise in financial reporting and assurance practices across multiple industries.
James holds a BASc degree from the University of California, San Diego, and is a Certified Public Accountant.
Peter Hong oversees iMDx’s legal department. Before joining iMDx in August 2021, Peter was an associate at Stradling Yocca Carlson & Rauth, P.C., where he represented both public and private companies in capital markets, M&A, and corporate governance matters. Prior to that, he worked at the New York office of Covington & Burling LLP, where he represented underwriters in the initial public offerings and follow-on offerings of biotechnology companies. At Covington, Peter also advised overseas clients with regard to restructuring, employment matters and the formation of U.S. subsidiaries.
Peter earned his JD from Columbia Law School and his Bachelor of Science in Business Administration from Washington University in St. Louis. He is admitted to practice law in New York and California.
Ryan Andrews joined iMDx in 2019 and currently serves as Vice President of Commercial, leading the strategic commercialization of iMDx’s innovative products and solutions. Prior to this role, he held key leadership positions within the company, including Director and Senior Director of Marketing, where he played a pivotal role in shaping iMDx’s market strategy and brand presence.
With extensive experience in the diagnostics and life sciences industry, Ryan brings a deep understanding of market dynamics, business development, and commercial execution. His expertise spans product commercialization, strategic partnerships, and market expansion, ensuring iMDx’s solutions reach the healthcare providers and patients who need them most.
Before joining iMDx, Ryan was a Principal at Bethesda Group, LLC, a boutique consulting firm specializing in guiding small and mid-stage diagnostic companies and investment groups through market entry, product launches, and commercialization strategies. He has also held sales, marketing, and operational leadership roles at Thermo Fisher Scientific, Life Technologies, and Cytovance Biologics, where he gained extensive experience in the biotechnology, diagnostics, and life sciences sectors.
Ryan holds an MBA from the University of Mississippi and remains committed to advancing precision diagnostics and improving patient outcomes through innovative commercial strategies.
Sandra is an activator and results-driven leader with expertise in operational leadership, commercialization, and corporate integration. With a strong record of driving transformation across small and mid-sized organizations, Sandra brings a unique ability to align cross-functional teams, streamline operations, and deliver measurable business outcomes.
Sandra joined iMDx in December 2019, and in her current role, she leads business operations in support of product development, working closely with senior leadership to ensure alignment with the company’s long-term strategic goals. She champions scalable processes, fosters continuous improvement, and supports innovation throughout the organization.
Beyond her corporate responsibilities, Sandra serves as Vice President of the Orange County chapter of the Healthcare Businesswomen’s Association (HBA), where she partners with the board to shape the chapter’s vision, drive strategic initiatives, and engage with the Chapter Advisory Board to elevate leadership and inclusion in the healthcare industry.
Sandra is known for driving consensus among teams, focused execution of goals and turning strategy into action.
Sandra earned a Bachelor of Business Administration (B.B.A.) and HR Management Certification from California State University, Fullerton.
Innovation resonates most with me because it challenges us to find new solutions for patients, for science, and for the future of healthcare. It drives continuous improvement and meaningful impact.
But innovation doesn’t happen in a vacuum. It thrives when grounded in integrity, fueled by courage, aligned with putting patients first, with everyone working as One Team.
To me, innovation is the engine, and it is powered by all our values working together.
Andrea James is an expert in guiding financial strategy through multiple phases of growth, raising and stewarding capital, and building relationships with high quality institutional investors. Prior to joining iMDx in 2024, she served in a series of escalating roles at Axon Enterprise, Inc. (Nasdaq: AXON), including Chief Communications Officer and Head of Investor Relations, and Senior Vice President of Strategy. She played a key role in the company’s growth from a $1 billion to a $20 billion market capitalization and established Axon’s corporate strategy function, overseeing capital stewardship, mergers and acquisitions, strategic partnerships, and investments. Her leadership contributed to more than $550 million in equity capital offerings.
Before joining Axon, Andrea assisted Tesla, Inc. (Nasdaq: TSLA) with strategic investor relations, and has also served as Vice President and Senior Research Analyst at Dougherty & Co. (now Colliers Securities), specializing in researching disruptive technologies.
Andrea holds a Bachelor of Science, summa cum laude, in Computer Information Systems from American University. She also earned a Master of Science in Journalism from Northwestern University, graduating with Kappa Tau Alpha honors.
Johnson Chiang is an experienced technology leader with a strong background in molecular diagnostics, focusing on product development, systems integration, and regulatory strategy. Johnson joined iMDx in 2021, having previously served as Chief Technology Officer at Alveo Technologies, an IVD company that specializes in developing cutting-edge molecular diagnostic tests. At iMDx, he continues to leverage his expertise to drive innovation in diagnostic solutions.
Previously, Johnson led the development of the be.well COVID-19 Test at Alveo Technologies, which completed a U.S. clinical trial and earned the CE mark and UK approval. In addition to his leadership in product development, he was involved in fundraising efforts that raised $50MM over four years and played a key role in securing the XPrize Grand Award for Rapid COVID Testing. Earlier in his career, Johnson was the Head of Systems Integration & Molecular Biology at Foundation Medicine, Inc., and held senior management roles at Life Technologies and Thermo Fisher Scientific. One of his key achievements was leading the Oncomine Dx Target Test, the first NGS-based CDx test approved by the FDA. Additionally, he holds several patents and has published numerous papers in biotechnology.
Johnson holds a Ph.D. in BioMEMS (Micro Electro-Mechanical Systems) from the University of California, Irvine. He also earned a Master of Engineering from The Ohio State University.
Ekkehard (Ekke) Schütz is a renowned leading expert in molecular genetics, diagnostics, and cell-free DNA (cf-DNA) research. He joined iMDx in April 2021 through its acquisition of Chronix Biomedical Inc. and now serves as Managing Director of Chronix Biomedical GmbH (a fully owned subsidiary of iMDx) and Chief Medical Officer (CMO) for Europe.
Under his leadership, Chronix became a leader in cf-DNA diagnostics, producing numerous publications and securing a broad patent portfolio, including ten patent families with many issued patents in the U.S. and Europe, which he invented.
Fellow of the National Academy for Clinical Biochemistry (now FAACC) since 2014, Ekke has published over 190 peer-reviewed papers, contributed to 100+ congress abstracts, and received several international scientific awards. He has also been a reviewer for top scientific journals, including PNAS, Clinical Chemistry, Clinical Biochemistry, and Nucleic Acids Research.
Ekke trained in laboratory medicine at Georg-August-University Hospital in Goettingen, Germany under Prof. Dr. Michael Oellerich, a renowned expert in therapeutic drug monitoring and transplantation surveillance.
Each of our company values is important to me, but the most important one is patient first!
For me as M.D. my major driving force during my entire career was to establish diagnostic measures that would make an impact by helping patients.
It is very satisfying to see that we all at iMDx share this goal as our first corporate value.
Josh Riggs is an accomplished and results-driven business leader with extensive experience in market access, molecular diagnostics, and strategic business development. He joined iMDx in August 2020, where he quickly became a key driver of the company’s growth and innovation. Initially serving as Senior Director of Business Development and General Manager of Transplant, Josh demonstrated exceptional leadership and business acumen, which ultimately led to his appointment as CEO in December 2022. As CEO, Josh has spearheaded the strategic pivot of iMDx, leading the organization to decentralize its testing approach and expand its impact on patient care.
Prior to his tenure at iMDx, Josh founded and led Intelliger Consulting, a firm specializing in healthcare marketing strategies. He also served as a principal at Bethesda Group, LLC, where he advised diagnostic companies and investors on market entry, commercialization, and expansion strategies.
Before venturing into the healthcare and diagnostics sectors, Josh gained valuable operational experience in the manufacturing industry. As part of the team at Industrial Timber, a startup manufacturer, he was responsible for managing and establishing multiple manufacturing facilities across the southeastern United States.
Josh holds an MBA from the University of Mississippi.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.