Legal & Compliance
HIPAA Privacy Notice
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.
FYR Diagnostics (“FYR Diagnostics”) is committed to protecting the privacy of your protected health information or “PHI” in accordance with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), its implementing regulations, and other applicable laws and regulations governing your PHI. Your PHI includes all individually identifiable health information transmitted or maintained by FYR Diagnostics which relates to your past, present or future health, treatment, or payment for health care services.
FYR Diagnostics is required by law to maintain the privacy of your PHI. We are also required to provide you with this Notice of our legal duties and privacy practices. This Notice describes our legal duties, privacy practices, and your patient rights under HIPAA. We are required to follow all terms of this Notice that are currently in effect and are required to notify you and other affected individuals in the event of a breach involving unsecured PHI. FYR Diagnostics stores PHI electronically and such PHI may be subject to electronic disclosure in accordance with this Notice and HIPAA.
How We May Use or Disclose Your Health Information
FYR Diagnostics may use your PHI for treatment, payment, or healthcare operations purposes and for other purposes permitted or required by law. Not every possible use or disclosure that FYR Diagnostics may make with your PHI is listed in this Notice, but all of our uses or disclosures of your PHI will fall into one of the categories listed below. We need your written authorization to use or disclose your PHI for any purpose not covered by one of the categories below. With limited exceptions, we will not use or disclose psychotherapy notes, use or disclose your PHI for marketing or fundraising purposes or sell your PHI unless you have signed an authorization. You may revoke any authorization you sign for such disclosures at any time. If you revoke your authorization, we will no longer use or disclose your PHI except to the extent we have already taken action based on your authorization. We may use and disclose your PHI for the following purposes:
FYR Diagnostics provides laboratory testing for individuals, state agencies, physicians, and other healthcare professionals, and we use your PHI in our testing processes. We disclose your PHI to authorized recipients who order tests or need access to your test results for treatment, benefits, or public health purposes. We may use and disclose PHI to contact you to remind you of an appointment or to tell you about our health-related products and services that may be of interest to you. Examples of other treatment-related purposes include disclosure to a pathologist to help interpret your test results or use of your PHI to contact you to obtain another specimen, if necessary.
FYR Diagnostics may use and disclose your PHI for purposes of billing and payment. For example, we may disclose your PHI to health plans or other payers to determine whether you are enrolled with the payer or eligible for health benefits or to obtain payment for our services. If you are insured under another person’s health insurance policy (for example, parent, spouse, domestic partner or a former spouse), we may also send invoices to the subscriber whose policy covers your health services.
FYR Diagnostics may use and disclose your PHI for activities necessary to support our healthcare operations, such as performing quality checks on our testing, internal audits, arranging for legal services, or developing reference ranges for our tests.
We may provide your PHI to other companies or individuals that need it to provide services to us. These other entities, known as “business associates,” are required to maintain the privacy and security of PHI. For example, our business associates may use your PHI to conduct billing, collections, imaging, courier, or record storage services on our behalf.
You and the Individuals Involved in Your Care
We may disclose relevant PHI to You or your personal representative, a family member, friend, caregiver or other individual involved in your healthcare or payment for your healthcare, if you tell us that this is acceptable to you or you do not object; or if in our professional judgment, we believe that you do not object.
As Required by Law
We may use and disclose your PHI as required by federal, state, or local law. For example, FYR Diagnostics may disclose your PHI when required by public health disclosure laws.
Law Enforcement Activities and Legal Proceedings
We may use and disclose your PHI if necessary to prevent or lessen a serious threat to your health and safety or that of another person. We may also provide PHI to law enforcement officials, for example, in response to a warrant, investigative demand or similar legal process, or for officials to identify or locate a suspect, fugitive, material witness, or missing person. We may disclose your PHI as required to comply with a court or administrative order. We may disclose your PHI in response to a subpoena, discovery request or other legal process in the course of a judicial or administrative proceeding, but only if efforts have been made to tell you about the request or to obtain an order of protection for the requested information.
We may use or disclose PHI for research purposes when permitted by law, such as when an Institutional Review Board or privacy board has reviewed the research proposal and plans to ensure the privacy of your PHI and determined that your authorization is not required. We may also use or disclose PHI about deceased patients to researchers if certain requirements are met. We may use and disclose a limited data set containing some of your PHI for research purposes. However, we will only disclose a limited data set if we enter into a data use agreement with the recipient.
Other Uses and Disclosures
As permitted by HIPAA, we may also disclose your PHI to:
- Social Services Agencies
- Public Health Authorities
- The Food and Drug Administration
- Health Oversight Agencies
- Military Command Authorities
- National Security and Intelligence Organizations
- Correctional Institutions
- Organ and Tissue Donation Organizations
- Coroners, Medical Examiners and Funeral Directors
- Workers Compensation Agents
- Governmental Agencies and Officials involved in oversight of health care systems, including the United States Department of Health and Human Services
We may also disclose PHI to those assisting in disaster relief efforts so that family or friends can be notified about your condition, status and location.
Incidental Uses and Disclosures
Sometimes, your PHI may be used or disclosed in the course of our primary uses and disclosures, such as for treatment, payment or healthcare operations. For example, we may use it in a telephone conversation with a provider. We are permitted to make such incidental uses and disclosures as long as we take reasonable steps to minimize them, and have in place appropriate safeguards to protect them.
Note Regarding State Law
For all of the above-stated purposes for which FYR Diagnostics may use your PHI, when state or local law is more restrictive than federal law, we are required to follow the more restrictive law.
Your Patient Rights
Receive Testing Information
You have the right to access, inspect, and copy your PHI that we have created. You may receive your test results via the clinic or provider who collected your sample. Under certain limited circumstances, FYR Diagnostics may deny your access to a portion of your 3 records. For example, you do not have a right to inspect and copy information that FYR Diagnostics has collected in connection with, or in reasonable anticipation of, any legal claim or proceeding.
Amend Health Information
You may request amendments (changes) to your PHI by making a written request to FYR Diagnostics if you believe the information is inaccurate or incomplete. However, we may deny the request in some cases (such as if we determine the PHI is accurate, and complete, or the law does not permit FYR Diagnostics to amend the requested information). If we deny your request to change your PHI, we will provide you with a written explanation of the reason for the denial and let you know about further actions you may take. FYR Diagnostics cannot amend information created by your physician or any other person other than FYR Diagnostics.
Accounting of Disclosures
You have the right to receive a list of certain disclosures of your PHI made by FYR Diagnostics in the past six years from the date of your written request. Under the law, this does not include disclosures made for treatment, payment, or healthcare operations or certain other purposes. Further, you will not receive an accounting of: (i) disclosures made to you, (ii) disclosures made pursuant to your authorization, (iii) disclosures made for purposes of treatment, payment, or health care operations, and (iv) disclosures made to friends or family in your presence or because of an emergency. If you request more than once accounting in any twelve (12) month period, FYR Diagnostics may charge you a reasonable fee for each accounting after the first accounting statement.
You may request that we agree to restrictions on certain uses and disclosures of your PHI. We are not required to agree to your request, except for requests to limit disclosures to your health plan for purposes of payment or healthcare operations when you have paid us for the item or service covered by the request out-of-pocket and in full and when the uses or disclosures are not required by law. However, if FYR Diagnostics does agree to your request, FYR Diagnostics is bound by such agreement, except when otherwise required by law, in emergencies, or when the information is necessary to treat you. FYR Diagnostics must agree to your request for a limitation or restriction on the disclosure of your Health Information to a health plan if you pay for a service or health care item out-of-pocket in full and the disclosure is exclusively for the purpose of payment or operations.
Request Confidential Communications
You have the right to request that we send your health information by alternative means or to an alternative address, and we will accommodate reasonable requests. Copy of this Notice You have the right to obtain a paper copy of this Notice upon request. How to Exercise Your Rights You may write or send an email to us with your specific request, including requesting a form to complete to obtain a copy of your test results. FYR Diagnostics will consider your request and provide you a response.
If you believe FYR Diagnostics has violated your privacy rights, you have the right to file a complaint with us. You also have the right to file a complaint with the Secretary of the U.S. Department of Health and Human Services, Office for Civil Rights. Complaints to the Secretary should be sent to:
U.S. Department of Health and Human Services, Hubert H. Humphrey Building, 200 Independence Ave. S.W., Washington, D.C. 20201 or by visiting www.hhs.gov/ocr/privacy/hipaa/complaints.
FYR Diagnostics will not penalize or retaliate against any individual for filing a complaint.
To file a complaint with us, or should you have any questions about this Notice, send an email to us at email@example.com or write to us at the following address:
FYR Diagnostics Attention: Privacy Officer 1121 East Broadway St Ste. 105 Missoula, MT 59802
You may also contact the Privacy Officer at (406) 303- 3560 ext 700.
Changes to this Notice
We reserve the right to amend the terms of this Notice to reflect changes in our privacy practices, and to make 4 the new terms and practices applicable to all PHI that we maintain about you, including PHI created or received prior to the effective date of the Notice revision. Our Notice is displayed on our website and in a visible location in FYR’s physical facility(ies). You may also request a copy of the most current version of this Notice at any time by contacting us at: firstname.lastname@example.org.
FYR Diagnostics complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. FYR Diagnostics does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. If you believe that FYR Diagnostics has failed to provide you its services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with the:
U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at: https://ocrportal.hhs.gov/ocr/portal/lobby.jsf
Or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C. 20201 (800)368-1019, (800) 537-7697 (TDD)
Should you have any questions concerning this Notice, please visit our website at www.fyrdiagnostics.com. You may also email email@example.com or call our Customer Service team at (406) 303-3560 ext 1.
Service Terms & Conditions
Sequencing Services Terms & Conditions
These Sequencer Services Terms and Conditions govern any Order (defined below) for sequencing services provided by FYR Diagnostics, Inc. (“FYR”) to you, either as an individual or an entity (“Customer”) (FYR and Customer are individually referred to herein as a “Party” and collectively as the “Parties”). By signing the Order, you accept these Sequencer Services Terms and Conditions on behalf of your entity or employer and, if on behalf of your employer, you represent and warrant that you have the requisite authority to bind your employer.
- “Agreement” means, collectively, these Terms and Conditions, any Order and any applicable amendments thereto
- “Customer Samples” means biological specimens or other materials provided to
FYR, or caused to be provided to FYR, by Customer for the Services.
- “FYR IP” means any methods, materials, data, processes, equipment and all
intellectual property rights thereto that are owned or controlled by FYR or licensed to FYR.
- “Order” means a statement of work, purchase order or service order that describes
the Services to be provided by FYR and is executed by both Parties.
- “Results” means any data, information, reports or other analysis generated by
FYR through the Services and delivered to Customer, but will not, in any event, include FYR IP.
- “Services” means all sequencing services and any additional services, including
but not limited to research and analysis, that are described in the applicable Order.
- “Terms and Conditions” means these Sequencer Services Terms and Conditions,
which may be updated or amended from time to time by FYR as set forth herein
2) Services; Customer Samples; Results
- Services. FYR agrees to perform the Services for Customer as described in the
applicable Order. FYR will provide qualified and trained personnel to conduct the Services and will perform all Services in accordance with all applicable laws and regulations, as well as FYR’s laboratory testing policies and procedures. FYR will use best efforts to adhere to the schedule set forth in the Order, but Customer understands that delays may happen and will be notified by FYR in the event of a significant delay. FYR may delegate performance of the Services, or a portion thereof, to a subcontractor without notice to Customer.
- Customer Samples. Customer will transmit all Customer Samples and
accompanying information to FYR in accordance with state and federal privacy regulations and laws and any specific instructions provided by FYR. Unless otherwise authorized in writing by FYR prior to the transmitting of a Customer Sample, Customer will ensure that no personally identifiable information or protected health information is provided to or accessible by FYR. Customer will notify FYR of any relevant safety information and other hazardous characteristics or properties of the Samples. Customer represents and warrants that it has the right to transfer the Customer Samples to FYR and allow FYR to use the Customer Samples for the Services and any other use agreed to by the Parties. Customer Samples and all information transmitted to FYR with the Customer Samples will be considered the Confidential Information of Customer. Unless otherwise specified in the Order or agreed to in writing, any Customer Samples not
destroyed or used in the Services will be destroyed after ninety (90) days.
- Results. FYR will deliver to Customer all Results set forth in the Order.
Customer acknowledges and agrees that the Results are neither guaranteed accurate nor guaranteed to produce any particular result. In the event that any Result obtained by FYR is “inconclusive” or “invalid” or a Customer Sample is otherwise delivered to FYR in a non- testable condition, FYR will not be obligated to test and/or retest such Customer Sample without further authorization from Customer and agreement to pay any necessary additional fees.
- CLIA-Certified Laboratory. To the extent necessary for the Services, FYR will
maintain a CLIA-certified diagnostic reference testing laboratory (CLIA License No.
27D2190551) and will follow all applicable federal and state laws and regulations appurtenant for the term of this Agreement. To the extent necessary for the Services, FYR will notify Customer in the event of a loss of CLIA certification status.
3) Payment Terms
- Payment Process. Customer will make all payments for the Services according to
the payment amounts and schedules stated in the applicable Order. Within thirty (30) days of receiving such invoices, Customer will remit payment to FYR according to FYR’s written instructions. Customer will also reimburse FYR for any reasonable expenses incurred in the performance of the Services.
- Taxes. Any federal, state, county, municipal or international sales, or use tax,
excise, charge or other tax assessment and any penalties and interest associated therewith, assessed or charged on the sale of the Services will be paid by Customer.
- Late Fees and Collection. Any amount not paid when due will accrue interest
until paid at the rate of 1.5% per month or the maximum amount allowed by law, whichever is less. Customer will be responsible for any reasonable costs of collection (including collection agency fees and attorneys’ fees) incurred by FYR. If invoices for Services are not timely paid, subsequent Services may be canceled, delayed or subject to prepayment until overdue amounts are paid.
- Third Party Reimbursement. Neither Party will be entitled to bill any third party
reimbursement programs for the Services. As used herein, the term “third-party reimbursement programs” will include, but not necessarily be limited to, health maintenance organizations, private health insurance companies, Medicare and Medicaid programs and other third-party payors.
- Fair Market Value. The Parties acknowledge that the compensation set forth in
this Agreement is consistent with fair market value in arms-length transactions and is not based upon the volume or value of referrals or business between the Parties. The Parties will, in good faith, periodically review the amount of the payments to ensure they remain at fair market value.
- No Inducement to Refer. It is not the purpose of this Agreement to induce patient
referrals. The Parties acknowledge that there is no requirement or understanding under this Agreement, express or implied, that either Party will refer patients to the other Party.
4) Term And Termination
- Term. The Agreement will commence on the date on which the last party signs the Order and will remain in effect through the term of any Order or until terminated in accordance with this Section 4.
- Termination. Either Party may terminate this Agreement, without cause, breach or penalty, upon thirty (30) days’ prior written notice to the other Party.
- Effect of Termination. Upon the termination of this Agreement for any reason or for no reason, neither Party will have further rights against, or obligations to, the other Party except with respect to any rights or obligations accruing prior to the date and time of termination and any obligations, promises or agreements that expressly extend beyond the termination or which by their nature extend beyond the termination.
Each Party will maintain the confidentiality of any information provided to it by the other Party that is identified as confidential or can reasonably be regarded as confidential and will take precautions that are at least as protective of its own information to prevent the unauthorized disclosure or use of such confidential information (“Confidential Information”). Confidential Information does not include: any information or material that is (a) already known to the recipient Party; (b) publicly known other than by a wrongful act of the recipient Party; (c) received from a third party lawfully entitled to disclose it; (d) disclosed pursuant to an enforceable order of a court or administrative agency; and/or (e) is independently developed by or for the recipient Party. Upon written request, each Party will return all of the other Party’s Confidential Information. Each Party acknowledges and agrees that a breach or violation of this Section by it will have an irreparable, material and adverse effect upon the other Party and that damages arising from any such breach or violation may be difficult to ascertain. Without limiting any other remedy at law or in equity available to such Party, in the event of any breach of any covenant contained in this Agreement by a Party, the other Party will have the right to seek an immediate injunction enjoining the Party from breaching or violating of such covenant or covenants, without the need to post any security or bond. The confidentiality obligations set forth in this Section 5 will survive for a period of one (1) year after expiration or termination of this Agreement.
As between the Parties, Customer will be the exclusive owner of Customer Confidential Information, Customer Samples and Results, and FYR will be the exclusive owner of FYR IP and any improvement, modifications or derivative works thereof, even if developed during the performance of the Services. Customer hereby grants to FYR a worldwide, non-exclusive, royalty-free, transferable, sublicensable, perpetual and irrevocable license to use the Results for any purpose, including providing the Services, improving existing services and products and developing new products and services; provided, however, that FYR’s use of the Results in no way identifies Customer. Nothing in the Agreement will be construed as conferring to Customer explicitly or by implication, estoppel or otherwise any license, right or immunity under FYR’s intellectual property rights, including FYR IP.
7) Limitation Of Liability
UNDER NO CIRCUMSTANCES WILL FYR OR ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, SUCCESSORS OR ASSIGNS BE LIABLE TO CUSTOMER OR ANY THIRD PARTY FOR ANY SPECIAL, INDIRECT, CONSEQUENTIAL, PUNITIVE DAMAGES OR OTHER DAMAGES INCLUDING BUT NOT LIMITED TO, LOSS OF REVENUES, LOSS OF PROFITS OR LOSS OF DATA, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. SHOULD THE FOREGOING LIMITATION BE DETERMINED TO BE UNENFORCEABLE IN ANY RESPECT, THE UNENFORCEABLE PART WILL BE DEEMED REMOVED, AND THE REMAINDER WILL REMAIN IN EFFECT. THE TOTAL LIABILITY OF FYR OR ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, SUCCESSORS OR ASSIGNS TO CUSTOMER OR ANY THIRD PARTY FOR ANY DAMAGES IS LIMITED TO THE AMOUNT PAID BY CUSTOMER DURING THE PRECEDING THREE (3) MONTHS TO FYR.
ALL SERVICES PROVIDED UNDER THIS AGREEMENT ARE FURNISHED AS IS, WHERE IS, AND WITH ALL FAULTS AND WITHOUT WARRANTY OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
9) General Terms
- Independent Contractor Status. In the performance of this Agreement, it is
mutually understood and agreed that FYR and its personnel are at all times acting and
performing as an independent contractor with, and not as employees, joint venturers, agents or lessees of Customer and that FYR personnel will not have any claim under this Agreement against Customer for vacation pay, sick leave, retirement benefits, social security, disability, workers compensation, unemployment insurance or any other employee benefits.
- No Waiver. The failure of any Party to insist at any time upon the strict
observance or performance of any of the provisions of this Agreement or to exercise any right or remedy as provided herein will not impair any such right or remedy or be construed as a waiver or relinquishment thereof. Every right and remedy given by this Agreement to the Parties may be exercised from time to time and as often as may be deemed expedient by the Parties, as the case may be. A waiver will only be effective if in writing and a waiver by either Party of a breach or failure to perform hereunder will not constitute a waiver of any subsequent breach or failure.
- No Third-Party Benefit. This Agreement is intended for the exclusive benefit of
the Parties hereto and their respective successors and permitted assigns and nothing contained in this Agreement will be construed as creating any rights or benefits in or to any third party.
- Assignment; Exclusivity. Customer may not assign any interest or obligation
under this Agreement without FYR’s prior written consent. Customer understands and
acknowledges that the Services are provided on a non-exclusive basis, and FYR reserves all rights to continue to provide similar Services to third parties.
- Severability. If any clause or provision is be judged invalid or unenforceable by a
court of competent jurisdiction or by operation of any applicable law, it will not affect the
validity of any other clause or provision, but will remain in full force and effect. Each provision of this Agreement will be enforceable independently of any other claim or cause of action.
- Press. Customer may not publish any press release, make any other public
announcement or otherwise communicate with any news media or public source concerning this Agreement or the transactions contemplated hereby without the prior written consent of FYR. Unless Customer states otherwise in writing at the time of signature on its first Order, FYR may use Customer’s name and logo in any public materials, including promotional or marketing materials.
- Force Majeure. The failure or delay of either of the Parties to perform any
obligation under this Agreement (except the payment of money) by reason of earthquake, flood, fire or other act of God, riots, wars, strikes, lockouts, labor disturbances, accidents in transportation or other causes beyond its reasonable control will not be deemed to be a breach of this Agreement.
- Governing Law; Venue. This Agreement will be construed and interpreted in
accordance with the laws of the State of Montana. Any action arising out of or to enforce this Agreement must be brought in courts in the State of Montana. The Parties consent to the jurisdiction of the courts in the State of Montana and to service of process by registered mail, return receipt requested, or by any other manner provided by law.
- Complete Agreement. This Agreement supersedes all prior agreements and
understandings between the Parties and constitutes the entire agreement of the Parties on this matter. The Terms and Conditions may be amended, updated or modified from time to time by FYR, in its sole and absolute discretion. Any amended, updated or modified Terms and Conditions will apply to Orders that are instituted after the date the amended, updated or modified Terms and Conditions are posted online. In the event of a conflict between these Terms and Conditions and the Order, these Terms and Conditions will control. Any Customer terms of purchase and/or terms or conditions in a purchase order or other ordering document will have no effect and are hereby expressly rejected by FYR.
- Notices. Any notices must be hand delivered or mailed, via certified mail, to:
FYR Diagnostics, Inc.
1121 East Broadway Street
MonTEC, Suite 155
Missoula, MT 59802