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Data Protection Declaration and Consent to Use Data by https://clear-forward.com and https://clear-forward.nl ClearForward Scope of Clinical Consulting Services and HIPAA Compliance Agreement, Terms and Conditions
a) One-time ClearForward account set up;
b) Clinical evaluation to determine the clinical applicability of Clear Aligner treatment (all appropriate records and prescription forms must be submitted online through Arcad Platform);
c) Complimentary on-going review of Cleaer Aligner Clinical Treatment Preferences in Arcad Platform;
d) Unlimited modifications for each individual treatment i.e. Full or Express Service; and
(I) The following terms used in this Agreement shall have the same meaning as those terms in the HIPAA Rules: Breach, Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices, Protected Health Information, Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.
(II) Specific definitions:
A. Business Associate. “Business Associate” shall generally have the same meaning as the term “business associate” at 45 CFR 160.103, and in reference to the party to this agreement, shall mean ClearForward, B.V.
B. Covered Entity. “Covered Entity” shall generally have the same meaning as the term “covered entity” at 45 CFR 160.103, and in reference to the party to this agreement, shall mean the Company
C. HIPAA Rules. “HIPAA Rules” shall mean the Privacy, Security, Breach Notification, and Enforcement Rules at 45 CFR Part 160 and Part 164.
(b) Obligations and Activities of Business Associate. The Business Associate agrees to:
(I) Not use or disclose protected health information other than as permitted or required by the Agreement or as required by law;
(II) Use appropriate safeguards, and comply with Subpart C of 45 CFR Part 164 with respect to electronic protected health information, to prevent use or disclosure of protected health information other than as provided for by the Agreement;
(III) Report to covered entity any use or disclosure of protected health information not provided for by the Agreement of which it becomes aware, including breaches of unsecured protected health information as required at 45 CFR 164.410, and any security incident of which it becomes aware;
(IV) In accordance with 45 CFR 164.502(e)(1)(ii) and 164.308(b)(2), if applicable, ensure that any subcontractors that create, receive, maintain, or transmit protected health information on behalf of the business associate agree to the same restrictions, conditions, and requirements that apply to the business associate with respect to such information;
(V) Make available protected health information in a designated record set to the covered entity as necessary to satisfy covered entity’s obligations under 45 CFR 164.524;
(VI) Make any amendment(s) to protected health information in a designated record set as directed or agreed to by the covered entity pursuant to 45 CFR 164.526, or take other measures as necessary to satisfy covered entity’s obligations under 45 CFR 164.526;
(VII) Maintain and make available the information required to provide an accounting of disclosures to the covered entity as necessary to satisfy covered entity’s obligations under 45 CFR 164.528;
(VIII) To the extent the business associate is to carry out one or more of covered entity’s obligation(s) under Subpart E of 45 CFR Part 164, comply with the requirements of Subpart E that apply to the covered entity in the performance of such obligation(s); and
(IX) Make its internal practices, books, and records available to the Secretary for purposes of determining compliance with the HIPAA Rules.
(c) Permitted Uses and Disclosures by Business Associate.
(I) Business associate may only use or disclose protected health information as necessary to perform the Services and the Additional Services described in this Agreement.
(II) Business associate may use or disclose protected health information as required by law.
(III) Business associate agrees to make uses and disclosures and requests for protected health information consistent with covered entity’s minimum necessary policies and procedures.
(IV) Business associate may not use or disclose protected health information in a manner that would violate Subpart E of 45 CFR Part 164 if done by covered entity except for the specific uses and disclosures set forth below.
A. Business associate may use protected health information for the proper management and administration of the business associate or to carry out the legal responsibilities of the business associate.
B. Business associate may disclose protected health information for the proper management and administration of business associate or to carry out the legal responsibilities of the business associate, provided the disclosures are required by law, or business associate obtains reasonable assurances from the person to whom the information is disclosed that the information will remain confidential and used or further disclosed only as required by law or for the purposes for which it was disclosed to the person, and the person notifies business associate of any instances of which it is aware in which the confidentiality of the information has been breached.
C. Business associate may provide data aggregation services relating to the health care operations of the covered entity.
D. Covered Entity’s Privacy Practices and Restrictions. Covered entity shall notify business associate of any limitation(s) in the notice of privacy practices of covered entity under 45 CFR 164.520, to the extent that such limitation may affect business associate’s use or disclosure of protected health information.
E. Obligations of Business Associate Upon Termination.Upon termination of this Agreement for any reason, business associate, with respect to protected health information received from covered entity, or created, maintained, or received by business associate on behalf of covered entity, shall:
(I) Retain only that protected health information which is necessary for business associate to continue its proper management and administration or to carry out its legal responsibilities;
(II) Destroy the remaining protected health information that the business associate still maintains in any form;
(III) Continue to use appropriate safeguards and comply with Subpart C of 45 CFR Part 164 with respect to electronic protected health information to prevent use or disclosure of the protected health information, other than as provided for in this Section, for as long as business associate retains the protected health information;
(IV) Not use or disclose the protected health information retained by business associate other than for the purposes for which such protected health information was retained and subject to the same conditions set out hereinabove; and
(V) Destroy the protected health information retained by business associate when it is no longer needed by business associate for its proper management and administration or to carry out its legal responsibilities.
(VI) The obligations of business associate under this Section shall survive the termination of this Agreement.
(a) Authority to Execute Agreement. The undersigned parties to this Agreement warrant and represent that they have the power and authority to enter into this Agreement in the names, titles and capacities herein stated and on behalf of any entities, persons or firms represented or purported to be represented by such respective party.
(b) Waiver. A waiver by either party of any of the terms and conditions of this Agreement in any instances shall not be deemed or construed to be a waiver of such term or condition for the future, or of any subsequent breach thereof, or of any other term and condition of the Agreement.
(c) Amendments. This Agreement may be amended only by an instrument in writing executed by the undersigned parties.
(d) Notice. Any notice, request, demand or other communication permitted to be given hereunder shall be in writing and shall be deemed to be duly given when personally delivered to an executive officer of Company or to Consultant, as the case may be, or upon confirmation of delivery by a bona fide international courier service. Either party may change, by written notice transmitted in the manner prescribed above, the address to which notices are to be sent.
(e) Dispute Resolution. Any dispute arising out of or in connection with this Agreement, including any question regarding its existence, validity or termination, shall be referred to and finally resolved by arbitration under the LCIA Rules, which Rules are deemed to be incorporated by reference into this clause. The number of arbitrators shall be one. The seat, or legal place, of arbitration shall be London, England. The language to be used in the arbitral proceedings shall be English. The governing law of the contract shall be the substantive law of the Netherlands.
(f) Headings. The headings in this contract are inserted for convenience of reference only and will not effect interpretation of this contract.
(g) Assignment. This Agreement is personal to each of the parties hereto, and, except as herein otherwise provided, neither party may assign, transfer in any way or delegate any of the rights or obligations hereunder without first obtaining the written consent of the other party. This Agreement and all of Consultant’s rights and obligations hereunder may be assigned or transferred by it, in whole or in part, to and shall be binding upon and inure to the benefit of, any “successor” of Consultant. As used herein, the term “successor” shall mean only any person, firm, corporation or other business entity which at any time by merger, consolidation or otherwise shall have acquired all or substantially all of the stock of Consultant or to which Consultant shall have transferred all or substantially all of its assets. Any such successor shall be deemed to be substituted for all purposes as Consultant hereunder.
(h) Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original but all of which shall constitute one instrument. A signed photocopy or facsimile of this Agreement shall have the same force and effect as that of an original.
ClearForward services are not provided by, nor affiliated with, Align Technology, Inc., the maker of Invisalign® products and ClinCheck® software. Invisalign® and ClinCheck®, among others, are registered trademarks of Align Technology, Inc. ClearForward provides treatment planning services and clinical advice for Invisalign® trained doctors at their request and agree to all of ClearForward terms and conditions.