Kelvi – Hypothermia Devices, Inc.

Kelvi App Patient Participation Agreement

This Kelvi App Patient Participation Agreement (“Participation Agreement”) is entered into between Kelvi – Hypothermia Devices, Inc. Kelvi Medical Solutions, Inc. (“Kelvi”), and the individual identified below (“You”).

A.        Kelvi provides heating and cooling therapy devices (“Kelvi Devices”) which provide customized therapeutic treatments (“Treatments”) for individual patients (“Patients”) under the direction of their health care providers (“Clinicians”). Kelvi Devices are programmed and operated directly through a touch screen on the Kelvi Device, or through a mobile app on a smartphone or tablet (“Kelvi App”).

B.        Clinicians can use the Kelvi App under a Subscription Agreement with Kelvi, for Patients they register with Kelvi. When a Clinician requests Patient registration, Kelvi requires the Patient to agree to certain terms and conditions to provide assurance of the proper use of the Kelvi App and Kelvi Devices, and of Services and Licensed Content available through the Kelvi App.

C.        You have been invited to register for use of the Kelvi App by Your Clinician. If You wish to register as a Patient, please review this Participation Agreement and electronically sign and submit it to Kelvi as provided below. Upon Kelvi’s notification to You and Your Clinician, You will be registered as a Patient and may use the Kelvi App, the Services and Licensed Content, during the Term of this Participation Agreement.

1. Documents Incorporated by Reference

In order to complete Your registration You must accept and agree to the following documentation, which are hereby incorporated by reference in this Participation Agreement. Any reference to the “Participation Agreement” in this Participation Agreement and in any of these documents shall be interpreted to include all of the following documents:  

1. Terms of Patient Participation.

The Terms of Patient Participation are attached as Addendum A below. The Terms of Patient Participation provide the terms under which You may use the Kelvi App, the Services and Licensed Content.  

2. End User License Agreement.

The End User License Agreement (“EULA”) is attached as Addendum B below. The EULA provides the terms of the licenses for the Kelvi App, the Services and Licensed Content under this Participation Agreement.

3. Patient Privacy Notice.

The Patient Privacy Notice attached as Addendum C below is Kelvi’s notice to You about how Kelvi may use, disclose and administer Your Protected Health Information.

4. Patient Authorization.

In order to provide the Kelvi App and Services, Kelvi uses Treatment Information to create data sets which may be used, alone or in combination with Treatment Information from other sources and other relevant information, to develop and improve protocols for heating and cooling therapies (“Derived Information”). Because Treatment Information includes information about Your health care, Kelvi needs Your authorization to use Your Treatment Information for this purpose (“Authorization”). You must electronically sign and submit the Authorization attached as Addendum D below to complete Your registration. More information about the Authorization is provided Section 13 of the Terms of Patient Participation.

2. Electronic Contracting and Communications

1. Electronic Agreement.

This Participation Agreement is an electronic contract that sets out legally binding terms of Your use of the Kelvi App, Services and Licensed Content. You Patient hereby consent to have this Participation Agreement provided in electronic form. You agree that by clicking the "I accept" box below You are agreeing to the terms and conditions of this Participation Agreement and that this action constitutes an electronic signature. You have the right to receive this Participation Agreement in non-electronic form, upon request. You may withdraw Your consent to have this Participation Agreement provided to You in electronic form by contacting Kelvi. A withdrawal will not affect the legal validity or enforceability of this Participation Agreement provided to and electronically signed by You prior to the effective date of your withdrawal.

2. Consent to Electronic Communication

By entering into this Participation Agreement You understand that Kelvi may send the Patient communications or data regarding the Kelvi App, Services and Licensed Content, including but not limited to (a) notices about Your use of the Kelvi App, Services and Licensed Content, including any notices concerning violations of this Participation Agreement and (b) updates, via electronic mail. You acknowledge that the use of email to provide notices and updates is essential to performance under this Participation Agreement.

3. Kelvi Contact Information.

Communications to Kelvi for purposes of this Participation Agreement must be directed to :

<CONTACT INFORMATION>

4. Patient Agreement and Information.

By completing the following information and clicking “I accept” I, the undersigned Patient, agree to the terms of this Participation Agreement and its incorporated documents.  

/APPROPRIATE FIELDS/

/SIGNATURE BLOCK/

I ACCEPT

Addendum A:  Kelvi App Terms of Patient Participation

Effective Date: ________________

These Terms of Patient Participation are incorporated in and incorporate the Kelvi App Patient Participation Agreement (“Participation Agreement”), including all documentation incorporated in the Participation Agreement by reference. These Terms of Patient Participation apply to the use of the Kelvi App, Services and License Content by the Patient (“You”).

1. Patient Registration and Patient Account Pages.

Your Clinician may register You by submission of a request for registration to Kelvi through the Clinician’s Clinician Account Page. Upon receipt of a request for registration Kelvi will create a Patient Account and Patient Account Page and notify You of the registration and creation of the Patient Account Page. Upon Your signature and submission of the Participation Agreement to Kelvi, Kelvi will activate Your Patient Account Page as a Service subject to the Participation Agreement, and notify You and Your Clinician of the activation.

2. Term and Termination.

a.        The Term of Your Participation Agreement begins on the date Kelvi notifies You that Your registration has been accepted.

b.        You may terminate Your Participation Agreement at any time upon notice to Kelvi and to Your Clinician, without cause and for any reason.

c.        Kelvi may terminate Your Participation Agreement at any time upon notice to You and Your Clinician for Your breach of any of Your obligations under the Participation Agreement.

d.        Your Clinician may terminate Your Participation Agreement at any time upon notice to You and Kelvi.

d.        The Participation Agreement will terminate at any time Your Clinician’s Kelvi App subscription is terminated, unless Your Clinician arranges a transfer of Your Patient Account to another Clinician as described in Section 3.

e.        The Participation Agreement will terminate at any time You withdraw Your Authorization for Kelvi to use Your Treatment Information as provided in Section 13.

3. Transfer of Clinicians.

Upon written request by Your Clinician and written consent by You, Your Account may be transferred to another Clinician which has a current Subscription Agreement with Kelvi.

4. Effect of Termination.

Upon termination of the Participation Agreement all licenses for the Kelvi App, Services and Licensed Content, and access to the Services and Licensed Content shall terminate, as of the date of termination.

5. Modification of Participation Agreement.

Kelvi may amend the Participation Agreement at any time by written notice to You and Your Clinician, effective no sooner than sixty (60) days from the date of the notice. In the event You do not accept the amendment, You must terminate the Participation Agreement as provided in Section 2 of these Terms of Patient Participation. If You do not terminate the Participation Agreement and You use the Kelvi App or otherwise access the Services after the effective date of the amendment, You will be deemed to have accepted the amendment.

6. Applications, Services and Content Provided by Kelvi.

a.        Kelvi makes the Kelvi App and any improvements, enhancements or other modifications to the Kelvi App (“Updates”) available for download through the Apple App Store for Apple-branded devices, and through the Google Play Store for Android devices (“Compatible Devices”). You are solely responsible for procuring and maintaining Compatible Devices including hardware, firmware, operating systems and any other software necessary or desirable for installation and use of the Kelvi App and for use of the Apple App Store or Google Play Store to obtain the Kelvi App and Updates in compliance with the terms and conditions applicable to those online stores.

b.        Kelvi makes the Services and Licensed Content, and any modifications to Licensed Content (“Modifications”) available through the Kelvi App over the Internet from Compatible Devices. You are solely responsible for procuring and maintaining Internet connectivity and services compatible with use of the Kelvi App and Services, including sufficient bandwidth for effective access and usage.

c.        Licensed Content may include text, graphics, images, and information created by Kelvi (“Kelvi Content”) or by third parties (“Third Party Content”), as well as websites and online services created by third parties (“Third Party Services”). Licensed Content is provided for informational purposes only. Licensed Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. You should consult with Your Clinician with respect to the interpretation and Your understanding of Licensed Content.

7. Kelvi App Performance Warranty.

During the Term of Your Participation Agreement, the Kelvi App will provide You with access to the Services and will support access to and where applicable display or download of Licensed Content, provided that the Kelvi App is installed on an Authorized Device (as defined in the EULA) which You maintain as a Compatible Device, and subject to availability of Internet, Support Services, Third Party Services and Third Party Content.

8. Services and Licensed Content Availability.

During the Term of Your Participation Agreement, Kelvi will provide the Services, including Your Patient Account Page and access to and where applicable display or download of Licensed Content, for access by the Kelvi App installed on the Your Authorized Device which You maintain as a Compatible Device, and subject to availability of Internet, Support Services, Third Party Services and Third Party Content.

9. Services and Content Provided by Third Parties

a.        Certain functions included in or supporting the Services are provided and administered by third parties (“Subcontractors”) and provided by agreement between Kelvi and the Subcontractor.  

b.        Websites and online services provided by third parties (“Third Party Services”) may be accessed or made available through the Services, provided by agreement between Kelvi and the Third Party Services provider.

c.        Licensed Content may include text, graphics, images, and information created by third parties (“Third Party Content”), provided by agreement between Kelvi and the Third Party Content provider.

10. Patient Device and Account Responsibility

You are solely responsible for the security of Your Authorized Device(s) and the protection of any user names, passwords and other identifier and authentication mechanisms used to access Authorized Devices, the Kelvi App, the Services, Licensed Content and Treatment Information. You are also solely responsible for all electronic communications, including those containing business information, Patient registration information, and all other data of any kind contained within transmissions, messages, emails or otherwise entered electronically through the Services or under Your Account. Kelvi will rely upon any electronic communications it receives under Your passwords, user name, and/or account number as having been sent by You. You agree to immediately notify Kelvi if You become aware of any loss or theft of the Your Authorized Device or unauthorized use of any of Your passwords, user names, and/or account information.

11. Disclaimer

THE KELVI APP, ALL SERVICES AND ALL LICENSED CONTENT ARE PROVIDED ON AN "AS IS" BASIS ONLY.  ACCORDINGLY, BUT WITHOUT IN ANY WAY LIMITING THE GENERALITY OF THE FOREGOING, KELVI DOES NOT REPRESENT OR WARRANT THAT THE KELVI APP, THE SERVICES OR ANY LICENSED CONTENT WILL MEET THE REQUIREMENTS OF ANY PERSON OR WILL OPERATE ERROR-FREE OR CONTINUOUSLY, AND KELVI MAKES NO OTHER REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OR REPRESENTATIONS CONCERNING MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY ONE OR MORE OF THE INFORMATION, GOODS AND SERVICES REFERRED TO ABOVE.  YOU AGREE THAT KELVI HAS MADE NO AGREEMENTS, REPRESENTATIONS OR WARRANTIES OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS PARTICIPATION AGREEMENT, AND THAT NO FUTURE AGREEMENT, REPRESENTATION OR WARRANTY OF KELVI WITH REGARD TO INFORMATION, GOODS OR SERVICES PROVIDED UNDER THIS PARTICIPATION AGREEMENT SHALL BE EFFECTIVE UNLESS EXPRESSLY STATED IN AN AMENDMENT TO THIS PARTICIPATION AGREEMENT.

12. Limitations on Kelvi Liability

a.        Except for Treatment Information, data displayed by the Kelvi App and provided through the Kelvi App or Services, including but not limited to Licensed Content, is for general informational purposes only and is not guaranteed by Kelvi, its agents, or any third party. Treatment Information may be used by Your Clinician for Your care purposes subject to the Clinician’s exercise of due care and independent professional judgment and at the Clinician’s sole risk.  

b.        In no event shall Kelvi be responsible for any harm to Your health or safety, damages or losses suffered or incurred by You as the result of any error, omission, delay or failure to perform by Kelvi which was caused or contributed to by You or a Clinician, or due to any error or omission by You or a Clinician.

13. Patient Authorization for Kelvi Use of Treatment Information.

a.        In order to provide the Kelvi App and Services, Kelvi uses Treatment Information to create data sets which may be used, alone or in combination with Treatment Information from other sources and other relevant information, to develop and improve protocols for heating and cooling therapies (“Derived Information”).

b.        Treatment Information may include Protected Health Information of Patients subject to the Business Associate Contract. Derived Information is de-identified and does not include Protected Health Information.

c.        As a condition to Your registration Kelvi requires You to execute an authorization to Your Clinician(s) to permit Kelvi to use Your Protected Health Information to create such Derived Information. Kelvi will provide Your Clinician(s) with this authorization electronically upon receipt from You.

d.        In the event You withdraw Your authorization Kelvi shall terminate Your Participation Agreement to avoid the unauthorized use of Protected Health Information. Your Clinician may continue to use Kelvi Devices to provide Treatments to Your but will be unable to use the Kelvi App for such purposes.

14. Assignment

You have no right to assign this Participation Agreement, in whole or in part, by operation of law or otherwise. Any attempt to assign this Participation Agreement will be void and of no effect. Kelvi may assign this Participation Agreement to any assignee which agrees to be bound by the terms of this Participation Agreement. Subject to the foregoing, this Participation Agreement will bind and inure to the benefit of each party's successors and assigns.

15. Dispute Resolution.

1. Arbitration

Any dispute, claim, question or disagreement arising from or relating to the Participation Agreement, or the breach hereof or thereof (in each case, a "Dispute"), except a dispute arising under Section  8(f) of the EULA, shall be resolved by binding arbitration under the rules of the American Arbitration Association. The arbitration proceedings will be final and there will be no right of appeal therefrom. The party receiving an award rendered in any such arbitration proceeding will be entitled to have judgment entered thereon. The arbitrator will determine the prevailing party and such party shall be entitled to reasonable attorneys' fees and costs which shall be part of the award.

2. Jurisdiction and Venue

Jurisdiction and venue for any dispute arising out of or in connection with the Participation Agreement shall be in the _____________ Court for ____________ County, at __________, California.

3. Legal Fees and Costs

In the event of legal proceedings arising from or pertaining to Your Participation Agreement the substantially prevailing party shall be awarded its reasonable attorneys’ fees and costs of litigation, including any on appeal or in bankruptcy proceedings.

Addendum B:  End User License Agreement

Effective Date: ____________

This End User License Agreement (“EULA”) is incorporated in and incorporates the Kelvi App Patient Participation Agreement (“Participation Agreement”), including all documentation incorporated in the Participation Agreement by reference. During the Term of the Participation Agreement the Patient (“You”) shall be entitled to the following licenses to install and use the Kelvi App and Updates, use the Services, and possess and make use of Licensed Content and Modifications.

1. Title

You agree that as between Kelvi and You, Kelvi shall have sole and exclusive ownership of, and all right, title, and interest in and to, the Kelvi App, all Kelvi and Licensed Content and all Updates and Modifications (including ownership of all copyrights and other intellectual property rights), subject only to the rights expressly granted to You under the Participation Agreement.  Entry into the Participation Agreement provides You with a limited right to use the same solely upon the terms expressly set forth herein.

2. Kelvi App License.

Kelvi grants You a nontransferable license to use the Kelvi App on any Apple-branded or Android products which are Compatible Devices (“Authorized Devices”) that You own, to access and use the Services and Licensed Content, for purposes of Your care by Your Clinician.

3. Services License.

Kelvi grants You a nontransferable license to use the Services through the Clinician’s licensed Kelvi App, to access and use included Services and Licensed Content, for purposes of Your care by Your Clinician..  

4. Content License.

Kelvi grants You a nontransferable license to access, view and copy Licensed Content obtained by use of the Services, for purposes of Your care by Your Clinician..

5. Patient Account Page License.

Kelvi grants You a nontransferable license to access, view, copy and enter information in the Patient Account Page, for purposes of Your care by Your Clinician.

6. Term of Licenses.

The term of the EULA and the licenses granted herein shall begin on the Effective Date of the Participation Agreement and shall end on the date of termination of the Participation Agreement.

7. Limited Intellectual Property Warranty

a.        Kelvi hereby warrants with respect to the Kelvi App, the Services and the Licensed Content that Kelvi has the legal right and authority to grant You the License(s) contemplated by this EULA.

b.        In the event of any claim or allegation that Your use or possession of the Kelvi App, the Services, or any Licensed Content constitutes a violation of a third party’s intellectual property rights, Kelvi will diligently seek to resolve such claim or allegation, and to clear the title to or obtain a valid license for Your use or possession of the Kelvi App, Services, or Licensed Content or implement a reasonable substitute for the Kelvi App or Kelvi Materials, if reasonably possible. In the event Kelvi is unable to do so within a reasonable time You may terminate the Participation Agreement.

c.        Subject to the limitations of the Participation Agreement Kelvi will indemnify, hold harmless and defend You against any and all claims that Your use of the Kelvi App, the Services or Licensed Content for any purpose authorized under the Participation Agreement during the term of the Participation Agreement violated any third party’s patent, copyright or other intellectual property rights.

8. Limitations on Use and Distribution

a.        You may not distribute or make the Kelvi App available over a network where it could be used by multiple devices at the same time, or transfer, redistribute or sublicense the Kelvi App or any Update. If You sells Your Authorized Device to a third party, You must remove the Kelvi App (as Updated if applicable) from the Authorized Device before doing so.

b.        You may not copy, reverse-engineer, disassemble, attempt to derive the source code of, modify, or create derivative works of the Kelvi App, any Service, or any Licensed Content, or any part thereof (except as and only to the extent that any foregoing restriction is prohibited by applicable law or to the extent as may be permitted by the licensing terms governing use of any open-source components included with the Kelvi App, Service, or Licensed Content, if and to the extent applicable).

c.        You acknowledge and agrees that the Kelvi App, the Services, and the Licensed Content are licensed to You solely for purposes of Your care by Your Clinician. You may not use the Kelvi App, Services, or Licensed Content for any other purposes, and may not rent the Kelvi App, access to the Services, or Licensed Content, or share them with other parties.  The unauthorized reproduction or redistribution of the Kelvi App or any Services software or any Licensed Content by You is prohibited by law and may result in severe civil and criminal penalties.  The Kelvi App, Services and Licensed Content may only be used by You in the United States of America and in any territory of the United States of America.

d.        You may not use the Kelvi App or Services to harass, abuse, stalk, threaten or defame any person or entity, and You agree that Kelvi is not responsible or liable for any such use.

e.        You may not use the Kelvi App, Services or Licensed Content in any manner that is inconsistent with the terms of this EULA or that infringes the intellectual property rights of Kelvi or any third party.

f.        You may not use the Kelvi App, Services or Licensed Content for any purposes prohibited by United States law and the laws of the jurisdiction in which the Kelvi App was obtained or is used.

g.        You acknowledge that any violation of Section 8 will cause irreparable damage to Kelvi, which could not be adequately redressed by monetary damages.  You therefore agree that in the event of an actual or threatened violation of Section 8, during or after the Term of the Participation Agreement, Kelvi shall be entitled to both temporary and permanent injunctive relief against You from any court of competent jurisdiction, without first submitting the matter to arbitration as provided in Section 15(a) of the Terms of Patient Participation, and in addition to all other remedies which Kelvi may have at law, in equity or otherwise.

9. United States Governmental Users.        

The Kelvi App and Services and related documentation are "Commercial Items", as that term is defined at 48 C.F.R. §2.101, consisting of "Commercial Computer Software" and "Commercial Computer Software Documentation", as such terms are used in 48 C.F.R. §12.212 or 48 C.F.R. §227.7202, as applicable. Consistent with 48 C.F.R. §12.212 or 48 C.F.R. §227.7202-1 through 227.7202-4, as applicable, the Kelvi App and Services and related documentation are, if applicable, licensed to U.S. Government end users (a) only as Commercial Items and (b) with only those rights as are granted to all other end users pursuant to the terms and conditions herein. Unpublished rights are reserved under the copyright laws of the United States.

10. Effect of Termination of Participation Agreement.

Upon the termination of the Participation Agreement the licenses granted by this EULA shall terminate automatically, and Kelvi shall terminate Your ability to use the Kelvi App and access the Services and Licensed Content.

Addendum C:  Patient Privacy Notice

Effective Date: ____________

This Patient Privacy Notice is incorporated in and incorporates the Kelvi App Patient Participation Agreement (“Participation Agreement”), including all documentation incorporated in the Participation Agreement by reference.

A.        The following Notice describes the personal information which may be obtained by Kelvi about You in the course of Your use of the Kelvi App, Services and Licensed Content. This information will be referred to as “Protected Health Information” in this Notice, and will include any information which could reasonably identify You and has to do with Your past, present or future health or health care, or payment for Your past, present or future health care. This Notice also describes the uses and disclosures Kelvi may make of Your Protected Health Information, and Your rights with respect to such information.

B.        Kelvi manages and is responsible for the hardware and software platform used to implement the Kelvi App, the Services and Licensed Content. Kelvi does not create or provide Your Protected Health Information. Your Protected Health Information is created or provided:

• By You when You submit the Participation Agreement to and register with Kelvi and update Your Account Information, in any communications between You and Kelvi or between Kelvi and Your Clinician(s), and in Kelvi’s records of administrative matters concerning Your Account. This is referred to as “Patient Account Information.”
• In the course of Your Treatments by Your Clinician. This is referred to as “Treatment Information.”
• In the course of Your transactions and activities using the Kelvi App, the Services, Licensed Content and Patient Account Page. This is referred to as “Patient Metadata.”

C.        Your Clinician may be a “Covered Entity” under a federal law called “HIPAA.” If so, Kelvi is a “Business Associate” of the Clinician under HIPAA, and Kelvi’s use and disclosure of Your Protected Health Information is subject to regulation under HIPAA. It is also subject to the terms of a contract between Kelvi and Your Clinician called a Business Associate Contract, which also applies to Kelvi’s use and disclosure of Your Protected Health Information. This Notice applies whether or not Your Clinician is a Covered Entity.

1. What Types of Information Does this Notice Cover?

This information covered by this Notice includes the following types of Protected Health Information:

• Patient Account Information. This information includes Your contact and payment information, as well as Kelvi’s administrative records for You, and communications between Kelvi and You, and Kelvi and Your Clinician.
• Treatment Information. This information includes the records of Treatment programmed by Your Clinician, including treatment protocols and ___________________.
• Patient Metadata. This information may include information about devices on which the Kelvi App is installed, including operating system, other installed apps, IP addresses, and Internet services and browser used; the Kelvi Device(s) the Kelvi App is used with; activities engaged in when using the Kelvi App and Services, including how often the Kelvi App is used and Services and Licensed Content is opened, and activity involving those Services and Licensed Content.

16. Subcontractors and Services Providers.

In the ordinary course of business Kelvi uses services providers and vendors to perform services or functions on Kelvi’s behalf or on its behalf (“Subcontractors and Services Providers”), which Kelvi may permit to obtain, create, maintain, use or disclose Your Protected Health Information. Kelvi will not authorize Subcontractors and Services Providers to obtain, create, maintain, use or disclose Your Protected Health Information except for the purposes for which Kelvi makes such information available to them, subject to the conditions of this Notice.

17. How Does Kelvi Use and Disclose Protected Health Information?  

The purposes for which Kelvi may use and disclose Protected Health Information depends upon the type of information, as described below.  

1. Patient Account Information.

Kelvi may use or disclose Patient Account Information to administer Your Account, for purposes of Kelvi’s management and administration, and to fulfill Kelvi’s legal responsibilities, subject to specific limitations as provided in HIPAA and the Business Associate Contract (as applicable). Kelvi will not sell Your Patient Account Information to any third party or use it for marketing purposes.    

2. Treatment Information.

Kelvi may use Treatment Information to create records which may be used, alone or in combination with Treatment Information about other Patients and other relevant information, to develop and improve protocols for heating and cooling therapies (“Derived Information”). Derived Information does not include information which would identify You and is not Protected Health Information subject to this Notice.

3. Patient Metadata.

Kelvi may use or disclose Patient Metadata to administer Your Account, for purposes of Kelvi’s management and administration, and to fulfill Kelvi’s legal responsibilities, to provide You with Services and Licensed Content, to improve the performance of the Kelvi App, Services and Kelvi Devices, and to create records which do not include information which would identify You and is not Protected Health Information subject to this Notice (“Derived Information”), subject to  any limitations provided in HIPAA and the Business Associate Contract.  Kelvi will not sell Your Patient Metadata to any third party or use it for marketing purposes.

18. May I Request Access to or a Copy of Kelvi’s Records of My Protected Health Information?

You may request a copy of or access to Your Protected Health Information which Kelvi maintains in a Designated Record Set on behalf of Your Clinician. Except as noted below, requests for access to Your Protected Information should be directed to Your Clinician.

1. Patient Account Information.

You may access and copy Your registration information at any time during the Term of Your Participation Agreement from Your Patient Account Page. Any request for other information must be directed to Your Clinician.

2. Treatment Information.

Any request for Treatment Information must be directed to Your Clinician.

3. Patient Metadata.

Patient Metadata is not part of a Designated Record Set and is not available for copying or access.

19. May I Request the Amendment of Kelvi’s Records of My Protected Health Information?

You may request amendment of Your Protected Health Information which Kelvi maintains in a Designated Record Set on behalf of Your Clinician. Except as noted below, requests for amendment of Your Protected Information should be directed to Your Clinician.

1. Patient Account Information.

You may amend Your registration information at any time during the Term of Your Participation Agreement from Your Patient Account Page. Any request to amend other information must be directed to Your Clinician.

2. Treatment Information.

Any request to amend Treatment Information must be directed to Your Clinician.

3. Patient Metadata.

Patient Metadata is not part of a Designated Record Set and is not available for amendment.

20. May I Request an Accounting of Disclosures of Kelvi’s Records of My Protected Health Information?

Requests for an accounting of disclosures of Your Protected Information must be directed to Your Clinician.

21. What Are Kelvi’s Obligations to Maintain the Security of Protected Health Information?

Kelvi complies with the HIPAA Security Rule and uses reasonable and appropriate safeguards to protect Protected Health Information.

22. What Are a My Responsibilities?

You are responsible for:

• Providing complete and accurate contact information, and keeping it current, in case Kelvi needs to notify You with respect to any issue concerning Your Protected Health Information.  
• Maintaining Your Authorized Device, and Kelvi Device if applicable, in good working order with all current updates.  
• Keeping Your Authorized Device, and Kelvi Device if applicable, physically secure from access by any individual You do not wish to have potential access to Your Protected Health Information.
• Keeping Your Authorized Device technically secure by maintaining a robust password or other authentication token, which You do not share with anyone else.
• Notifying Kelvi immediately if Your password or other authentication token has been obtained by someone else or Your Authorized Device, or Kelvi Device if applicable, has been stolen or lost.
• Maintaining the administrative, physical and technical security of any mobile device or computer You use to access Your Account.

23. Can Kelvi Change the Terms of this Notice?

Kelvi reserves the right to change and update this Notice or publish a new notice as appropriate to address legal matters, user preferences, changes in technology, changes to the Kelvi App or Services or Patient Account Page, or other matters affecting Kelvi’s privacy practices, subject to the terms of the Participation Agreement. If Kelvi does change this Notice, Kelvi will notify You as provided in the Participation Agreement.

24. When Does This Notice Apply?

This Notice is effective as of the effective date stated above, and replaces any prior privacy notices or policies Kelvi may have published. It will remain in effect until it is replaced by a new or updated Notice published by Kelvi.

25. Can I Get More Information?

• If You have any questions or would like more information about this Notice please contact Kelvi at:

 <CONTACT INFORMATION>

Addendum D:  Patient Authorization for Disclosure of Treatment Information

This Patient Authorization for Disclosure of Treatment Information is made by the undersigned individual (“I” and “Me”) for purposes of the Kelvi – Hypothermia Devices, Inc. Kelvi App Patient Participation Agreement (“Participation Agreement”) between Me and Kelvi – Hypothermia Devices, Inc. (“Kelvi”), which is hereby incorporated by reference

By executing this Authorization below and submitting it to Kelvi I authorize and direct the Clinician(s) identified below to disclose to and permit Kelvi to use My Protected Health Information described below for the purposes described below.

1. Protected Health Information to Be Disclosed.

The Protected Health Information to be disclosed is records of the treatments programmed into a Kelvi Device by a Clinician for purposes of providing Me with therapeutic heating and cooling Treatments using a Kelvi App, and related information created in the course of such Treatments (“Treatment Information”).

26. Persons Authorized to Make the Disclosure(s).

The persons authorized to disclose the above Protected Health Information include any physician, physical therapist or other health care provider who uses or used the Kelvi App to provide Me with Treatments using the Kelvi Device (“My Clinician(s)”).

27. Authorized Recipient of the Disclosure(s).

The disclosures shall be made to Kelvi – Hypothermia Devices, Inc., or its agents.

28. Purposes of the Disclosure(s).

The purpose of the disclosures is to support development and improvement of protocols for heating and cooling therapies by Kelvi.

29. Expiration Date.

This Authorization will expire upon the termination of the Participation Agreement between Me and Kelvi.

30. Acknowledgments.

I understand and acknowledge that:

• I may revoke this Authorization at any time, by notice in writing to Kelvi at:

<CONTACT INFORMATION>

• My treatment, payment, health plan enrollment, or eligibility for benefits may not be conditioned on obtaining this Authorization. My Clinician(s) may no longer be able to program Treatments remotely using the Kelvi App if this Authorization has been revoked, but may continue programming Treatments directly through the Kelvi Device.
• Once my Protected Health Information has been disclosed to Kelvi, it will no longer be subject to the Privacy Rule and may be redisclosed by Kelvi, subject to the conditions of Kelvi’s Patient Privacy Notice in effect as of the date of this Authorization.

31. Consent to Electronic Signature.

I understand that this Authorization is an electronic document that sets out legally binding terms authorizing the disclosure of My Protected Health Information. I hereby consent to have this Authorization provided in electronic form. I hereby acknowledge and agree that by clicking the "I accept" box below, I am acknowledging the terms of this Authorization and that Kelvi and any Clinician receiving it will rely upon it as My Authorization, and that My clicking of the “I accept” box” constitutes My electronic signature.

I understand that I have the right to receive a copy of this Authorization in non-electronic form, upon request to Kelvi using the contact information provided in Section 6. I may withdraw My consent to have this Authorization in electronic form by revoking this Authorization as provided above. A withdrawal will not affect the legal validity of this Authorization as electronically signed by Me prior to the effective date of My revocation.  

32. Individual Information and Signature

/APPROPRIATE FIELDS/

/SIGNATURE BLOCK/