This Business Associate
Agreement (this “Agreement”) is made
and entered into by and between the entity or individual agreeing to be
bound to the terms of this Agreement (“Covered
Entity” or “you”) and
Jiro Health Inc., a Delaware public benefit corporation
(“Business Associate”), effective as of the
date of your acceptance hereof (“Effective
Date”). Business Associate and Covered Entity may each be
referred to in this Agreement as a “Party” or
collectively as the “Parties.”
BY CLICKING “I AGREE”, YOU (A) ACKNOWLEDGE THAT YOU HAVE READ AND
UNDERSTAND THIS AGREEMENT; (B) REPRESENT AND WARRANT THAT YOU HAVE THE
RIGHT, POWER, AND AUTHORITY TO ENTER INTO THIS AGREEMENT AND, IF
ENTERING INTO THIS AGREEMENT FOR AN ORGANIZATION, THAT YOU HAVE THE
LEGAL AUTHORITY TO BIND THAT ORGANIZATION; AND (C) ACCEPT
THIS AGREEMENT AND AGREE THAT YOU ARE LEGALLY BOUND BY ITS TERMS. YOU
ARE PROHIBITED FROM USING OR ACCESSSING BUSINESS ASSOCIATE’S SOFTWARE
PLATFORM WITHOUT ACCEPTANCE OF THIS AGREEMENT.
RECITALS
WHEREAS, the Parties have agreed to certain service
arrangements, pursuant to which Business Associate will provide certain
items, products or services (the “BAA
Services”) to, for, or on behalf of Covered Entity that
may involve the creation, receipt, maintenance, or transmission of PHI
(as defined herein) (the “Services
Arrangement”);
WHEREAS, now and in the future Business Associate
may have access to Protected Health Information, as such term is defined
under the Privacy Rule and Security Rule at 45 C.F.R. § 160.103, limited
to such information created or received by Business Associate from or on
behalf of Covered Entity hereunder (as used herein,
“Protected Health Information” or
“PHI”), and Business Associate may create,
receive, maintain, or transmit PHI in providing items, products or
services to Covered Entity.
WHEREAS, both Parties desire to meet their
obligations to protect PHI under: (i) the Standards for Privacy of
Individually Identifiable Health Information (“Privacy
Rule”) and the Security Standards (“Security
Rule”) published by the U.S. Department of Health and
Human Services (“DHHS”) at 45 CFR parts 160
through 164 under the Health Insurance Portability and Accountability
Act of 1996 (“HIPAA”), as amended from time to
time; (ii) the additional Privacy and Security Rule requirements
pursuant to Subtitle D of the Health Information Technology for Economic
and Clinical Health Act (“HITECH”), as amended
from time to time; and (iii) the final Omnibus Rule implementing
additional Privacy and Security Rule requirements pursuant to HITECH
(“Omnibus Rule”), as may be further amended
from time to time.
NOW THEREFORE, in consideration of the foregoing and
for other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the Parties hereby agree as
follows:
Definitions.
Regulatory citations in this Agreement are to the United States Code of
Federal Regulations (“CFR”), as promulgated,
interpreted, and amended from time to time by DHHS, for so long as such
regulations are in effect. Unless otherwise specified in this Agreement,
all terms not otherwise defined herein will have the meaning established
for purposes of parts 160 through 164 of Title 45 of the CFR, as amended
from time to time.
Permitted Uses
and Disclosures of PHI.
Use
of PHI. As specified in this Agreement, Business Associate
may use or disclose PHI created, received, maintained, or transmitted
for or on behalf of Covered Entity (a) as necessary to perform the BAA
Services, including to retrieve, receive, maintain, normalize, analyze,
aggregate, and transmit PHI through electronic health record systems,
health information exchanges, claims data sources, and other systems or
integrations authorized by Covered Entity, (b) as otherwise permitted or
required by the Services Arrangement, including the use of artificial
intelligence (“AI”) technologies in connection
with any BAA Services that constitute a permitted use or disclosure of
PHI under HIPAA, or (c) as otherwise permitted by applicable law or
Required by Law.
Data
Analysis. Business Associate may: (a) use, analyze, and
disclose PHI in its possession for the public health activities and
purposes set forth at 45 CFR § 164.512(b); and (b) aggregate PHI of
Covered Entity in Business Associate’s possession with PHI of other
customers and covered entities that Business Associate has in its
possession through its capacity as a business associate to such other
entities, provided that the purpose of such aggregation is to provide
Covered Entity with benchmarking or other data analyses relating to the
Health Care Operations of Covered Entity.
Business
Activities of Business Associate. Unless otherwise limited
in this Agreement, Business Associate may:
Use
PHI in its possession for its proper management and administration and
to fulfill any present or future legal responsibilities of Business
Associate;
Disclose
PHI in its possession to third parties for the purpose of its proper
management and administration or to fulfill any present or future legal
responsibilities of Business Associate, provided that: (i) the
disclosures are permitted by applicable law or Required by Law; (ii) the
disclosures do not require an authorization or “opportunity to agree”;
or (iii) Business Associate obtains and maintains reasonable written
assurances from the third party receiving the PHI that such party will
hold and maintain the PHI confidentially, only use the disclosed PHI as
permitted by applicable law or Required by Law or for the purposes of
the disclosure, and notify Business Associate if the third party becomes
aware that the confidentiality of the PHI has been breached; and
Responsibilities
of the Parties With Respect to PHI.
Responsibilities
of Business Associate. With regard to its use or disclosure
of PHI, Business Associate will:
Use
or disclose the minimum amount of PHI necessary as permitted or required
by this Agreement, including in connection with the use of AI
technologies, or as otherwise Required by Law to accomplish the intended
purpose of such use or disclosure;
To
the extent Business Associate carries out one or more of Covered
Entity’s obligations under the Privacy Rule, comply with the same
Privacy Rule requirements that apply to Covered Entity;
Develop
and use appropriate safeguards (including implementing administrative,
physical, and technical safeguards for electronic PHI
(“ePHI”)) to protect the confidentiality,
integrity, and availability of and to prevent the use or disclosure of
PHI other than as provided for by this Agreement or applicable law;
For
any stored and transmitted PHI, secure such PHI through technology
standards Required by Law, as applicable;
Promptly
report to the designated Privacy Officer of Covered Entity any use or
disclosure of PHI that is not permitted by applicable law or Required by
Law or this Agreement of which Business Associate becomes aware;
Promptly
report to the designated Privacy Officer of Covered Entity any breach in
the security, confidentiality, integrity, or availability of ePHI that
Business Associate creates, receives, maintains, or transmits on behalf
of Covered Entity and of which Business Associate becomes aware;
Mitigate,
to the extent reasonably practicable, any harmful effects from any known
use or disclosure of PHI or ePHI by Business Associate in violation of
this Agreement;
Ensure,
consistent with 45 C.F.R. § 164.502(e)(1)(ii), that any subcontractor of
Business Associate that creates, receives, maintains, or transmits PHI
on behalf of Business Associate agrees to the same restrictions and
conditions that apply to Business Associate under this Agreement with
respect to such PHI;
Make
available all records, books, agreements, policies, and procedures
relating to the confidentiality or integrity of PHI to the Secretary of
DHHS for purposes of determining compliance with the Privacy Rule,
Security Rule, or Omnibus Rule; and
Responsibilities
of Covered Entity. With regard to the use or disclosure of
PHI by Business Associate, Covered Entity will:
Obtain
from an Individual any and all consents or authorizations Required by
Law, including HIPAA and applicable state law, prior to furnishing
Business Associate the PHI pertaining to that Individual;
If
required by applicable law, (i) provide Individuals with clear,
understandable disclosures with respect to Covered Entity’s use of AI
technologies for permitted uses and disclosures of PHI under HIPAA or
applicable state law, (ii) inform Individuals of their right to opt out
of having PHI processed or accessed by AI technologies, (iii) promptly
notify Business Associate of any Individual’s revocation of consent or
opt-out request related to the BAA Services that involve AI processing,
and (iv) maintain documentation of all Individual consents and opt-outs
related to AI processing;
Promptly
notify Business Associate of any changes or limitations in the notice of
privacy practices of Covered Entity to the extent that such change or
limitation may affect Business Associate’s creation, receipt,
maintenance, or transmission of PHI for or on behalf of Covered Entity,
including obligations among the Parties with respect to reproductive
health matters, the responsibilities for which shall remain with Covered
Entity;
Promptly
notify Business Associate of any changes in, or revocation of, the
permission by an Individual to use or disclose such Individual’s PHI, to
the extent such changes may affect Business Associate’s creation,
receipt, maintenance, or transmission of PHI pursuant to this Agreement;
Promptly
notify Business Associate of any restriction on the use or disclosure of
an Individual’s PHI that Covered Entity has agreed to or is required to
abide by under 45 CFR § 164.522, to the extent such restriction may
affect Business Associate’s use or disclosure of PHI;
Participate
in joint risk assessments or mitigation efforts upon reasonable request
by Business Associate when such collaboration is necessary to address
system vulnerabilities or ongoing threats;
Refrain
from requesting that Business Associate or the BAA Services use or
disclose PHI in any manner that would not be permissible under HIPAA or
other applicable law if done by Covered Entity;
Remain
solely responsible for managing whether Covered Entity’s end users are
authorized to share, disclose, create or use PHI within the BAA
Services;
Use
controls available within the BAA Services to ensure that use of PHI is
limited to the BAA Services for end users that use the BAA Services in
connection with PHI and will not, and will ensure that its end users do
not, circumvent, disable, modify, amend, or defeat any settings,
protections or other security in place within the BAA Services, or to
otherwise use the BAA Services in a manner that is not in compliance
with applicable law, and will remain solely responsible for ensuring
that its and its end users’ use of the BAA Services complies with HIPAA
and that it will implement appropriate safeguards designed to prevent
against unauthorized use or disclosure of PHI, and as otherwise required
under HIPAA, with respect to the BAA Services; and
Designate
a security liaison or privacy officer (“Privacy
Officer”) responsible for coordination and communication
with Business Associate regarding security and breach matters.
Responsibilities
of the Parties with Respect to Breach Notification. Covered
Entity and Business Associate will comply with HITECH and any
implementing regulations regarding breach notification, as such
regulations may be in effect from time to time (collectively, the
“Breach Notification Rules”).
Except
as provided by 45 CFR § 164.412, Business Associate will give Covered
Entity notice of any Breach of Unsecured PHI without unreasonable delay
and in no event later than the maximum time allowable under applicable
law after Business Associate discovered such Breach. For purposes of
reporting a Breach to Covered Entity, the discovery of the Breach will
be deemed to occur as of the first day on which Business Associate knows
or, by exercising reasonable diligence, should have known of such
Breach. Business Associate will be deemed to have knowledge of such
Breach if it is known, or by exercising reasonable diligence should have
been known, by any person who is an employee, director, officer, or
lawful agent of Business Associate.
More
specifically and for purposes of this Agreement, a
“Breach” is an unauthorized acquisition,
access, use, or disclosure of Unsecured PHI, which compromises the
security or privacy of the PHI, but specifically excluding the
exceptions set forth in 45 C.F.R. § 164.402. A Breach will be presumed
to compromise (i.e., pose a risk of financial, reputational, or
other harm to the Individual whose PHI was breached), unless the Parties
can demonstrate in writing the low probability that such PHI has been
compromised.
Responsibilities
of the Parties with Respect to Designated Record Sets. This
Section 3.4 applies only if, in the course of Business Associate
performing the BAA Services, Business Associate maintains Designated
Records Sets containing PHI. In such case:
Business
Associate will: (i) at the reasonable request of, and in the reasonable
time and manner designated by, Covered Entity, provide Covered Entity,
the Individual to whom such PHI relates, or such Individual’s authorized
representative, with access to and, where required by HIPAA, an
electronic copy of PHI maintained by Business Associate in a Designated
Record Set, in order to satisfy a request by such Individual under
HIPAA; and (ii) at the reasonable request of, and in the reasonable time
and manner designated by, Covered Entity, make or incorporate any
desired amendment(s) to the PHI maintained by Business Associate in a
Designated Record Set that Covered Entity directs.
Representations
and Warranties. Each Party represents and warrants to the other
Party:
Authority.
The Party has full authority, and has obtained all necessary approvals
and consents, to enter into the Services Arrangement and this Agreement
and will comply with all applicable federal and state privacy and
security laws and regulations with respect to PHI.
Term and
Termination.
Term.
This Agreement will become effective on the Effective Date and will
continue in effect unless terminated as provided in this Article 5. In
addition, certain provisions and requirements of this Agreement will
survive the expiration or termination of this Agreement in accordance
with Section 6.8 below.
Automatic
Termination. This Agreement will automatically terminate
without any further action of the Parties upon the termination or
expiration of all Services Arrangements between Covered Entity and
Business Associate.
Effect
of Termination. Upon the termination of this Agreement
pursuant to this Article 5, Business Associate will return or destroy
within a commercially reasonable period, not to exceed ninety (90) days
all PHI, including ePHI, identifiable to Covered Entity that is within
Business Associate’s possession. If return or destruction of said PHI is
not feasible, Business Associate will notify Covered Entity in writing,
of the conditions that make return or destruction infeasible. If
Business Associate determines that the return or destruction of said PHI
is not feasible, for as long as Business Associate maintains such PHI,
Business Associate will extend the protections of this Agreement to such
PHI and limit further uses or disclosures of such PHI to the purposes
that make the return or destruction of the PHI infeasible. The Parties
acknowledge and agree that return or destruction is infeasible with
respect to PHI contained in archival, disaster-recovery, or backup
systems, PHI subject to a litigation hold or legal-retention
requirement, and PHI that Business Associate is expressly authorized to
retain under the Services Arrangement. Further, Business Associate has
no obligation to return or destroy de-identified data, aggregated data,
or any derivative works thereof, none of which constitute PHI.
Miscellaneous.
Nature
of Agreement; Independent Contractors. Nothing in this
Agreement will be construed to create an employer-employee relationship
or partnership, joint venture, or other joint business relationship
between the Parties or any of their affiliates. Business Associate is an
independent contractor, not an agent, of Covered Entity.
Compliance
with Law; Change of Law. Each Party agrees to comply with
HIPAA and HITECH and their implementing regulations, in each case, as
applicable to the obligations of such Party under this Agreement. If
there is any amendment to any provision of HIPAA or HITECH, or their
implementing regulations, which materially alters either Party’s
obligations under this Agreement, the Parties will negotiate in good
faith mutually acceptable and appropriate amendment(s) to this Agreement
to give effect to such revised obligations; provided, however, that if
the Parties are unable to agree on mutually acceptable amendment(s)
within 60 days of the relevant change of law, either Party may terminate
this Agreement consistent with Sections 5.4 and 6.9 herein.
Construction
of Terms. The terms of this Agreement will be construed in
light of any interpretation or guidance on HIPAA, HITECH, the Privacy
Rule, the Security Rule, or the Omnibus Rule issued by DHHS from time to
time. Furthermore, any ambiguity in this Agreement will be resolved to
permit the Parties to comply with the applicable Rule.
Governing Law. This Agreement shall be governed
by and construed in accordance with the same internal laws that govern
the Services Arrangement.
Survival.
This Section 6.8 will survive termination of this Agreement for any
reason. Further, the respective rights and obligations of Business
Associate and Covered Entity under the provisions of Sections 2.3, 3.1,
3.2, 3.3, 5.4, and 6.5 will survive the expiration or termination of
this Agreement for so long as such PHI is retained by Business
Associate.
Amendment;
Waiver. This Agreement may not be modified, nor will any
provision of this Agreement be waived or amended, except in a writing
duly agreed and accepted by authorized representatives of the Parties;
provided that, Business Associate may amend this Agreement upon at least
thirty (30) days’ prior written notice to Covered Entity. Covered
Entity’s continued use of the BAA Services following the notice period
constitutes acceptance of such amendment. A waiver with respect to one
event will not be construed as continuing or as a bar to or waiver of
any right or remedy as to subsequent events.
Assignment
of Rights and Delegation of Duties. This Agreement is
binding upon and inures to the benefit of the Parties and their
respective successors and permitted assigns. However, neither Party may
assign any of its rights or delegate any of its obligations under this
Agreement without the prior written consent of the other Party.
Notwithstanding any provisions herein to the contrary, Business
Associate retains the right to assign or delegate any of its rights or
obligations in this Agreement in connection with an assignment to an
affiliate or in connection with any merger, reorganization,
consolidation, sale of assets or similar transaction. Assignments made
in violation of this Section 6.10 will be null and void.
Severability.
The provisions of this Agreement are severable, and if any provision of
this Agreement will be held or declared to be illegal, invalid, or
unenforceable, the remainder of this Agreement will continue in full
force and effect as though such illegal, invalid, or unenforceable
provision had not been contained in this Agreement.
No
Third Party Beneficiaries. Nothing in this Agreement is
intended to confer, nor will anything in this Agreement be considered or
construed to confer, on any person other than the Parties, or their
respective successors and permitted assigns, any rights, remedies,
obligations, or liabilities under or by reason of this Agreement.
Notices.
Any notices to be given under this Agreement shall be made in writing
and sent or delivered to the applicable Party in accordance with the
notice provisions set forth in the Services Arrangement.