SCHEDULE A BUSINESS ASSOCIATE AGREEMENT
This Business Associate Agreement (“BAA”) is by and between Horizon Clinical Research, Inc. (“Business Associate”), and Customer (“Covered Entity”), and is effective as of the Effective Date.
WHEREAS , the parties have entered into the Terms of Use pursuant to which the Business Associate will provide certain services to, for, or on behalf of Covered Entity involving the use or disclosure of Protected Health Information (“PHI”), and pursuant to such Terms of Use, Business Associate may be considered a “business associate” of Covered Entity; and
WHEREAS , Covered Entity and Business Associate intend to protect the privacy and provide for the security of PHI disclosed to Business Associate pursuant to the Terms of Use in compliance with the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and the Standards for Privacy of Individually Identifiable Health Information promulgated thereunder by the U.S. Department of Health and Human Services at 45 CFR § 160 and § 164 (the “HIPAA Rules”), and the Health Information Technology for Economic and Clinical Health Act of 2009 (the “HITECH Act”), in each case as amended from time to time; and
WHEREAS , the purpose of this BAA is to satisfy certain standards and requirements of the HIPAA Rules and the HITECH Act, as the same may be amended from time to time.
NOW, THEREFORE , in consideration of the mutual promises below and the exchange of information pursuant to this BAA, the parties agree as follows:
1. Definitions
Terms used but not otherwise defined in this BAA shall have the same meaning as set forth in 45 CFR Parts 160, 162 and 164, or the HITECH Act.
2. Obligations of Business Associate
Business Associate may Use or Disclose such De-identified Data to third parties at its discretion, provided such de-identification is performed using either the Expert Determination or Safe Harbor method in accordance with 45 C.F.R. §164.514(a)-(c), and Business Associate maintains documentation of the method used.
b. Nondisclosure. Business Associate shall not Use or further Disclose PHI other than as permitted or required by this BAA.
Business Associate shall use appropriate safeguards to prevent Use or Disclosure of PHI other than as provided for by this BAA. Business Associate shall implement administrative, physical, and technical safeguards in compliance with 45 C.F.R. §§164.308, 164.310, and 164.312, and shall comply with the documentation requirements under 45 C.F.R. §164.316.
d. Reporting of Disclosures; Mitigation. Business Associate shall report to Covered Entity any use or disclosure of PHI not provided for by this BAA of which Business Associate becomes aware. Business Associate agrees to mitigate, to the extent practicable, any harmful effect that is known to Business Associate of a use or disclosure of PHI by Business Associate in violation of the requirements of this BAA.
e. Business Associate’s Agents. Business Associate shall ensure that any subcontractors, to whom it provides PHI received from (or created or received by Business Associate on behalf of) Covered Entity agree to the same restrictions and conditions that apply to Business Associate with respect to such PHI.
f. Availability of Information to Covered Entity. Business Associate shall make available to Covered Entity (or, as directed by Covered Entity, to an Individual) such information as Covered Entity may request, and in the time and manner designated by Covered Entity, to fulfill Covered Entity’s obligations (if any) to provide access to, provide a copy of, and account for disclosures with respect to PHI pursuant to HIPAA and the HIPAA Rules, including, but not limited to, 45 CFR §§ 164.524 and 164.528.
g. Amendment of PHI. Business Associate shall make any amendments to PHI in a Designated Record Set that the Covered Entity directs or agrees to at the request of Covered Entity or an Individual, and in the time and manner designated by Covered Entity, to fulfill Covered Entity’s obligations (if any) to amend PHI pursuant to HIPAA and the HIPAA Rules, including, but not limited to, 45 CFR § 164.526, and Business Associate shall, as directed by Covered Entity, incorporate any amendments to PHI into copies of such PHI maintained by Business Associate.
h. Internal Practices. Business Associate shall make its internal practices, books and records relating to the use and disclosure of PHI received from Covered Entity (or created or received by Business Associate on behalf of Covered Entity) available to the Secretary, in a time and manner designated by Covered Entity or the Secretary, for purposes of the Secretary determining Covered Entity’s compliance with HIPAA and the HIPAA Rules.
i . Documentation of Disclosures for Accounting. Business Associate agrees to document such disclosures of PHI and information related to such disclosures as would be required for Covered Entity to respond to a request by an Individual for an accounting of disclosures of PHI in accordance with 45 CFR § 164.528.
j. Access to Documentation for Accounting. Business Associate agrees to provide to Covered Entity or an Individual, in a time and manner designated by Covered Entity, information documented in accordance with Section 2(i) of this BAA in a time and manner as to permit Covered Entity to respond to a request by an Individual for an accounting of disclosures of PHI in accordance with 45 CFR § 164.528.
Business Associate shall notify Covered Entity within ten (10) days of Discovery of any Breach of Unsecured PHI. Business Associate shall conduct a risk assessment in accordance with 45 C.F.R. §164.402 to determine whether a Breach of Unsecured PHI has occurred and provide a written summary of such assessment to Covered Entity upon notification.
l. Minimum Necessary. When using, disclosing, or requesting PHI from the Covered Entity, or in accordance with any provision of this BAA, Business Associate shall limit PHI to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request.
3. Obligations of Covered Entity
a. Covered Entity shall be responsible for using appropriate safeguards to maintain and ensure the confidentiality, privacy and security of PHI transmitted to Business Associate pursuant to the BAA and this BAA, in accordance with the standards and requirements of HIPAA and the HIPAA Rules, until such PHI is received by Business Associate.
b. Upon request, Covered Entity shall provide Business Associate with the notice of privacy practices that Covered Entity produces in accordance with 45 CFR § 164.520, as well as any changes to such notice.
c. Covered Entity shall provide Business Associate with any changes in, or revocation of, permission by an Individual to use or disclose PHI, if such changes affect Business Associate’s permitted or required uses or disclosures.
d. Covered Entity shall notify Business Associate of any restriction to the use or disclosure of PHI that Covered Entity has agreed to in accordance with 45 CFR § 164.522, if such restriction affects Business Associate’s permitted or required uses or disclosures.
4. Term and Termination
a. Term. The Term of this BAA shall become effective as of the Effective Date and shall terminate when all of the PHI provided by Covered Entity to Business Associate, or created or received by Business Associate on behalf of Covered Entity, is destroyed or returned to Covered Entity, or, if it is infeasible to return or destroy PHI, protections are extended to such information, in accordance with the termination provisions of this Section. The provisions of this BAA shall survive termination of the BAA to the extent necessary for compliance with HIPAA and the HIPAA Rules.
b. Material Breach. A material breach by either party of any provision of this BAA shall constitute a material breach of the BAA, if such breach is not cured by the breaching party within thirty (30) days of receipt of notice describing the material breach.
c. Reasonable Steps to Cure Breach. If either party learns of an activity or practice of the other party that constitutes a material breach or violation of the other party’s obligations under the provisions of this BAA, then the non-breaching party shall notify the breaching party of the breach and the breaching party shall take reasonable steps to cure such breach or violation, as applicable, within a period of time which shall in no event exceed thirty (30) days. If the breaching party’s efforts to cure such breach or violation are unsuccessful, the non-breaching party shall either terminate the BAA, if feasible, or if termination of the BAA is not feasible and the breaching party has violated the HIPAA Rules, the non-breaching party may report the breaching party’s breach or violation to the Secretary.
d. Judicial or Administrative Proceedings. Either party may terminate the BAA, effective immediately, if the other party is named as a defendant in a criminal proceeding for an alleged violation of HIPAA, or a finding or stipulation that the other party has violated any standard or requirement of HIPAA or other security or privacy laws is made in any administrative or civil proceeding in which the party has been joined.
e. Effect of Termination.
Business Associate shall return at Covered Entity’s expense, or destroy all PHI received from Covered Entity (or created or received by Business Associate on behalf of Covered Entity) that Business Associate still maintains in any form, and shall retain no copies of such PHI, except in archival or backup systems. Business Associate shall delete PHI in backup or archival systems pursuant to its normal data retention cycle and shall not access such PHI unless required by law.
In the event that Business Associate determines that returning or destroying the PHI is infeasible, Business Associate shall provide to Covered Entity notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the parties that return or destruction of PHI is infeasible, Business Associate shall extend the protections of this BAA to such PHI and limit further uses and disclosures of such PHI to those purposes that make the return or destruction infeasible, for so long as Business Associate maintains such PHI. The obligations of Business Associate under this Section shall survive the termination of the BAA.
5. Amendment to Comply with Law
The parties specifically agree to take such action as is necessary to implement the standards and requirements of HIPAA, the HIPAA Rules, the HITECH Act, and other applicable laws relating to the security or confidentiality of PHI. This includes applicable state privacy laws, including but not limited to the California Consumer Privacy Act (CCPA) as amended by the California Privacy Rights Act (CPRA).
6. No Third Party Beneficiaries
Nothing in this BAA is intended to confer, nor shall anything herein confer, upon any person other than Covered Entity, Business Associate and their respective successors and assigns, any rights, remedies, obligations or liabilities whatsoever and no other person or entity shall be a third party beneficiary of this BAA.
7. Effect on BAA
Except as specifically required to implement the purposes of this BAA, or to the extent inconsistent with this BAA, all other terms of the BAA shall remain in full force and effect.
8. Interpretation
This BAA shall be interpreted as broadly as necessary to implement and comply with HIPAA, the HIPAA Rules and any other applicable law relating to security and privacy of PHI. Any ambiguity in this BAA shall be resolved in favor of a meaning that permits Covered Entity to comply with the HIPAA Rules.
9. Regulatory References
A reference in this BAA to a section in the HIPAA Rules or the HITECH Act means the section as in effect or as amended, and for which compliance is required