1. HIPAA Compliance
The Federal Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (45 C.F.R. Parts 160-164) ("HIPAA") sets forth standards for protecting the privacy of individually identifiable health information. HIPAA's requirements become effective as of April 14, 2003. Pursuant to HIPAA, Business User on behalf of itself and its related covered entities including all entities controlled, partially controlled, owned, partially owned, managed or partially managed by Business User (referred to in this Addendum as the "Covered Entity") is required to enter into Business Associate Agreements with all of its contractors, agents and related and unrelated third parties that perform a function or activity on behalf of such Covered Entity that involves providing contractors, agents, and related and unrelated third-parties with individually identifiable health information. This Addendum is made a part of any Agreements executed between the parties (the "Agreement"). This Addendum is intended to comply with the Covered Entity's requirements under HIPAA. The Parties to the Agreement hereby acknowledge and agree that LLC is a "Business Associate" of Covered Entity as that term is defined by HIPAA. For purposes herein, Business Associate and Covered Entity shall be collectively referred to as the "Parties." Capitalized terms used in this Addendum and not otherwise defined herein shall have the meanings set forth in HIPAA, which definitions are hereby incorporated by reference.
2. Obligations and Activities of Business Associate
(a) Business Associate agrees to use or disclose Protected Health Information ("PHI") received from or on behalf of Covered Entity or created for Covered Entity only as permitted or required by this Addendum, the Agreement or as required by law.
(b) Business Associate agrees to implement administrative, physical and technical safeguards that reasonably and appropriately protect the confidentiality, integrity and availability of any electronic PHI that it creates, receives, maintains or transmits on behalf of the Covered Entity. Business Associate shall document and keep its documentation with respect to these security measures available for inspection, upon reasonable request.
(c) 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 Addendum.
(d) Business Associate agrees to report to Covered Entity any security incident (including any attempted or actual unauthorized access or breach of PHI) and/or any use or disclosure of the PHI not provided for by this Addendum of which it becomes aware.
(e) Business Associate agrees to ensure that any agent, including a subcontractor, to whom it provides PHI received from, or created or received by Business Associate on behalf of, Covered Entity agrees to the same restrictions and conditions that apply through this Addendum to Business Associate with respect to such information.
(f) Business Associate agrees to make internal practices, books, and records, including policies and procedures and PHI, relating to the use and disclosure of PHI received from, or created or received by Business Associate on behalf of, Covered Entity available to the Covered Entity, or to the Secretary, in a time and manner mutually agreed by the Parties or designated by the Secretary, for purposes of the Secretary determining Covered Entity's compliance with the Privacy Rule.
(g) 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 Protected Health Information in accordance with 45 C.F.R. §164.528.
(h) Business Associate agrees to provide to Covered Entity, in time and manner mutually acceptable to the Parties, information collected in accordance with Section 2(g) of this Addendum, to permit Covered Entity to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 C.F.R. §164.528.
(i) To the extent that Business Associate has PHI in a Designated Record Set, Business Associate agrees to provide access, at the request of Covered Entity, and in the time and manner mutually agreed by the Parties, to PHI in a Designated Record Set, to Covered Entity or, as directed by Covered Entity, to an Individual in order to meet the Covered Entity's requirements under 45 C.F.R. §164.524.
(j) To the extent that Business Associate has PHI in a Designated Record Set, Business Associate agrees to make any amendment(s) to PHI in a Designated Record Set that the Covered Entity directs or agrees to pursuant to 45 C.F.R. Section Code 164.526 at the request of Covered Entity, and in the time and manner mutually agreed by the Parties.
3. Permitted Uses and Disclosures by Business Associate
Except as otherwise limited in this Addendum, Business Associate may use or disclose PHI to perform functions, activities, or services for, or on behalf of, Covered Entity as specified in the Agreement.
(a) Except as otherwise pmited in this Addendum, Business Associate may use PHI for the proper management and administration of the Business Associate or to carry out the legal responsibipties of the Business Associate.
(b) Except as otherwise pmited in this Addendum, Business Associate may use PHI to provide Data Aggregation services to Covered Entity as permitted by 45 C.F.R. §164.504(e)(2)(i)(B).
(c) Business Associate may use PHI to report violations of law to appropriate Federal and State authorities, consistent with §164.502(j)(1).
4. Obligations of Covered Entity
(a) Upon request, Covered Entity shall provide Business Associate with a copy of its Notice of Privacy Practices.
(b) Covered Entity shall notify Business Associate of any pmitations in its notice of privacy practices, to the extent that such pmitation may affect Business Associate's use or disclosure of PHI.
(c) Covered Entity shall notify Business Associate of any changes in, or revocation of, permission by an Individual to use or disclose PHI, to the extent that such changes may affect Business Associate's use or disclosure of PHI.
(d) Covered Entity shall not request Business Associate to use or disclose PHI in any manner that would not be permissible under the Privacy Rule if done by Covered Entity.
5. Term and Termination.
(a) Term. The Term of this Addendum shall be effective upon execution of the Addendum by both Parties and, except for the rights and obpgations set forth in this Addendum specifically surviving termination, shall terminate upon the termination of the final Agreement executed between the Parties.
(b) Termination for Cause. In addition to any termination provisions otherwise set forth in the Agreement, upon Covered Entity's knowledge of a material breach by Business Associate, Covered Entity shall either:
(i) Provide an opportunity for Business Associate to cure the breach or end the violation and terminate this Addendum and the Agreement if Business Associate does not cure the breach or end the violation within the time specified by Covered Entity;
(ii) Immediately terminate this Addendum and the Agreement if Business Associate has breached a material term of this Addendum and cure is not possible; or
(iii) If neither termination nor cure is feasible, Covered Entity shall report the violation to the Secretary.
(c) Effect of Termination.
(i) Except as provided in paragraph (ii) below of this section, upon termination, for any reason, of this Addendum or the final Agreement executed between the Parties, Business Associate shall return or destroy all PHI received from Covered Entity, or created or received by Business Associate on behalf of Covered Entity. Business Associate shall retain no copies of the PHI.
(ii) 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. Business Associate shall extend the protections of this Addendum to such PHI and pmit 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.
6. Miscellaneous.
(a) Regulatory References. A reference in this Addendum to a section in the Privacy Rule means the section as in effect or as amended.
(b) Amendment. The Parties agree to take such action as is necessary to amend this Addendum from time to time as is necessary for Covered Entity to comply with the requirements of HIPAA.
(c) Survival. The respective rights and obligations of Business Associate under Section 6(c) of this Addendum shall survive the termination of this Addendum and any Agreements executed between the Parties.
(d) Interpretation. Any ambiguity in this Addendum shall be resolved to permit Covered Entity to comply with the Privacy Rule.
(e) Conflicts. To the extent that there is any conflict between the provisions of this Addendum and the Agreement, the provisions of this Addendum shall control. To the extent that the law of the state in which the Covered Entity does business is more stringent than Federal law regarding privacy issues, the law of such state shall control, unless such state law is expressly preempted by the Federal law.
(f) Response to Subpoenas. In the event that Business Associate receives a subpoena or similar notice or request from any judicial, administrative or other party arising out of or in connection with this Addendum or the Agreement, including, but not pmited to, any unauthorized use or disclosure of PHI or any failure in Business Associate's security measures, Business Associate shall promptly forward a copy of such subpoena, notice or request to Covered Entity.