Definitions and interpretationThe following definitions and rules of interpretation apply in this Agreement.
Definitions
Controller: The Customer;
Data Subject: an individual who is the subject of Personal Data.
Personal Data: means any information relating to an identified or identifiable natural person that is processed by the Processor as a result of, or in connection with, the provision of the Services; an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person.
Processor: the Supplier;
Processing, processes and process: either any activity that involves the use of Personal Data or as the Data Protection Legislation may otherwise define processing, processes or process. It includes any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording. organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction. Processing also includes transferring Personal Data to third parties.
Data Protection Legislation: all applicable privacy and data protection laws including the General Data Protection Regulation ((EU) 2016/679) and the Data Protection Act 2018 and any applicable national implementing laws, regulations and secondary legislation in Ireland relating to the processing of Personal Data and the privacy of electronic communications, as amended, replaced or updated from time to time, including the Privacy and Electronic Communications Directive (2002/58/EC) and the Privacy and Electronic Communications (EC Directive) Regulations 2003 (SI 2003/2426).
Personal Data Breach: a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, Personal Data transmitted, stored or otherwise processed.
A reference to writing or written includes faxes and email.
In the case of conflict or ambiguity between any of the provisions of this Agreement and the provisions of any agreement governing the provision of the Services, the provisions of this Agreement will prevail
Personal data types and processing purposes
The Controller and the Processor acknowledge that for the purpose of the Data Protection Legislation, the Controller is the controller and the Processor is the processor.
The Controller retains control of the Personal Data and remains responsible for its compliance obligations under the applicable Data Protection Legislation, including providing any required notices and obtaining any required consents, and for the processing instructions it gives to the Processor.
Processor’s obligations
The Processor will only process the Personal Data to the extent, and in such a manner, as is necessary for the Business Purposes in accordance with the Controller’s written instructions. The Processor will not process the Personal Data for any other purpose or in a way that does not comply with this Agreement or the Data Protection Legislation. The Processor must promptly notify the Controller if, in its opinion, the Controller’s instruction would not comply with the Data Protection Legislation.
The Processor must promptly comply with any Controller request or instruction requiring the Processor to amend, transfer, delete or otherwise process the Personal Data, or to stop, mitigate or remedy any unauthorised processing.
The Processor will maintain the confidentiality of all Personal Data and will not disclose Personal Data to third parties other than it subcontractors unless the Controller or this Agreement specifically authorises the disclosure, or as required by law. If a law, court, regulator or supervisory authority requires the Processor to process or disclose Personal Data, the Processor must first inform the Controller of the legal or regulatory requirement and give the Controller an opportunity to object or challenge the requirement, unless the law prohibits such notice.
The Processor will reasonably assist the Controller with meeting the Controller’s compliance obligations under the Data Protection Legislation, taking into account the nature of the Processor’s processing and the information available to the Processor, including in relation to Data Subject rights, data protection impact assessments and reporting to and consulting with supervisory authorities under the Data Protection Legislation.
The Processor must promptly notify the Controller of any changes to Data Protection Legislation that may adversely affect the Processor’s performance of the Services.
Processor’s employees
The Processor will ensure that all employees:
are informed of the confidential nature of the Personal Data and are bound by confidentiality obligations and use restrictions in respect of the Personal Data;
have undertaken training on the Data Protection Legislation relating to handling Personal Data and how it applies to their particular duties; and
are aware both of the Processor’s duties and their personal duties and obligations under the Data Protection Legislation and this Agreement.
The Processor will take reasonable steps to ensure the reliability, integrity and trustworthiness of all of the Processor’s employees with access to the Personal Data.
Security
The Processor must at all times implement appropriate technical and organisational measures against unauthorised or unlawful processing, access, disclosure, copying, modification, storage, reproduction, display or distribution of Personal Data, and against accidental or unlawful loss, destruction, alteration, disclosure or damage of Personal Data.
The Processor must implement such measures to ensure a level of security appropriate to the risk involved, including as appropriate:
the encryption of personal data;
the ability to ensure the ongoing confidentiality, integrity, availability and resilience of processing systems and services;
the ability to restore the availability and access to personal data in a timely manner in the event of a physical or technical incident; and
a process for regularly testing, assessing and evaluating the effectiveness of security measures.
Personal Data Breach
The Processor will promptly and without undue delay notify the Controller if any Personal Data is lost or destroyed or becomes damaged, corrupted, or unusable. The Processor will use its reasonable endeavours to restore such Personal Data
The Processor will immediately and without undue delay notify the Controller if it becomes aware of:
any accidental, unauthorised or unlawful processing of the Personal Data; or
any Personal Data Breach.
Where the Processor becomes aware of (a) and/or (b) above, it shall, without undue delay, also provide the Controller with the following information:
description of the nature of (a) and/or (b), including the categories and approximate number of both Data Subjects and Personal Data records concerned;
the likely consequences; and
description of the measures taken, or proposed to be taken to address (a) and/or (b), including measures to mitigate its possible adverse effects.
Immediately following any unauthorised or unlawful Personal Data processing or Personal Data Breach, the parties will co-ordinate with each other to investigate the matter. The Processor will reasonably co-operate with the Controller in the Controller’s handling of the matter, including:
assisting with any investigation;
facilitating interviews with the Processor’s employees and others involved in the matter;
aking available all relevant records, logs, files, data reporting and other materials required to comply with all Data Protection Legislation or as otherwise reasonably required by the Controller; and
taking reasonable and prompt steps to mitigate the effects and to minimise any damage resulting from the Personal Data Breach or unlawful Personal Data processing.
The Processor will not inform any third party of any Personal Data Breach without first obtaining the Controller’s prior written consent, except for its subcontractors or when required to do so by law.
The Processor agrees that the Controller has the sole right to determine:
whether to provide notice of the Personal Data Breach to any Data Subjects, supervisory authorities, regulators, law enforcement agencies or others, as required by law or regulation or in the Controller’s discretion, including the contents and delivery method of the notice; and
whether to offer any type of remedy to affected Data Subjects, including the nature and extent of such remedy.
Cross-border transfers of personal data
The Processor uses European registered IT services providers some of which may have employees located outside the European Economic Area (EEA) or in countries with a finding of adequate protection. Those employees will not normally have access to Personal Data. In the case Personal Data is required to be accessed by those employees to debug specific customer issues, they may be given time limited, restricted and logged remote access to Personal Data under supervision by The Processor. Access will be removed when not required. The data will not be moved off an AWS server in Europe. In this case any data transfer will be covered by EU standard contractual clauses in a Data Protection Agreement with the Services Provider.
Other than as set out in clause 7.1, the processor The Processor may not transfer or otherwise process Personal Data outside the European Economic Area (EEA) or to countries with a finding of adequate protection without obtaining the Controller’s prior written consent and subject to any conditions the Controller may require in respect of any such consent.
Complaints, data subject requests and third party rights
The Processor shall take such technical and organisational measures as may be appropriate, and promptly provide such information to the Controller as the Controller may reasonably require, to enable the Controller to comply with:
the rights of Data Subjects under the Data Protection Legislation, including subject access rights, the rights to rectify and erase personal data, object to the processing and automated processing of personal data, and restrict the processing of personal data; and
information or assessment notices served on the Controller by any supervisory authority under the Data Protection Legislation.
The Processor must notify the Controller immediately if it receives any complaint, notice or communication that relates directly or indirectly to the processing of the Personal Data or to either party’s compliance with the Data Protection Legislation.
The Processor must notify the Controller within 5 working days if it receives a request from a Data Subject for access to their Personal Data or to exercise any of their related rights under the Data Protection Legislation.
The Processor will give the Controller its full co-operation and assistance in responding to any complaint, notice, communication or Data Subject request.
The Processor must not disclose the Personal Data to any Data Subject or to a third party other than at the Controller’s request or instruction, as provided for in this Agreement or as required by law.
Term and termination
This Agreement will remain in full force and effect so long as the processor continues to provide the Services to the Controller (Term).
Any provision of this Agreement that expressly or by implication should come into or continue in force on or after termination of the provision of the Services in order to protect Personal Data will remain in full force and effect.
The Controller may terminate this agreement in the event of a material breach by the Processor which is not remedied within 30 days of written notice to do so on written notice to the Processor.
If a change in any Data Protection Legislation prevents either party from fulfilling all or part of the Services, the parties will suspend the processing of Personal Data until that processing complies with the new requirements. If the parties are unable to bring the Personal Data processing into compliance with the Data Protection Legislation within 30 days, they may terminate the agreement for Services between them.
Subcontractors
The Processor may engage subcontractors in relation to the provision of the Services provided such subcontractor enters into an agreement with the Processor which contains terms substantially inline with the terms of this Agreement.
Data return and destruction
At the Controller’s request, the Processor will give the Controller a copy of or access to all or part of the Controller’s Personal Data in its possession or control in the format and on the media reasonably specified by the Controller.
On termination of the provision of the Services for any reason or expiry of its term, the Processor will securely delete or destroy or, if directed in writing by the Controller, return and not retain, all or any Personal Data related to this Agreement in its possession or control, except for one copy that it may retain and use for 6 years for audit purposes only.
If any law, regulation, or government or regulatory body requires the Processor to retain any documents or materials that the Processor would otherwise be required to return or destroy, it will notify the Controller in writing of that retention requirement, giving details of the documents or materials that it must retain, the legal basis for retention, and establishing a specific timeline for destruction once the retention requirement ends.
The Processor will certify in writing that it has destroyed the Personal Data within 14 days after it completes the destruction.
Records
The Processor will keep detailed, accurate and up-to-date written records regarding any processing of Personal Data it carries out for the Controller, including but not limited to, the access, control and security of the Personal Data, approved subcontractors and affiliates, the processing purposes, categories of processing, any transfers of personal data to a third country and related safeguards, and a general description of the technical and organisational security measures referred to in clause 5.1 (Records).
The Processor will ensure that the Records are sufficient to enable the Controller to verify the Processor’s compliance with its obligations under this Agreement and the Processor will provide the Controller with copies of the Records upon request.
Audit
The Processor will provide the Controller with such information as it reasonably requires from time to time to verify the Processor’s compliance with its Agreement,
If a Personal Data Breach occurs or is occurring, or the Processor becomes aware of a breach of any of its obligations under this Agreement or any Data Protection Legislation, the Processor will:
conduct its own audit to determine the cause;
produce a written report that includes detailed plans to remedy any deficiencies identified by the audit;
provide the Controller with a copy of the written audit report; and
remedy any deficiencies identified by the audit as soon as reasonably possible.
Warranties
The Processor warrants and represents that:
its employees, subcontractors, agents and any other person or persons accessing Personal Data on its behalf are reliable and trustworthy and have received the required training on the Data Protection Legislation relating to the Personal Data;
it will process the Personal Data in compliance with the Data Protection Legislation and other laws, enactments, regulations, orders, standards and other similar instruments;
it has no reason to believe that the Data Protection Legislation prevents it from providing any of the Services; and
considering the current technology environment and implementation costs, it will take appropriate technical and organisational measures to prevent the unauthorised or unlawful processing of Personal Data and the accidental loss or destruction of, or damage to, Personal Data, and ensure a level of security appropriate to:
the harm that might result from such unauthorised or unlawful processing or accidental loss, destruction or damage;
the nature of the Personal Data protected; and
comply with all applicable Data Protection Legislation and its information and security policies, including the security measures required in clause 5.1.
The Controller warrants and represents
that the Processor’s expected use of the Personal Data for the Business Purposes and as specifically instructed by the Controller will comply with the Data Protection Legislation; and
the Controller has all required consents and authorisations to transfer the Customer Data to the Process and to permit the Processor to process the Customer Data in accordance with this Schedule.
SCHEDULE 2
Background
The Customer is either a “covered entity” or “business associate” of a covered entity as each are defined under the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, as amended by the HITECH Act (as defined below) and the related regulations promulgated by HHS (as defined below) (collectively, “HIPAA”) and, as such, is required to comply with HIPAA’s provisions regarding the confidentiality and privacy of Protected Health Information (as defined below);
The Customer and Supplier, each a “Party” and, collectively, the “Parties” have entered into or will enter into one or more agreements under which the Supplier provides or will provide certain specified services to The Customer (collectively, the “Agreement”);
In providing the Services pursuant to the Agreement, the Supplier will have access to Protected Health Information;
By providing the Services pursuant to the Agreement, the Supplier will become a “business associate” of the Customer as such term is defined under HIPAA;
Both Parties are committed to complying with all federal and state laws governing the confidentiality and privacy of health information, including, but not limited to, the Standards for Privacy of Individually Identifiable Health Information found at 45 CFR Part 160 and Part 164, Subparts A and E (collectively, the “Privacy Rule”); and
Both Parties intend to protect the privacy and provide for the security of Protected Health Information disclosed to the Supplier pursuant to the terms of this Agreement, HIPAA and other applicable laws.
Agreement
Definitions. For purposes of this Business Associate Agreement (BAA), the Parties give the following meaning to each of the terms in this Section 1 below. Any capitalized term used in this BAA, but not otherwise defined, has the meaning given to that term in the Privacy Rule or pertinent law.
“Affiliate” means a subsidiary or affiliate of the Customer that is, or has been, considered a covered entity, as defined by HIPAA.
“Breach” means the acquisition, access, use, or disclosure of PHI in a manner not permitted under the Privacy Rule which compromises the security or privacy of the PHI, as defined in 45 CFR §164.402.
“Breach Notification Rule” means the portion of HIPAA set forth in Subpart D of 45 CFR Part 164.
“Data Aggregation” means, with respect to PHI created or received by the Supplier in its capacity as the “business associate” under HIPAA of the Customer, the combining of such PHI by the Supplier with the PHI received by the Supplier in its capacity as a business associate of one or more other “covered entity” under HIPAA, to permit data analyses that relate to the Health Care Operations (defined below) of the respective covered entities. The meaning of “data aggregation” in this BAA shall be consistent with the meaning given to that term in the Privacy Rule.
“Designated Record Set” has the meaning given to such term under the Privacy Rule, including 45 CFR §164.501.B.
“De-Identify” means to alter the PHI such that the resulting information meets the requirements described in 45 CFR §§164.514(a) and (b).
“Electronic PHI” means any PHI maintained in or transmitted by electronic media as defined in 45 CFR §160.103.
“Health Care Operations” has the meaning given to that term in 45 CFR §164.501.
“HHS” means the U.S. Department of Health and Human Services.
“HITECH Act” means the Health Information Technology for Economic and Clinical Health Act, enacted as part of the American Recovery and Reinvestment Act of 2009, Public Law 111-005.
“Individual” has the same meaning given to that term i in 45 CFR §§164.501 and 160.130 and includes a person who qualifies as a personal representative in accordance with 45 CFR §164.502(g).
“Privacy Rule” means that portion of HIPAA set forth in 45 CFR Part 160 and Part 164, Subparts A and E.
“Protected Health Information” or “PHI” has the meaning given to the term “protected health information” in 45 CFR §§164.501 and 160.103, limited to the information created or received by the Supplier from or on behalf of the Customer.
“Security Incident” means the attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system.
“Security Rule” means the Security Standards for the Protection of Electronic Health Information provided in 45 CFR Part 160 & Part 164, Subparts A and C.
“Unsecured Protected Health Information” or “Unsecured PHI” means any “protected health information” as defined in 45 CFR §§164.501 and 160.103 that is not rendered unusable, unreadable or indecipherable to unauthorized individuals through the use of a technology or methodology specified by the HHS Secretary in the guidance issued pursuant to the HITECH Act and codified at 42 USC §17932(h).
Use and Disclosure of PHI.
Except as otherwise provided in this BAA, the Supplier may use or disclose PHI as reasonably necessary to provide the Services described in the Agreement to the Customer, and to undertake other activities of the Supplier permitted or required of the Supplier by this BAA or as required by law.
Except as otherwise limited by this BAA or federal or state law, the Customer authorizes the Supplier to use the PHI in its possession for the proper management and administration of the Supplier’s business and to carry out its legal responsibilities. The Supplier may disclose PHI for its proper management and administration, provided that (i) the disclosures are required by law; or (ii) the Supplier obtains, in writing, prior to making any disclosure to a third party (a) reasonable assurances from this third party that the PHI will be held confidential as provided under this BAA and used or further disclosed only as required by law or for the purpose for which it was disclosed to this third party and (b) an agreement from this third party to notify Business Associate immediately of any breaches of the confidentiality of the PHI, to the extent it has knowledge of the breach.
The Supplier will not use or disclose PHI in a manner other than as provided in this BAA, as permitted under the Privacy Rule, or as required by law. The Supplier will use or disclose PHI, to the extent practicable, as a limited data set or limited to the minimum necessary amount of PHI to carry out the intended purpose of the use or disclosure, in accordance with Section 13405(b) of the HITECH Act (codified at 42 USC §17935(b)) and any of the act’s implementing regulations adopted by HHS, for each use or disclosure of PHI.
The Supplier may use PHI to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR §164.502(j)(1).
Safeguards Against Misuse of PHI. The Supplier will use appropriate safeguards to prevent the use or disclosure of PHI other than as provided by the Agreement or this BAA and the Supplier agrees to implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity and availability of the Electronic PHI that it creates, receives, maintains or transmits on behalf of the Customer. The Supplier agrees to take reasonable steps, including providing adequate training to its employees to ensure compliance with this BAA and to ensure that the actions or omissions of its employees or agents do not cause the Supplier to breach the terms of this BAA.
Reporting Disclosures of PHI and Security Incidents. The Supplier will report to the Customer in writing any use or disclosure of PHI not provided for by this BAA of which it becomes aware and the Supplier agrees to report to the Customer any Security Incident affecting Electronic PHI of the Customer of which it becomes aware. The Supplier agrees to report any such event promptly, without undue delay, but in no case later than 30 calendar days of becoming aware of the event.
Reporting Breaches of Unsecured PHI. The Supplier will notify the Customer in writing promptly upon the discovery of any Breach of Unsecured PHI in accordance with the requirements set forth in 45 CFR §164.410, but in no case later than 30 calendar days after discovery of a Breach./li>
Mitigation of Disclosures of PHI. The Supplier will take reasonable measures to mitigate, to the extent practicable, any harmful effect that is known to the Supplier of any use or disclosure of PHI by the Supplier or its agents or subcontractors in violation of the requirements of this BAA.
Agreements with Agents or Subcontractors. The Supplier will ensure that any of its agents or subcontractors that have access to, or to which the Supplier provides, PHI agree in writing to the restrictions and conditions concerning uses and disclosures of PHI contained in this BAA and agree to implement reasonable and appropriate safeguards to protect any Electronic PHI that it creates, receives, maintains or transmits on behalf of the Supplier or, through the the Supplier, the Customer. The Supplier shall ensure that all subcontracts and agreements provide the same level of privacy and security as this BAA.
Access to PHI by Individuals.
Upon request, the Supplier agrees to furnish the Customer with copies of the PHI maintained by the Supplier in a Designated Record Set in the time and manner reasonably specified by the Customer to enable the Customer to respond to an Individual’s request for access to PHI under 45 CFR §164.524.
In the event any Individual or personal representative requests access to the Individual’s PHI directly from the Supplier, the Supplier within ten business days, will forward that request to the Customer. Any disclosure of, or decision not to disclose, the PHI requested by an Individual or a personal representative and compliance with the requirements applicable to an Individual’s right to obtain access to PHI shall be the sole responsibility of the Customer.
Amendment of PHI.
Upon request and instruction from the Customer, the Supplier will amend PHI or a record about an Individual in a Designated Record Set that is maintained by, or otherwise within the possession of, the Supplier as directed by the Customer in accordance with procedures established by 45 CFR §164.526. Any request by the Customer to amend such information will be completed by the Supplier within 15 business days of the Customer’s request.
In the event that any Individual requests that the Supplier amend such Individual’s PHI or record in a Designated Record Set, the Supplier within ten business days will forward this request to the Customer. Any amendment of, or decision not to amend, the PHI or record as requested by an Individual and compliance with the requirements applicable to an Individual’s right to request an amendment of PHI will be the sole responsibility of the Customer.
Accounting of Disclosures.
The Supplier will document any disclosures of PHI made by it to account for such disclosures as required by 45 CFR §164.528(a). The Supplier also will make available information related to such disclosures as would be required for the Customer to respond to a request for an accounting of disclosures in accordance with 45 CFR §164.528. At a minimum, the Supplier will furnish the Customer the following with respect to any covered disclosures by the Supplier: (i) the date of disclosure of PHI; (ii) the name of the entity or person who received PHI, and, if known, the address of such entity or person; (iii) a brief description of the PHI disclosed; and (iv) a brief statement of the purpose of the disclosure which includes the basis for such disclosure.
The Supplier will furnish to the Customer information collected in accordance with this Section 10, within ten business days after written request by the Customer, to permit the Customer to make an accounting of disclosures as required by 45 CFR §164.528, or in the event that the Customer elects to provide an Individual with a list of its business associates, the Supplier will provide an accounting of its disclosures of PHI upon request of the Individual, if and to the extent that such accounting is required under the HITECH Act or under HHS regulations adopted in connection with the HITECH Act.
In the event an Individual delivers the initial request for an accounting directly to the Supplier, the Supplier will within ten business days forward such request to the Customer.
Availability of Books and Records. The Supplier will make available its internal practices, books, agreements, records, and policies and procedures relating to the use and disclosure of PHI, upon request, to the Secretary of HHS for purposes of determining the Customer’s and the Supplier’s compliance with HIPAA, and this BAA.
Responsibilities of the Customer. With regard to the use and/or disclosure of Protected Health Information by the Supplier, the Customer agrees to:
Notify the Supplier of any limitation(s) in its notice of privacy practices in accordance with 45 CFR §164.520, to the extent that such limitation may affect the Supplier’s use or disclosure of PHI.
Notify the Supplier of any changes in, or revocation of, permission by an Individual to use or disclose Protected Health Information, to the extent that such changes may affect the Supplier’s use or disclosure of PHI.
Notify the Supplier of any restriction to the use or disclosure of PHI that the Customer has agreed to in accordance with 45 CFR §164.522, to the extent that such restriction may affect the Supplier’s use or disclosure of PHI.
Except for data aggregation or management and administrative activities of the Supplier, the Customer shall not request the Supplier to use or disclose PHI in any manner that would not be permissible under HIPAA if done by the Customer.
Data Ownership. The Supplier’s data stewardship does not confer data ownership rights on the Supplier with respect to any data shared with it under the Agreement, including any and all forms thereof.
Term and Termination.
This BAA will remain in full force and effect so long as the Supplier continues to provide the Services to the Customer under the Agreement.
The Customer may terminate immediately this BAA, if the Customer makes a determination that the Supplier has breached a material term of this BAA and the Supplier has failed to cure that material breach, to the Customer’s reasonable satisfaction, within 30 days after written notice from the Customer. The Customer may report the problem to the Secretary of HHS if termination is not feasible.
If the Supplier determines that the Customer has breached a material term of this BAA, then the Supplier will provide the Customer with written notice of the existence of the breach and shall provide the Customer with 30 days to cure the breach. The Customer’s failure to cure the breach within the 30-day period will be grounds for immediate termination of the BAA by the Supplier. The Supplier may report the breach to HHS.
Upon termination of the Agreement or this BAA for any reason, all PHI maintained by the Supplier will be returned to the Customer or destroyed by the Supplier. The Supplier will not retain any copies of such information except for one copy that it may retain and use for 6 years if required for audit purposes only. This provision will apply to PHI in the possession of the Supplier’s agents and subcontractors. If return or destruction of the PHI is not feasible, in the Supplier’s reasonable judgment, the Supplier will furnish the Customer with notification, in writing, of the conditions that make return or destruction infeasible. Upon mutual agreement of the Parties that return or destruction of the PHI is infeasible, the Supplier will extend the protections of this BAA to such information for as long as the Supplier retains such information and will limit further uses and disclosures to those purposes that make the return or destruction of the information not feasible. The Parties understand that this Section 14.D. will survive any termination of this BAA.
Regulatory References./ A reference in this BAA to a section in HIPAA means the section as in effect or as amended at the time.
Amendments and Waiver. This BAA may not be modified, nor will any provision be waived or amended, except in writing duly signed by authorized representatives of the Parties. A waiver with respect to one event shall not be construed as continuing, or as a bar to or waiver of any right or remedy as to subsequent events.
HITECH Act Compliance. The Parties acknowledge that the HITECH Act includes significant changes to the Privacy Rule and the Security Rule. The privacy subtitle of the HITECH Act sets forth provisions that significantly change the requirements for business associates and the agreements between business associates and covered entities under HIPAA and these changes may be further clarified in forthcoming regulations and guidance. Each Party agrees to comply with the applicable provisions of the HITECH Act and any HHS regulations issued with respect to the HITECH Act. The Parties also agree to negotiate in good faith to modify this BAA as reasonably necessary to comply with the HITECH Act and its regulations as they become effective but, in the event that the Parties are unable to reach agreement on such a modification, either Party will have the right to terminate this BAA upon 30days’ prior written notice to the other Party.
SCHEDULE 1 Processor Terms
Definitions and interpretation
The following definitions and rules of interpretation apply in this Agreement.
Definitions:
Controller: The Customer;
Data Subject: an individual who is the subject of Personal Data.
Personal Data: means any information relating to an identified or identifiable natural person that is processed by the Processor as a result of, or in connection with, the provision of the Services; an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person.
Processor:the Supplier;
Processing, processes and process: either any activity that involves the use of Personal Data or as the Data Protection Legislation may otherwise define processing, processes or process. It includes any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording. organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction. Processing also includes transferring Personal Data to third parties.
Data Protection Legislation: all applicable privacy and data protection laws including the General Data Protection Regulation ((EU) 2016/679) and the Data Protection Act 2018 and any applicable national implementing laws, regulations and secondary legislation in Ireland relating to the processing of Personal Data and the privacy of electronic communications, as amended, replaced or updated from time to time, including the Privacy and Electronic Communications Directive (2002/58/EC) and the Privacy and Electronic Communications (EC Directive) Regulations 2003 (SI 2003/2426).
Personal Data Breach: a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, Personal Data transmitted, stored or otherwise processed.
A reference to writing or written includes faxes and email.
In the case of conflict or ambiguity between any of the provisions of this Agreement and the provisions of any agreement governing the provision of the Services, the provisions of this Agreement will prevail
Personal data types and processing purposes
The Controller and the Processor acknowledge that for the purpose of the Data Protection Legislation, the Controller is the controller and the Processor is the processor.
The Controller retains control of the Personal Data and remains responsible for its compliance obligations under the applicable Data Protection Legislation, including providing any required notices and obtaining any required consents, and for the processing instructions it gives to the Processor.
Processor’s obligations
The Processor will only process the Personal Data to the extent, and in such a manner, as is necessary for the Business Purposes in accordance with the Controller’s written instructions. The Processor will not process the Personal Data for any other purpose or in a way that does not comply with this Agreement or the Data Protection Legislation. The Processor must promptly notify the Controller if, in its opinion, the Controller’s instruction would not comply with the Data Protection Legislation.
The Processor must promptly comply with any Controller request or instruction requiring the Processor to amend, transfer, delete or otherwise process the Personal Data, or to stop, mitigate or remedy any unauthorised processing.
The Processor will maintain the confidentiality of all Personal Data and will not disclose Personal Data to third parties other than it subcontractors unless the Controller or this Agreement specifically authorises the disclosure, or as required by law. If a law, court, regulator or supervisory authority requires the Processor to process or disclose Personal Data, the Processor must first inform the Controller of the legal or regulatory requirement and give the Controller an opportunity to object or challenge the requirement, unless the law prohibits such notice.
The Processor will reasonably assist the Controller with meeting the Controller’s compliance obligations under the Data Protection Legislation, taking into account the nature of the Processor’s processing and the information available to the Processor, including in relation to Data Subject rights, data protection impact assessments and reporting to and consulting with supervisory authorities under the Data Protection Legislation.
The Processor must promptly notify the Controller of any changes to Data Protection Legislation that may adversely affect the Processor’s performance of the Services.
Processor’s employees
The Processor will ensure that all employees:
are informed of the confidential nature of the Personal Data and are bound by confidentiality obligations and use restrictions in respect of the Personal Data;
have undertaken training on the Data Protection Legislation relating to handling Personal Data and how it applies to their particular duties; and
are aware both of the Processor’s duties and their personal duties and obligations under the Data Protection Legislation and this Agreement.
The Processor will take reasonable steps to ensure the reliability, integrity and trustworthiness of all of the Processor’s employees with access to the Personal Data.
Security
The Processor must at all times implement appropriate technical and organisational measures against unauthorised or unlawful processing, access, disclosure, copying, modification, storage, reproduction, display or distribution of Personal Data, and against accidental or unlawful loss, destruction, alteration, disclosure or damage of Personal Data.
The Processor must implement such measures to ensure a level of security appropriate to the risk involved, including as appropriate:
the encryption of personal data;
the ability to ensure the ongoing confidentiality, integrity, availability and resilience of processing systems and services;
the ability to restore the availability and access to personal data in a timely manner in the event of a physical or technical incident; and
a process for regularly testing, assessing and evaluating the effectiveness of security measures.
Personal Data Breach
The Processor will promptly and without undue delay notify the Controller if any Personal Data is lost or destroyed or becomes damaged, corrupted, or unusable. The Processor will use its reasonable endeavours to restore such Personal Data
The Processor will immediately and without undue delay notify the Controller if it becomes aware of:
any accidental, unauthorised or unlawful processing of the Personal Data; or
any Personal Data Breach.
Where the Processor becomes aware of (a) and/or (b) above, it shall, without undue delay, also provide the Controller with the following information:
description of the nature of (a) and/or (b), including the categories and approximate number of both Data Subjects and Personal Data records concerned;
the likely consequences; and
description of the measures taken, or proposed to be taken to address (a) and/or (b), including measures to mitigate its possible adverse effects.
Immediately following any unauthorised or unlawful Personal Data processing or Personal Data Breach, the parties will co-ordinate with each other to investigate the matter. The Processor will reasonably co-operate with the Controller in the Controller’s handling of the matter, including:
assisting with any investigation;
facilitating interviews with the Processor’s employees and others involved in the matter;
making available all relevant records, logs, files, data reporting and other materials required to comply with all Data Protection Legislation or as otherwise reasonably required by the Controller; and
taking reasonable and prompt steps to mitigate the effects and to minimise any damage resulting from the Personal Data Breach or unlawful Personal Data processing.
The Processor will not inform any third party of any Personal Data Breach without first obtaining the Controller’s prior written consent, except for its subcontractors or when required to do so by law.
The Processor agrees that the Controller has the sole right to determine:
whether to provide notice of the Personal Data Breach to any Data Subjects, supervisory authorities, regulators, law enforcement agencies or others, as required by law or regulation or in the Controller’s discretion, including the contents and delivery method of the notice; and
whether to offer any type of remedy to affected Data Subjects, including the nature and extent of such remedy.
Cross-border transfers of personal data
The Processor uses an Irish registered services provider which has a small number of employees who are located in India. Those employees have restricted and logged remote access to Personal Data. While Personal Data is not accessed by them in normal operation it may be accessed to debug specific customer issues. The data will not be moved off an AWS server in Europe. The data transfer is covered by EU standard contractual clauses in a Data Protection Agreement with the Services Provider.
Other than as set out in clause 11.1, the processor The Processor may not transfer or otherwise process Personal Data outside the European Economic Area (EEA) or to countries with a finding of adequate without obtaining the Controller’s prior written consent and subject to any conditions the Controller may require in respect of any such consent.
Complaints, data subject requests and third party rights
The Processor shall take such technical and organisational measures as may be appropriate, and promptly provide such information to the Controller as the Controller may reasonably require, to enable the Controller to comply with:
the rights of Data Subjects under the Data Protection Legislation, including subject access rights, the rights to rectify and erase personal data, object to the processing and automated processing of personal data, and restrict the processing of personal data; and
information or assessment notices served on the Controller by any supervisory authority under the Data Protection Legislation.
The Processor must notify the Controller immediately if it receives any complaint, notice or communication that relates directly or indirectly to the processing of the Personal Data or to either party’s compliance with the Data Protection Legislation.
The Processor must notify the Controller within 5 working days if it receives a request from a Data Subject for access to their Personal Data or to exercise any of their related rights under the Data Protection Legislation.
The Processor will give the Controller its full co-operation and assistance in responding to any complaint, notice, communication or Data Subject request.
The Processor must not disclose the Personal Data to any Data Subject or to a third party other than at the Controller’s request or instruction, as provided for in this Agreement or as required by law.
Term and termination
This Agreement will remain in full force and effect so long as the processor continues to provide the Services to the Controller (Term).
Any provision of this Agreement that expressly or by implication should come into or continue in force on or after termination of the provision of the Services in order to protect Personal Data will remain in full force and effect.
The Controller may terminate this agreement in the event of a material breach by the Processor which is not remedied within 30 days of written notice to do so on written notice to the Processor without further liability or obligation.
If a change in any Data Protection Legislation prevents either party from fulfilling all or part of the Services, the parties will suspend the processing of Personal Data until that processing complies with the new requirements. If the parties are unable to bring the Personal Data processing into compliance with the Data Protection Legislation within 30 days, they may terminate the agreement for Services between them.
Subcontractors
The Processor may engage subcontractors in relation to the provision of the Services provided such subcontractor enters into an agreement with the Processor which contains terms substantially inline with the terms of this Agreement.
Data return and destruction
At the Controller’s request, the Processor will give the Controller a copy of or access to all or part of the Controller’s Personal Data in its possession or control in the format and on the media reasonably specified by the Controller.
On termination of the provision of the Services for any reason or expiry of its term, the Processor will securely delete or destroy or, if directed in writing by the Controller, return and not retain, all or any Personal Data related to this Agreement in its possession or control, except for one copy that it may retain and use for 6 years for audit purposes only.
If any law, regulation, or government or regulatory body requires the Processor to retain any documents or materials that the Processor would otherwise be required to return or destroy, it will notify the Controller in writing of that retention requirement, giving details of the documents or materials that it must retain, the legal basis for retention, and establishing a specific timeline for destruction once the retention requirement ends.
The Processor will certify in writing that it has destroyed the Personal Data within 14 days after it completes the destruction.
Records
The Processor will keep detailed, accurate and up-to-date written records regarding any processing of Personal Data it carries out for the Controller, including but not limited to, the access, control and security of the Personal Data, approved subcontractors and affiliates, the processing purposes, categories of processing, any transfers of personal data to a third country and related safeguards, and a general description of the technical and organisational security measures referred to in clause 5.1 (Records).
The Processor will ensure that the Records are sufficient to enable the Controller to verify the Processor’s compliance with its obligations under this Agreement and the Processor will provide the Controller with copies of the Records upon request.
Audit
The Processor will provide the Controller with such information as it reasonably requires from time to time to verify the Processor’s compliance with its Agreement,
If a Personal Data Breach occurs or is occurring, or the Processor becomes aware of a breach of any of its obligations under this Agreement or any Data Protection Legislation, the Processor will:
conduct its own audit to determine the cause;
produce a written report that includes detailed plans to remedy any deficiencies identified by the audit;
provide the Controller with a copy of the written audit report; and
remedy any deficiencies identified by the audit as soon as reasonably possible.
Warranties
The Processor warrants and represents that:
its employees, subcontractors, agents and any other person or persons accessing Personal Data on its behalf are reliable and trustworthy and have received the required training on the Data Protection Legislation relating to the Personal Data;
it ill process the Personal Data in compliance with the Data Protection Legislation and other laws, enactments, regulations, orders, standards and other similar instruments;
it has no reason to believe that the Data Protection Legislation prevents it from providing any of the Services; and
considering the current technology environment and implementation costs, it will take appropriate technical and organisational measures to prevent the unauthorised or unlawful processing of Personal Data and the accidental loss or destruction of, or damage to, Personal Data, and ensure a level of security appropriate to:
the harm that might result from such unauthorised or unlawful processing or accidental loss, destruction or damage;
the nature of the Personal Data protected; and
comply with all applicable Data Protection Legislation and its information and security policies, including the security measures required in clause 5.1.
The Controller warrants and represents
that the Processor’s expected use of the Personal Data for the Business Purposes and as specifically instructed by the Controller will comply with the Data Protection Legislation; and
the Controller has all required consents and authorisations to transfer the Customer Data to the Process and to permit the Processor to process the Customer Data in accordance with this Schedule.
