United States

Identify and respond to suspected or known incidents, mitigate harmful effects, and document incidents and their outcomes. NIST recommends linkage to HIPAA Breach Notification Rule timelines.

A covered entity may permit a business associate to handle ePHI only after obtaining satisfactory assurances via written contract. NIST recommends due diligence, security questionnaires, and ongoing monitoring of BAs.

A business associate may permit a business associate that is a subcontractor to create, receive, maintain, or transmit electronic protected health information on its behalf only if the business associate obtains satisfactory assurances, in accordance with 164.314(a), that the subcontractor will appropriately safeguard the information.

Document the satisfactory assurances required by paragraph (b)(1) of this section through a written contract or other arrangement with the business associate that meets the applicable requirements of 164.314(a).

The contract or other arrangement required by 164.308(b)(3) must meet the requirements of paragraph (a)(2)(i), (a)(2)(ii), or (a)(2)(iii) of this section, as applicable.

The contract between a covered entity and a business associate must provide that the business associate will comply with the applicable Security Rule requirements, ensure subcontractors comply, report security incidents including breaches, and authorize termination by the covered entity if the business associate violates a material term.

The requirements of paragraph (a)(2)(i) of this section apply to the contract or other arrangement between a business associate and a subcontractor required by 164.308(b)(4) in the same manner as such requirements apply to contracts or other arrangements between a covered entity and business associate.

Define and apply processes to manage the security risk suppliers introduce.

Establish and agree the relevant security requirements in each supplier contract.

Extend security requirements down the ICT products and services supply chain.

Govern acquisition, use, management and exit of cloud services against your security requirements.

Define incident roles, processes and readiness before an incident happens.

Identify, document and keep current the legal and contractual obligations relevant to security, and your approach to meeting them.

Identify and meet privacy and PII-protection requirements from law, regulation and contract.

Where relevant, the contract to process personal data must address the organization's role in assisting the customer with the customer's own obligations, taking account of the nature of processing and the information available to it, covering as relevant privacy by design and by default, achieving security of processing, notifying breaches to a supervisory authority and to cust...

The organization must provide the ability to return, transfer or dispose of personal data securely and must make its policy available to the customer, managing the capability securely whether the outcome is return to the customer, transfer to another organization or controller, deletion, destruction, de-identification or archiving, providing the assurance the customer needs tha...

The organization must disclose to the customer any use of subcontractors to process personal data before that use, with provisions included in the customer contract, disclosing that subcontracting is used and the names of the relevant subcontractors, the countries and international organizations to which they can transfer data, and the means by which they are obliged to meet or...

The organization must engage a subcontractor to process personal data only according to the customer contract, obtaining written authorization from the customer before the subcontractor processes the data, whether through appropriate clauses in the customer contract or a specific one off agreement, holding a written contract with every such subcontractor that addresses implemen...

Where it holds a general written authorization, the organization must inform the customer of any intended change involving the addition or replacement of a subcontractor that processes personal data, giving the customer the opportunity to object, and where it changes the subcontractor carrying out some or all of the processing, written authorization from the customer is require...

Agreements with suppliers shall specify whether PII is processed and the minimum technical and organizational measures the supplier must meet for the organization to meet its information security and PII protection obligations, shall clearly allocate responsibilities between the organization, its partners, suppliers and applicable third parties taking account of the type of PII...

For a PII controller, an incident that involves PII shall trigger a review to determine whether a breach involving PII requiring a response has occurred, an event alone not necessarily triggering it; when a breach has occurred the response shall include the relevant notifications and records, jurisdictions defining when the supervisory authority and PII principals must be notif...