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covered entity is an individual, business, or agency that is NOT a health care provider that conducts certain transactions in electronic form, NOT a health care clearinghouse, and NOT a health plan. Examples of noncovered HIPAA entities: Fitbit.
HIPAA requires Covered Entities to only work with Business Associates who assure complete protection of PHI. These assurances have to be in writing in the form of a contract or other agreement between the Covered Entity and the BA. HHS can audit BAs and Subcontractors for HIPAA compliance, not just Covered Entities.
Who Needs a Business Associate Agreement? Any Business Associate you share PHI or ePHI with over the course of the work they've been hired to do is who needs a Business Associate Agreement.
A business associate contract is not required with persons or organizations whose functions, activities, or services do not involve the use or disclosure of [PHI], and where any access to [PHI] by such persons would be incidental, if at all.
A business associate agreement establishes a legally-binding relationship between HIPAA-covered entities and business associates to ensure complete protection of PHI. This type of agreement is necessary if business associates can potentially access PHI during their work.
Basically, if your organization interacts with protected health information (PHI) from a health provider, health insurer, or similar covered entity (CE) your organization is considered a business associate (BA) which must comply with all HIPAA/HITECH regulations and be HIPAA compliant.
The HIPAA Rules require covered entity and business associate customers to obtain satisfactory assurances in the form of a business associate agreement (BAA) with the CSP that the CSP will, among other things, appropriately safeguard the protected health information (PHI) that it creates, receives, maintains or ...
$31,000 fine for not having a Business Associate Agreement.