Does a Covered Entity Need to Sign a Business Associate Agreement

Not all of these services have to manage your customers` information. However, some of them, like an email provider like Hushmail, could eventually deal with PHI. If you are a covered entity, this PHI must be protected. A trade partnership agreement, also known as commercial partnership agreements, is a legally binding document that sets out a party`s responsibilities with respect to personal health information (PHI). The contract must include a privacy policy to protect PHI and electronic PHI (ePHI) for cloud services, applications, storage and communications. The companies covered are hospitals and healthcare providers and are different from business partners. Business partners are not employed by the companies covered. However, a business partner provides a service to the covered entity in the course of business. 4.

Report security incidents and data breaches to the relevant company. (45 CFR 164.314(a), 164.410 and 164.502(e)). The contract must provide that the BA (or subcontractor) must put in place appropriate administrative, technical, and physical safeguards to ensure the confidentiality, integrity, and availability of ePHI and to comply with the requirements of the HIPAA security rule. Some of these measures may be provided for in the BAA or may be left to the discretion of the BA. The BAA should also include permitted uses and disclosures of PSRs to meet the requirements of the HIPAA Privacy Rule. In the event that persons who are not authorized to access the information access the PSR, e.B. in the event of an internal breach or cyberattack, the business partner is required to inform the relevant entity of the breach and possibly send notifications to persons whose PSR has been compromised. The timing and responsibilities for notifications should be set out in detail in the agreement. These are the parts of a business partnership agreement according to the Health and Social Services (HHS) guidelines: however, there is an additional element as cloud services are also considered business partners. Therefore, covered companies must ensure that they also have BAAs.

Before uploading PHI data to cloud services, the relevant entity must have a BAA signed with its suppliers. Business partners are natural or legal persons who carry out certain activities involving the use or direct dissemination of PHI or ePHI. These activities include operational management and administration in accordance with the data protection rule and the administrative simplification rules. 1. Explain the limitations of the obligations of business partners discussed above. Hopefully, the company concerned realizes that a business partner agreement is not necessary and is ready to give up the agreement. The functions and activities of business partners include: handling or managing complaints; data analysis, processing or management; Verification of use; quality assurance; Invoicing; performance management; practice management; and scaling. Services to business partners include: legal; actuarial science; Accounting; Council; data aggregation; Management; administrative; Accreditation; and financially. See the definition of “trading partner” in 45 CFR 160.103. For those types of employees who are not business partners, Total HIPAA recommends the following: If the “employee” is a contractor who works exclusively for your business, or a sole proprietor with other customers, you cannot expect the person to create privacy and security policies and procedures such as a BA or BAS.

There`s no point in asking them to sign a BAA or a subcontractor BAA because they don`t have the compliance infrastructure required by HIPAA. Under HIPAA and HITECH, business partners must follow certain security rules and review them regularly when working with a covered company. In order for both parties to protect each other, it is important to cover the most important parts of a trade partnership agreement. The omission of important details can lead to legal problems in the future. For some vendors, you only need a service level agreement (SLA). However, for vendors who create, receive, manage, or transfer PSRs on behalf of your organization (called trading partners), you must have a business partnership agreement in addition to the SLA. Even if your provider can`t really see the PHI (e.B. because it`s encrypted), you`ll still need a BAA with them. While it is almost always necessary for a business partner to sign an agreement with a covered company when a business partner creates, receives, maintains or transfers ePHI on behalf of the covered company, the company is not a business partner and no agreement is required if the company does not provide a covered service to the covered company (i.e. a landscaper). HHS can audit BAs and contractors for HIPAA compliance, not just covered companies.

This means that organizations must have a Business Partnership Agreement (BAA) for all three tiers in order to meet HIPAA requirements. It is in your mutual interest to reach an agreement, as all three classifications are responsible for the protection of PSR. Jay Pink is a lawyer who works with businesses and families on estate planning and business law issues. His CPA degree and work in several family businesses throughout his career have allowed him to provide valuable insights into successful business operations. He has founded many companies – LLC, Corps Partnerships and non-profit organizations. Business partners who violate HIPAA can face penalties ranging from $100 to more than $50,000 per violation. (45 CFR 160,404). If the violation is due to wilful negligence, the Office of Civil Rights (“OCR”) must impose a fine of at least $10,000 per violation. (Id.). If the Business Partner has acted intentionally and fails to correct the breach within thirty (30) days, ocR shall impose a penalty of at least $50,000 per breach. (Id.). A single violation can result in many violations.

For example, the loss of a laptop containing hundreds of PHI patients can be hundreds of violations. Similarly, any day on which a relevant business or business partner fails to implement a required policy is a separate violation. (45 CFR 160,406). In addition to regulatory penalties, business partners who fail to comply with business partnership agreements may also be held liable for contractual damages and/or claims for compensation set forth in the business partnership agreement. From award-winning HIPAA training to contracts and agreements, we can meet your needs so you can protect your business. If you hire a subcontractor and that contractor comes into contact with a PHI, you will need to do a BAA between the two of you. The confidentiality rule states that all business partner contractors must accept restrictions identical to those of the original business partner. The Department of Health and Human Services` Office of Civil Rights (HHS/OCR) can impose hefty fines and corrective action plans if you don`t have a BAA with your BAs. When HHS/OCR audits your organization, you must also be able to present your business partnership agreements and prove that you have done due diligence with your BAs. 5. If the business partner uses subcontractors or other companies to provide services to the relevant company in which PHI is involved, sign business partnership agreements with the subcontractors. .