Business Associate Agreement: A Basic Guide
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What Is A Business Associate Agreement?
A business associate agreement, also known as business associate contracts, is a legally-binding document that establishes a party’s responsibilities regarding personal healthcare information (PHI). The contract must provide guidance on a privacy policy for protecting PHI and electronic PHI (ePHI) on cloud services, applications, storage, and communications.
Numerous rules and regulations are surrounding PHI and ePHI. Health care lawyers can help business associates and providers draft an agreement.
Here is an article about what a business associate agreement is .
Understanding Business Associate Agreements
Business associate agreements are specific to healthcare providers and others who deal with PHI. They are part of the continuous effort to ensure that PHI and ePHI are not inadvertently or intentionally disclosed to unauthorized individuals. Specific individuals must sign a business associate agreement and acknowledge all applicable laws.
Who Should Sign A Business Associate Agreement?
All relevant parties should sign a business associate agreement. However, these agreements are generally signed by managers with protocols implemented and delegated to the team individually.
These are the following individuals who typically sign a business agreement:
- Vendors
- Contractors
- Hospitals
- Clinics
- Labs
- Attorneys
- And more
If you have questions about who should be signing a business associate agreement in your organization, ensure that you speak with healthcare lawyers for advice. They can help you identify all parties with a vested legal or financial interest in the matter.
Here is an article on the basics of business associate agreements .
Who Needs A Business Associate Agreement?
There are two parties who could need a business associate agreement. The first one is a business associate, and the second is a covered entity. Both parties have separate duties and responsibilities that should be carefully established in a business associate agreement.
Who Is Considered A Business Associate?
Business associates are individuals or business entities who perform specific activities that involve the direct use or divulgence of PHI or ePHI. These activities include operation management and administration according to the Privacy Rule and Administrative Simplification Rules.
A business associate can range from software companies to cloud services providers. Anyone who could potentially view PHI or ePHI and is not a covered entity employee is a business associate.
Covered Entity vs. Business Associate
Covered entities are hospitals and healthcare providers and are different from business associates. Business associates are not employed by covered entities. However, a business associate provides a service to the covered entity as part of its normal course of business.
Here is an article about business associates .
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Parts of a Business Associate Agreement
Under HIPAA and HITECH, business associates must follow specific security rules and routinely review them when working with a covered entity. For both parties to protect themselves, it is essential to address the key parts of a business associate agreement. Leaving out important details can result in legal problems in the future.
These are the parts of a business associate agreement under Health and Human Services (HHS) guidelines:
- Part #1: Establish permitted uses of PHI as well as any disclosures.
- Part #2: Require that the business associate not use the information as permitted or required by law.
- Part #3: Demand that the business associate utilize reasonable security protocols to prevent unauthorized use of PHI.
- Part #4: Set terms and conditions related to breaches of PHI.
- Part #5: Address the business associate’s obligation to handle PHI copy requests.
- Part #6: Explain how HIPAA obligations require business associates to comply with applicable laws.
- Part #7: Require the business associate to maintain high internal standards and practice related to the handling of PHI.
- Part #8: Determine how contract terminations should be handled as well as how to return or destroy PHI data.
- Part #9: Specify how business associates should deal with subcontractors and their use of PHI.
- Part #10: Provide for contract termination of a material business associate violation from the terms contained within.
As you can see, business associate agreements are highly technical and complex. It is necessary and imperative to understand the role of HIPAA compliance and BAAs when forging this type of relationship with a covered entity. If you have any questions, privacy lawyers are able to provide specific legal advice.
Image via Pexels by Ketut Subiyanto
HIPAA-Compliance and BAAs
The Health Insurance Portability and Accountability Act (HIPAA) sets standards that are not just limited to covered entities. HIPAA standardized how PHI should be used, stored, transmitted, and disclosed for everyone working in the healthcare industry. Since business associates use PHI, it is essential that BAAs comply with current rules and regulations.
Here is an article about HIPAA business associate agreements .
BAAs and Cloud Services
Before business associates can use, store, or process PHI, they must ensure that the services of the covered entities are secure. Even if the business associate claims that they are HIPAA and HITECH compliant, they cannot use ePHI until a risk analysis is performed when it is being stored in the cloud.
However, there is an added element in that cloud services are also considered business associates. As such, covered entities must ensure that they have BAAs in place with them as well. Before uploading any PHI data to cloud services, the covered entity must have a signed BAA with their providers.
Cloud computing service providers can be liable for accessing ePHI if their services do not comply with HIPAA standards, even if they did not see any data. It is also essential to remember that not all cloud computing providers are willing to sign BAAs.
Also, BAAs do not necessarily make cloud services to be HIPAA compliant upon signing. Even with an agreement in place, HIPAA laws can be violated, which means that no provider can be authentically HIPAA compliant alone.
Simply put, HIPAA compliance is determined by how the platform is used.
Getting Help With a Business Associate Agreement
Federal and state laws take HIPAA violations seriously. As such, it is critical to hire healthcare lawyers when getting help with a business associate agreement. The value, knowledge, and experience they provide will protect you and your organization in the future while avoiding common pitfalls.
These are the advantages of hiring healthcare lawyers when dealing with a business associate agreement:
- Vast knowledge of laws that help you avoid HIPAA violations
- Ability to interpret laws and court rulings when making decisions
- Business associates and covered entities will understand their rights
- Experience will help clients better prepare for the transaction
- Manage expectations among all negotiating parties
- Compliance under all federal, state, and county regulations and laws, such as the CCPA
- Representation in case future disputes arise
Due to the intricate nature of healthcare laws, especially those related to PHI and HIPAA, ensure that you do not make the critical mistake of guessing your way through the business associate agreement. Doing so could create problems in the future, and the losses could far outweigh the costs of hiring privacy lawyers the first time around.
Privacy lawyers will listen to your needs and draft a contract that meets them. They will also focus on keeping patient information private and secure.
Here is an article with resources for providers on PHI compliance and data security .
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Jason is a self-starting, go-getting lawyer who takes a pragmatic approach to helping his clients. He co-founded Fortify Law because he was not satisfied with the traditional approach to providing legal services. He firmly believes that legal costs should be predictable, transparent and value-driven. Jason’s entrepreneurial mindset enables him to better understand his clients’ needs. His first taste of entrepreneurship came from an early age when he helped manage his family’s small free range cattle farm. Every morning, before school, he would deliver hay to a herd of 50 hungry cows. In addition, he was responsible for sweeping "the shop" at his parent's 40-employee HVAC business. Before becoming a lawyer, he clerked at the Lewis & Clark Small Business Legal Clinic where he handled a diverse range of legal issues including establishing new businesses, registering trademarks, and drafting contracts. He also spent time working with the in-house team at adidas® where, among other things, he reviewed and negotiated complex agreements and created training materials for employees. He also previously worked with Meriwether Group, a Portland-based business consulting firm focused on accelerating the growth of disruptive consumer brands and facilitating founder exits. These experiences have enabled Jason to not only understand the unique legal hurdles that can threaten a business, but also help position them for growth. Jason's practice focuses on Business and Intellectual Property Law, including: -Reviewing and negotiating contracts -Resolving internal corporate disputes -Creating employment and HR policies -Registering and protecting intellectual property -Forming new businesses and subsidiaries -Facilitating Business mergers, acquisitions, and exit strategies -Conducting international business transactions In his free time, Jason is an adventure junkie and gear-head. He especially enjoys backpacking, kayaking, and snowboarding. He is also a technology enthusiast, craft beer connoisseur, and avid soccer player.
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Jason has been providing legal insight and business expertise since 2001. He is admitted to both the Virginia Bar and the Texas State Bar, and also proud of his membership to the Fellowship of Ministers and Churches. Having served many people, companies and organizations with legal and business needs, his peers and clients know him to be a high-performing and skilled attorney who genuinely cares about his clients. In addition to being a trusted legal advisor, he is a keen business advisor for executive leadership and senior leadership teams on corporate legal and regulatory matters. His personal mission is to take a genuine interest in his clients, and serve as a primary resource to them.
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Business Associate Agreement
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Can you explain the key components and legal requirements of a Business Associate Agreement?
I am a small business owner in the healthcare industry and recently started working with a new vendor to handle our patient data. I have been asked to sign a Business Associate Agreement (BAA) by the vendor, but I am not familiar with the legal requirements and key components of such an agreement. I want to ensure that I am compliant with HIPAA regulations and that our patient data is adequately protected, so I would appreciate it if you could provide me with a clear understanding of what a BAA entails, what provisions should be included, and any potential legal pitfalls I should be aware of before signing.
Dolan W.
Hello! As you may know, a Business Associate Agreement ensures compliance with HIPAA when a healthcare entity shares patient data with an outside vendor. The BAA specifies how the vendor, or business associate, will use, disclose, and protect the Protected Health Information they access. It must include safeguards for PHI, like data protection measures and prompt notification in case of a data breach (e.g. if someone hacks into your systems). The agreement should also cover what happens to PHI once the contract ends, requiring the business associate to return or destroy it. Specific terms may allow your business to audit the vendor's compliance or end the contract if they fail to meet HIPAA standards. Lastly, make sure any subcontractors involved also comply with HIPAA to maintain data security throughout the process because rogue employees sometimes do whatever they want. We are able to draft BAAs for you. Just request me on the site and best of luck! Dolan
Quick, user friendly and one of the better ways I've come across to get ahold of lawyers willing to take new clients.
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