{"id":3081,"date":"2020-09-04T11:49:20","date_gmt":"2020-09-04T11:49:20","guid":{"rendered":"https:\/\/www.empowerelearning.com\/blog\/?p=3081"},"modified":"2020-09-09T07:32:37","modified_gmt":"2020-09-09T07:32:37","slug":"what-you-need-to-know-about-business-associate-agreements","status":"publish","type":"post","link":"https:\/\/www.empowerelearning.com\/blog\/what-you-need-to-know-about-business-associate-agreements\/","title":{"rendered":"What you need to know about business associate agreements"},"content":{"rendered":"<h2><b>Are business associate agreements really important?\u00a0<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Let&#8217;s explore the question in the blog below. First, let&#8217;s take a look at three <\/span><i><span style=\"font-weight: 400;\">HIPAA fines<\/span><\/i><span style=\"font-weight: 400;\"> imposed by <\/span><i><span style=\"font-weight: 400;\">the<\/span><\/i> <i><span style=\"font-weight: 400;\">Office of Civil Rights<\/span><\/i> <i><span style=\"font-weight: 400;\">(OCR)<\/span><\/i><span style=\"font-weight: 400;\"> in <\/span><i><span style=\"font-weight: 400;\">2019<\/span><\/i><span style=\"font-weight: 400;\"> and <\/span><i><span style=\"font-weight: 400;\">2020<\/span><\/i><span style=\"font-weight: 400;\">.\u00a0\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">In <\/span><i><span style=\"font-weight: 400;\">2019<\/span><\/i><span style=\"font-weight: 400;\">, two organizations paid more than a million dollars for not signing <\/span><i><span style=\"font-weight: 400;\">business associate agreements<\/span><\/i><span style=\"font-weight: 400;\">.\u00a0<\/span>\n<ul>\n<li style=\"font-weight: 400;\"><i><span style=\"font-weight: 400;\">Cottage Health<\/span><\/i><span style=\"font-weight: 400;\"> paid <\/span><i><span style=\"font-weight: 400;\">$3 million<\/span><\/i><span style=\"font-weight: 400;\">, and<\/span><\/li>\n<li style=\"font-weight: 400;\"><i><span style=\"font-weight: 400;\">Sentara Hospitals<\/span><\/i><span style=\"font-weight: 400;\"> paid <\/span><i><span style=\"font-weight: 400;\">$2.17 million<\/span><\/i><span style=\"font-weight: 400;\">.\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">In June <\/span><i><span style=\"font-weight: 400;\">2020<\/span><\/i><span style=\"font-weight: 400;\">, the <\/span><i><span style=\"font-weight: 400;\">OCR<\/span><\/i><span style=\"font-weight: 400;\"> penalized another covered entity for a similar violation. <\/span><i><span style=\"font-weight: 400;\">Lifespan<\/span><\/i><span style=\"font-weight: 400;\"> will pay <\/span><i><span style=\"font-weight: 400;\">$1,040,000<\/span><\/i><span style=\"font-weight: 400;\"> as penalty. It must ensure that all <\/span><i><span style=\"font-weight: 400;\">business associate agreements<\/span><\/i><span style=\"font-weight: 400;\"> are in place within <\/span><i><span style=\"font-weight: 400;\">90 days<\/span><\/i><span style=\"font-weight: 400;\">.\u00a0\u00a0<\/span><\/li>\n<\/ul>\n<h2><b>What you need to know about Business associate agreements<\/b><\/h2>\n<h3><b>What is a Business Associate Agreement (BAA)?\u00a0<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Under the US law, all healthcare providers need to follow the <\/span><i><span style=\"font-weight: 400;\">Heath and Insurance Portability and Accountability Act<\/span><\/i> <i><span style=\"font-weight: 400;\">(HIPAA)<\/span><\/i><span style=\"font-weight: 400;\"> if their work involves patients\u2019 <\/span><i><span style=\"font-weight: 400;\">protected health information (PHI)<\/span><\/i><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">If a covered entity wants to outsource their work, they need to follow certain rules set by <\/span><i><span style=\"font-weight: 400;\">HIPAA<\/span><\/i><span style=\"font-weight: 400;\">.\u00a0 Activities or functions involving protected health information can be outsourced only if &#8211;\u00a0\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The vendor has been classified as a <\/span><i><span style=\"font-weight: 400;\">Business associate<\/span><\/i><span style=\"font-weight: 400;\">, and<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">You have signed a <\/span><i><span style=\"font-weight: 400;\">business associate agreement (BAA)<\/span><\/i><span style=\"font-weight: 400;\"> with the vendor.\u00a0<\/span><\/li>\n<\/ul>\n<h3><b>Disclosing PHI to a business associate<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">A covered entity can disclose PHI to a vendor only after receiving satisfactory assurance about how the vendor would use the PHI. The assurance should be in the written form. Vendors need to assure that they will &#8211;\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Use the PHI only for the purpose for which they have been engaged,<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Safeguard the PHI from misuse, and\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Help the covered entity comply with their obligations under the Privacy rule.\u00a0<\/span><\/li>\n<\/ul>\n<h2><b>Business associate subcontractor agreements\u00a0<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Vendors must follow the same rules, when subcontracting their work.\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The vendor must sign a <\/span><i><span style=\"font-weight: 400;\">business associate agreement<\/span><\/i><span style=\"font-weight: 400;\"> with the subcontractor.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The agreement should have assurances like the one that the <\/span><i><span style=\"font-weight: 400;\">business associate<\/span><\/i><span style=\"font-weight: 400;\"> gave to the covered entities.\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The three <a href=\"https:\/\/www.empowerelearning.com\/blog\/the-three-rules-of-hipaa-the-basics-you-need-to-know\/\">HIPAA rules<\/a> apply to the subcontractors of <\/span><i><span style=\"font-weight: 400;\">business associates<\/span><\/i><span style=\"font-weight: 400;\"> as well. The subcontractors too must follow the same standards as the <\/span><i><span style=\"font-weight: 400;\">business associates<\/span><\/i><span style=\"font-weight: 400;\">. Neither one can use the PHI for purposes not in their <\/span><i><span style=\"font-weight: 400;\">business associate agreement<\/span><\/i><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The agreement needs to be in place before the disclosure of PHI happens. Failure to have a signed <\/span><i><span style=\"font-weight: 400;\">business associate agreement<\/span><\/i><span style=\"font-weight: 400;\"> with a <\/span><i><span style=\"font-weight: 400;\">business associate<\/span><\/i><span style=\"font-weight: 400;\"> is a HIPAA violation. <\/span><i><span style=\"font-weight: 400;\">Covered entities<\/span><\/i><span style=\"font-weight: 400;\">, <\/span><i><span style=\"font-weight: 400;\">business associates<\/span><\/i><span style=\"font-weight: 400;\">, and sub-contractors <a href=\"https:\/\/www.empowerelearning.com\/blog\/why-you-need-to-encrypt-your-devices-unencrypted-laptop-costs-more-than-1-million-to-a-healthcare-provider\/\">can be penalized<\/a> for the violation.\u00a0<\/span><\/p>\n<h3><b>Exceptions to business associate agreement standards\u00a0<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">HIPAA allows a few exceptions to the BAA rule. No such contract is required if you are disclosing the PHI to &#8211;<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Health care providers for the treatment of an individual.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Health plan sponsor\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Health plans and agencies, where the activity is <a href=\"https:\/\/www.empowerelearning.com\/blog\/how-to-share-phi-without-violating-hipaa-ocr-relaxes-phi-laws-for-business-associates\/\">authorized by law<\/a>.\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The OCR considers the agreement as a written assurance from the vendor. By signing a contract the vendor assures that it has\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Conducted the risk assessment as required, and<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Put in place all necessary protections.\u00a0<\/span><\/li>\n<\/ul>\n<h3><b>What should business associate agreements include?\u00a0<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">As per the HIPAA rules, the <\/span><i><span style=\"font-weight: 400;\">business associate agreement<\/span><\/i><span style=\"font-weight: 400;\"> must\u00a0<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Describe how the <\/span><i><span style=\"font-weight: 400;\">business associate<\/span><\/i><span style=\"font-weight: 400;\"> can use the PHI. It should specify both the permitted and required PHI use.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Provide that the <\/span><i><span style=\"font-weight: 400;\">business associate<\/span><\/i><span style=\"font-weight: 400;\"> will not use or further disclose the PHI other than as permitted or required by the agreement or by the law.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Require the <\/span><i><span style=\"font-weight: 400;\">business associate<\/span><\/i><span style=\"font-weight: 400;\"> to protect the PHI from inappropriate usage or disclosure.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Require the <\/span><i><span style=\"font-weight: 400;\">business associate<\/span><\/i><span style=\"font-weight: 400;\"> to <a href=\"https:\/\/www.empowerelearning.com\/blog\/hipaa-breach-when-you-dont-need-to-report-and-how-to-handle-a-hipaa-breach\/\">report HIPAA breaches<\/a> to the covered entity.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Include assurance from the <\/span><i><span style=\"font-weight: 400;\">business associate<\/span><\/i><span style=\"font-weight: 400;\"> that it would return or destroy the PHI upon termination of the contract.\u00a0<\/span><\/li>\n<\/ol>\n<p><i><span style=\"font-weight: 400;\">Business associate agreements<\/span><\/i><span style=\"font-weight: 400;\"> between <\/span><i><span style=\"font-weight: 400;\">business associates <\/span><\/i><span style=\"font-weight: 400;\">and their subcontractors must follow the same rules as mentioned above. The OCR can take action against <\/span><i><span style=\"font-weight: 400;\">business associates<\/span><\/i><span style=\"font-weight: 400;\"> for failing to address a breach or violation by their subcontractor.\u00a0<\/span><\/p>\n<h3><b>How to comply with the BAA standards?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Before you hire a vendor, figure out if it should be labeled as a <\/span><i><span style=\"font-weight: 400;\">business associate<\/span><\/i><span style=\"font-weight: 400;\">. You should label a vendor as a <\/span><i><span style=\"font-weight: 400;\">business associate<\/span><\/i><span style=\"font-weight: 400;\"> if the job involves creating, disclosing, maintaining, receiving, or transmitting PHI on your behalf.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Next, you\u2019d want to understand if the vendor can follow HIPAA. Ask the vendor to conduct a risk assessment of their system, and put in place a risk-management plan.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The next step would be the signing of a <\/span><i><span style=\"font-weight: 400;\">business associate agreement<\/span><\/i><span style=\"font-weight: 400;\"> with the vendor. Remember, this should all happen before you begin disclosing PHI to the vendor.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">But why go through all this trouble? That\u2019s because it would help establish liability in case of a data breach. Unless there is a signed <\/span><i><span style=\"font-weight: 400;\">business associate agreement<\/span><\/i><span style=\"font-weight: 400;\"> in place, OCR can hold covered entities liable for HIPAA violations by their <\/span><i><span style=\"font-weight: 400;\">business associates<\/span><\/i><span style=\"font-weight: 400;\">.<\/span><i><span style=\"font-weight: 400;\">\u00a0<\/span><\/i><\/p>\n<h3><b>Penalties for not signing a BAA<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Covered entities can also be penalized for not signing <\/span><i><span style=\"font-weight: 400;\">business associate agreements<\/span><\/i><span style=\"font-weight: 400;\"> with their Business associates. Here are some more examples in which covered entities were fined because of carelessness with <\/span><i><span style=\"font-weight: 400;\">business associate agreements<\/span><\/i><span style=\"font-weight: 400;\">.\u00a0\u00a0\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><i><span style=\"font-weight: 400;\">North Memorial Health Care<\/span><\/i><span style=\"font-weight: 400;\"> of Minnesota. The hospital paid a fine of more than <\/span><i><span style=\"font-weight: 400;\">$1.5 million<\/span><\/i><span style=\"font-weight: 400;\"> for not signing a written agreement with its <\/span><i><span style=\"font-weight: 400;\">business associate<\/span><\/i><span style=\"font-weight: 400;\">.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><i><span style=\"font-weight: 400;\">Care New England Health System<\/span><\/i><span style=\"font-weight: 400;\"> paid nearly <\/span><i><span style=\"font-weight: 400;\">$400,000<\/span><\/i><span style=\"font-weight: 400;\"> for failing to update its <\/span><i><span style=\"font-weight: 400;\">business associate agreement<\/span><\/i><span style=\"font-weight: 400;\"> with its <\/span><i><span style=\"font-weight: 400;\">business associate<\/span><\/i><span style=\"font-weight: 400;\">.\u00a0<\/span><\/li>\n<\/ul>\n<h3><b>How often to update your BAA?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">The case of Care New England underlines why covered entities must review and update their contracts with vendors regularly. As per HIPAA, you must change your <\/span><i><span style=\"font-weight: 400;\">business associate agreement<\/span><\/i><span style=\"font-weight: 400;\">, if\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">HIPAA regulations have been updated, or\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Your relationship with the <\/span><i><span style=\"font-weight: 400;\">business associate<\/span><\/i><span style=\"font-weight: 400;\"> has changed.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Under the law, the final responsibility of protecting a patient&#8217;s PHI rests with the covered entity.\u00a0<\/span><\/p>\n<h2><b>Direct liability clauses and indemnity provisions<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">In case of a serious breach, the OCR would scrutinize the <\/span><i><span style=\"font-weight: 400;\">business associate agreement<\/span><\/i><span style=\"font-weight: 400;\"> closely. If the <\/span><i><span style=\"font-weight: 400;\">business associate<\/span><\/i><span style=\"font-weight: 400;\"> is at error, then the OCR would hold the <\/span><i><span style=\"font-weight: 400;\">business associate<\/span><\/i><span style=\"font-weight: 400;\"> liable. But, in case of serious negligence, the covered entity could be fined too.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">That\u2019s why you must ensure that your <\/span><i><span style=\"font-weight: 400;\">business associate agreement<\/span><\/i><span style=\"font-weight: 400;\"> with your vendor is well-drafted. Be very specific. It should include language that indemnifies you of your vendor\u2019s mistakes. The contract should underline how you interpret permitted and accepted use of PHI.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Moreover, be really specific about their legal liabilities under the three HIPAA rules. Pay special attention to important issues such as &#8211;<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Reporting breach incidents<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Risk analysis and risk management plan<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Providing timely service to patients when asked for a copy of their PHI, or amending it.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.empowerelearning.com\/blog\/who-should-take-hipaa-training-and-why-its-so-important\/\">HIPAA training<\/a> for employees\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Compliance documentation.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Business associate agreements should have become a norm by now. Unfortunately, it\u2019s still not so. A vendor saying that they are HIPAA compliant is not enough. Even if it\u2019s a cloud service, or your email service provider, you need to have a <\/span><i><span style=\"font-weight: 400;\">business associate agreement<\/span><\/i><span style=\"font-weight: 400;\"> with them.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">If you have any queries about <\/span><i><span style=\"font-weight: 400;\">business associate agreements<\/span><\/i><span style=\"font-weight: 400;\">, please post your queries in the comments section below.\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Are business associate agreements really important?\u00a0 Let&#8217;s explore the question in the blog below. First, let&#8217;s take a look at three HIPAA fines imposed by the Office of Civil Rights (OCR) in 2019 and 2020.\u00a0\u00a0 In 2019, two organizations paid more than a million dollars for not signing business associate agreements.\u00a0 Cottage Health paid $3 [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":3082,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5,138,140,9],"tags":[77,155],"class_list":["post-3081","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-education","category-elearning","category-empower","category-hipaa","tag-hipaa","tag-phi"],"_links":{"self":[{"href":"https:\/\/www.empowerelearning.com\/blog\/wp-json\/wp\/v2\/posts\/3081","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.empowerelearning.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.empowerelearning.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.empowerelearning.com\/blog\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.empowerelearning.com\/blog\/wp-json\/wp\/v2\/comments?post=3081"}],"version-history":[{"count":0,"href":"https:\/\/www.empowerelearning.com\/blog\/wp-json\/wp\/v2\/posts\/3081\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.empowerelearning.com\/blog\/wp-json\/wp\/v2\/media\/3082"}],"wp:attachment":[{"href":"https:\/\/www.empowerelearning.com\/blog\/wp-json\/wp\/v2\/media?parent=3081"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.empowerelearning.com\/blog\/wp-json\/wp\/v2\/categories?post=3081"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.empowerelearning.com\/blog\/wp-json\/wp\/v2\/tags?post=3081"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}