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HIPAA regulations pertaining to the relationships of business entities that share PHI are now being enforced. HIPAA Business Associates are covered directly under the Privacy Rule’s use and disclosure limitations, the Security Rule’s safeguard provisions, and the Breach Notification Rule’s notification requirements. HIPAA Business Associates are responsible for their own compliance with the regulations and may be held directly liable for any violations of the regulations. Whether your organization is a Business Associate or a Covered Entity that hires HIPAA Business Associates, you have significant obligations in compliance that you overlook at your peril.
Key Topic Areas:
A provider of services to a healthcare entity may be considered a HIPAA Business Associate if they create, receive, maintain, or transmit HIPAA Protected Health Information (PHI) on behalf of those entities, whether or not the required agreements are in place, and is subject to the obligations imposed on such business partners by the HIPAA regulations. Certain activities can place a firm in a business associate relationship, and once that’s the case, there are compliance obligations that can lead to significant penalties if ignored. This presentation will help entities working with healthcare information on behalf of others understand the obligations under HIPAA and see what needs to be done to ensure data are properly protected and penalties for noncompliance are avoided. In this modern environment of electronic systems, potential security threats, and big penalties in the millions of dollars for non-compliance, it is essential to understand your obligations and act accordingly under HIPAA.
The definition of a HIPAA Business Associate casts a wide net of healthcare business activities, including any business that creates, receives, maintains, or transmits any Protected Health Information on behalf of a HIPAA Covered Entity or Business Associate, and even sub-contractors of Business Associates are also treated as business associates, greatly expanding the pool of entities under regulation to some that may not even be aware they have become HIPAA Business Associates.
Based on recent enforcement actions, it is now more important than ever to carefully consider whether a BA designation is appropriate or not – Business Associate Agreements are not to be entered into lightly. The requirements have a direct impact on what needs to be put into the business associate agreements you establish. And, in order to satisfy their clients’ requirements for adequate assurances of good practices, Business Associates may be asked to provide not just a simple contract, but also third-party reviews and assessments of HIPAA compliance.
HHS has issued a guidance document to explain how Business Associates may be liable for compliance enforcement under HIPAA, giving a ten-item list of ways an entity could become liable under the regulations. Some of the specifications are far from trivial, such as complying with the Security Rule, but the organization of items relevant to Business Associates is a helpful guide.
Business Associate Agreements are now more important than ever because breaches by Business Associates are becoming more common and carry tremendous expenses for the affected covered entities. Audit and penalty liabilities confirm the need to make sure covered entities and Business Associates are in compliance before HHS OCR knocks on the door.