The latest regulations also change such things as who is a Business Associate: the definition now casts a much wider 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.
Business Associates have requirements to comply with HIPAA privacy protections and security safeguards, and are subject to enforcement and penalties directly by HHS. Health Information Exchanges, Regional Health Information Exchanges, and e-Prescribing gateways are also considered to be Business Associates, and Sub-contractors of Business Associates are considered to be Business Associates as well under the new rules. 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.
Business Associate Agreements and provision of evidence of good practices commensurate with the risk involved are now more important than ever, because breaches by Business Associates are becoming more common and carry tremendous expenses for the affected covered entities. New audit and penalty requirements increase the need to make sure covered entities and Business Associates are in compliance before HHS OCR or your state Attorney General knocks on the door.
Updates to the HIPAA regulations now being enforced contain numerous changes based, for the most part, on The HITECH Act passed in 2009. Some of the most significant changes have to do with how Business Associates of HIPAA covered entities are treated under the regulations. HIPAA Business Associates are now 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 was a Covered Entity or a Business Associate before the new rules or not, you have significant obligations in compliance that you overlook at your peril.
Because the regulations have expanded the obligations of HIPAA Business Associates, 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.
In addition, Business Associates may need to provide for their covered entity clients rights of individuals to receive electronic copies of information held electronically, ask for certain restrictions on disclosures, and other capabilities that covered entities must have in place, depending on what is called for in the agreement.
All kinds of covered entities, and now, business associates of covered entities as well, need to review their HIPAA compliance, policies, and procedures to see if they are prepared to meet the challenges of compliance today. In addition, Business Associates have emerged as a leading source of health information breaches, and we will discuss what covered entities should do to ensure good practices by their Business Associates in order to avoid the considerable expense of breaches.
Compliance Manager, HIPAA Privacy Officer, HIPAA Security Officer, CEO, Office Manager, HR Director, Privacy Officer, CIO, Records Release Manager, HIM Manager, Counsel
is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a wide variety of healthcare entities. He is a frequent speaker regarding HIPAA, including speaking engagements at numerous regional and national healthcare association conferences and conventions and the annual NIST/OCR HIPAA Security Conference. Sheldon-Dean has more than 18 years of experience specializing in HIPAA compliance, more than 36 years of experience in policy analysis and implementation, business process analysis, information systems and software development, and eight years of experience doing hands-on medical work as a Vermont certified volunteer emergency medical technician. Sheldon-Dean received his B.S. degree, summa cum laude, from the University of Vermont and his master’s degree from the Massachusetts Institute of Technology
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