HIPAA Business Associates provide key services to HIPAA Covered Entities and other Business Associates, and may work in complex arrangements such as with Hybrid Entities, Affiliated Covered Entities, and Organized Health Care Arrangements. They 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, will be 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 Business Associate before the new rules or not, you have significant obligations in compliance that you overlook at your peril.
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. 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 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 knocks on the door.
Key Topic Areas:
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 their role.
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.
Areas Covered In The Session:
- The regulations will be reviewed and their effects on usual practices for Business Associates and their relationships with covered entities, hybrid entities, affiliated covered entities (ACEs) and organized health care arrangements (OHCAs) will be discussed.
- We will describe the kinds of entities that qualify as Business Associates and why it is important to carefully consider the designation before using it.
- We will explain what a Business Associate needs to do under the regulations, provide a policy framework for information security, and show what policies need to be changed and how.
- We will describe the required and recommended elements of a Business Associate Agreement, including identifying the template language provided by the US Department of Health and Human Services and its role in the process.
- We will explore the questions that should be posed to HIPAA Business Associates to ensure they have considered good privacy and security compliance practices in their businesses.
- The new enforcement penalty structure and the latest plans for audits by HHS OCR will be described and a plan for being prepared for audits will be discussed.
Who will benefit:
- Compliance Director
- Privacy Officer
- Security Officer
- Information Systems Manager
- HIPAA Officer
- Chief Information Officer
- Health Information Manager
- Healthcare Counsel/lawyer
- Office Manager
About The Presenter:
Jim Sheldon-Dean 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. Jim Sheldon-Dean has 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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