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 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 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.
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.
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. 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 recently 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. 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.
- Review regulation and their effects on usual practices for Business Associates and their relationships with covered entities
- Understand different the kinds of entities that qualify as Business Associates and why it is important to carefully consider the designation before using it
- Examine other types of HIPAA entities, such as Hybrid entities, Affiliated Covered Entities, and Organized Health Care Arrangements, how they relate to Business Associates, and when Business Associate Agreements may be required among the various entities
- Review the new HHS guide to guide to the direct enforcement liabilities of Business Associates under the HIPAA regulations.
- Know what a Business Associate needs to do under the regulations, provide a policy framework for information security, and show what policies need to be in place
- Know 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
- 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.
- Learn new enforcement penalty structure and the latest plans for audits by HHS OCR and a plan for being prepared for audits and enforcement actions
Areas Covered in the Session:
- HIPAA regulations their effects on usual practices for Business Associates
- Relationships with HIPAA covered entities
- Types of HIPAA entities
– Hybrid entities
– Affiliated Covered Entities
– Organized Health Care Arrangements,
- Requirement of Business Associate Agreements
- New HHS guide
- Policy framework for information security
- Elements of a Business Associate Agreement
- HIPAA business associates and Privacy & Security compliance
- New enforcement penalty structure
- HHS OCR latest plan for Audit
- Live Q&A Session
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Who Should Attend:
- Healthcare CEOs
- Healthcare CFOs
- Compliance directors
- Privacy Officers
- Security Officers
- Information Systems Managers
- HIPAA Officers
- Chief Information Officers
- Health Information Managers
- Healthcare Counsel/lawyers
- Office Managers
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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