HIPAA And Business Associates: Identifying And Managing Entity Relationships

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HIPAA regulations about 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 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.

Learning Objective:

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, 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 comply before HHS OCR knocks on the door.

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 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 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.
• We will review the new HHS guide to guide to the direct enforcement liabilities of Business Associates under the HIPAA regulations.
• 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 in place.
• 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 and enforcement actions will be discussed.
• Live Q&A Session

Suggested Attendees:

• Compliance Director
• CEO
• CFO
• Privacy Officer
• Security Officer
• HIPAA Privacy Officers
• HIPAA Security Officers
• Information Security Officers
• Risk Managers
• Compliance Officers
• Privacy Officers
• Health Information Managers
• Information Technology Managers
• Information Systems Managers
• Medical Office Managers
• Chief Financial Officers
• Systems Managers
• Chief Information Officer
• Healthcare Counsel/lawyer
• Operations Directors
• Insurers
• Hospitals
• Practice Groups
• Records Release Manager
• HR Director
• Office Manager
• Electronic Healthcare Information Systems Staff

Presenter Biography:

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.  Sheldon-Dean has more than two decades of experience specializing in HIPAA compliance, four decades 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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