Description:
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.
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.
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.
Background:
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 was a Business Associate before the new rules or not, 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.
In addition, new guidance has outlined the compliance liabilities for HIPAA Business Associates, while massive security breaches by HIPAA Business Associates grab headlines every day.
Why should you attend:
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 client's 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.
Any Business Associate and any entity hiring a Business Associate must be aware of the compliance obligations of the HIPAA Business Associate and what must be expected in the relationship to ensure the establishment of the appropriate relationship and procedures to satisfy regulators.
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.
Who will Benefit:
- Compliance Manager
- HIPAA Privacy Officer
- HIPAA Security Officer
- CEO
- Office Manager
- HR Director
- Privacy Officer
- CIO
- Records Release Manager
- HIM Manager
- Counsel
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