Advertisement

July 26, 2014

HITECH Omnibus Rule Basics

As we pore through the 562-page HITECH Omnibus Rule released by the Department of Health and Services late Thursday afternoon, here are some top line bullet points:

  • Effective Date:  Rule becomes effective on March 26, 2013.  Covered entities and business associates must comply by September 23, 2013.
  • Business Associates are now front and center – During its announcement yesterday, Leon Rodriguez, director of the HHS Office for Civil Rights (OCR) clearly pointed out that “some of the largest breaches” reported to the agency have involved business associates.    The Omnibus Rule applies all of the HIPAA Security Rule standards and implementation specifications and certain HIPAA Privacy Rule provisions directly to business associates and it adds “subcontractors” to the definition of “business associate” and requires business associates to enter into written contracts with subcontractors that are substantially similar to business associate agreements.   Although there is a bit of a runway before effectiveness of the provisions, there is no time to waste for companies to determine (a) whether they are indeed “business associates” under this new, expanded view (may be some surprises), and (b) if you are a BA, how far down your technology “stack” you may have to go under the Omnibus Rule to determine who are your “subcontractors.”   Also, this is a good time for covered entities to get busy to determine and catalog exactly who is a “business associate” for their purposes.   Risk assessments and gap analyses always take more time than estimated.   OCR’s comments yesterday are consistent with its view that business associate compliance with HITECH is poor, resulting in breaches and other security incidents jeopardizing patient privacy.  During the public comment period, entities filed comments requesting additional time and assistance for business associates and subcontractors.  In response, OCR provided a link to pre-existing compliance guidance.
  • Breach Notification:  Omnibus Rule replaces the current version of the HIPAA Breach Notification Rule with a new version stating that an acquisition, access, use, or disclosure of PHI not permitted under the Privacy Rule is presumed to be a breach unless a covered entity or business associate can demonstrate a low probability that the PHI has been compromised based on a four-factor risk assessment.
  • Enforcement:  The Omnibus Rule incorporates the increased and tiered civil money penalty structure provided by the HITECH Act with penalties based on the level of negligence with a maximum penalty of $1.5 million per violation.

Director Rodriguez was clear in his statement yesterday:  ”This final omnibus rule marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented.  These changes not only greatly enhance a patient’s privacy rights and protections, but also strengthen the ability of my office to vigorously enforce the HIPAA privacy and security protections, regardless of whether the information is being held by a health plan, a health care provider, or one of their business associates.”

More to come in the days and weeks ahead.

©1994-2014 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

About the Author

Cynthia Larose, Privacy, Security, Attorney, Mintz Levin, Law Firm
Member

Cynthia is Chair of the firm’s Privacy & Security Practice and a Certified Information Privacy Professional (CIPP).  She represents companies in information, communications, and technology, including e-commerce and other electronic transactions. She counsels clients through all stages of the “corporate lifecycle,” from start-ups through mid- and later-stage financings to IPO, and has broad experience in technology and business law, including online contracting issues, licensing, domain name issues, software development, and complex outsourcing transactions.

...
617-348-1732

Boost: AJAX core statistics

Legal Disclaimer

You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's  Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only. Any legal analysis, legislative updates or other content and links should not be construed as legal or professional advice or a substitute for such advice. No attorney-client or confidential relationship is formed by the transmission of information between you and the National Law Review website or any of the law firms, attorneys or other professionals or organizations who include content on the National Law Review website. If you require legal or professional advice, kindly contact an attorney or other suitable professional advisor.  

Some states have laws and ethical rules regarding solicitation and advertisement practices by attorneys and/or other professionals. The National Law Review is not a law firm nor is www.NatLawReview.com  intended to be  a referral service for attorneys and/or other professionals. The NLR does not wish, nor does it intend, to solicit the business of anyone or to refer anyone to an attorney or other professional.  NLR does not answer legal questions nor will we refer you to an attorney or other professional if you request such information from us. 

Under certain state laws the following statements may be required on this website and we have included them in order to be in full compliance with these rules. The choice of a lawyer or other professional is an important decision and should not be based solely upon advertisements. Attorney Advertising Notice: Prior results do not guarantee a similar outcome. Statement in compliance with Texas Rules of Professional Conduct. Unless otherwise noted, attorneys are not certified by the Texas Board of Legal Specialization, nor can NLR attest to the accuracy of any notation of Legal Specialization or other Professional Credentials.

The National Law Review - National Law Forum LLC 4700 Gilbert Ave. Suite 47 #230 Western Springs, IL 60558  Telephone  (708) 357-3317 If you would ike to contact us via email please click here.