United States: Meeting the HIPAA Omnibus Rule Compliance Deadline: What Providers Need to Know

Last Updated: June 27 2013
Article by Holly Carnell and Meggan Michelle Bushee

Significant changes have been made to the privacy and security obligations of providers with respect to patients' protected health information (PHI) with the release of the Omnibus Final Rule (Omnibus Rule) on January 17, 2013. With the Omnibus Rule, the Department of Health and Human Services (HHS) made important changes to the privacy and security requirements under HIPAA and the HITECH Act, including creating a new breach standard, clarifying the definition of a business associate, and implementing the increased liability and penalty structure mandated by the HITECH Act. Except with respect to certain grandfathered business associate agreements, covered entities and business associates are required to come into full compliance with the Omnibus Rule by September 23, 2013. With this compliance deadline quickly approaching, providers need to take the steps discussed below to ensure that they will be in full compliance by the deadline.

1. Updating Internal Policies.

In order to comply with the Omnibus Rule, providers must update their internal privacy policies to reflect the changes to the HIPAA Privacy Rule, Security Rule, and Breach Notification Rule. Below are certain key changes that a provider will likely need to make to its internal privacy policies.

a. Breach standard. The Omnibus Rule changed the standard for determining whether a breach of unsecured PHI has occurred, and thus, when a provider must follow the notification requirements under HIPAA. Who must be notified however, has remained unchanged. The new breach standard should be included in providers' internal policies on responding to a potential breach. Once the new standard has been incorporated into a provider's policies, the provider should no longer use the prior breach standard, even for potential breaches that occur prior to the Omnibus Rule's compliance deadline of September 23, 2013.

b. Marketing and sale of PHI. Under the Omnibus Rule, the marketing of third party products and services and sale of PHI is generally prohibited. These general prohibitions do not apply if the provider has received valid authorization from the patient. Therefore, in order for a provider to market third party services to patients based on their PHI, or to sell or provide access to PHI for payment, the provider must request permission to do so from each patient whose PHI it wishes to use. Providers should also ensure that any definitions of "marketing" and "sale of PHI" in their policies comports with the revised definitions and standards under the Omnibus Rule.

c. Decedents' PHI. Under the Omnibus Rule, the definition of "protected health information" now expressly excludes the health information of a person who has been deceased for more than 50 years. In addition, the Omnibus Rule provides that providers may disclose the PHI of a deceased person to such person's family members, relatives, or close friends, or other individuals indicated by the deceased, who were involved either in the deceased's care or the payment of care. Providers may disclose only PHI that is relevant to the family member, relative, or friend's involvement in the deceased's care. PHI cannot be disclosed if the provider is aware that the deceased person expressed a prior preference for it not to be disclosed to the person in question.

d. Disclosures to schools. A provider's policies on when PHI can be disclosed should also reflect the new permitted disclosure of proof of immunizations to schools. Under the Omnibus Rule, providers may disclose proof of immunization to schools if the school is required by state, or other, law to have proof of immunization prior to admitting the individual, and the provider obtains and documents the oral agreement to the disclosure by either a parent, guardian, or other person acting in loco parentis of the individual, or from the individual if he or she is an adult or emancipated minor.

e. Patient rights to limit disclosures. Under the Omnibus Rule, a provider must comply with a patient's request that PHI regarding a specific health care item or service not be disclosed to a health plan for purposes of payment or health care operations if the patient paid out-of-pocket, in full, for that item or service.

f. Provision of electronic copies of medical records. Providers complying with a patient's request for an electronic copy of his or her PHI are required to provide access to such records in the electronic format requested by the patient if the records are maintained by the provider in an electronic designated record set and are readily producible in the requested format. There has been no change to the rules regarding whether a provider is required to grant access to a patient's medical records.

Providers should assess whether it makes sense to take the opportunity to replace their policies or update existing policies. HHS has posted on its websitethe audit protocol derived from the recently completed audit pilot program. The audit protocol provides a helpful list of the items that an auditor will review when assessing whether a covered entity is in compliance with HIPAA. We recommend using the audit protocol provided by HHS to assess whether existing policies generally pass muster. If existing policies generally meet the requirements in the audit protocol, it likely makes sense to update existing forms. If however, existing policies are generally lacking, it may be more cost effective to replace existing policies with new, Omnibus Rule-compliant, policies.

After the policies are finalized, the provider should formally adopt and approve the policies pursuant to any procedural requirements in the provider's governing documents or standard operating procedures.

2. Staff Training.

It is important that a provider's policies are both updated and implemented. Once a provider has updated its privacy policies, workforce members should receive training on any new and revised policies. In particular, management and higher-level employees should be fully trained on the new breach standard, so that, if necessary, they can correctly perform the required analysis.

Training is important both as a preventative measure and to ensure compliance with HIPAA and the HITECH Act. Training should be documented and maintained in the event training logs and program details are requested during an audit or investigation.

3. Notice of Privacy Practices.

The Omnibus Rule modifies and expands the content of the notice of privacy practices (NPP) that a provider is required to maintain and distribute to its patients. After a provider has updated its NPP, the provider must make the NPP readily available to existing patients who request a copy on or after the effective date of the revisions; must post the revised notice on its website, if applicable; and must post the notice in a prominent location on its premises. New patients who receive services for the first time after modification of an NPP should be provided with a copy of the revised NPP. Consistent with the existing rules, providers should retain copies of previous versions of their NPPs and of any written acknowledgements by patients of receipt of NPPs.

4. Business Associate Agreements.

Providers should revise their business associate agreement (BAA) form to reflect the new requirements under the Omnibus Rule. Providers must enter into new BAAs or modify existing BAAs by September 23, 2013. However, existing BAAs that were entered into on or before January 25, 2013 and have not been modified after March 26, 2013 do not have to be updated until September 23, 2014.

Once the provider has updated its form BAA, we recommend conducting an inventory of all current BAAs (including BAAs in which the provider is the covered entity and BAAs in which the provider is a business associate or subcontractor). Each of these BAAs will need to be modified by an amendment or replaced with the provider's revised form BAA. This may also be a good opportunity to consider whether the protections and restrictions in the form agreement go far enough in protecting patients and the provider.

Providers should review all business relationships to ensure they have a BAA in place where one is required under HIPAA. Providers may have relationships that did not previously require a BAA, but do now under the Omnibus Rule's expansion of the definition of "business associate." One key change to the definition of business associate is the inclusion of subcontractors of business associates that deal with PHI. However, covered entities are not required to enter into BAAs with downstream subcontractors. Rather, the business associate who contracts with the subcontractor must enter into a BAA with the subcontractor.

In light of the numerous changes that have been made to HIPAA under the Omnibus Rule, it is important for providers to start working on compliance with the new requirements as soon as possible. Please contact the authors if you would like more information about compliance with the Omnibus Rule or HIPAA compliance generally.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Topics
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions