United States: 3 Weeks To HITECH Omnibus Liftoff!

Checklist for Covered Entities and Business Associates

As the countdown to the compliance deadline for the Health Information Technology for Economic and Clinical Health (HITECH) Act Omnibus Rule begins, we offer the following as a reminder of tasks that covered entities, business associates, and subcontractor business associates should complete by September 23, 2013. Whether you have a robust HIPAA compliance program in place or are a business associate entering the HIPAA regulatory regime for the first time, this checklist illustrates key updates and revisions. Additional topics and requirements may apply in specific situations.


 Covered entities must update and then post their notices of privacy practices in a clear and prominent location. If the covered entity maintains a website, the notice also must be posted there. Notices now must include the following provisions:

  • Breach notification statement: a statement that the covered entity must notify an affected individual of a breach of unsecured protected health information (PHI); 
  • Authorizations: a description of the disclosures of PHI requiring an authorization (e.g., psychotherapy notes, marketing, and sale of information, and a statement that other uses or disclosures not described in the notice require authorization);
  • Fundraising disclosures: a statement that the recipient of fundraising materials may opt out of future fundraising communications; and
  • Restrict disclosure to health plans: a description of an individual's right to restrict disclosure of PHI to health plans if he or she paid for the relevant care.

Covered entities must update HIPAA authorization forms before engaging in marketing or sales of PHI.

Covered entities must update privacy policies and procedures, and business associates should develop policies to address any applicable Privacy Rule requirements, including changes in the following areas:

  • Individual access. If an individual requests a digital copy of certain electronic PHI or directs a covered entity in writing to transmit a copy to another person, the covered entity generally must produce the information in the format requested if readily producible within 30 days or negotiate an alternative format. Covered entities no longer have extra time to respond to requests for off-site records.
  • Requested restrictions on health plan disclosures. Unless the disclosure is required by law, covered entities must abide by individuals' requests to restrict disclosures of PHI to health plans for payment or operations purposes if the individual or someone on their behalf paid the covered entity in full for the care to which the restriction pertains.
  • Sale of PHI. Covered entities and business associates must obtain written authorization to exchange PHI for direct or indirect remuneration (in addition to sales, this includes PHI access and licensing agreements), unless one of several exceptions applies. The authorization must disclose that the exchange will result in remuneration.
  • Marketing. Covered entities must obtain written authorization to use and disclose PHI for marketing purposes, including most non-face-to-face communications when the covered entity receives payment to make the communication. If payment is involved, the marketing authorization must disclose that fact.
  • Fundraising. Covered entities now may disclose more information to institutionally-related foundations for fundraising, but they must explain how the recipient may opt out of receiving future fundraising communications. The opt-out method cannot be burdensome to individuals.
  • Research. If a covered entity engages in research, it should review the new, relaxed standards applicable to research as described in 45 CFR § 164.508(b).
  • Deceased persons. Covered entities may disclose PHI to family members or others involved in a decedent's health care or payment for care when the disclosure is relevant to their involvement and not inconsistent with the decedent's previously-expressed wishes. Also, health information of persons deceased for more than 50 years is no longer considered PHI and therefore is not regulated under HIPAA.

Covered entities and business associates must train their employees on these HITECH changes.


The Omnibus Rule expanded the definition of "business associate" to include many new entities. Covered entities and business associates should identify (1) business associates who transmit PHI with routine access to it, (2) business associates who maintain, create, or receive PHI for you, and (3) for business associates, the subcontractors to whom you delegate a function, activity, or service involving PHI (e.g., cloud storage providers).

Covered entities need updated BAAs with new business associates. Now that they are regulated directly, it is equally important for business associates to have BAAs in place with their covered entity clients and with subcontractors.

BAAs must contain the elements required by 45 CFR § 164.314(a) and .504(e) by the compliance deadline, unless the BAA was in place before January 25, 2013 and has not been amended since (in those cases, BAAs may be updated as late as September 22, 2014). In addition to previous requisites, BAAs must require business associates to:

  • Comply with the Security Rule;
  • Execute BAAs with their subcontractors;
  • To the extent the business associate will carry out an obligation of a covered entity, agree to comply with any HIPAA rule applicable to that obligation; and
  • Timely report breaches of unsecured PHI to the covered entity.


The Omnibus Rule did not substantially change the HIPAA security standards other than to make them directly applicable to business associates, who now must meet all the administrative, technical, and physical safeguards for electronic PHI. Importantly, the following safeguards have been at the forefront of recent HITECH enforcement actions:

  • Security risk assessment. Documenting an electronic PHI risk assessment is foundational. This safeguard requires an inventory of PHI and a complete and accurate assessment of the level of risk faced based on the likelihood of a threat occurring and the criticality of any impact should that threat occur.
  • Address encryption. Although encryption isn't mandatory, the security risk of electronic PHI stored or transmitted is best safeguarded by encryption. If encryption isn't reasonable and appropriate, you must document why that is and implement an equivalent alternative measure.
  • Device controls. Many reported breaches involve remote devices containing PHI (e.g., laptops, smart phones, thumb drives, and home computers). The Office for Civil Rights expects covered entities and business associates to pay special attention to risk management, policies and procedures, and training to safeguard remote device access, storage, and transmission of PHI.


The Omnibus Rule modified the standard for reporting breaches of unsecured PHI. No longer will the "risk of harm" threshold be available to eliminate reporting. Under the new standard, a breach is reportable unless (1) the covered entity or business associate demonstrates a low probability that the information has been compromised based on a thorough risk assessment, or (2) the breach fits within certain limited exceptions. In light of this modified standard, covered entities and business associates should revise their breach notification policies and procedures.

  • Incident response policies and procedures. An incident response team needs to be able to quickly (1) review a potential breach, (2) identify whether it is reportable and how to mitigate harm, and (3) remediate the problem.
  • Breach analysis. An incident response team should address and document: 
  • The nature and extent of the PHI involved, including the types of identifiers and the likelihood of re-identification;
  • The unauthorized person who used the PHI or to whom the unauthorized disclosure was made
  • Whether the PHI was actually acquired or viewed; and
  • The extent to which the risk to the PHI has been mitigated following any impermissible use or disclosure.

Finally, in light of increased financial risks, covered entities and business associates should audit existing insurance policies to determine the scope and extent of existing coverage and consider whether additional coverage is warranted.

Copyright 2013, American Health Lawyers Association, Washington, DC. Reprint permission granted.

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 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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.