Breach Notification: New Rules!

by Davis Wright Tremaine LLP
Contact

If you sponsor a group health plan that is subject to the HIPAA Privacy and Security Rules, it is time to review and revise your policies and procedures and re-train your employees regarding the proper procedures when Protected Health Information is impermissibly used or disclosed.

On Jan. 25, 2013, the Department of Health and Human Services (HHS) issued significant new guidance on the rules that govern protected health information (PHI) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The Omnibus Rule implements most of the privacy and security provisions of the Health Information Technology for Economic and Clinical health (HITECH) Act and extends the reach of HIPAA. Specifically, the Rule requires covered entities, including group health plans and their business associates, to make changes to their policies and procedures, Notices of Privacy Practices and business associate agreements. The purpose of this Advisory is to discuss the impact of the Omnibus Rule on employers sponsoring group health plans that are covered entities under HIPAA.

For these employers, the Omnibus Rule requires you to revise your breach notification policies and procedures. The new Rule applies to breaches discovered after Sept. 23, 2013.

Under the HITECH Act, group health plans and business associates are required to provide notification following the discovery of a breach of unsecured PHI. The Omnibus Rule revises the definition of “breach” in a manner that increases the likelihood that health plans will have to provide notification when PHI is impermissibly used or disclosed. The new definition of “breach” is that there is an unauthorized acquisition, access, use or disclosure of PHI that compromises the security or privacy of that PHI. Notification of the breach is required unless the covered entity plan or business associate demonstrates there is a low probability that the PHI has been compromised or that an exception to the notification rules applies. The new definition also creates a presumption that any unauthorized acquisition, access, use or disclosure of PHI is a breach and shifts the burden to the group health plan or business associate to demonstrate through a risk assessment that there is a low probability that the PHI has been compromised. Risk assessments must be thorough, completed in good faith, and the conclusions must be reasonable.

There are four factors that must be considered when assessing the probability that PHI has been compromised: 1) the nature and extent of the PHI involved; 2) the unauthorized person who used the PHI or to whom the disclosure was made; 3) whether the PHI actually was acquired or viewed; and, 4) the extent to which the risk to the PHI has been mitigated.

  1. What is the nature and extent of the PHI involved? When evaluating the nature and extent of the PHI involved, the guidance advises that entities should consider the type of PHI involved and whether the information that is was disclosed was of a more sensitive nature. For example, with respect to financial information, the disclosure of information that might increase the risk of identity theft is highly sensitive. For clinical information, the guidance suggests not just considering the nature of the services described in the information, but the amount of detailed clinical information involved (e.g. diagnosis, mediation, test results). The type of information involved will help entities determine the probability that the information may be used in a manner adverse to the individual.
  2. Who was the unauthorized person? When evaluating who impermissibly used the PHI or to whom the impermissible disclosure was made, entities should consider whether the unauthorized person has independent obligations to protect the privacy and security of the information. If the receiving entity has independent obligations to comply with HIPAA, the risk should be low that the PHI will be compromised by that entity.

    In addition, entities should determine whether the unauthorized person who received the PHI has the ability to re-identify the information. If they do not, the probability that the information will be compromised would also be considered low.
  3. Was the PHI was acquired and viewed? Covered entities and business associates should determine if the PHI was actually acquired or viewed or , if only the opportunity existed for the information to be acquired or viewed. For example, if information is mailed to the wrong individual, and that individual opens the envelope and informs the sender they have received the information in error, clearly as a result of the unauthorized disclosure, the information was actually viewed and acquired.
  4. Has the risk to the PHI been mitigated? Covered entities and business associates should consider the extent to which the risk to PHI has been mitigated. Examples of ways that a covered entity or business associate can mitigate the risk would be obtaining the recipient’s satisfactory assurance that the information will not be further used or disclosed, such as through a confidentiality agreement. The guidance provides that this factor, when considered in combination with the factor regarding the unauthorized recipient of the information, may lead to different results in terms of the risk to the protected health information. For example, a covered entity may be able to rely on assurances from some parties, but not others.

If an evaluation of these factors fails to demonstrate that there is a low probability that the PHI has been compromised, breach notification is required.

The rules governing the timing, the content and the methods for providing the notice, as previously set forth in interim breach notification regulations, have not been changed.

The changes under the Omnibus Rule will likely also impact the policies and procedures of group health plans mandated by the Privacy and Security Rules. This is a good time for employers to ensure ongoing Privacy and Security Rule compliance, update their policies and procedures for changes in their group health plan operations, and update training, as appropriate.

For a further discussion of the changes made by the Omnibus Rule, please see our related advisory.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Davis Wright Tremaine LLP | Attorney Advertising

Written by:

Davis Wright Tremaine LLP
Contact
more
less

Davis Wright Tremaine LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.