HIPAA Omnibus Regulations: Protections for Genetic Information

by Ogletree, Deakins, Nash, Smoak & Stewart, P.C.
Contact

Today’s post focuses on the treatment of genetic information under the new regulations for the Privacy and Security Rules of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Ogletree Deakins has previously released a blog post describing the omnibus regulations and an article detailing the revised breach notification rules.

The new regulations finalize changes made to reflect the Genetic Information Nondiscrimination Act of 2008 (GINA). The changes are in addition to the revisions made for Health Information Technology for Economic and Clinical Health Act (HITECH Act).

The new regulations largely adopt 2009 proposed HIPAA regulations on plan use of genetic information with a few key changes. GINA bars a health plan from using genetic information for underwriting purposes. The new regulations define “genetic information,” “health plans,” and “underwriting purposes” broadly. As a result, the amount of information protected as genetic information can be quite significant. The new regulations clarify certain issues regarding each definition:

  • Genetic Information – The regulations define health information as including genetic information, meaning an individual’s individually identifiable genetic information generally will be protected health information (PHI) for covered entities and their business associates.  Genetic information includes the genetic tests, genetic counseling, and genetic education of an individual and his or her family members, and the medical history of those family members. A family member includes any dependent or relation to the fourth degree (e.g., great-great-grandparents or grandchildren, children of first cousins) or closer, without reference to the existence of biological ties. The preamble states that all genetic information is protected, whether the information originated before or after the compliance date for the final regulations.
  • Health Plan – All plans and insurers, including long term care insurers, must protect genetic information as PHI under the Privacy Rule. The final regulations expand GINA’s scope to provide that all plans and insurers covered by the HIPAA Privacy Rule are subject to the new regulation’s ban on the use of genetic information for underwriting purposes. This definition carves out long term care insurers because the government needs to assess the impact of restrictions on that industry. Future guidance may revisit this exception.
  • Underwriting Purposes – Under the new regulations, underwriters are health plans, including employer-sponsored health plans, not just insurers, and underwriting is more than an insurer’s determination of whether to extend an insurance contract to an individual or group, although it certainly includes such activities. Any plan or insurer may not factor genetic information when determining eligibility and measuring premiums, contributions, cost-sharing, or benefits. The new regulations exclude from underwriting an evaluation of an individual’s right to a benefit when the determination is based on medical appropriateness. A plan or insurer may use genetic information (e.g., genetic tests, relevant family medical history) if that information is necessary for its evaluation, but must limit such use to the minimum genetic information necessary to make the determination.

Since health plans cannot use genetic information for underwriting purposes, plan administrators must scrub genetic information from “summary health information” shared with plan sponsors and insurers during the underwriting process. As the preamble to the final regulations makes clear, the prohibition against the use or disclosure of genetic information for underwriting purposes is a material change that must be reflected in a plan’s privacy notice if the plan performs underwriting. This and other regulatory changes may also require revisions to health plan documents, policies, procedures, and forms required to comply with HIPAA and its Privacy and Security Rule obligations.

In many cases, an employer should avoid collecting genetic information wherever possible.  Many employers and plans have already eliminated requests for health information about family members and other genetic information from their health risk assessments and other forms.  Given the amount of genetic information present in health records, however, and the role genetic information plays in medical assessments, plans cannot eliminate all use of genetic information from their operations. Plans should implement a comprehensive strategy to identify and manage genetic information where such information is part of a plan’s documentary record and to limit its use as required by the new regulations.

Stephen A. Riga is an associate in the Indianapolis office of Ogletree Deakins.

 

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.

© Ogletree, Deakins, Nash, Smoak & Stewart, P.C. | Attorney Advertising

Written by:

Ogletree, Deakins, Nash, Smoak & Stewart, P.C.
Contact
more
less

Ogletree, Deakins, Nash, Smoak & Stewart, P.C. 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.
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.