United States: Final HIPAA / HITECH Regulations Published: Revisions That Impact Research Activities

Last Updated: January 29 2013
Article by Jennifer J. Daniels

Healthcare

The long-awaited HIPAA/HITECH Final Rule is out! The Final Rule - titled Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules - includes several provisions that impact research activities, most of which are consistent with the proposed rule published on July 14, 2010. And, while in many ways the Final Rule makes things harder for Covered Entities and Business Associates, research involving the use of Protected Health Information just got a little easier.

Compound Authorizations

As those involved in human subject research know, from the beginning, the Privacy Rule created enormous headaches for researchers because it prohibited Covered Entities from combining an authorization for research that conditions research-related treatment upon the signing of the authorization (conditioned research) with another authorization for research that does not condition treatment upon the signing of an authorization (unconditioned research). So, for example, an authorization to participate in a clinical trial for a study drug could not be combined with an authorization to bank data and tissue samples or to participate in an optional sub-study.

The Final Rule adopts the proposal to amend 45 C.F.R. § 164.508(b)(3)(i) and (iii) to allow a Covered Entity to combine conditioned and unconditioned authorizations for research, provided that the compound authorization (1) clearly differentiates between the conditioned and unconditioned research components, and (2) clearly allows the individual the option to opt-in to the unconditioned research activities. The Final Rule permits the use of compound authorizations for any type of research activities, including optional sub-studies, and secondary future use of data (to the extent secondary future use is permitted by the Final Rule as discussed below), except where the research involves the use and/or disclosure of psychotherapy notes.

The Final Rule does not allow an authorization to include an option to opt-out of the unconditioned research activities. So, for example, the authorization cannot say "check here if you do not want your data provided to the biospecimens bank." In the commentary to the Final Rule, the Department of Health and Human Services (HHS) approves of three methods proposed by the Secretary's Advisory Committee on Human Research Protections (SACHRP) to obtain the necessary opt-in for unconditioned research activities: (1) a combined consent / authorization form for a clinical trial and optional banking component, with a check-box for the individual to have the choice to opt-in to the optional banking component, and one signature; (2) a combined consent / authorization form for a clinical trial and optional banking component, with one signature for the clinical trial and another signature to indicate the individual agrees to the optional banking component; and (3) a combined consent / authorization form for a clinical trial and optional banking component, with a check box to opt-in to the banking component, one signature, but with the detailed information about the banking presented in a separate brochure or information sheet referenced directly in the consent / authorization form. HHS clarifies that, for the third approach, the brochure or information sheet must be incorporated by reference into the authorization / consent form such that it is considered part of the form. In addition, if the brochure or information sheet includes any of the required elements of the authorization, and the authorization has not been altered by an IRB approved waiver, then the brochure / information sheet must be made available to potential research participants before they are asked to sign the authorization. Finally, in such cases, a Covered Entity must keep not only the signed authorization, but also a copy of the brochure or information sheet, in order to comply with documentation requirements under the Privacy Rule.

HHS explains in the preamble that Covered Entities are permitted but are not required to create compound authorizations for conditioned and unconditioned research activities. So, researchers may choose to use separate authorization forms. HHS makes clear that Covered Entities and researchers have flexibility in the methods used to distinguish the conditioned and unconditioned research activities and to provide the individual with a clear opportunity to opt-in to the unconditioned portions.

In response to a comment asking whether a portion of the compound authorization can be revoked without revoking the entire authorization, HHS clarifies that, where it is clear that an individual is revoking only part of a compound authorization, then the researchers can proceed accordingly. If it is not clear that only a specific part of the compound authorization is being revoked, then the researchers must either obtain written clarification from the participant or the entire authorization must be treated as revoked.

Authorization for Future Research Uses

Since its initial promulgation, HHS has interpreted Section 164.508(c)(1)(iv) of the Privacy Rule to require that authorizations for research be study specific. In other words, HHS took the position that a Covered Entity could not obtain an authorization from an individual that allowed PHI to be used for future, unspecified research, but rather each authorization had to specify the study for which PHI would be used and disclosed. As one scientist at a pharmaceutical company once put it to me, Ford Motor Company is allowed to take data it obtained from the last car it built to build a better car, but HIPAA prevents pharmaceutical manufacturers from using data collected in one study to build a better study the next time. So, to comply with the Privacy Rule, research sponsors jumped through hoops to be able to use PHI collected from one study for additional purposes, including forever tinkering with informed consent language to try to provide as specific a description as possible while still allowing for some flexibility to conduct additional research in the future, and adding broad data use language to clinical trial agreements to allow for the use of a limited data set in future research studies.

Now, HHS has modified the requirement that research authorizations be study specific. This modification does not make any changes to the authorization requirements in the regulations themselves - a HIPAA authorization for future research must still address each of the core elements required by § 164.508(c). But, in the preamble to the Final Rule, HHS says that it no longer interprets the "purpose" provision in § 164.508(c)(1)(iv) as requiring that an authorization be study specific. In order to satisfy the requirement that an authorization include a description of each purpose of the requested use or disclosure, HHS explains that an authorization for future research must adequately describe such purposes such that it would be reasonable for the individual to expect that his or her PHI could be used or disclosed for such future research. This could include specific statements with respect to sensitive research to the extent such research is contemplated. HHS clarifies that its intent is to give Covered Entities, researchers and IRBs flexibility in determining what adequately describes future research purposes.

It is important to note that HHS is not permitting authorizations to simply state that PHI may be used for future, unspecified research. HHS has aimed to bring the requirements for specificity under HIPAA in line with what is required by the Common Rule, which is to seek informed consent for future research so long as the future research uses are described in sufficient detail to allow an informed consent.

Also, HHS explains in the preamble to the Final Rule that there is no prohibition against the description of the information to be used or disclosed including PHI created after the end of the main study (e.g., allowing for disclosure of "your future medical records relating to a particular disease / condition").

Sale of PHI

Section 13405(d)(1) of the HITECH Act prohibits a Covered Entity or Business Associate from receiving direct or indirect remuneration in exchange for the disclosure of PHI unless the Covered Entity or Business Associate has obtained an individual's authorization pursuant to Section 164.508 that states whether the PHI can be further exchanged for remuneration by the entity receiving the information. The statute provides for several exceptions from the prohibition, which the Final Rule adopts, but HHS makes certain clarifications as to its scope. HHS creates a new defined term in the final rule for "sale of protected health information," which sale requires specific authorization. The defined term explicitly excludes disclosures for research purposes where the only remuneration received by the Covered Entity or Business Associate is a reasonable, cost-based fee to cover the cost to prepare and transmit the PHI for such purposes.

HHS does not consider a "sale of PHI" to encompass payments that a Covered Entity may receive in the form of grants, or contracts or other arrangements to perform research activities, because any provision of PHI to the payer is a byproduct of the service being provided to the payer by the Covered Entity. HHS explains, therefore, that the payment by a research sponsor to a Covered Entity to conduct a research study is not considered a "sale of PHI," even if the research results disclosed to the sponsor include PHI. Similarly, the receipt of a grant or funding from a government agency to conduct a research program is not a sale of PHI, even if some PHI is released to the government agency. But, a disclosure of PHI by a Covered Entity to an outside researcher, where the outside researcher is conducting research in exchange for remuneration and no services are being performed by the Covered Entity in exchange for the payment, would be considered a "sale of PHI," unless the only remuneration received by the Covered Entity is a reasonable, cost-based fee to cover the cost to prepare and transmit the data for such purposes. In determining whether the fee is reasonable, the Covered Entity can consider direct and indirect costs, including labor, materials and supplies for generating, storing, retrieving and transmitting PHI, related costs and overhead. However, HHS is clear that fees charged to incur a profit from the disclosure of PHI are not allowed without authorization.

HHS explains in the preamble to the Final Rule that ongoing research projects under existing authorizations, waivers of authorization or data use agreements are grandfathered such that the Covered Entity need not obtain a new authorization if there is a disclosure involved that amounts to a "sale of PHI." HHS goes on to say that the Covered Entity or Business Associate, not the IRB, is responsible for determining whether any fees paid to the Covered Entity or Business Associate in exchange for PHI cover only the Covered Entity's or Business Associate's costs to prepare and transmit PHI for research. Based on this discussion in the preamble - which indicates that an IRB is not in a position to determine whether a fee paid to a researcher is "a reasonable, cost-based fee to cover the cost to prepare and transmit the data" - it is unclear whether an IRB is able to waive the need for an authorization under § 164.512(i) for research where there is payment made for the disclosure of PHI. It may be that an IRB would grant a waiver of the need for an authorization if the Covered Entity certifies that any payment is a reasonable, cost based fee to cover the cost to prepare and transmit the data.

HHS refuses in the Final Rule to exclude a Limited Data Set from the prohibition on a sale of PHI. A Covered Entity may continue to use and/or disclose a Limited Data Set in accordance with an existing Data Use Agreement until the Data Use Agreement is renewed or is modified or until one (1) year from the compliance date of the Final Rule, whichever is earlier, even if the disclosure would otherwise require authorization because of remuneration paid for PHI.

Effective Date

The Final Rule is effective March 26, 2013. Covered Entities, Business Associates and Subcontractors will have 180 days beyond the effective date to come into compliance, which 180 days expire on September 23, 2013.

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.

Authors
Jennifer J. Daniels
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
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.

Disclaimer

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.

Registration

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.

Cookies

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.

Links

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.

Mail-A-Friend

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.

Emails

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 .

Security

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.