United States: ONC's Draft Trusted Exchange Framework: Seeking Nationwide Interoperability For Health Information Networks

On January 5, 2018, the Office of the National Coordinator for Health Information Technology ("ONC"), an office within the U.S. Department of Health and Human Services, released its Draft Trusted Exchange Framework (the "Draft Framework"), setting forth a roadmap for a public-private partnership designed to promote interoperability among health information networks ("HINs").

Since the 2004 Executive Order 13335 which established the ONC, the goal of development and nationwide implementation of interoperable health information technology infrastructure has been a federal priority. Presently, there are over 100 regional HINs, each of which serves as a conduit through which electronic healthcare-related information is shared among member organizations. Many of these HINs are not connected, and, generally speaking, interoperability among HINs is limited. This has the effect of limiting patient health information that a provider or health system can access or share, unless the provider or health system joins multiple HINs. Through the 21st Century Cures Act (the "Cures Act"), Congress required ONC to take steps to address this limitation, by establishing a nationwide, interoperable health information exchange framework that can be used by all types of health care stakeholders, including HINs, government agencies, patients, providers, payors, technology developers, and public health organizations. The Draft Framework sets out a series of principles on which any exchange among HINs should be based, and then proposes a set of terms and conditions to which HINs would need to voluntarily agree in order to become "qualified HINs" that would be connected through the framework proposed by ONC, which it refers to as the "Trusted Exchange Framework." In a January 11, 2018 webinar regarding the Draft Framework, ONC officials described this effort by explaining that the goal of the Draft Framework is to increase "data liquidity" throughout the American health care system. ONC also provided a draft "User's Guide" for understanding the Draft Framework.

The Draft Framework works towards Congress' aim of interoperability through a two-part framework. Part A outlines six foundational principles to engender trust among all stakeholders who or that may ultimately participate in the Trusted Exchange Framework, and Part B describes the minimum terms and conditions to which HINs would need to agree in order to be included in ONC's online Trusted Exchange Framework directory. The principles articulated in Part A are as follows:

  1. Standardization. Stakeholders should adhere to industry and federally recognized standards, policies, best practices and procedures.
  2. Transparency. Stakeholders should conduct all exchanges openly and transparently (e.g., publicly releasing terms, conditions and contractual agreements that govern the exchange of information).
  3. Cooperation and Non-Discrimination. Stakeholders should collaborate across the continuum of care to exchange Electronic Health Information ("EHI") regardless of the competitive nature of stakeholders (e.g., stakeholders should not create policies that use the law as a pretext for limiting access to patient information to health care providers or health plans outside of their preferred network).
  4. Privacy, Security and Patient Safety. Stakeholders should exchange EHI in a secure manner that promotes patient safety and ensures data integrity (e.g., ensuring that data are consistently and accurately matched to the right patient, so care is provided based on the right information).
  5. Access. Stakeholders should ensure that individuals and their authorized caregivers have easy access to their EHI.
  6. Data-Driven Accountability. "Interoperability" should include the ability for participants to request and receive multiple patient records in a single instance, consistent with applicable legal requirements, for more effective use of data analytics to lower the cost of care and improve the health of the population.

The minimum required terms and conditions contemplated in Part B are designed to support the principles in Part A. In particular, Part B focuses on technical rules and details relating to the obligations of qualified HINs to adopt common authentication processes for network participants and a minimum core set of organizational and operational policies to enable the exchange of EHI among networks. ONC designed the terms and conditions to align with, and in some instances exceed, HIPAA privacy and security requirements (e.g., requiring participants to notify the recognized coordinating entity ("RCE") tasked with implementing the Trusted Exchange Framework within 15 days of a breach).

ONC hopes that the combination of principles in Part A and terms and conditions in Part B will create a single "on-ramp" for the electronic exchange of health information among HINs, permitting all types of health care stakeholders to participate in nationwide exchange regardless of the IT platform with which they work locally. In its study of approximately 70 hospitals, ONC found that a majority of hospitals use at least three interoperability methods, providing evidence that the Trusted Exchange Framework has the potential to achieve a significant reduction in costly, complex, and redundant methods for access to and exchange of EHI. Health care stakeholders with an interest in greater access to EHI data flows will be keenly interested in how the Trusted Exchange Framework develops and how access to EHI that they can use to spur innovation may be improved as a result. HINs and technology developers will need to carefully assess what steps will need to be taken to comply with the proposed terms and conditions set forth in the Draft Framework.

ONC considers the introduction of the Draft Framework to be the first step in fostering a public-private partnership to create national interoperability of HINs. Although ONC drafted the framework, it intends for the draft to be modified and ultimately finalized by an industry-based RCE, which will be selected through a competitive bidding process to manage and oversee the Trusted Exchange Framework. ONC is accepting public comments about the Draft Framework until February 18, 2018. After the comment period, ONC contemplates that an RCE will be selected by "mid-2018" and a final Trusted Exchange Framework and Common Agreement will be published in the Federal Register by the end of 2018.

We will continue to monitor the development of the Trusted Exchange Framework and analyze its impact on various stakeholders, including HINs, technology developers, and health care providers.

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.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
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