United States: 21st Century Cures Act – Provisions Relating To Digital Health: Interoperability And Information Blocking

On July 10, 2015, the House of Representatives approved the 21st Century Cures Act (HR 6) (the "bill") by a vote of 344-77. In addition to increasing medical research funding and expediting the process of making breakthrough therapies available to patients, if enacted into law, the bill would impose significant new requirements related to the regulation of health information technology ("IT"). Most significantly, the bill would require that in order to qualify for beneficial treatment under certain Federal laws, qualified electronic health records ("EHRs") must meet newly specified interoperability standards. Failing to achieve interoperability is significant because it directly risks decertification of the vendor's IT and, as a result, risks the loss of a provider's Meaningful Use incentive payments and eligibility for the Stark Law Exception and Anti-Kickback Statute Safe Harbor applicable to the donation of EHRs and services. The bill also would require that vendors of EHR technology certify interoperability to the U.S. Department of Health and Human Services ("HHS"), and would prohibit vendors and health care providers from information blocking. This Alert summarizes key elements of these important changes to the Federal regulation of digital health information.


Due to the magnitude of health information maintained in EHRs and the numerous relationships patients maintain with health care entities and professionals, the ability to access and exchange medical information between providers and researchers is paramount to medical innovation and patient care. Effectively, the bill addresses the pervasive need to standardize health IT in an efficient and timely manner to achieve health IT interoperability. Specifically, the bill requires that health IT vendors ensure that their certified EHRs:

  1. Securely transfer all electronic health information to and from all other certified health IT for authorized use; and
  2. Allow for the complete access, exchange, and use of all electronic health information for authorized use without special efforts by the requestor.

In order to achieve the secure and complete exchange of information contemplated by the bill, vendors will need to incorporate baseline interoperability standards in six identified areas: (1) vocabulary and terminology; (2) content and structure; (3) transport; (4) security; (5) service; and (6) querying and requesting health information for access, exchange, and use. The bill tasks HHS with providing clarifying guidance on the interoperability standards while allowing vendors flexibility in implementing product compatibility.

Prohibited Information Blocking

In addition to requiring interoperability, the bill prohibits information blocking by vendors, health care providers, and health information system providers (e.g. operators of health information exchanges and data registries). "Information blocking" is broadly defined to include numerous practices that prevent, interfere, or burden information exchange. These practices range from charging unreasonable fees, to contractually agreeing to restrict an authorized exchange, to developing or implementing health IT likely leading to fraud or waste.

Such a broad definition risks the imposition of civil monetary penalties for not only egregious information blocking, but for actions resulting from internal policies and industry best practices vendors and providers have in place to protect the privacy and security of the entity and/or its patients. Providers may be especially susceptible to confusion, considering that providers historically have been given the ability to control the release of information based on professional judgment and business decisions.

Guidance and Implementation

The bill requires that HHS provide vendors with an initial set of interoperability standards and implementation specifications by January 1, 2017.1 Vendor compliance would be required 12 months after the rulemaking. In contrast, enforcement for information blocking could begin as early as 30 days after the issuance of the rule.

Vendor Certification

The bill requires that vendors' certification of qualified EHRs made after January 1, 2018, comply with the interoperability standards. In certifying, vendors of qualified EHRs must specifically:

  1. Attest to HHS that the entity has implemented the interoperability standards and that it has not and will not information block; in doing so, it must include pricing information related to data exchange for the purpose of future public comparison among health IT products;
  2. Attest that the entity has successfully and rigorously tested the real world use of the record;
  3. Attest that the entity has in place data-sharing programs based on common data elements through such mechanisms as application programming interfaces without the requirement for vendor-specific interfaces;
  4. Publish application programming interfaces and associated documentation, with respect to health information within such records, for search and indexing, harmonization and vocabulary translations, and use interface applications; and
  5. Demonstrate to HHS that information from the EHR can be exchanged, accessed, and used through the interfaces without special effort.

As stated, failure to comply risks decertification of the technology for Meaningful Use purposes, under the CMS Medicare and Medicaid EHR Incentive Program. Moreover, decertified IT and services cannot be donated under the Stark Law Exception or Anti-Kickback Safe Harbor that protect donations of certain EHR. For these reasons, decertified IT is not attractive to provider customers. The bill makes clear that providers would not be penalized for the actions of its vendors for failing to meet the interoperability standards for certification. As such, for EHRs that become decertified due to failing to meet the interoperability standards for the Meaningful Use reporting periods for payment years beginning 2020, providers will receive a minimum one-year hardship exception and be allowed to transition to different EHRs.


HHS would be given authority to investigate claims of vendors offering providers qualified EHRs in violation of any attestation. Vendors and other entities offering providers qualified EHRs in violation of an attestation (whether providing false information at the time of the attestation or by act or practice after such attestation) shall be subject to a civil monetary penalty in an amount determined by HHS through rulemaking. The bill is not likely to alter the current governmental approach, under which providers generally will not be the target of interoperability enforcement; however, a provider without a qualified EHR may risk enforcement if it represents to HHS otherwise, for example, during Meaningful Use attestation. Providers without qualified EHRs also risk the loss of Meaningful Use payments if they cannot meet a hardship exception. Additionally, providers would need to consider that even without Federal enforcement, the failure to maintain a qualified EHR could risk violation of contractual terms that incorporate such requirements, of data security laws, or of internal procedures based on best practices, due to inadequate technology. The bill also would grant HHS the authority to subject any person or entity to civil monetary penalties for information blocking. The National Coordinator, acting as a technical consultant, would be authorized to share information related to investigations with the Federal Trade Commission ("FTC"), potentially magnifying any violation and penalty.

Data Privacy Implications

The bill states that HHS will set forth exceptions to information blocking to protect patient safety and privacy and to promote competition and consumer welfare, although it is unclear at this time how the exceptions will interact with existing law, like the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"). Notably, HIPAA does not generally mandate that a provider make accessible or disclose patient health information to another entity; however, the bill's information blocking requirements may push entities to disclose information more freely or expand system access to other entities. Such activities may expose the entity to other liabilities. The bill's impact on how providers and contractors treat health information is significant due to the potential conflict with patient authorizations, proprietary rights, and breach notification obligations, as well as state laws that restrict the use of sensitive data such as mental health and HIV records. For instance, the bill's prohibition of information blocking may risk the disclosure of patient information that requires additional protection. Alternatively, the bill may negate the need for a patient's authorization, whereas an internal policy or state law may require consent regarding certain information. Conflicting requirements and unclear guidance may burden entities to carve out accessible information and maintain differentiating policies and updates to Notice of Privacy Practices.

Prospects for the Legislation

Although the Cures Act has cleared the hurdle of the House, the prospects of passage in the Senate remain uncertain. The Senate Health, Education, Labor & Pensions Committee ("HELP Committee") has held numerous hearings over the past several months as it considers its own medical innovation legislation. However, the HELP Committee has not yet released even a discussion draft of its legislation, and one is not expected until at least the end of the Senate recess in August. Following the House's passage of the Cures Act, HELP Committee Chairman Lamar Alexander (R-TN) stated that the Senate's work would continue "on a parallel track . . . to produce a bill that [the Senate] can combine with 21st Century Cures and send to the President's desk."

Prior passage of the Cures Act, the White House, via a statement of administration policy, objected to the bill's use of the government's Strategic Petroleum Reserve to offset the bill's funding increases. The White House would have preferred that the bill directly address sequestration and ensure that FDA has sufficient funding to support all the programs established in the bill. The White House also expressed concern regarding the proposals relating to drug exclusivity and drug manufacturer communications with payors. Whether the Senate's proposed legislation will address the White House's concerns remains to be seen.

Re-authorization of the Prescription Drug User Fee Act ("PDUFA VI") is slated to occur in 2017. Given that PDUFA VI is considered "must-pass" legislation, it is possible that a number of issues under consideration in the Cures Act, particularly those issues lacking consensus, will be deferred until that latter debate.


1 The bill negates the role of HIT Standards Committee to affect the development and modification of the interoperability standards. Alternatively, it requires HHS contract with a health care standards development organization accredited by American National Standards Institute ("ANSI").

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 Topics
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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