United States: FDA, ONC and FCC Report Outlines Proposed Health Information Technology Regulatory Strategy and Recommendations

On April 3, 2014, the U.S. Food and Drug Administration, in conjunction with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, issued a draft report that describes the agencies' "proposed strategy and recommendations on an appropriate, risk-based regulatory framework" for health information technology.  In this On the Subject, we provide a brief overview of the draft report and discuss its implications.

Health information technology (health IT) describes a broad array of tools that enable the transmission, receipt, storage and/or analysis of health information.  If designed, developed, implemented, used and maintained appropriately, health IT promises to facilitate the coordination of medical care, reduce health care costs and improve patient outcomes.  If implemented without sufficient safeguards, however, health IT may expose patients to risk.

The U.S. Food and Drug Administration (FDA) has long expressed an interest in—and, to a certain extent, actually regulated—health IT.  The Federal Food, Drug and Cosmetic Act gives the FDA the authority to regulate medical devices (i.e., "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article" that is "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease..."), which could potentially allow the FDA to assert jurisdiction over most, if not virtually all, types of health IT.  In statements during the past year, the FDA's Center for Devices and Radiological Health (CDRH) has generally expressed a plan to apply a risk-based approach that would focus the agency's regulatory oversight on higher risk health IT products.  The extent to which the agency will ultimately assert its jurisdiction over health IT, however, remains unclear. 

In response to concerns regarding the potential extent of FDA's jurisdiction over health IT, members of Congress have proposed legislation (e.g., the SOFTWARE Act and the PROTECT Act) that would eliminate the FDA's jurisdiction over health IT products determined within the legislation to be low risk.  The extent to which such legislation may be considered or approved by Congress is unclear at this time.

In the meantime, the Food and Drug Administration Safety and Innovation Act included a provision that requires the FDA, in conjunction with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), to issue a report that describes the agencies' "proposed strategy and recommendations on an appropriate, risk-based regulatory framework" for health IT.  The agencies issued a draft of the report on April 3, 2014.

The draft report is unremarkable because it largely reiterates previous agency statements (e.g., last year's FDA guidance on mobile medical applications).  The report does, however, confirm that the FDA intends to take a reasoned, risk-based approach to the regulation of health IT.  Key recommendations from the report include:

  • FDA should take a "limited, narrowly-tailored approach" to the regulation of health IT.  The report proposes the creation of three health IT categories based on product functionality and potential risk:
    • FDA intends to focus its regulatory oversight on health IT with "medical device" functionality (e.g., computer-aided detection/diagnostic software, radiation treatment planning, robotic surgical planning and control software)
    • In contrast, health IT with "health management" functionality (e.g., health information and data management, data capture and encounter documentation, electronic access to clinical results, medication management, provider order entry, and most clinical decision support software) will not be the focus of regulatory oversight because the risks associated with such products are "generally low compared to the potential benefits"
    • No additional oversight is planned for health IT with "administrative" functionality (e.g., software intended to facilitate admissions, billing and claims processing, scheduling, general purpose communication or determination of health benefit eligibility) because it generally poses "limited or no risk to patient safety"
  • ONC-coordinated activities and private-sector capabilities should form the basis of health IT oversight.  The use of existing standards, best practices, certification and accreditation programs and industry-led testing, the development of quality standards and the selective use of tools such as voluntary listing, reporting and training will support both innovation and patient safety.
  • The agencies should create a public-private entity, the Health IT Safety Center, to coordinate health IT oversight.  The Health IT Service Center would serve as a trusted convener of health IT stakeholders, with the ultimate goal of "assisting in the creation of a sustainable, integrated health IT learning system that avoids regulatory duplication and leverages and complements existing and ongoing efforts."

The agencies intend to hold a public meeting on this subject in May 2014, and will accept comments on the draft report until July 7, 2014.


The draft report is encouraging for the medical industry in that it confirms the FDA's plan to take a product-specific, risk-based approach to the regulation of health IT.  Health IT manufacturers and investors may be disappointed, however, by the report's reiteration of previous agency statements and lack of specific, substantive details regarding future regulatory oversight.  Several critical questions remain unanswered, including:

  • What characteristics of clinical decision support software are likely to trigger regulatory oversight?
  • To what extent will items that combine multiple types of functionality (e.g., health management/medical device) be subject to regulatory oversight?
  • To what extent will electronic health records be subject to regulatory oversight?
  • To what extent will ONC activities impact overall health IT regulation?

For now, interested entities should consider submitting comments regarding the draft report and participating in the upcoming public meeting.  After the draft report is finalized, the FDA is expected to begin issuing substantive guidance, including guidance specific to clinical decision support software; therefore, interested entities should monitor communications from FDA.  Finally, in light of ongoing congressional interest in this issue, interested entities should stay apprised of legislative activity that, if enacted, would change the FDA's authority to regulate health IT.

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
Drinker Biddle & Reath LLP
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Drinker Biddle & Reath LLP
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