United States: Digital Health Care Alert: Is Your Health Care App Subject To HIPAA?

The U.S. Department of Health & Human Services' Office for Civil Rights (OCR) recently provided guidance (in the form of six "real-life" scenarios) to help health care app developers ("Developers") determine whether their consumer data collection activities make them subject to HIPAA. In general, those apps offered directly to consumers for them to use to track their fitness activities, blood pressure levels, glucose levels, etc. are not required to comply with HIPAA (however, other state data protection laws might apply to the collection and use of personal information). On the other hand, apps that are offered in conjunction with a covered health care provider or a health plan are more likely to be candidates for HIPAA compliance.

The key question is whether the Developer is creating, receiving, maintaining and transmitting protected health information (PHI) on behalf of a Covered Entity. If the answer is yes, then the Developer would have to comply with HIPAA rules as a Business Associate of the Covered Entity.

OCR's guidance states that those apps that give consumers the ability to upload a copy of their medical records that they have previously downloaded from their provider's Electronic Health Record (EHR) will not be subject to HIPAA unless the Developers are maintaining that health information on behalf of those providers or those providers' vendors as Business Associates of the Covered Entity. Even if a doctor recommends a specific health care app to his or her patient and the patient downloads that app, enters his or her health information and shares that information with the doctor through the app, the Developer is still not required to comply with HIPAA as long as the Developer has not contracted with the doctor to provide the app's services. The fact that the patient used the app to share his or her information with the doctor does not, in and of itself, make the Developer a Business Associate of the doctor.

OCR specifically called out those apps that offer users the ability to connect to a health care provider's or health plan's EHR—where there's an interoperability arrangement between those entities and the app developer and no other business relationship between the parties—as a scenario in which HIPAA compliance would likely not be required. However, if, for instance, at the direction of a provider, a patient downloads a health app to his or her smart phone, and  the provider has contracted with the Developer for patient management services (examples are: remote patient health counseling, monitoring of patients' food and exercise, patient messaging, EHR integration and application interfaces), and the information provided by the patient is automatically incorporated into the provider's EHR, then the Developer would be considered a Business Associate since the app is a means for providing those patient management services.

In a more nuanced scenario, a Developer would have to comply with HIPAA rules if the app is offered by the consumer's health plan (the example mentioned in the guidance relates to a mobile PHR that allows users to download and store health plan records and check the status of claims and coverage decisions, and also contains the plan's wellness tools for members). However, if the Developer were to also offer a separate, direct-to-consumer version of the app, the Developer's activities with respect to such version would not be subject to HIPAA rules (the implication being, however, that the health information collected from these two versions of the app would need to be separately stored).

The guidance document also contains a list of "Key Questions" to help Developers determine if they will be considered a Business Associate under HIPAA. As with the scenarios above, these questions are organized around the issues of who the Developer's customers are and how much control a consumer/user has over his or her data. If you are a Developer and your customers are Covered Entities under HIPAA (e.g., hospitals, doctors' offices, clinics, pharmacies, or other health care providers that conduct electronic transactions, health plans, wellness programs offered as part of an employer's self-funded health plan), or Business Associates to a Covered Entity, you will need to comply with HIPAA. If you are only offering your app directly to consumers, and your users independently select your app and control all decisions as to whether to send their data to a third party, you are probably not required to comply with HIPAA—although other data protection laws will apply.

Click here to read OCR's complete guidance.

New Compliance Guidance for the HIPAA Security Rule

OCR has also published a "Crosswalk" that maps the connections between the National Institute of Standards and Technology (NIST) Framework for Improving Critical Infrastructure Cybersecurity Framework ("NIST Framework") and the HIPAA Security Rule's standards. The NIST Framework is a voluntary, risk-based approach that helps organizations in any industry understand, communicate and manages cybersecurity risks. Since the Security Rule's standards are scalable and technology-neutral, this Crosswalk provides more concrete/practical guidance for "how" Business Associates (and Covered Entities) can assess their current compliance status, from a technical standpoint, and identify any possible gaps. For instance, one of the "required" standards under the Security Rule is the performance of a Risk Assessment. Within that standard, the Crosswalk sets out five subcategories that are fairly granular (e.g., asset vulnerabilities are identified and documented; threat and vulnerability information is received from information sharing forums and sources; threats, both internal and external, are identified and documented, etc.) and provides more clarity on the components of a Risk Assessment. One caveat—OCR states that compliance with the Crosswalk is not a "guarantee" of HIPAA compliance. Nevertheless, the crosswalk should go some way to making the Security Rule standards less nebulous.

Click here for a copy of the Crosswalk.​​

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.

Events from this Firm
25 Oct 2017, Conference, California, United States

CALOBA is excited to bring you our General Counsel (GC) roundtable event. Our distinguished panel of top legal counsel will share their experiences at the helm of some of the top technology companies.

30 Oct 2017, Seminar, California, United States

This program will address some of the hottest legal and policy topics that online platforms have brought to the fore: free speech, hate speech, fake news, privacy and surveillance, artificial intelligence, augmented reality, changing notions of “ownership” of information and software-enabled consumer products, and the perennial issue of copyright.

8 Nov 2017, Conference, California, United States

Fenwick & West is proud to be participating in PLI’s 49th Annual Institute on Securities Regulation scheduled for November 8-10, 2017 at The Roosevelt Hotel in New York City. The Institute is considered the premier conference, as well as one of the longest running, in the securities law field.

In association with
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
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.


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.


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.


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.


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.


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.


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.