United States: Navigating the FTC's Mobile Health App Tool and Guidance

Last Updated: May 26 2016
Article by Elizabeth G. Litten

Originally published by Data Protection Law & Policy

On 4 April 2016, the US Federal Trade Commission ('FTC') released an interactive web-based tool for mobile health app developers, to help them understand which federal laws and regulations might apply to their app ('the Tool'). In addition, the FTC also released its Mobile Health App Developers: FTC Best Practices guidance, which provides advice on how to incorporate privacy and security into apps ('the Guidance'). Elizabeth G. Litten, Partner and HIPAA Privacy Officer at Fox Rothschild LLP, provides insight on the usefulness of the Tool and the Guidance for app developers, and highlights the gaps that remain.

The FTC deserves credit for trying to clarify for mobile health app developers which, among myriad federal laws and regulations, might apply to their apps. The Tool identifies four potentially applicable federal laws: the Health Insurance Portability and Accountability Act 1996 ('HIPAA'); the Federal Food, Drug, and Cosmetic Act 1938 ('the FD&C Act'); the Federal Trade Commission Act 1914 ('the FTC Act'); and the FTC's Health Breach Notification Rule (the 'FTC Breach Rule') (collectively, the 'Mobile Health App Laws.') The Mobile Health App Laws are enforced by three separate federal agencies: the Office for Civil Rights ('OCR') within the Department of Health & Human Services; the Food and Drug Administration ('FDA'); and the FTC (collectively with OCR and FDA, the 'Mobile Health App Agencies'). The Tool guides users through a series of questions designed to help the developer identify the applicable Mobile Health App Law(s) that must be taken into account during the development of the mobile health app.

Usefulness of the Tool

The goal is laudable, and the Tool is not all that bad. It is easy to use and highlights the key questions the regulators would ask in determining whether and how the Mobile Health App Laws might apply to a particular app. However, users should not be deluded into thinking that the Tool will lead directly to regulatory compliance. Rather, they should be forewarned that it is likely to highlight the need for a much deeper dive into one or more complex regulatory schemes. For example, the Tool's questions are embedded with terms defined in the various Mobile Health App Laws, and while the Tool includes helpful links to the definitions, many of the definitions are themselves embedded with regulatory definitions and links to other agency guidance documents. Furthermore, even the most diligent consideration of the applicable definitions and the most conscientious decision-making applied to answering the questions leads to rather inconclusive answers, 'You may be subject to the HIPAA rules,' or 'It's likely that the FTC Act applies.'

Remaining issues

Gaps in regulations

The Tool also does not alert a user to the fact that, once the user correctly identifies which Mobile Health App Law(s) applies, additional gaps remain. First, the Mobile Health App agencies have not yet adopted regulations or issued final guidance in certain areas particularly germane to apps, and some of the guidance that has been issued is so fact-sensitive that its utility is questionable. For example, the Food and Drug Administration ('FDA') has not yet issued final guidance related to clinical decision support software.

Uncertainty of HIPAA application

Second, guidance accessible from the Office for Civil Rights' ('OCR') mobile health portal for use in determining whether apps are subject to HIPAA, shows that how an app is accessed by a consumer can determine whether HIPAA applies to the information collected via the app. OCR's Health App Use Scenarios & HIPAA guidance sets forth six factual scenarios designed to help a mobile health app developer understand when HIPAA applies to information collected via the app, but OCR's answers highlight the fact that an app may be subject to HIPAA when downloaded from one source and not when that same app is downloaded from another. The sixth factual scenario provides: 'Consumer downloads to her smart phone a mobile personal health record app offered by her health plan that offers users in its network the ability to request, download and store health plan records and check the status of claims and coverage decisions. The app also contains the plan's wellness tools for members, so they can track their progress in improving their health. Health plan analyses health information and data about app usage to understand effectiveness of its health and wellness offerings. App developer also offers a separate, direct-to-consumer version of the app that consumers can use to store, manage, and organise their health records, to improve their health habits and to send health information to providers.'

OCR answers the question, 'Is App Developer a HIPAA Business Associate?' and, thus, subject to HIPAA, as follows:

'Yes, with respect to the app offered by the health plan, and no, when offering the direct-to consumer app. Developer is a business associate of the health plan, because it is creating, receiving, maintaining or transmitting protected health information ('PHI') on behalf of a covered entity. Developer must comply with applicable HIPAA Rules requirements with respect to the PHI involved in its work on behalf of the health plan. But its direct-to-consumer product is not provided on behalf of a covered entity or other business associate, and developer activities with respect to that product are not subject to the HIPAA Rules. Therefore, as long as the developer keeps the health information attached to these two versions of the app separate, so that information from the direct-toconsumer version is not part of the product offering to the covered entity health plan, the developer does not need to apply HIPAA protections to the consumer information obtained through the direct-to-consumer app.'

Other laws may apply

Finally, another gap not obvious to users of the Tool, is the fact that Mobile Health App agencies and their respective Mobile Health App Laws may not be the only federal laws mobile health app developers need to worry about. For example, an app subject to the FDA Act may also be subject to regulations promulgated by another federal agency, the Federal Communications Commission.

Legal advice v. practical advice

Mobile health app developers less immediately interested in legal advice and more interested in practical advice they can incorporate into the development of an app, may want to forego the Tool and turn to the Guidance.

When the mobile app developer uses the Tool, they may not know for certain which Mobile Health App Laws (or other applicable laws) apply, but will likely have a good idea as to the type of lawyer they might need to consult

The Guidance includes eight broad categories of tips that provide developers with concrete and specific answers to common questions related to the privacy and security of the information collected by an app. General reminders, such as, 'Make sure your app doesn't access consumer information it doesn't need,' are followed by specific tips like, 'For example, if you're developing a running app, think about whether it really needs access to other resources - like consumers' contacts. If not, your app shouldn't access the operating system's application programming interface for that information.'

Another practical tip under the category entitled, 'Innovate How You Communicate With Users,' suggests that the app specifically ask a user (and require the user to affirmatively answer) if the user agrees to permit the app to collect and/or share specific health data (for example, blood pressure readings). This tip suggests that these specific consents be separate from the app's general privacy policy or terms of service so that users understand and can focus on the question and the consent given.

The Guidance also includes the useful reminder that the building blocks of an app contribute to (or detract from) its security, such as, 'If you use a software tool developed by another company, it's still your responsibility to ensure it conforms to your privacy promises and consumer expectations' (not to mention that you had better be certain you have the legal right to use such software tool). These are the type of tips a privacy and security-focused attorney often offers, and are available in a clear, easy-to-read format without the attorney fee.

In fact, I would encourage mobile health app developers to closely review the Guidance, and perhaps peruse the free resources listed in the sixth and eighth categories (entitled, 'Don't reinvent the wheel,' and, 'Don't Forget About Other Applicable Laws', respectively) before attempting to navigate the Tool. When the mobile app developer subsequently uses the Tool, it may not know for certain which Mobile Health App Laws (or other applicable laws) apply, but will likely have a good idea as to the type of lawyer it might need to consult to explore it applicability and associated compliance responsibilities.

This article was first published in Volume 13 Issue 5 of Data Protection Law & Policy (May 2016). Data Protection Law & Policy, launched in 2004, is the monthly law journal dedicated to making sure that businesses and public services alike can find their way through the regulatory and organisational maze of data privacy compliance to reap the rewards of effective, well-regulated and transparent use of data. Visit www.e-comlaw.com for details.

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.

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Elizabeth G. Litten
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