Social media sites are transforming not only the daily lives of consumers, but also how companies interact with consumers. Here at Morrison Foerster, across all of our practice groups, we are seeing complex, cutting-edge legal issues arising out of social media. As with the Internet boom during the mid-to-late 1990s, social media is generating new legal questions at a far faster pace than the law’s ability to provide answers to such questions. In an effort to stay on top of these emerging issues, and to keep our clients and friends informed of new developments, Morrison Foerster publishes this blog devoted to the law and business of social media.<h2>ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Aaron is the chair of the firm’s Technology Transactions Group and co-chair of the Interactive + Digital Media Group. He advises clients on a wide range of complex transactions involving intellectual property and technology, including structuring and negotiating strategic licensing, development, collaboration, procurement, and distribution deals.Aaron’s practice focuses on advising both established and emerging companies in a variety of data- and technology-intensive sectors, including software, SaaS, cloud-based technology, digital media (social media, AR/VR, gaming, streaming media, AdTech), AI, healthcare, consumer electronics, e-commerce, other online business models, and mobile applications. He also maintains an active practice counseling companies on branding and marketing, trademark licensing, and content-related transactions, as well as the intellectual property aspects of mergers, acquisitions, asset spin-offs, and private equity investments.He has represented clients such as Autodesk, Meta, OpenAI, Splunk, Konami, Kaiser Permanente, SoftBank, Visa, and Yahoo, among others.Aaron has been recognized by numerous publications for his work on market-defining technology transactions. He is currently ranked by Chambers USA for “Technology Transactions.”Aaron also serves as co-editor of Socially Aware, the firm’s award-winning newsletter and blog devoted to the law and business of social media, and regularly publishes on various IP and technology-related topics. Aaron is also a sought-after speaker on new and emerging areas of law, and is a frequent presenter and panelist at conferences and legal services programs. In addition to his active practice, Aaron regularly provides pro bono assistance to various nonprofit and charitable organizations such as Common Sense Media and the Starlight Children’s Foundation. He is a member of the board of directors of California Lawyers for the Arts.While in law school at the University of California, Berkeley, Boalt Hall School of Law, Aaron served as executive editor of the California Law Review and was elected to the Order of the Coif. Following law school, Aaron served as law clerk to the Honorable William H. Orrick and the Honorable Martin J. Jenkins, both United States District Judges for the Northern District of California.

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Partner

Aaron is the chair of our Technology Transactions Group. He advises clients on a wide range of complex transactions involving intellectual property and technology, including structuring and negotiating strategic licensing, development, collaboration, procurement, and distribution deals. Aaron’s practice focuses on advising both established and emerging companies in a variety of data– and technology–intensive sectors, including software, SaaS, cloud computing, AR/VR, AI, gaming, healthcare, consumer electronics, social media, e–commerce, other online business models, and mobile applications. He also maintains an active practice counseling companies on the intellectual property aspects of mergers, acquisitions, asset spin–offs, and private equity investments.

Aaron P. Rubin

Lawrence Gallick is of counsel in the firm’s Austin office and a member of the Technology Transactions Group.Lawrence focuses his practice on technology transactions and licensing matters. His diverse experience includes advising on SaaS agreements, cross-licensing agreements, research and collaboration agreements, development agreements, and distribution agreements. He counsels a broad range of companies across the software, hardware, life sciences, biotech and FinTech spaces, as well as other entities including universities.He advises clients in connection with general corporate matters including contract negotiations, and leasing and technology placement agreements.Lawrence also serves as co-editor of <a href="https://www.sociallyawareblog.com/" target="_blank">Socially Aware</a>, the firm’s award-winning newsletter and blog devoted to the law and business of social media, and regularly publishes on various IP and technology-related topics.Prior to joining the firm, Lawrence was counsel at another major law firm. Before earning his law degree, Lawrence was a web consultant, project manager, and web developer in Portland, Oregon, where he managed and consulted on projects using industry methodologies and performed custom development and integration of content management systems.Lawrence was named a Super Lawyers “Rising Star” in 2015 and 2018–2022, and is licensed in both California and New York. Lawrence earned his J.D. from the University at Buffalo School of Law, where he was the electronic systems editor for the Buffalo Law Review and awarded the ABA-BNA Award for Excellence in the Study of Intellectual Property Law.

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Lawrence Gallick

Anthony Ramirez is a partner in the Technology Transactions Group in the New York office of Morrison Foerster.Anthony advises clients on general commercial and transactional matters. He regularly advises companies on the IP aspects of their M&A transactions. His clients include technology, digital media and content for television and music, financial services, and communications companies with diverse intellectual property assets and issues.His practice focuses on the legal aspects of developing, licensing, and commercializing technology and intellectual property, as well as negotiating general commercial contracts, including outsourcing transactions, as well as content and data licenses. He regularly assists clients with legal issues relating to licensing and commercialization of digital media and content, digital content that is distributed over the Internet or streamed, mobile applications and social media, as well as the licensing of recorded music for distribution via digital platforms. Anthony is also experienced with issues relating to open-source software, software development, artificial intelligence and machine learning, cloud-based technology, and protection of proprietary information.Anthony has extensive experience working on matters involving disruptive technologies, such as blockchain. He has helped fintech clients with general intellectual property issues in connection with terms of service for online financial products and services.Anthony is an integral part of the outside pro bono legal team for nonprofit organizations based in New York, including advising clients on legal issues regarding entertainment, social media, privacy rights, and the negotiation of outsourcing and service agreements. Anthony received his J.D. from the University of Michigan Law School in 2009. He received his B.S. from Cornell University in 2004.

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Anthony Ramirez is a partner in the Technology Transactions Group in the New York office of Morrison Foerster. He advises clients on general commercial and transactional matters. His clients include technology, media, and communications companies with considerable intellectual property assets. His practice focuses on the legal aspects of licensing and commercializing technology and intellectual property, as well as negotiating general commercial contracts. He also regularly assists clients with legal issues relating to mobile applications and social media.

Anthony M. Ramirez

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Socially Aware is devoted to the law and business of social media, proactively addressing emerging issues and keeping our clients informed of new developments. We cover fields such as artificial intelligence, privacy and data security, Section 230, intellectual property, and much more.

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Lawrence W. Gallick on Toth v. Everly Well, Inc.

On April 12, 2013, the UK’s Office of Fair Trading (OFT), the UK regulator for consumer affairs and competition, announced that it was launching an investigation into children’s web- and app-based games. In particular, the OFT is looking into whether such games comply with the <a href="http://www.legislation.gov.uk/uksi/2008/1277/contents/made">Consumer Protection from Unfair Trading Regulations 2008</a> (“Regulations”), and are not misleading or aggressive (for example, directly encouraging children to buy something or to pester their parents or other adults to buy something on their behalf). The investigation is expected to take six months to complete, and will take into account views from mobile app platform operators and other businesses operating in this market, together with the views of parents and consumer groups.The investigation was launched in response to reports of children racking up substantial bills on so-called “free” online and app-based games. For example, in March 2013, it was reported that a 5-year-old boy amassed a bill of £1,700 in just 15 minutes via <a href="http://www.bbc.co.uk/news/uk-england-bristol-21629210">add-ons</a> while playing the “free” game “Zombies vs Ninja.” There are thousands of games like this that are marketed as being free to download but, once the user starts playing, present advertising encouraging the user to pay to get access to extra levels or to receive in-game extras such as virtual coins, gems or other tokens.The OFT estimates that, as of April 9, 2013, 80 of the 100 top-grossing Android apps were free to download, yet raised revenue through these kinds of in-app purchases. Although platforms will often enable password protection to restrict in-app purchases, such measures will not prevent purchases by children who know their parents’ password or by parents who, at the request of their children, insert their password without appreciation of the risks.The Regulations, which implement the <a href="http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:149:0022:0039:en:PDF">Unfair Commercial Practices Directive 2005/29/EC</a>, state that unfair commercial practices are prohibited. A commercial practice is deemed to be unfair if it contravenes the requirements of professional diligence and materially distorts, or is likely to materially distort, the economic behavior of the consumer with regard to the product. Aggressive commercial practices are those that impair the average consumer’s freedom of choice or conduct through the use of harassment, coercion or undue influence, and that thereby cause, or are likely to cause, the consumer “to take a transactional decision he would not have taken otherwise.” Undue influence includes exploiting a position of power in relation to the consumer.The Regulations clearly provide that it is unfair to include in an advertisement a direct exhortation to children to buy advertised products, or persuade their parents or other adults to buy advertised products for them. Breach of the Regulations can lead to criminal penalties such as a fine or imprisonment for up to two years.The OFT has made it clear that no company that is included in its investigation should be assumed to have broken the Regulations. In addition, the OFT has stated that it does not wish to ban in-app purchases, but rather to determine whether they are compliant with the Regulations in order to ensure that children are protected. Nevertheless, the OFT has indicated that it will take enforcement action against offending companies if necessary. The outcome of the OFT’s investigation is expected to be published in October 2013.In the meantime, a number of guides have appeared providing advice to parents on how to block in-app purchases (including guidance published by the UK communications regulator, Ofcom), and at least one major app distributor has added in-app purchase warnings to its app store listings. This could be the key to future settings: allowing users to filter out in-app purchase applications when downloading them.It will be interesting to see what approach the OFT decides to take as a result of its investigation, and where it believes responsibility should lie. Should parents be expected to take more control over their children’s gaming activities or should providers be required to do more, e.g., by providing more information warning users on the nature of these “freemium” apps contained within their stores?Lastly, note that this investigation may have consequences for game providers operating elsewhere in Europe. Because the Regulations are based on EU law, other EU regulators will be watching the progress of the OFT investigation closely to consider whether they, too, need to scrutinize games providers’ compliance with the equivalent laws in their territories.

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Playing Fair? UK’s OFT Investigates Online and App-Based Games

Playing Fair? UK’s OFT Investigates Online and App-Based Games

On April 12, 2013, the UK’s Office of Fair Trading (OFT), the UK regulator for consumer affairs and competition, announced that it was launching an investigatio

Article courtesy of Morrison & Foerster’s Mobile Payments PracticeLawmakers in Washington, D.C., continue to show interest in understanding and developing regulatory proposals relating to mobile apps. The interest appears to be driven, at least in part, by policymakers’ concerns about consumer privacy when using mobile phones and other smart hand-held devices. The issue of consumer privacy, as well as the security of financial information, and the use of mobile also apps has been raised in the context of Congressional hearings held to understand the new ways in which consumers are paying, and taking payments, via smartphone.The recent introduction of a bill focusing on mobile apps and privacy issues is another indicator of ongoing legislative interest in mobile phone technology and ways in which smartphones are used. On May 9, 2013, Representative Hank Johnson (D-GA) introduced H.R. 1913, the “Application Privacy, Protection, and Security Act of 2013” (“APPS Act”). H.R. 1913 was referred to the House Committee on Energy and Commerce for consideration. As of June 4, 2013, the bill had five co-sponsors.Representative Johnson’s introduction of the APPS Act follows the release, in January 2013, of a discussion draft of the bill that was developed through an Internet-based legislative project launched by the congressman’s office in July 2012. The following provides a brief overview of the APPS Act, as introduced.User NoticesUnder the APPS Act, app developers would be required to provide users with a notice, before collecting their personal data, describing the terms and conditions governing the collection, use, storage and sharing of personal data. Developers would also be required to obtain the consent of the users to these terms and conditions.The bill would require this notice to users to include the following:<ul><li>The categories of personal data that the app will collect;</li><li>The purposes for which the personal data will be used;</li><li>The categories of third parties with which the personal data will be shared; and</li><li>A “data retention policy” that governs the length of time for which the personal data will be stored and a description of the user’s rights under the bill to notify the app developer and request that the developer refrain from collecting additional personal data through the app.</li></ul>The APPS Act would direct the Federal Trade Commission (FTC) to issue regulations specifying the format, manner and timing of the notice. In promulgating the regulations, the FTC would consider how to ensure the “most effective and efficient” communication to the user regarding the treatment of personal data.Data SecurityThe APPS Act would also require app developers to take reasonable and appropriate measures to prevent unauthorized access to personal data collected by apps. This provision demonstrates that concerns about consumer privacy continue to be a driving force for policymakers in crafting legislative proposals.FTC Enforcement and Safe HarborThe APPS Act would provide for FTC enforcement, pursuant to the FTC’s unfair or deceptive acts or practices authority under the FTC Act, but would not foreclose private rights of action, or actions by state attorneys general or other state officials. Pursuant to a safe harbor provision, app developers would satisfy the APPS Act’s requirements, and requirements of implementing regulations, by adopting and following a code of conduct for consumer data privacy developed in the multi-stakeholder process convened by the U.S. Department of Commerce’s National Telecommunications and Information Administration (NTIA). The NTIA process is an outgrowth of the White House white paper, “Consumer Data Privacy in a Networked World,” which advocated the coupling of voluntary privacy codes of conduct with federal legislation establishing consumer “Bill of Rights” principles.The full text of H.R. 1913 is accessible on the Web site of the Government Printing Office at: <a href="http://www.gpo.gov/fdsys/pkg/BILLS-113hr1913ih/pdf/BILLS-113hr1913ih.pdf">http://www.gpo.gov/fdsys/pkg/BILLS-113hr1913ih/pdf/BILLS-113hr1913ih.pdf</a>.

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Senior Partner

Rick has nearly 50 years of experience advising banks, retailers, insurers, and other companies throughout the United States on the full range of financial services and payment system issues.

Rick Fischer

Rick has nearly 50 years of experience advising banks, retailers, insurers, and other companies throughout the United States on the full range of financial services and payment system issues.

Mobile Apps Bill Introduced in the House of Representatives

Article courtesy of Morrison & Foerster’s Mobile Payments Practice Lawmakers in Washington, D.C., continue to show interest in understanding and developing regu

Mobile Apps Bill Introduced in the House of Representatives

Following concerns raised by bloggers, the UK government has clarified that small blogs will be exempt from the scope of the new UK press watchdog which is to be introduced as a result of the findings of the <a href="http://www.levesoninquiry.org.uk/">Leveson Inquiry</a>.In 2007, Clive Goodman, then-editor of UK newspaper News of the World, and private investigator Glenn Mulcaire were convicted of the illegal interception of phone messages, and in early 2011, it was revealed that other News of the World reporters had also hacked phones.  Later in 2011, the UK government <a href="https://www.gov.uk/government/organisations/department-for-culture-media-sport">Department for Culture, Media and Sport</a> (DCMS) commenced a public inquiry into the <a title="Culture" href="http://en.wikipedia.org/wiki/Culture">culture</a>, practices and <a title="Ethics" href="http://en.wikipedia.org/wiki/Ethics">ethics</a> of the <a title="British (people)" href="http://en.wikipedia.org/wiki/British_%28people%29">British</a> <a title="Newspapers" href="http://en.wikipedia.org/wiki/Newspapers">press</a>, chaired by <a href="http://www.levesoninquiry.org.uk/people/lord-justice-leveson-chairman/">Lord Justice Leveson</a>.  In November 2012, following a series of public hearings, Lord Justice Leveson’s inquiry published the <a href="http://www.official-documents.gov.uk/document/hc1213/hc07/0780/0780.asp">Leveson Report</a>, which made recommendations for a new independent regulator for the UK press.  As a result of the Leveson Report, the UK government has proposed that a new press watchdog be established by royal charter and backed by legislation; this new self-regulatory system will apply to all “relevant publishers.”The Crime and Courts Act 2013The relevant legislation, the <a href="http://www.legislation.gov.uk/ukpga/2013/22/contents/enacted">Crime and Courts Act 2013</a> (the “Act”), became law on April 25, 2013.  (In terms of the <a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/142808/18_March_2013_v6_Draft_Royal_Charter.pdf">royal charter</a> itself, a draft royal charter put forward by the UK government and a <a href="http://www.guardian.co.uk/media/2013/apr/25/press-regulation-newspaper-groups-royal-charter">rival draft</a> put forward by some of the leading UK newspapers are due to be considered by the <a href="http://privycouncil.independent.gov.uk/">Privy Council</a> in June 2013.)  Section 41 of the Act sets out the four criteria that a publication must meet to be a “relevant publisher.”  A relevant publisher must:<ul><li>Publish “news-related” material (i.e., news, information or opinion about current affairs or gossip about celebrities, public figures or other persons in the news);</li><li>Publish in the course of a business;</li><li>Publish material written by different authors; and</li><li>Publish material subject to editorial controls.</li></ul>For purposes of the Act, “publication” means on a website, in hard copy or by any other means.The draft royal charter proposed by the UK government goes on to make clear that the proposed self-regulatory scheme will cover those who publish in the UK, where a person is deemed to publish in the UK if “the publication takes place in the United Kingdom or is targeted primarily at an audience in the United Kingdom”; the rival royal charter drafted by the press does not suggest any changes to these provisions.  Although there is no guidance in the draft royal charter as to the interpretation of “takes place in the United Kingdom,” it appears that the royal charter could cover foreign operators that publish in the UK, in addition to the UK press itself.  We note that the risk to such publishers that are based in the United States, at least with respect to defamation claims, may be limited by the <a href="http://www.gpo.gov/fdsys/pkg/PLAW-111publ223/pdf/PLAW-111publ223.pdf">SPEECH Act</a>,” which was signed into law in the U.S. in August 2010 as a response to so-called “libel tourism.”(As a general matter, the SPEECH Act prohibits a U.S. federal or state court from recognizing or enforcing a foreign defamation judgment unless the foreign jurisdiction’s defamation law provided at least as much protection of freedom of speech and press as the U.S. Constitution, as well as the constitution and laws of the state in which the court is located.  The SPEECH Act further prohibits U.S. courts from recognizing or enforcing a foreign defamation judgment against the provider of an “interactive computer service,” as defined in <a href="http://www.law.cornell.edu/uscode/text/47/230">Section 230</a> of the Communications Decency Act (CDA), unless such court determines that the judgment would be consistent with Section 230 if the relevant information had been provided in the U.S.)A website operator is not considered to have editorial control over material published on its site if the operator did not post the material, even if the operator moderates statements published by others.  This is consistent with the approach taken in <a href="http://www.legislation.gov.uk/ukpga/2013/26/section/5/enacted">Section 5</a> of the UK’s new <a href="http://www.legislation.gov.uk/ukpga/2013/26/contents/enacted">Defamation Act 2013</a>, which provides that a website operator’s defence of not having posted defamatory material will not be defeated merely because the operator has moderated a statement posted by others.“Micro-Businesses” and the Small Blog Exemption<a href="http://www.legislation.gov.uk/ukpga/2013/22/schedule/15/enacted">Schedule 15</a> of the Crime and Courts Act 2013 states that a person who, in carrying out a “micro-business,” publishes news-related material which is either (i) contained in a multi-author blog (a blog that contains contributions from different authors) or (ii) published on an incidental basis that is relevant to the main activities of the business, will not be classified as a relevant publisher for purposes of the Act.  “Micro-businesses” are defined as those with fewer than 10 employees and an annual turnover of less than £2 million.Note, however, that a publication that is exempt from the Act as a micro-business could still choose to join the regulatory system and receive the legal benefits otherwise only available to relevant publishers—benefits that include cost protection if a claimant chooses to sue in court instead of using the regulator’s arbitration scheme.DCMS has created the following <a href="http://www.flickr.com/photos/thedcms/8663308157/">infographic</a> for use in determining whether or not a publication is a relevant publisher:Image by <a href="https://www.gov.uk/government/organisations/department-for-culture-media-sport">DCMS</a> via <a href="http://creativecommons.org/licenses/by-nd/2.0/">Creative Commons Attribution-NoDerivs 2.0 Generic (CC BY-ND 2.0)</a> license.Other ExemptionsSchedule 15 also specifies other categories of publications which are exempt from the new system, even when the test for relevant publishers is met.  These exemptions cover special-interest titles, scientific or academic journals, broadcasters and book publishers, as well as any public body, charity or company that publishes news about their activities.

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New UK Press Self-Regulation – With a Small Blog Exemption

New UK Press Self-Regulation – With a Small Blog Exemption

Following concerns raised by bloggers, the UK government has clarified that small blogs will be exempt from the scope of the new UK press watchdog which is to b

In late May 2013, the U.S. Food and Drug Administration (FDA) sent an enforcement letter to a mobile medical app developer for failing to obtain a 510(k) clearance before marketing the app, which the FDA said appears to be a “device” under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA). The mobile app—the uChek Urine Analyzer developed by Biosense Technologies Private Limited and available through the iTunes App store—allows a user to read urine dipsticks using a camera phone to screen for diabetes and urinary tract infections. The FDA’s letter signals the type of oversight the FDA intends to exercise over mobile medical app developers, although the agency has not released final guidance in this murky area.FDA Previously Indicated Light Regulation of Medical Mobile AppsIn March, Congress urged the FDA to clarify the regulation of mobile medical apps in three days of hearings before the House Energy and Commerce Committee. The FDA generally relieved concerns raised by the mobile communications industry, which had feared heavy regulation of mobile phones and tablets as medical devices. Christy Foreman, the Director of the Office of Device Evaluation in the Center for Devices and Radiological Health (CDRH) at the FDA, testified before the committee that the FDA intends to limit regulation to a small subset of apps, in accordance with the FDA’s July 2011 draft guidance on mobile medical apps.The FDA proposed a narrowly tailored approach focusing on apps that could threaten patient safety if they do not work as intended. These include apps that either: (1) affect the performance or functionality of a currently regulated medical device or (2) have traditionally been considered medical devices. Consistent with this philosophy, the agency does not intend to regulate mundane apps that help people achieve a healthier lifestyle, such as pedometers or calorie counters. Nor does the agency plan to regulate apps that track medical data but otherwise do not meet the definition of “device” in section 201(h) of the FDCA because they are not intended to diagnose, treat, or cure conditions or diseases.Specifically, the 2011 draft guidance indicated that the FDA will regulate mobile apps that qualify as medical devices under section 201(h) and that are intended to perform one of two functions: (1) serve as an accessory to a regulated medical device—for example, an app that allows doctors to diagnose patients by viewing medical images on a tablet; or (2) transform a mobile platform into a regulated medical device—for example, an app that allows a patient to measure blood glucose with a smartphone. The FDA’s recent enforcement letter to Biosense falls squarely in line with this proposed regulatory scheme. As the FDA noted in its letter, the uChek app is intended for use with urinalysis dipsticks that have received 510(k) clearance for “direct visual reading.” However, the app allows a mobile phone to analyze the dipsticks and that means “the phone and device as a whole functions as an automated strip reader” that requires new clearance.FDA Does Not Intend to Regulate Other Mobile TechnologyIn a prepared statement released on the day of her testimony, Foreman laid out the boundaries of the FDA’s proposed mobile medical app policy. The statement made clear that the FDA does not intend to regulate mobile technology apart from the medical apps themselves. Thus, the FDA will not regulate the sale or general consumer use of smartphones or tablets. Entities that solely distribute mobile medical apps (such as owners and operators of the “iTunes App store” or the “Android market”) will not be considered medical device manufacturers. And mobile platform manufacturers will not be deemed medical device manufacturers simply because their platforms support mobile medical apps regulated by the FDA. Based on these statements, smartphone manufacturers and app distributors can put to rest for now any concerns they might have had about FDA oversight regarding health-related mobile apps.FDA’s Statements on Mobile App Regulation Ease Uncertainty in IndustryCongress held the recent hearings in response to uncertainty among mobile app developers, which the House Energy and Commerce Committee voiced in a letter to the FDA Commissioner in early March. The letter relayed industry fears of widespread regulation by the FDA and concerns over the lack of final guidance on the regulation of mobile medical apps. At the hearing, the committee also inquired whether the FDA intends for smartphones, tablets, and other devices that display mobile medical apps to be taxed as medical devices under the Patient and Protection and Affordable Care Act (PPACA). Foreman deflected these questions, noting that the IRS, not the FDA, has the authority to impose taxes on medical devices.Though the mobile medical app market has been growing, Foreman’s testimony showed that the industry is still in its infancy. Foreman stated that the FDA receives fewer than 20 submissions per year for mobile medical apps, which amounts to approximately 0.5% of all medical device applications the agency reviews each year. All mobile medical apps cleared thus far have gone through the 510(k) process, which in 2011 and 2012 took an average of 67 days to complete. The agency has not yet deemed any mobile medical apps to be Class III medical devices.Further Guidance Expected Later This YearMobile medical app developers should look for a final guidance from the FDA on regulation of mobile medical apps later this year. Though Foreman initially projected that the guidance would be published in “the coming months,” when pushed to be more specific she narrowed her projection to the end of the FDA’s fiscal year in September. Technological developments in mobile medical apps have far outpaced the FDA’s sluggish timing in releasing its final guidance. Congress and mobile app developers will be watching closely to see if the FDA’s final guidance brings the clarity and light regulation of mobile medical apps that the agency has proposed. In the meantime, developers whose apps work in tandem with regulated medical devices should pay attention to the FDA’s enforcement letter to Biosense and consider whether FDA clearance is appropriate. We will continue to monitor this topic and provide relevant updates.