Archives: Mobile Apps

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New York AG Settlement with App Developers Serves as a Warning for the Need for Evidence-Backed Commercial Claims

On March 23, 2017, the New York Attorney General’s office announced that it has settled with the developers of three mobile health (mHealth) applications (apps) for, among other things, alleged misleading commercial claims. This settlement highlights for mHealth app developers the importance of systematically gathering sufficient evidence to support their commercial claims. Read the full … Continue Reading

Digital Health Solutions are Key to Success under Health Care Payment Innovations

Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held devices—is empowering the innovation needed to meet the imperative for a transition from payment based on volume to payment based on value that is … Continue Reading

OCR Guidance Underscores Importance of Authentication under HIPAA

In its tenth OCR Cyber Awareness Newsletter of the year (Newsletter), the Office for Civil Rights (OCR) reminded HIPAA-covered entities and business associates of the importance of selecting an appropriate authentication method to protect electronic protected health information (ePHI). Authentication is the process used to “verify whether someone or something is who or what it … Continue Reading

FTC Weighs-in on Telehealth, Comments on Delaware’s Occupational Therapy Practice Rule

On August 3, 2016, the Federal Trade Commission (FTC) staff submitted public comments regarding the Delaware Board of Occupational Therapy Practice’s proposed regulation for the provision of occupational therapy services via telehealth in Delaware (the Proposed Regulation).  The FTC’s comments to the Proposed Regulation follow its comments to Alaska’s telehealth legislation earlier this year and evidence its … Continue Reading

Augmented Reality

If you haven’t heard about newest gaming craze yet, it’s based on what is called “augmented reality” (AR) and it could potentially impinge on your home life and workplace as such games allow users to “photograph” imaginary items overlaid with objects existing in the real world. An augmented reality game differs from “virtual reality” in … Continue Reading

Guidance on Low Risk General Wellness Devices Is Finalized

On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory requirements for low risk products that promote a healthy lifestyle—coined “general wellness products.” In the Final Guidance, the FDA makes minimal substantive changes to … Continue Reading

Digital Health: An Improving Environment for Investors

The integration of technology into health care delivery is exploding throughout the health industry landscape. Commentators speculating on the implications of the information revolution’s penetration of the health care industry envision delivery models rivaling those imagined by celebrated science fiction authors, and claim that the integration of information technology into even the most basic health … Continue Reading

AMA Approves New Ethical Guidance Policy and Encourages Telemedicine Training for Students and Residents

New Ethical Guidelines On June 13, the American Medical Association (AMA) adopted a new ethical guidance policy governing the practice of telemedicine that will be published in the coming months. The policy is based on a report from the AMA Council on Ethical and Judicial Affairs and builds upon the AMA’s 2014 telemedicine guidance. Consistent … Continue Reading

Mobile Health Tools, Developers Need Better Data Protection Guidance, Attorney Jennifer Geetter Says

After three government agencies collectively created an online tool to help developers navigate federal regulations impacting mobile health apps, McDermott partner Jennifer Geetter was interviewed by FierceMobileHealthcare on the need for mobile health development tools. Read the full article from FierceMobileHealthCare.… Continue Reading

Developing and Implementing an Effective Telemedicine Informed Consent Form

The search by consumers, payers and providers for more efficient, effective and convenient care delivery models has led to an explosion of technological innovation in the health care sector. This explosion has supported the increased use of telemedicine by providers to reach patients who were previously out of reach, and to provide more timely and cost-effective … Continue Reading

Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws

This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps that collect, create and share consumer information, including health information. The interactive series of questions and answers augments and cross-references existing … Continue Reading

FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016,  the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for managing postmarket cybersecurity vulnerabilities in medical devices that contain software or programmable logic and software that is a medical device, including networked medical devices. The … Continue Reading

GPEN Children’s Privacy Sweep Announced

On 11 May 2015, the UK Information Commissioner’s Office (ICO), the French data protection authority (CNIL) and the Office of the Privacy Commissioner of Canada (OPCC) announced their participation in a new Global Privacy Enforcement Network (GPEN) privacy sweep to examine the data privacy practices of websites and apps aimed at or popular among children. … Continue Reading

Telehealth: Implementation Challenges in an Evolving Dynamic

As part of its four-part Digital Health webinar series, on April 14, 2015, McDermott Will & Emery presented “Telehealth: Implementation Challenges in an Evolving Dynamic.” Telehealth (also known as telemedicine) generally refers to the use of technology to support the remote delivery of health care.  For example: A health care provider in one place is … Continue Reading

Recent Decisions Narrow Scope of Liability under Video Privacy Protection Act

Two significant decisions under the Video Privacy Protection Act (VPPA) in recent weeks have provided new defenses to companies alleged to have run afoul of the statute.  Bringing the long-running litigation against Hulu to a close–at least pending appeal–the court in In re: Hulu Privacy Litigation granted summary judgment in favor of Hulu, holding that … Continue Reading

National Roadmap for Health Data Sharing: FTC Advocates Preservation of Privacy and Competition

On April 1, 2015, the Office of the National Coordinator for Health Information Technology (ONC), which assists with the coordination of federal policy on data sharing objectives and standards, issued its Shared Nationwide Interoperability Roadmap and requested comments.  The Roadmap seeks to lay out a framework for developing and implementing interoperable health information systems that … Continue Reading

The Consumer Privacy Bill of Rights Redux

On February 27, 2015, the Obama White House released an “Administration Discussion Draft” of its Consumer Privacy Bill of Rights Act of 2015 (Proposed Consumer Privacy Act).  The Proposed Consumer Privacy Act revises and builds on the “Consumer Privacy Bill of Rights” that the Obama White House released in its 2012 Consumer Data Privacy in … Continue Reading

Consumer Health Information Update from Both Sides of the Atlantic

As we reported in May 2014, the Federal Trade Commission (FTC) convened stakeholders to explore whether health-related information collected from and about consumers — known as consumer-generated health information (CHI) — through use of the internet and increasingly-popular lifestyle and fitness mobile apps is more sensitive and in need of more privacy-sensitive treatment than other … Continue Reading

The FTC Did Some Kid-ding Around in 2014

2014 was a busy year for the Federal Trade Commission (FTC) with the Children’s Online Privacy Protection Act (COPPA).  The FTC announced something new under COPPA nearly every month, including: In January, the FTC issued an updated version of the free consumer guide, “Net Cetera:  Chatting with Kids About Being Online.”  Updates to the guide … Continue Reading

Any Progress? The Draft Data Protection Regulation Celebrates its Third Anniversary

On the third anniversary of the EU Commission’s proposed new data protection regime, the UK ICO has published its thoughts on where the new regime stands. The message is mixed: progress in some areas but nothing definitive, and no real clarity as to when the new regime may come into force. The legislative process involves … Continue Reading

In with the New: 2015 Privacy, Advertising and Digital Media Predictions – Part I

What privacy, advertising and digital media trends will make headlines in 2015?  Digital Health for one,  Big Data for another. Digital Health The 2015 International Consumer Electronics Show (CES) started yesterday.  Sessions like “Sensibles: The Smarter Side of Wearables” and “DIY Health: Consumer Accessible Innovation” suggest that the consumer health issues explored by the Federal Trade … Continue Reading

Privacy and Data Protection: 2014 Year in Review

In 2014, regulators around the globe issued guidelines, legislation and penalties in an effort to enhance security and control within the ever-shifting field of privacy and data protection. The Federal Trade Commission confirmed its expanded reach in the United States, and Canada’s far-reaching anti-spam legislation takes full effect imminently. As European authorities grappled with the … Continue Reading

Join Us at BAA’s Marketing Law Conference for a Panel Discussion on Developments in Mobile Marketing

For those Of Digital Interest readers attending the Brand Activation Association’s (BAA) 36th Annual Marketing Law Conference, please join McDermott partner – and Of Digital Interest editor – Julia Jacobson as she moderates a panel titled “New and Unexpected: Developments in Mobile Marketing – Mobile Tracking, Apps and Mobile Payments.” She will be joined by Ira … Continue Reading

GPEN Publishes Privacy Sweep Results

On 10 September 2014, the Global Privacy Enforcement Network (GPEN) published the results of its privacy enforcement survey or “sweep” carried out earlier in 2014 with respect to popular mobile apps.  The results of the sweep are likely to lead to future initiatives by data protection authorities to protect personal information submitted to mobile apps. … Continue Reading
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