News & Analysis as of

Mobile Health Apps

Health Apps: Convenience Vs. Security Risks

by Jackson Lewis P.C. on

The pace of innovation in healthcare today has produced an amazing increase in the number of available mobile apps for health-related information. More than 300,000 healthcare apps are available online. These apps are...more

Apple Releases Electronic Health Record Aggregation Tool in iOS 11.3

by Knobbe Martens on

According to an Apple press release, iPhone users will now be able to store and view their medical records on their phones as part of a new feature found in iOS 11.3. Although many patients are already familiar with...more

Study Identifies Cybersecurity and Privacy Shortcomings in Health Apps

by Reed Smith on

A recent study conducted by researchers at the University of Piraeus, published in the Institute of Electrical and Electronics Engineers’ Access journal (29 January 2018), has indicated that many popular health apps have...more

Sharing and Mining Patient Data in Digital Health and Telemedicine: Laws You Need to Know

by Foley & Lardner LLP on

The use of new technologies such as digital health applications, telemedicine, and information exchanges can provide game-changing benefits for providers and patients alike. However, with increased sharing comes increased...more

Digital Health: CE marking of medical devices

by Hogan Lovells on

In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. ...more

Telehealth and the Changing Regulatory Landscape: Opportunities and Challenges in the Digital Health Ecosystem

by McDermott Will & Emery on

What if you didn’t have to take time out of your day to see a physician in person when you needed a prescription? What if a diagnosis could be delivered over video chat? What if your psychiatrist was available at the press of...more

FDA Clears mHealth App That Uses AI to Signal Signs of Stoke

by Kelley Drye & Warren LLP on

FDA announced last week that it has cleared for marketing an mHealth app that uses artificial intelligence (AI) to analyze CT images for signs of stroke. The app, called Contact, is a clinical decision support tool marketed...more

FDA Releases 2018 Roadmap: Focus On Digital Health Continues

by Kelley Drye & Warren LLP on

Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Roadmap” addresses continued focus on digital health, among other priorities,...more

Big Brother is a Pill: Digital Tracking Drugs

by McGuireWoods LLP on

Drug adherence programs have significantly evolved over the last few years with drug companies, health plans, and providers taking steps to monitor patient medication compliance. Drug adherence is the degree to which a...more

FDA Clears First Apple Watch Medical Device Accessory

by Knobbe Martens on

The FDA recently cleared the first medical device accessory for the Apple Watch — AliveCor’s KardiaBand. According to AliveCor, the Kardiaband is a mobile, real-time electrocardiogram (EKG) reader that can record an EKG...more

Building a Health App? Part 7: Commercialization and Strategic Partners

Given the uncertainty in reimbursement from private insurance and government programs such as Medicare and Medicaid, it is important early on to consider how best to land and leverage relationships with key customers and...more

Building a Health App? Part 6: HIPAA and Other Privacy and Security Considerations

Consumers are increasingly turning to health apps for a variety of medical and wellness-related purposes. This has in turn caused greater amounts of data—including highly sensitive information—to flow through these apps....more

Children's Products and the "Internet of Things": Data Privacy Beyond COPPA

by Stinson Leonard Street on

In this internet age, "smart" children’s products—those that collect, transmit or store electronic data—are on the rise. By some estimates, the smart toy market will reach $11.3 billion in sales by 2020. Manufacturers of...more

Building a Health App? Part 5: Contracting for Health App Construction

As you take your health app from innovative idea to reality, you will be engaging in a development project that will likely entail the procurement of technology, services and perhaps even content from third parties. For...more

Building a Health App? Part 4: Avoiding an FTC Enforcement Action

The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon...more

Gig Economy Ripples From Across The Pond: An App For Healthcare Workers On Demand?

by Fisher Phillips on

Roughly 3,500 miles on the other side of the Atlantic Ocean, the British government is contemplating an idea which will marry the national healthcare industry with the gig economy. Such an idea could send a ripple toward the...more

“Pact” Health App Breaks Pact, Settles With FTC

by Reed Smith on

Pact, Inc. settled charges with the FTC on September 21, 2017 that the mobile software application company engaged in deceptive acts and practices, unfair billing practices, and failure to disclose material terms relating to...more

Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...more

Building a Health App? Part 2: Protecting Your Intellectual Property

This post is the second in a series of weekly blog posts covering legal issues for consideration during the early stages of development of a health app and providing best practices to help guide you through a successful...more

FDA Approves First-Ever Mobile App for Addiction Treatment

by Knobbe Martens on

The FDA recently approved the marketing of the first-ever prescription digital therapeutic to be used in the treatment of substance use disorder (SUD)....more

Building a Health App? What You Need to Know

Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more

FDA Approves Bayer’s myBETAapp™

by Knobbe Martens on

On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer’s myBETAapp™ and BETACONNECT Navigator™. The myBETAapp joins the growing field of medical mobile applications, which the...more

[Webinar] Medical Device Connectivity: HIPAA, FDA and IP Considerations - June 14th, 2pm ET

by BakerHostetler on

Please join us for this complimentary CLE webinar. With increasing healthcare costs and the transition to value-based reimbursement, never has the need for connected medical devices been so great – and never have the...more

AGG Food and Drug Newsletter - May 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Potential HIPAA Pitfalls for Developers of Healthcare Apps

by Perkins Coie on

As federal and state governments struggle to address future healthcare regulation, demand for healthcare that is cheaper, better and faster continues to surge. Every day, new healthcare apps are being developed to respond...more

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