News & Analysis as of

Mobile Health Apps

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

Confirm Rx: Abbott Receives CE Mark for Smartphone Compatible ICM

by Knobbe Martens on

Abbott recently announced the CE Mark and first use of what it claims is “the world’s first smartphone compatible” insertable cardiac monitor (ICM), as reported by a press release dated May 8, 2017....more

Doctor, Doctor, Give Me the News, I’ve Got a Bad Case of Medical App Blues: Mobile Medical Application Developers Settle with New...

by Arnall Golden Gregory LLP on

The New York Office of the Attorney General recently announced settlements with developers of three mobile health applications due to misleading claims and deficient privacy practices. As a result of these settlements, the...more

New York Attorney General Announces Settlements with Three Mobile Health Application Developers

by Jones Day on

New York has made a mark on the regulatory and enforcement landscape for mobile health applications ("mobile health app") with the New York Attorney General's ("NY AG") March 23, 2017, announcement of settlements with three...more

HHS Plans To Launch Cybersecurity Center Focused On Medical App Security

by Dentons on

The US Department of Health and Human Services (HHS) announced on April 20 that it plans to launch a cybersecurity initiative modeled on the US Department of Homeland Security’s National Cybersecurity and Communications...more

HHS to Launch Cybersecurity Center

The Department of Health and Human Services (HHS) will soon launch a healthcare focused cybersecurity initiative modeled on the Homeland Security Department’s National Cybersecurity and Communications Integration Center...more

OCR Announces First HIPAA Settlement with Wireless Health Services Provider

by Morgan Lewis on

The $2.5 million settlement reflects the agency’s focus on mobile health privacy. On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a settlement with CardioNet, a...more

New York Regulators Lead the Charge to Fill Health Data Protection Gaps Left by Federal Law

by Hogan Lovells on

New York AG Settles Data Protection Enforcement Against Mobile Health Apps - After a year-long investigation into mobile health apps claiming to be able to measure vital signs or health indicators through smartphone...more

81 Results
|
View per page
Page: of 4
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.