News & Analysis as of

mHealth

K&L Gates LLP

US Regulatory Considerations Applicable to Digital Health Providers and Suppliers - Part III: FDCA

K&L Gates LLP on

This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act (FDCA), as well as regulatory issues unique to non-US companies. ...more

K&L Gates LLP

US Regulatory Considerations Applicable to Digital Health Providers and Suppliers – Part II: HIPAA (Continued) & Additional...

K&L Gates LLP on

In Part I, we provided a high-level overview of Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its provisions. In Part II, we discuss how HIPAA is applied to mobile health (mHealth) application...more

Perkins Coie

DHHS Updates Resources for Mobile Health App Developers

Perkins Coie on

The COVID-19 pandemic and the resulting need for patient access to remote healthcare, as well as the development of contact-tracing apps, have spotlighted the importance of health-focused mobile applications (mHealth apps)....more

Troutman Pepper

AGs Weave Themselves Into Patchwork of Digital-Health Regs

Troutman Pepper on

There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more

McDermott Will & Emery

NY Attorney General Sanctions Highlight Need for Higher Standards for mHealth Research and Development

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....more

Sheppard Mullin Richter & Hampton LLP

New York AG Takes Enforcement Action Against Heart Monitoring Apps: Murmurs of Concern are Heard in mHealth App World

In a move sure to cause murmurs in the large and growing mobile health application industry, the Office of New York Attorney General Eric Schneiderman (OAG) has used state trade laws to extract concessions and monetary...more

Fenwick & West Life Sciences Group

Top Trends in H1 2016 Digital Health Investments

A few months ago, following our fifth annual Digital Health Summit, the attendees made some predictions about product development and investment in the rapidly growing sector. Now that we are more than halfway through the...more

Polsinelli

Agencies Encourage New Privacy Regulations to Close the mHealth Black Hole and Keep Pace with Evolving Technologies

Polsinelli on

On July 19, 2016, the ONC submitted a report to Congress which suggests that health privacy regulations soon may be revised to catch up with the universe of mHealth technologies that now use and share personal health data....more

Morgan Lewis

Health Apps and HIPAA: OCR Publishes New Guidance For Health App Developers

Morgan Lewis on

OCR’s guidance presents hypothetical scenarios and key questions to help app developers determine when they are subject to HIPAA regulations. On February 11, the Department of Health and Human Services’ Office for Civil...more

Faegre Drinker Biddle & Reath LLP

Get Your Questions Ready

A lot has changed since the HIPAA Privacy Rule was finalized in 2002 and the HIPAA Security Rule was finalized a year later in 2003. The iPhone had not been released (that happened in 2007), Apple had just released the...more

Robins Kaplan LLP

[Webinar] The Digital Health Update: Recent Developments in the Regulation of Medical Devices and Health Apps - Sept. 22nd, 1:00...

Robins Kaplan LLP on

Tuesday, September 22, 2015, 1:00 P.M. CST -- Both the FDA and the FTC have been busy this summer. Just this month, both agencies took their strongest actions to date relating to cybersecurity and the regulation of medical...more

Davis Wright Tremaine LLP

[Webinar] Mobile Device Management for Health Care Organizations and Vendors - Sept. 10th, 10:00am PDT

In this webinar, we will demystify the HIPAA Security Rule and how to apply the administrative, physical, and technical safeguards in a mobile environment. We will discuss key takeaways from the recently released NIST Draft...more

Troutman Pepper

[Webinar] Beam It Up Safely: Navigating Data Privacy and Security in Telemedicine's Uncharted Territory - Sept. 17, 12:00pm EDT

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Science fiction programs once imagined a future where a doctor on a spaceship could treat a patient on a distant planet using groundbreaking technology. The health care industry may not yet have made this giant leap, but...more

Mintz - Intellectual Property Viewpoints

Crowdfunding and IP in Health and Biotech Start-ups (Part 1): The Beginning

Crowd Funding ImageThis is the first in a 3-part series about the use of crowdfunding in health and biotech start-ups. We start with the story of a tech start-up which set records for funding through a Kickstarter campaign,...more

Robins Kaplan LLP

[Webinar] Digital Health Update: Focus on Health Tech Startups - June 23, 1:00 CDT

Robins Kaplan LLP on

Health care startups are expected to attract billions in venture capital in the next few years. Despite the pace and excitement this surge of investment creates, these next-wave digital disruptors need to keep three legal...more

Mintz - Health Care Viewpoints

AMA Ethical Guidelines on Telemedicine Tabled for Further Review

On Monday, during the annual meeting of the American Medical Association (AMA) House of Delegates, the delegates voted to table a proposed measure to adopt ethical guidelines for physicians who provide telemedicine services....more

Mintz - ML Strategies

Health Care Update & Telehealth Policy Alert

Mintz - ML Strategies on

In the previous Congress, we saw a burst of policy and industry attention to telehealth as lawmakers and stakeholders alike recognized the cost, quality, and accessibility benefits of telehealth. In the first few months of...more

Mintz - Health Care Viewpoints

Injunction Blocks Implementation of Texas Telemedicine Regulations

Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that...more

Dickinson Wright

Legal and Regulatory Landscape for Mobile Health Technologies

Dickinson Wright on

Mobile health (mHealth) technologies continue to expand in application and implementation. Over the past decade, the breadth of these technologies has grown from the creation of healthcare-directed websites (think WebMD) to...more

Knobbe Martens

PilotFish Announces MedDevice Connection App

Knobbe Martens on

Applied PilotFish Healthcare Integration, Inc. (APHII) recently announced a new application called HealthConnect. APHII is the healthcare division of PilotFish Technology, a provider of middleware solutions for the...more

Burr & Forman

New Smartphone Software Provides Groundbreaking Opportunity for Medical Research

Burr & Forman on

Smartphone applications ("app") are saturating the health care world in numerous and various ways. There is an app to track your sleep, one to track your heart rate, one to track steps and even one to measure your blood...more

Dickinson Wright

Healthcare Legal News Volume 5 Number 2

Dickinson Wright on

According to a recent study by Accenture, by 2017 approximately 18 percent of the American public will purchase insurance through exchanges versus relying on traditional employer healthcare coverage or foregoing insurance...more

Morgan Lewis

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

Morgan Lewis on

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

Cooley LLP

Blog: Early 2015 Federal Policy Developments Impacting Medical Technology Companies

Cooley LLP on

Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. ...more

Foley & Lardner LLP

China Telemedicine Tackles Long Term Care: Business Opportunities and Government Guidance

Foley & Lardner LLP on

This post is the fifth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market. A China government policy...more

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