mHealth

News & Analysis as of

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

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

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

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

Health Care Update & Telehealth Policy Alert

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

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

[Event] HealthTech Rising Midwest Conference - Chicago, Ill, June 11, 2015

This event will bring together a select group of health care providers, health technology companies, investors, and entrepreneurs to explore new ideas, growth strategies and potential partnerships. Industry leaders will...more

Legal and Regulatory Landscape for Mobile Health Technologies

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

PilotFish Announces MedDevice Connection App

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

New Smartphone Software Provides Groundbreaking Opportunity for Medical Research

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

Healthcare Legal News Volume 5 Number 2

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

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

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

Blog: Early 2015 Federal Policy Developments Impacting Medical Technology Companies

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

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

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

Advertising Law - March 2015 #2

New DAA App Brings Choice to Mobile - Bringing consumer choice to mobile applications, the Digital Advertising Alliance released “AppChoices,” a free app that will allow consumers to opt out of tracking on mobile...more

Mobile Medical’s Validity Experts Get To Stay Behind The Wheel

As the established gatekeepers with respect to expert testimony, district courts have broad discretion on whether to admit or exclude such evidence. The Vermont district court recently opted to deny patentee defendant...more

Telehealth Bill Moving Forward in Florida-But Medicaid Coverage Sacrificed

Last week, the Florida Senate Health Policy Committee removed language from proposed telehealth legislation that would require Medicaid reimbursement for telemedicine services at the same rates as face-to-face examinations....more

EU Art. 29 Working Party Letter on Health Data and Apps

The EU Article 29 Working Party (“WP29”) has published a letter to the European Commission (“EC”) on the scope of health data in relation to lifestyle and well-being apps, following the EC’s Working Document on mHealth and...more

Alert: FDA Finalizes Guidance on Devices that Store and Transfer Data

The Food and Drug Administration (FDA) on February 6th, finalized guidance on certain medical devices that store and transfer data, opting for a very light regulatory touch. In its guidance, the FDA states that it doesn't...more

Regulatory Challenges Facing the mHealth Industry

Innovations in health care technology have created unique challenges for developers and investment companies. Among others, changing FDA guidelines, data security, and reimbursement are all substantial issues facing the...more

Is Your Mobile Health App HIPAA Compliant?

Mobile health apps (also known as mHealth apps) are increasingly popular with consumers. As of 2014, there were more than 100,000 mobile health apps available on iOS and Android platforms, and total revenue from mobile health...more

HHS to Address Lack of Clarity Regarding Mobile Health

A letter from the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights to Rep. Peter DeFazio (D-Ore.) signals an intent to move forward with providing clearer regulatory guidance relating to the Health...more

FDA Proposes Additional Flexibility for Mobile Health Products

Draft Guidances Address General Wellness Products and Device Accessories - The U.S. Food and Drug Administration (FDA or “the Agency”) has announced two more key parameters of its regulatory approach to mobile health...more

FDA Proposes to Apply Risk-Based Framework to Accessory Devices

In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”). This development is welcome...more

Telehealth, Health IT, and mHealth Policy: Considerations for Stakeholders

In recent months, as the conversation about reforming the health care system has shifted from websites and coverage expansion to achieving greater delivery system efficiencies, cost containment, and quality improvement, the...more

Mobile Health Apps are in a Boom Phase – Why is it so Hard for Pharmaceutical Companies to Find Users?

Mobile medical and health applications have been in a boom phase for the past few years, but despite this trend, one group of entities has had trouble breaking into the mobile medical app sphere, pharmaceutical (i.e., pharma)...more

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