Healthcare mHealth

News & Analysis as of

OCR Launches Interactive HIPAA Site for Mobile Health App Developers

On October 5, 2015, the Office for Civil Rights (OCR) announced the launch of a new platform for mobile health (mHealth) developers and others interested in the intersection of health information technology and HIPAA privacy...more

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

[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

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

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

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

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

mHealth Technology – Development in an Uncertain Regulatory Climate

The development and use of mobile technologies and devices is expanding at an incredibly fast pace and is changing, and in fact revolutionizing, the way patients and healthcare providers interact. Mobile medical technologies...more

FDA Draft Guidance Would Ease Regulatory Burdens for Certain mHealth Applications

On August 1, 2014, the Food and Drug Administration (FDA) released draft guidance that would exempt from premarket 510(k) review many low-risk medical devices--including certain mobile applications that can convert a cell...more

AMA Adopts Telemedicine Policy for Coverage and Payment of Telemedicine Services

During its Annual Meeting on June 11, 2014, the American Medical Association (AMA) voted to approve a list of guiding principles for coverage of and payment for telemedicine services, designed to “foster innovation in the use...more

Digital Health Investments Heat Up In 2014

Fundraising for digital health continued on its record pace in February with more than $320 million in venture, debt and private equity investment going into the burgeoning sector....more

Draft Framework for Interstate Medical Licensure Compact Released

A significant barrier to the interstate practice of telehealth is closer to being broken down. The Federation of State Medical Boards ("FSMB") recently completed and distributed a draft Interstate Medical Licensure Compact...more

Telemedicine: More Than New Technology

Technological advancements and the expansion of access to health care under the Affordable Care Act have pushed telemedicine to the new frontier of health care delivery. Originally Published in For The Record -...more

House Subcommittee Hears Testimony on Developing Mobile Medical Applications

Nearly one in three cell phone owners have used their phone to look for health information. Approximately 19% of smartphone owners have downloaded a mobile medical application (Medical App). These and many more statistics...more

Is Digital Health Poised To Grow Or Is It Hitting The Wall?

Recently, the Pew Internet & American Life Project (the “Pew Internet Report”) reported that nearly 70% of Americans are monitoring one or more health metrics for themselves or a loved one, but only 21% of those are using a...more

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