News & Analysis as of

FDA Draft Guidance Would Ease Regulatory Burdens for Certain mHealth Applications

On August 1, 2014, the Food and Drug Administration (FDA) released draft guidance that would exempt from premarket 510(k) review many low-risk medical devices--including certain mobile applications that can convert a cell...more

Capital Thinking: Technology and Communications

Legislative Activity - House Commerce SUBCommittees Will Hold Hearing ON 21st Century Technology for 21st Century Cures - The House Energy and Commerce Subcommittees on Communications and Technology and Health...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

The Success Checklist: What mHealth Investors and Entrepreneurs Should Know

A healthcare start-up developer has an intriguing concept for an app or a software solution. It may be an app tied to a sensor that is designed to transmit a diabetic's blood glucose levels to her physician, or an app that...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

mHealth Stakeholders: Updated Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary...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

Intellectual Property Topics for Mobile-Device Healthcare and Medical Information Technology

Developers seeking to innovate using wireless terminals, information networks and devices, as well as users seeking to exploit new innovations, generate proprietary rights that may need to be perfected, and which might be...more

mHealth Revenue Models: Finding the Right One for the Right App

One of the potentially thorniest issues that healthcare application developers should consider is what business model to employ in order to generate revenue, as this element of the business strategy has many facets and can be...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

Who Will Pay For Digital Health Apps?

The question of whether or not smartphone apps can play an important role in the delivery of healthcare services has been more or less answered with a resounding yes. From weight loss to diabetes monitoring to diagnosing ear...more

Hot Companies in Digital Health [Video]

With venture capital funding of digital health up 45 percent in 2012, according to Rock Health, we’re hearing a lot about mobile health apps and healthcare IT. You may be asking yourself what is digital health? Michael...more

FCC Releases Decision on New Funding Program for Rural Health: Broadband Connectivity Prioritized and the Expansion of...

Federal Communications Commission (FCC; the "Commission") decision making continues to be active in the area of telemedicine. Recently, on December 21, 2012, the agency released a lengthy decision updating its rules and...more

mHealth and the FCC: What Does the FCC Have to Do with Medical Devices?

Originally published in mHealth Newsletter on November 14, 2012. One might not associate the Federal Communications Commission (FCC) with mHealth issues. Yet, the FCC has a vital role to play in this field, and if...more

The P's & Q's of mHealth and Patient Engagement; Privacy and Security Issues

Orginally published in mHealth Newsletter on November 14, 2012. "Patient engagement is the holy grail of healthcare," according to one hospital executive. Indeed, there is real money in the development of products and...more

mHealth and Home Health: A Natural Fit

Originally published in mHealth Newsletter on November 14, 2012. Home health is an industry built on the core value of having hands-on-professionals providing quality healthcare in the comfort and privacy of the...more

Healthcare Reform and New mHealth Business Opportunities: What mHealth Entrepreneurs Should Know After the Presidential Election

Originally published in mHealth Newsletter on November 14, 2012 mHealth investors and mHealth entrepreneurs may struggle to understand what business opportunities are present in the U.S. healthcare system since the...more

FCC Will Work to Implement mHealth Task Force Report

In a move he says will improve the quality of health care and cut health system costs, FCC Chairman Julius Genachowski announced the Commission will work toward implementing recommendations proposed by the mHealth Task Force,...more

Stickiness Eludes Many Health and Fitness Apps

The New York Times recently ran a story titled, “It’s hard to stay friends with an exercise monitor” that underscored a problem facing many health and fitness apps – the risk that users quickly lose interest. ...more

Venture Investment in Digital Health Effectively Doubles in H1 2012

Venture investment in healthcare convergence technologies soared in the first half of 2012. According to a recent report from Burrill & Co, digital health, into which they group healthcare IT, mobile health and wireless...more

Aging in Place Drives mHealth Technologies

A lot of the momentum around the mobile health (or mHealth) market is tied to the growing interest in products that enable the elderly to age in place. A key to allowing people to stay in their homes as they age is the...more

FDA to Finalize Mobile Medical App Rules Following Bill Passage

Yesterday, the Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA) which provides reauthorization for major components of the Prescription Drug User Fee Act (PDUFA) set to expire at the end of...more

Pricing mobile health apps: Will consumers pay?

There are a lot of opportunities to be had creating mobile health apps for consumers. But there are still plenty of questions to be answered about how to build sustainable businesses. Who will pay for mhealth products? How...more

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