News & Analysis as of

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In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”).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FDA Draft Guidance Would Ease Regulatory Burdens for Certain mHealth Applications

On August 1, 2014, the Food and Drug Administration (FDA) released draft guidance that would exempt from premarket 510(k) review many low-risk medical devices--including certain mobile applications that can convert a cell...more

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

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

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 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

The Regulatory Future of mHealth: FCC, FDA and the United States Congress

As a general matter FDA regulates all medical devices and FCC regulates devices that utilize electromagnetic spectrum - i.e. broadcast devices. So with regard to mobile health devices - sensors, applications, systems - FDA...more

Human-Centered Design Key to Adoption for Digital Health Products

The recent Fenwick Digital Health Investor Summit included a presentation on how to design successful digital health products. Aimee Jungman, VP of Health and Wellness Innovation at frog design, discussed the four essential...more

Digital Health Investor Summit Highlights Market Potential

Last Friday we hosted our inaugural Digital Health Investor Summit in partnership with RockHealth at our Mountain View conference center. During the program, several key themes emerged that point to the inevitability of a...more

mHealth Alert: FCC Seeks Comments on AHA Proposal To Use Amateur Radio Stations in Emergency Preparedness Drills

The Federal Communications Commission (FCC) has invited interested parties to submit comments on a request by the American Hospital Association (AHA) that the FCC waive its rules so that hospitals may use amateur radio...more

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