mHealth

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In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”).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

Three Things Tech Titans Have That eHealth Needs

Large tech companies have been virtually lining up to announce their foray into the digital health space recently. Industry analysts have long suspected that an incumbent industry with a strong customer base could come in and...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FDA Draft Guidance Would Ease Regulatory Burdens for Certain mHealth Applications

On August 1, 2014, the Food and Drug Administration (FDA) released draft guidance that would exempt from premarket 510(k) review many low-risk medical devices--including certain mobile applications that can convert a cell...more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

Digital Health investment in May totaled $691 million, down from the impressive $924 million netted in April. The nearly $700 million in new capital, however, compares favorably to the $421 million taken in in March and shows...more

What are anonymous data?

Problems relating to what data/images/information can be consider anonymous is one of the major data protection issues of privacy law having an impact in any sector including the Internet of Things, eHealth and on any...more

Draft Guidelines for TeleICU Operations Released

The American Telemedicine Association released draft Guidelines for TeleICU Operations on March 28, 2014 and is seeking public comments through April 26, 2014. Practice guidelines can serve as a useful reference point...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

When Is An iPad More Than An iPad? When It Is An FDA Regulated Medical Device

In the late 1980s, the Food and Drug Administration (FDA) began publicly suggesting that electronic medical records were within its jurisdiction. A lot has changed in 20+ years. The proliferation of mobile computing platforms...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

Regulatory Landscape For Mobile Medical Apps (MMAs)

On December 6, 2013, I delivered a presentation on the FDA’s policy on mobile medical apps (MMA) to the Bar Association of Erie County. The event was well attended by attorneys practicing in diverse areas, including health,...more

Mobile Apps: FDA Publishes Its Final Guidance on Regulating Mobile Medical Apps

On September 25, 2013, the FDA announced publication of its final guidance for mobile medical apps. It’s a much awaited move on the part of the FDA....more

Mobile Apps: The FDA Is on Its Path of Enforcement Actions

Mobile health care is one of the most booming industries worldwide, with a strong potential for growth and an excellent financial prognosis. No wonder the industry attracted $900 million in venture capital funding in the year...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

Federal Communications Commission Expands Availability of 400 Million Dollar Rural Health Care Support Mechanism

Executive Summary: The Federal Communications Commission has released an Order significantly expanding access to $400 million in funds available to health care providers for more accessible and affordable broadband services....more

Social Media and Medicine

The Federation of State Medical Boards recently adopted Model Policy Guidelines for use of social media in medical practice. The use of social media by medical practitioners and the number of mobile medical and wellness...more

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