News & Analysis as of

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

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

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

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

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

“Clear and Conspicuous” FTC Guidance on Marketing Mobile Apps

The Federal Trade Commission (FTC or Commission) recently published a guide, Marketing your Mobile App: Get it Right From the Start, to help mobile app developers understand FTC advertising and privacy rules. ...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

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

mHealth: Technology's Healthcare Reform

"If you don't have mobility in your [healthcare] strategy, then you don't have a strategy," said Allina Health System's Susan Heichert at a 2012 national health information conference. As funds for traditional...more

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