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Mobile Apps mHealth Digital Health

K&L Gates LLP

US Regulatory Considerations Applicable to Digital Health Providers and Suppliers – Part II: HIPAA (Continued) & Additional...

K&L Gates LLP on

In Part I, we provided a high-level overview of Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its provisions. In Part II, we discuss how HIPAA is applied to mobile health (mHealth) application...more

Perkins Coie

DHHS Updates Resources for Mobile Health App Developers

Perkins Coie on

The COVID-19 pandemic and the resulting need for patient access to remote healthcare, as well as the development of contact-tracing apps, have spotlighted the importance of health-focused mobile applications (mHealth apps)....more

Troutman Pepper

AGs Weave Themselves Into Patchwork of Digital-Health Regs

Troutman Pepper on

There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more

Polsinelli

Agencies Encourage New Privacy Regulations to Close the mHealth Black Hole and Keep Pace with Evolving Technologies

Polsinelli on

On July 19, 2016, the ONC submitted a report to Congress which suggests that health privacy regulations soon may be revised to catch up with the universe of mHealth technologies that now use and share personal health data....more

Faegre Drinker Biddle & Reath LLP

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

Fenwick & West Life Sciences Group

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

Fenwick & West LLP

Hot Companies in Digital Health

Fenwick & West LLP on

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

Fenwick & West Life Sciences Group

“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

Fenwick & West Life Sciences Group

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

Fenwick & West Life Sciences Group

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

Fenwick & West Life Sciences Group

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

Fenwick & West Life Sciences Group

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

Fenwick & West Life Sciences Group

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

Fenwick & West Life Sciences Group

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

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