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

By: Michael Shuster 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...

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Pricing mobile health apps: Will consumers pay?

By: Michael Esquivel 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...

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FDA to Finalize Mobile Medical App Rules Following Bill Passage

By: Michael Shuster 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...

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Patients adopting mobile health faster than doctors

By: Michael Esquivel About half of patients believe mobile health technologies (or mHealth) will improve and help them manage their healthcare. However, only 27% of physicians encourage patients to use...

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Aging in Place Drives mHealth Technologies

By: Michael Esquivel 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...

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2012 USPTO Guidance After Mayo v. Prometheus

By: Michael Shuster The USPTO earlier this week issued a Memorandum to the Patent Examining Corps with the subject line "2012 Interim Procedure for Subject Matter Eligibility Analysis of Patent Claims...

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Are Biosimilar Names Key to Biosimilar Fates?

By: Michael Shuster "People's fates are simplified by their names" goes the quote from the Bulgarian novelist and playwright Elias Canetti. Whether this is indeed true for people is debatable but for...

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Survey Shows Consumers Will Pay More for Sensors than for Apps

By: Michael Esquivel A few weeks back I wrote about the challenges of pricing mobile apps. Now, as reported in MobiHealthNews, IMS Research in the UK has collected some hard data on consumer spending...

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Gene Therapy Wins Approval In Europe

By: Michael Shuster, Kevin Kabler On Friday, July 20th, the European Medicines Agency (EMA) for the first time recommended approval of a gene therapy product in the European Union. The landmark ruling...

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Venture Investment in Digital Health Effectively Doubles in H1 2012

By: Michael Esquivel 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...

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Clik here to view.

FDA to Finalize Mobile Medical App Rules Following Bill Passage

By: Michael Shuster 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...

View Article

Image may be NSFW.
Clik here to view.

Patients adopting mobile health faster than doctors

By: Michael Esquivel About half of patients believe mobile health technologies (or mHealth) will improve and help them manage their healthcare. However, only 27% of physicians encourage patients to use...

View Article

Image may be NSFW.
Clik here to view.

Aging in Place Drives mHealth Technologies

By: Michael Esquivel 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...

View Article


Image may be NSFW.
Clik here to view.

2012 USPTO Guidance After Mayo v. Prometheus

By: Michael Shuster The USPTO earlier this week issued a Memorandum to the Patent Examining Corps with the subject line "2012 Interim Procedure for Subject Matter Eligibility Analysis of Patent Claims...

View Article

Image may be NSFW.
Clik here to view.

Are Biosimilar Names Key to Biosimilar Fates?

By: Michael Shuster "People's fates are simplified by their names" goes the quote from the Bulgarian novelist and playwright Elias Canetti. Whether this is indeed true for people is debatable but for...

View Article


Image may be NSFW.
Clik here to view.

Survey Shows Consumers Will Pay More for Sensors than for Apps

By: Michael Esquivel A few weeks back I wrote about the challenges of pricing mobile apps. Now, as reported in MobiHealthNews, IMS Research in the UK has collected some hard data on consumer spending...

View Article

Image may be NSFW.
Clik here to view.

Gene Therapy Wins Approval In Europe

By: Michael Shuster, Kevin Kabler On Friday, July 20th, the European Medicines Agency (EMA) for the first time recommended approval of a gene therapy product in the European Union. The landmark ruling...

View Article


Image may be NSFW.
Clik here to view.

Venture Investment in Digital Health Effectively Doubles in H1 2012

By: Michael Esquivel 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...

View Article

Image may be NSFW.
Clik here to view.

USPTO Streamlines International Patent System through Global Patent Dossier...

By: Michael Shuster On Thursday United States Patent and Trademark Office (USPTO) Director David Kappos announced the Global Dossier Initiative, which aspires to be a "global portal for all...

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Biotech M&A Surges in Advance of Patent Expirations

By: Michael Shuster We've known for some time that the pharma patent cliff was driving M&A, and now we have additional empirical evidence. Biotech M&A is at a 5 year high, according to...

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