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...
View ArticlePricing 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...
View ArticleFDA 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 ArticlePatients 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 ArticleAging 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 Article2012 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 ArticleAre 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 ArticleSurvey 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 ArticleGene 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 ArticleVenture 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 ArticleFDA 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 ArticlePatients 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 ArticleAging 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 Article2012 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 ArticleAre 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 ArticleSurvey 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 ArticleGene 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 ArticleVenture 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 ArticleUSPTO 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...
View ArticleBiotech 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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