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Archives

Home /
Digital health advances set healthcare law on edge
0
By Michael H Cohen
In Business Law, FDA & FTC Law, Healthcare Law
Posted June 22, 2016

Digital health advances set healthcare law on edge

Digital health advances set healthcare law on edge because health tech develops exponentially while laws grow linearly.

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“The Doctor Weighs In” Features Interview on FDA Mobile Medical App Regulation
0
By Michael H Cohen
In FDA & FTC Law, Law Firm News
Posted March 1, 2016

“The Doctor Weighs In” Features Interview on FDA Mobile Medical App Regulation

Blogger Patricia Salber, MD MBA featured Understanding whether a medical app needs FDA regulation can be tricky on The Doctor Weighs In. In this videotaped interview, held at the 2015 Stanford [...]

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Digital health personalizes medicine, revolutionizes healthcare, and makes healthcare law anachronistic
0
By Michael H Cohen
In FDA & FTC Law, Healthcare Law
Posted November 8, 2015

Digital health personalizes medicine, revolutionizes healthcare, and makes healthcare law anachronistic

By putting healthcare in the hands of patients, healthcare technology is not only revolutionizing the way we think about medicine, but also the way laws shape personal health.

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How will FDA regulate predictive clinical software as predictive analytics pushes medical frontiers?
0
By Michael H Cohen
In FDA & FTC Law, Healthcare Law
Posted June 15, 2015

How will FDA regulate predictive clinical software as predictive analytics pushes medical frontiers?

Predictive analytics will push the frontiers of clinical care; the question is whether FDA regulation will promote or stifle innovation in the name of consumer protection.

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Federal bill to boost health IT innovation by exempting low-risk medical software and mobile apps from FDA regulation
0
By Michael H Cohen
In FDA & FTC Law
Posted May 1, 2015

Federal bill to boost health IT innovation by exempting low-risk medical software and mobile apps from FDA regulation

Senators Bennet and Hatch reintroduced the Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act, to "cut red tape at the Food and Drug Administration (FDA) and help [...]

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FDA is hands-off Low Risk General Wellness Products
0
By Michael H Cohen
In FDA & FTC Law
Posted February 15, 2015

FDA is hands-off Low Risk General Wellness Products

FDA has published a Draft Guidance on Low Risk Devices which suggest a hands-off FDA approach to consumer products that are intended for general wellness use, and, present low safety risk

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Daily Journal publishes “Future of Medicine is Just a Tap Away” as lead front-page article
0
By Michael H Cohen
In FDA & FTC Law, Healthcare Law, Law Firm News
Posted December 12, 2014

Daily Journal publishes “Future of Medicine is Just a Tap Away” as lead front-page article

The Daily Journal, California's largest legal news provider, published Future of Medicine is Just a Tap Away, by healthcare & FDA attorney Michael H. Cohen.

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FDA Cybersecurity Plan Adds to Mobile App Developer FDA Compliance Burden
0
By Michael H Cohen
In Healthcare Law
Posted July 28, 2013

FDA Cybersecurity Plan Adds to Mobile App Developer FDA Compliance Burden

The FDA now requires that mobile app developers create a cyber security plan and submit it to the FDA along with their mobile medical app / medical device submission.

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