Scott Gottlieb
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Does Apple's HealthKit Prove FDA Guidance Is Working?
Skepticism remains over the Food & Drug Administration’s regulation of mobile health. The approach will just slow innovation, as Scott Gottlieb, MD, an American Enterprise Institute analyst and former FDA deputy commissioner, argued recently in the Wall Street Journal...
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FDA Launches Open Source Tool to Help Capture Data from Patients
Today the U.S. Food and Drug Administration is announcing the MyStudies app, a new mobile technology to foster the collection of real world evidence via patients' mobile devices. Real world data can be collected from a variety of sources, such as electronic health records, claims and billing activities, and product and disease registries, as well as from patient-generated data including in home-use settings, or from data gathered from other sources, such as mobile devices. As part of the agency's work to foster greater opportunities around real world evidence, the FDA partnered with Kaiser Permanente on a pilot study to measure the functionality and engagement of the MyStudies app.
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Health Insurance Brokers Prepare Clients For Obamacare Sticker Shock
A California insurance broker, who sells health plans to individuals and small businesses, told me that she’s prepping her clients for a sticker shock. Her local carriers are hinting to her that premiums may triple this fall, when the plans unveil how they’ll billet the full brunt of Obamacare’s new regulations and mandates.
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Pandemics Are the Mother of Invention
Many believe that the Allies won WWII in large part because of how industry in the U.S. geared up to produce fantastic amounts of weapons and other war materials. It took some time for businesses to retool and get production lines flowing, during which the Axis powers made frightening advances, but once they did it was only a matter of time until the Allies would prevail. Similarly, COVID-19 is making scary inroads around the world, while businesses are still gearing up to produce the number of ventilators, personal protective equipment (PPE), tests, and other badly needed supplies. COVID-19 is currently outnumbering these efforts, but eventually we'll get the necessary equipment in the needed amounts. Eventually. What intrigues me, though, is how people are innovating, inventing new solutions to the shortages we face. I want to highlight a few of these:
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Questions About The FDA’s New Framework For Digital Health
In June 2017, the new Food and Drug Administration (FDA) commissioner Scott Gottlieb pre-announced his agency’s Digital Health Innovation Action Plan that indicates notable shifts in the agency’s approach to digital health technologies. This plan is an important step in FDA regulation of this area, a process that began in 2011 with a draft guidance, followed by significant congressional actions. The new changes should not be surprising, given critiques published by Gottlieb prior to re-joining the FDA...
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2018 Health Datapalooza
The gathering place for people and organizations creating knowledge from data and pioneering innovations that drive health policy and practice. Health Datapalooza sits at the nexus of ideas, evidence, and execution. Where Federal policymakers and regulatory leads take their seats beside Silicon Valley startups and the health system’s chief information officers. More than a meeting, Health Datapalooza is a diverse community of big thinkers and roll-up-our-sleeves-and-get-it-done problem solvers who share a mission to liberate and use data to improve health and health care.
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