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 This plan is an important step in FDA regulation of this area, a process that began in 2011 with a draft guidance, followed by significant congressional actions.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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Research from government and university labs has brought us technologies as ubiquitous as the internet, microwaves, and GPS. But the path from laboratory bench to market success goes uphill, and it’s a steep hill at that. Most projects never make it out of the lab, and instead of helping us stream Youtube videos or warm up leftovers, are left to languish, unused, forever. It’s a cruel irony, given that today’s tech economy is driven by the relentless search for innovation. But this uphill path is not insurmountable, especially not with the right partner to guide the way...

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Microbiome researchers Rob Knight, PhD, University of California San Diego, Jeffrey Gordon, MD, Washington University School of Medicine in St. Louis, and Norman Pace, PhD, University of Colorado Boulder, will share this year’s Massry Prize, splitting the $200,000 honorarium. These researchers lead a field that works to produce a detailed understanding of microbiomes — distinct constellations of bacteria, viruses and other microorganisms that live within and around us — and methods for manipulating microbiomes for the benefit of human and environmental health.

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Electronic medical records have become common, but the ability to share them easily between providers still lags. Frustrated that after 10 years of effort the state of Connecticut has yet to launch a functioning health information exchange (HIE) allowing physicians, hospitals and other health care providers to share patient medical records, the Connecticut Medical Society is offering one of its own. Available to all clinicians in the state and called CTHealthLink, it is based on a system currently used in Kansas...

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The patient, a powerfully built middle-aged restaurant worker, had awakened one morning with a tight pain in his shoulders that traveled down his right arm. At work, he could barely shrug his shoulders or turn his head. “My fingers were so weak,” he recalled, “that I couldn’t even get a good grip around a glass of water.” A senior doctor at a local clinic diagnosed a pinched nerve and prescribed a muscle relaxant. Two weeks later, only more incapacitated, the patient went to another clinic, where a younger doctor made the right diagnosis: A malignant tumor in his chest was pressing against a nerve to his arm...

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IN JULY, SAN Francisco Superior Court Judge Sharon Reardon considered whether to hold Lamonte Mims, a 19-year-old accused of violating his probation, in jail. One piece of evidence before her: the output of algorithms known as PSA that scored the risk that Mims, who had previously been convicted of burglary, would commit a violent crime or skip court. Based on that result, another algorithm recommended that Mims could safely be released, and Reardon let him go. Five days later, police say, he robbed and murdered a 71-year old man...

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A two-decade-old law designed to protect patients’ privacy may be preventing health care organizations from doing more to protect vulnerable health care data from theft or abuse. The Health Insurance Portability and Accountability Act (HIPAA) established strict rules for how health data can be stored and shared. But in making health care providers vigilant about privacy protection, HIPAA may inadvertently distract providers from focusing on something just as important: overall information security...

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