By Susan Kelly, Med Tech DIVE | June 17, 2019 Dive Brief: Former FDA Commissioner Robert Califf has suggested cybersecurity techniques the agency is incorporating into its program to protect internet-connected medical devices from hackers also could be used to fight the dissemination of medical misinformation that poses a rapidly [...]
By Rachel Wolfson, contributor, Forbes | June 13, 2019 The United States Food and Drug Administration (USFDA) announced today that IBM, KPMG, Merck and Walmart will be included in a pilot project in support of the U.S. Drug Supply Chain Security Act (DSCSA). Together, these companies will address the requirements [...]
The Medical Futurist | June 6, 2019 Mental health algorithms mimicking empathy? A.I. outsmarting human doctors? Simple big data analytical software presented with clever marketing tactics? It’s difficult to assess the actual state of play when it comes to artificial intelligence in healthcare. Moreover, there’s no database that contains all [...]
By Dave Muoio, MobiHealth News | June 4, 2019 At BIO 2019 in Philadelphia, a panel of industry experts discussed their experiences with the FDA's pilot program; ambiguities in drug, device and software pathways; and the hurdles digital health regulation has yet to properly address. Since it was first announced, [...]
By Dave Muoio, MobiHealth News | May 22, 2019 Companies planning an upcoming De Novo or 510(k) submission for their software medical device are eligible, but participation will not yield precertification. The FDA has put out a call for new companies to test drive the current framework of its Digital [...]
By Eric Wicklund, mHealth Intelligence | May 20, 2019 The US Food and Drug Administration has issued a warning that jury-rigged, altered or unauthorized mHealth platforms for diabetes care management could cause harm, even death. The US Food and Drug Administration is cracking down on do-it-yourself mHealth devices for people [...]
