In 2017, health IT entered the awkward teenage years by Evan Sweeney Thursday, December 21, 2017 The health IT sector is searching for an identity it can hold on to as it irons out difficult issues like interoperability and cybersecurity.
FDA’s clinical decision support guidelines get a mixed reaction by Evan Sweeney Thursday, December 7, 2017 The digital health industry waited six years for the FDA to release CDS guidance. Now that it's here, some say the agency didn't push far enough.
Apple, Fitbit among 9 companies selected for FDA pilot by Evan Sweeney Tuesday, September 26, 2017 Some of the world’s largest tech companies will help shape the FDA's innovative approach to digital health regulation through a new pilot program.
FDA begins filling positions for its new digital health unit by Evan Sweeney Monday, September 11, 2017 The FDA has officially kicked off a hiring process to fill more than a dozen positions within the agency’s new digital health unit.
FDA finalizes guidance on medical device interoperability by Evan Sweeney Wednesday, September 6, 2017 The agency's new guidance for medical device manufacturers highlights the importance of consistent data exchange between devices and systems.
9 companies will shape the FDA’s approach to digital health by Evan Sweeney Wednesday, August 2, 2017 The FDA has outlined basic concept of its new software precertification program, but companies selected for the pilot will have an outsized influence.
FDA’s Patel envisions new regulatory approach to digital health by Evan Sweeney Monday, May 22, 2017 As digital health innovation has outpaced the FDA’s regulatory structure, the agency’s top official wants to overhaul the approval process.
Mobile healthcare makes big headlines in 2016 by Judy Mottl Tuesday, December 20, 2016 This year brought a deluge of mobile healthcare technology news, from research findings to regulatory changes to new payer and provider tools.
Connected Health Conference highlights: Patient engagement, Uber partnerships and the FDA by Evan Sweeney Friday, December 16, 2016 This week’s Connected Health Conference covered health information technology and mHealth concerns ranging from FDA regulations to Uber partnerships.