Earlier this year, the U.S. FDA released its Medical Device Safety Action Plan, which outlined actions to enhance medical device safety and efficacy. Following public feedback, the agency is announcing a series of updates to encourage innovations that lead to safer medical devices.
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With six weeks to go until 2019, 24×7 Magazine chief editor Keri Forsythe-Stephens looks back on 2018 and discusses some of the most monumental moments of the year in HTM. She also teases the December and January issues of 24×7 Magazine.
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In this expert roundtable, six of the top authorities in HTM—all of whom serve on 24×7 Magazine’s editorial board—sit down with 24×7 Magazine Chief Editor Keri Forsythe-Stephens to discuss the last 12 months in HTM and reveal what they expect to see in 2019.
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Recently, the U.S. FDA issued draft guidance regarding medical device cybersecurity, as well as a cybersecurity playbook. In this article, 24×7 Magazine correspondent Aine Cryts reveals what you need to know about the FDA’s latest approach to healthcare technology—particularly as it relates to security. Don’t miss out.
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In a bid to help healthcare community stakeholders identify and minimize patient risks to health IT systems, AAMI has published a provisional standard: HIT1000-1(PS):2018, Safety and effectiveness of health IT software and systems—Part 1: Fundamental concepts, principles, and requirements.
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