Editor's Note The Food and Drug Administration (FDA) on January 7 issued a statement from Commissioner Scott Gottlieb, MD, on the agency’s new actions under the Digital Health Pre-Certification (Pre-Cert) Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations. Because digital…

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Editor's Note Zimmer Biomet and Apple Inc have begun a multiyear study that will allow surgeons to use Apple Watches to monitor activities, including heart rate, steps taken, and standing hours of up to 100,000 patients before and after hip and knee replacement surgery, the October 15 Reuters reports. Providers…

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Editor's Note The Food & Drug Administration (FDA) on October 17 announced a public workshop to discuss the newly released draft guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The need for effective cybersecurity to ensure medical device function and safety has become more important with…

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Editor's Note Despite ethical and legal obligations to protect patient privacy and efforts to establish best practices for healthcare information security, breach rates have increased since 2010, this study finds. Of 2,149 breaches that involved 176.4 million records, the most common entities breached were healthcare providers, with 1,503 breaches that…

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Editor's Note The Food & Drug Administration (FDA) on October 1 released a “Playbook,” developed by the Medical Device Cybersecurity Regional Incident Preparedness and Response (MITRE) Corp, to assist hospitals and other healthcare providers respond to cybersecurity incidents involving medical devices, the American Hospital Association reports.  The MITRE Playbook outlines…

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Editor's Note The Food and Drug Administration (FDA) has taken steps to ensure that medical device manufacturers do as much as possible to defend against hacking and other threats to their devices, according to a new report from the Department of Health & Human Services Office of Inspector General. The…

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Editor's Note Use of a standardized, electronic nursing handoff communication process resulted in decreased boarding time in the emergency department (ED) and increased bed flow efficiency, this study finds. Before implementation of the electronic nursing handoff process, the average ready to move-to-occupied time was 83.6 minutes. This decreased to 49…

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Editor's Note A safe and efficient postoperative telemedicine program is feasible using a commonly used electronic health record system (Epic), and it can improve patient satisfaction, optimize throughput, and increase revenue, this pilot study finds. After researchers constructed an eClinic platform in Epic, they enrolled 233 patients having laparoscopic cholecystectomy,…

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Editor's Note In this study, researchers at Lehigh University, Bethlehem, Pennsylvania, found that physicians and patients alike are dissatisfied with the use of electronic health records (EHRs). Researchers surveyed patients, physicians, mid-level providers, and nonclinical staff at two OB-GYN practices and a regional hospital from 2009 to 2013 during implementation…

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Editor's Note New data released in the Protenus Breach Barometer shows  more than 3.14 million patient records were compromised in 142 breach incidents reported to Health and Human Services or the media from April to June 2018, the August 8 Healthcare Informatics reports. This number is up from 1.13 million…

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