Friday, August 17, 2018
The Food and Drug Administration has issued new guidance spelling out its policy for organizations using electronic health record data in FDA-regulated clinical investigations, such as studies of the long-term safety and effectiveness of various drugs. Among other criteria, the EHRs need to contain certain privacy and security controls, the FDA says.
[ Read More ]obile apps are increasingly used in health care to promote wellness, treat and diagnose disease, aid clinical decision-making, and manage patient care in hospitals and homes.Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life. One factor that has been cited is uncertainty surrounding
[ Read More ]At long last, Eversense, the implantable continuous glucose monitoring system from Senseonics, has received FDA clearance to be marketed in the United States.The FDA is committed to advancing novel products that leverage digital technology to improve patient care, FDA Commissioner Dr. Scott Gottlieb said in a statement. These technologies allow patients to gain better control
[ Read More ]The Food and Drug Administration should consider some sort of measuring stick when assessing a vendor’s cybersecurity culture to determine if it qualifies for the agency’s proposed fast-path program for premarket approval of “software as a medical device” products, some industry stakeholders say.
[ Read More ]The proposed voluntary program is for review of “software-as-a-medical-device” products, or SaMD – software that is “intended to treat, diagnose, cure, mitigate or prevent disease or other conditions.” Today, such software faces the same regulatory review as medical device hardware.Examples of SaMD range from software that allows a smartphone to view images obtained from a
[ Read More ]Scott Gottlieb, MD, is bullish on the opportunities artificial intelligence could bring to EHRs, decision support and more.At AcademyHealths 2018 Health Datapalooza on Thursday, the U.S. Food and Drug Administration offered a vote of confidence for artificial intelligence in healthcare, promising more refined strategies for regulation, touting its tech incubator for AI innovation and announcing
[ Read More ]The Food and Drug Administration plans to launch a full-scale version of its digital health precertification program by the end of the year. Dubbed Pre Cert 1.0, the program will be the first formal iteration of a pilot project launched with nine companies last September.
[ Read More ]The agency released a five-point plan outlining regulatory changes to bolster medical device safety, including requiring manufacturers ensure devices can be updated and patched.
[ Read More ]The Food and Drug Administration appears to be taking a proactive and long-term approach toward improving medical-device safety. On April 17, the FDA released its Medical Device Safety Action Plan, in which regulators set out their goals for improving device safety, including tracking a product’s safety throughout its life-cycle and catalyzing innovation that will make
[ Read More ]The Food and Drug Administration has issued plans – some of which will require Congressional approval – for enhancing the safety of medical devices. Those include several proposals for advancing cybersecurity, including imposing new requirements on device manufacturers.
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