FDA adds digital health technology to 2018 policy roadmap
Profile: Tayla Holman
In an effort to help consumers make informed health decisions, the Food and Drug Administration (FDA) renewed its commitment to digital health technology in its 2018 strategic policy roadmap. The...
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Oversight of mobile medical apps clarified in FDA draft guidance
Profile: Tayla Holman
The Food and Drug Administration (FDA) has issued new draft guidance clarifying its oversight of mobile medical apps. Furthermore, the agency will loosen its regulations for certain technologies it...
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The 21st Century Cures Act: Implications for Health IT
Profile: Kristen Lee
The U.S. Senate passed the 21st Century Cures Act on Dec. 6, legislation that has some important implications for health IT including providing funding to 0 Comments
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CHIME plots ways to augment medical device interoperability
Profile: Alex Delvecchio
The FDA is making an effort to increase medical device interoperability, but their current plan for achieving that objective isn't comprehensive enough, according to a group of healthcare CIOs and IT executives. The College of Healthcare Information Management Executives (CHIME) wrote a letter...
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FDA gets tougher on IoT medical device cybersecurity
Profile: Shaun Sutner
Manufacturers and users of connected medical devices should take steps to ensure the cybersecurity of such devices, the FDA said in a new guidance document. The draft...
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FDA group to support combined EHR, electronic data capture systems
Profile: Alex Delvecchio
Clinical research and patient information captured during treatment are kept in different electronic systems and by separate organizations. The U.S. Food and Drug Administration (FDA) wants to support...
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FDA makes a deal with online patient group to study patient-reported drug safety data
Profile: Alex Delvecchio
The U.S. Food and Drug Administration (FDA) is teaming up with the largest online patient network to collect and study patient-reported drug safety data.
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New research: FDA-regulated digital health devices could save U.S. healthcare billions
Profile: Kristen Lee
Last year, the FDA seemed to lean toward deregulation of wellness, wearable and 1 Comment
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FDA takes hands-off approach to wellness devices
Profile: Shaun Sutner
If you have a pacemaker in your chest, the FDA wants to make sure the device works correctly. But if you want to wear a Fitbit, the agency will leave you alone. In another sign that the FDA intends to assume a markedly hands-off policy when it comes to the wellness devices and programs that are...
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FDA funding leads to medical device surveillance plan
Profile: Alex Delvecchio
Though it has a handle on measuring the safety and effectiveness of medical devices, the FDA isn't sure there's enough publically-accessible information for patients and clinicians to make fully-informed decisions about medical products. The road to a firm medical device surveillance policy began...
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