FDA to Divide Cybersecurity Risk Into Two Tiers
Medical devices that contain software, or are software, are subject to the well-known medical...
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Tag: use case
What You Really Need to Know about Digital Health
You Won't Find This Information in Publications or Vendor Blogs Just where does one draw the...
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Managing Digital Health Regulatory Uncertainty
Uncertainty abounds when managing digital health regulatory uncertainty regarding the FDA and...
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FDA’s Guidance Plans for Software in FY 2019
The FDA has released its plans for Final and Draft Guidance Documents for fiscal year 2019. Â ...
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HHS OIG on Cybersecurity and the FDA
The Office of the Inspector General (OIG) of Health and Human Services (HHS) recently released a...
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The IoMT Value Hierarchy Webinar
If you're reading this, you missed our in-depth discussion of the IoMT Value Hierarchy. Click the...
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10 Changes to the FDA’s Pre-Cert Program Model
In June 2018 the FDA released an update to its working model of the Software Precertification...
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Continuous Clinical Surveillance: ICU Monitoring Outside the ICU
If you're reading this, you missed our in-depth discussion with Brian McAlpine, of Bernoulli...
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Ranking the Importance of SaMD — Software as a Medical Device (UPDATE)
In the May 10th Pre-Cert webinar the FDA addressed an interesting risk matrix that was previously...
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Real-Time Situational Awareness Discussion with Dr Ben Kanter
If you're reading this, you missed our in-depth discussion with Ben, Kanter, MD, and CMIO of...
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Messaging Value Pyramid – A Discussion with Ron Remy
If you're reading this, you missed my live interview with Ron Remy. Click the button below to...
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The Inside Story on Wireless in Health Care – A Discussion with David Hoglund
Join me for an in-depth discussion with David Hogland, a long time colleague of mine as we discuss...
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Thoughts on Clinical Decision Support and its Future:Â Dr Greenes Interview
In two of my last blog posts, I have interviewed people and companies working in the support and...
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Will Pre-Cert Increase the Advantage of Big Companies? (UPDATE)
The impact of FDA's digital health Pre-Cert program has yet to be fully seen. There is much debate...
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Health Care Messaging and Orchestration — Systems of Action (UPDATED)
In this post we will delve into a growing enterprise software category, health care messaging...
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