Shannon Lantzy
@ShannonLantzy
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The future of healthcare is digital and delivered
Joined April 2008
For regulatory "reliance," separate science from value judgment. Thoughts from IMDRF. https://t.co/eCTkeoApqv
#newblogpost
shannonlantzy.com
International regulators need and want to rely on each other's regulatory decisions for efficiency but don't want to lose sovereign autonomy. Here's an approach to unlocking "reliance" To achieve...
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Regulators, regulatory folks: Are you using or testing GenAI for medtech or pharma regulatory work? Read more here, and I'd love your comments!
shannonlantzy.com
How are you using GenAI for regulatory strategy, prep, submission, review, and response? GenAI, ChatGPT, LLMs, oh my! I am having a lot of fun playing with all the various implementations popping...
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Health cyber innovators: the HSCC Strategic Plan is a gift
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Why do amazing innovations fail to gain traction in Healthcare?
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The Cure for What Ails Our Democracy
nytimes.com
We have to get past the idea that political conflicts are fights between good and evil.
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Why is helping healthcare so hard? (Alt: Better marketing and sales approaches for experts and entrepreneurs who want to bring a solution to the healthcare industry.)
shannonlantzy.com
Today's Focus: Why is helping healthcare so hard?
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90% of cyber risk assessment is wasted work; shift focus to quality #newblogpost
shannonlantzy.com
(And 7% of statistics are made up on the spot.) Nonetheless, the wasted energy going into assessing the risk of vulnerabilities that will never cause action should be redirected toward work that...
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Seeding communities is a way to make institutional change. #newblogpost
shannonlantzy.com
To do something new, try creating a community. I used to work almost exclusively with local colleagues and clients. Marylanders felt different from Virginians (and the DC residents were just oddbal...
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New Blog Post: Complying with FDA's medtech cybersecurity requirements means doing the right thing. This will create compliance. You can create more business value (revenue, time), by adding a dose of conviction and publicizing.
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I'm feeling pulled into discussions about payment... #medtech #digitalhealth
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This week's focus: Free consulting directly from FDA CDRH! (For eligible participants.)
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We can manage risk better than we can manage uncertainty. In Medtech cyber, there is a lot more uncertainty than well-characterized risk. %28Read more in the post.%29
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