Here's a video of Amy from 2017 ...
Dr Amy Abernethy on Improving Data Usage at the Point of Care
https://youtu.be/19mP7oqEy2A(https://www.ajmc.com/interviews/dr-amy-abernethy-on-improving-data-usage-at-the-point-of-care)
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Insightful conversation @StanfordMed on #data with @DrAbernethyFDA, @US_FDA Principal Deputy Commissioner & Acting CIO and @leftbundle made possible by @StanfordCDH
https://twitter.com/johannahmkim/status/1169755213898452992(A picture from their 'fire side chat' - I'm in the blue checkered shirt 3rd row from the back, 2nd person in).
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Dr. Amy Abernethy, FDA Principal Deputy Commissioner
Stanford Center for Digital Health
Sep 4, 2019, 2:53 PM (2 days ago)
https://www.eventbrite.com/e/a-conversation-with-dr-amy-abernethy-fda-principal-deputy-commissioner-tickets-71218774271#Scott MacLeod
1:28 PM (2 hours ago)
to amy.abernethy, Robert, robert.califf, Larry, Mintu
Dear Dr. Abernethy, (and Dr. Harrington, chair of Stanford Medicine, Dr. Califf of Duke University & former FDA Commissioner, Dr. Turakhia, and Dr. Viehland, chair of MIT OCW-centric wiki World University and School's Board),
Thanks so much for your excellent talk yesterday at Stanford Medicine's Center for Digital Health. And congratulations on becoming both the Principal Deputy Commissioner & Acting CIO of the US Food & Drug Administration (FDA).
The question I had in mind to ask you, but didn't get a chance, was how you as a 'Dukey' and speaking at Stanford, but now as FDA Commissioner, think of emerging projects such as Alphabet/Verily, Stanford and Duke's Project Baseline in terms of potential usefulness to you in your new role in the FDA? I'm writing to follow up with some related ideas, conceptually, and as the Founder, President and a Professor at CC-4 MIT OpenCourseWare-centric World University and School, which is like MIT OCW in 5 languages, and Wikipedia in 300 languages (and where WUaS as ~200 planned online universities is in Wikidata/Wikibase, which is Wikipedia's "back end" structured knowledge database in its ~300 languages).
Part of the WUaS idea here which could be helpful to you in your new FDA role, conceptually via World University and School, is the potential of generating a kind of university-centralization in the information technology age which is both distributed and about networks. So how could the FDA benefit for example, conceptually, with planned online Clinical Trials at WUaS (for all languages) - so speakers of all 7,111 known living languages -
https://wiki.worlduniversityandschool.org/wiki/Clinical_Trials_at_WUaS_(for_all_languages) - as researchers find new ways to do online clinical trials (e.g. sending packets in the mail to people in all ~200 countries for clinical trials from people's home computers)?
Major online Universities in countries' official / main languages at WUaS will emerge from here -
https://wiki.worlduniversityandschool.org/wiki/Nation_States (about ~200) - and since WUaS is planning for both online medical degrees with online teaching hospitals for online clinical care and research, these universities, like Duke and Stanford themselves, could become platforms for further FDA discourse, research and related questions. And WUaS is also planning online Law Schools for online law degrees in same countries' official languages, which could help too, FDA-wise, with related legal questions in the ways that FDA decisions could inform markets and regulatory questions in all ~200 countries, among many other related issues.
A) free-to-students' highest quality universal education
And, conceptually, and re the generation of university-centralization on the Internet in ways that might benefit you in your role as FDA Commissioner, WUaS donated ourselves to Wikidata / Wikibase in 2015 as a "back end" database in its ~300 languages, and received as a consequence our "front end" WUaS Miraheze MediaWiki in 2017, but these aren't interoperable yet. At this key moment of bringing these together, WUaS seeks to code for matriculated students in all ~200 countries' languages, and wiki-Universitians not only in Wikidata's 300 languages but also in all 7,111 known living languages - and then for all 7.5 billion people on the planet - as wiki teachers and learners, each a Wikidata Q-item, which is Wikidata's key identifier. In planning for all 7.5 billion people as wiki teachers and learners, WUaS seeks too to create free-to-students' highest quality universal education (MIT OCW-centric+). And large numbers of these people in the US and overseas could be involved in online clinical trials, and in many many other aspects of FDA processes, and re generating a kind of university-centralization re the global internet too.
B) facilitating a single cryptocurrency with blockchain, distributed potentially via Universal Basic Income (UBI) experiments (partly to alleviate poverty)
In planning for 7.5 billion people, WUaS also seeks to explore facilitating a single cryptocurrency with blockchain ledger backed by some number of ~200 countries' central banks (think what comes post-dollar, or after the Euro in 19 out of 28 Eurozone countries) and distributed potentially via Universal Basic Income (UBI) experiments (partly to alleviate poverty, and partly to plan for offsetting job loss due to automation, technology advances and robotics etc). All of this would have many implications for the FDA re insurance companies, big Pharma, the US government, etc.
C) 'avatar bot electronic medical records' for all 7.5 billion people.
And beyond the implications of 7.5 billion people re online clinical trials, conceptually, and re a single digital cryptocurrency, with coding, rules and regulations shared by some number of ~200 countries' central banks, World University and School also at this key moment of connecting or coding our "front end" with our "back end" would like to plan for 'avatar bot electronic medical or health records' for all 7.5 billion people. Think EPIC into 3D VR health records as electronic medical records for an integrated video record of all surgeries, for example, plus so much more - and see - https://scott-macleod.blogspot.com/2019/04/flower-mantises-hymenopus-coronatus.html - all of which could have innumerable implications for the FDA, especially if they emerged in some ways out of Alphabet / Stanford / Duke's Project Baseline data developments.
And lastly, conceptually, WUaS seeks to facilitate developing a realistic virtual earth, and not only for actual-virtual, physical-digital tele-robotic surgery, but for everything (think Google Street View with TIME SLIDER / Maps / Earth / TensorFlow / Translate with avatar bots of people and species like in Second Life but realistic, and at the cellular and atomic levels too) including medical device design and testing. In these developments, all of agriculture, food plant species, and with genetic engineering too, would develop (perhaps with Video-to-3D applications) in this realistic virtual earth - and potentially in regulate-able ways per the FDA as well.
To close with some further questions, how could the FDA develop an AI & machine learning focus which is Alphabet-centric in part with its TensorFlow, and re some of the items above - and yet also government-neutral? And what's the FDA's engagement with Alphabet / Verily / Google Tensor Flow in these regards? WUaS is in Google, and as platforms, is Google-centric with planning for TensorFlow, Wikidata/Wikbase-centric in 300 languages, and CC-4 MIT OpenCourseWare-centric in its 5 languages.
Am glad for World Univ & Sch to be collaborating with Stanford in this sense presently - http://med.stanford.edu/cdh/connect.html - and in seeking further too to explore collaboration with Stanford Medicine, as well as with Alphabet's / Stanford's / Duke's Project Baseline, - and to potentially support the FDA in your mission and goals as well.
And here are the beginning MIT OCW-centric World University Medical Schools -
https://wiki.worlduniversityandschool.org/wiki/World_University_Medical_School and
https://wiki.worlduniversityandschool.org/wiki/Hospital - planned online in ~200 countries' official and main languages -
https://wiki.worlduniversityandschool.org/wiki/Languages (in ~200 nation states -
https://wiki.worlduniversityandschool.org/wiki/Nation_States) as well as
https://wiki.worlduniversityandschool.org/wiki/Clinical_Trials_at_WUaS_(for_all_languages) if they might be of help to you in your new role as FDA Commissioner and acting Chief Information Officer.
By the way, WUaS also has a new wing (as of 2017), a new legal entity, called the WUaS Press or WUaS Corporation, which isn't operational yet, and where WUaS seeks to provide pharmaceuticals to our online teaching hospitals in ~200 countries' languages, for example, which could be of benefit to the FDA in planning process and regulatory questions, and especially with regard to market questions - and also esp. re generation of a kind of useful university-centralization in the information age. World University and School became a 501 (c) (3) non-profit in 2010, and recently is officially in Google for Nonprofits.
Am hoping these coding projects might generate a kind of useful university-centralization in the information technology age for you at the FDA, if this might at all be of help to you, Amy.
Thank you for your inspiring and very far-reaching 'fire side chat' at Stanford Medicine CDH yesterday especially, Mintu and Amy!
Sincerely, Scott
Scott MacLeod -
https://twitter.com/scottmacleodWorld Univ and Sch Twitter -
http://twitter.com/WorldUnivandSchLanguages - World Univ -
http://twitter.com/sgkmacleodWUaS Press -
https://twitter.com/WUaSPress“Naked Harbin Ethnography” book (in Academic Press at WUaS) -
http://twitter.com/HarbinBook(OpenBand (Berkeley) -
https://twitter.com/TheOpenBand )
--
- Scott MacLeod - Founder, President & Professor
- World University and School
-
http://worlduniversityandschool.org- 415 480 4577
-
http://scottmacleod.com- CC World University and School - like CC Wikipedia with best STEM-centric CC OpenCourseWare - incorporated as a nonprofit university and school in California, and is a U.S. 501 (c) (3) tax-exempt educational organization.
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Sunday, September 8, 2019
Scott MacLeod
1:10 PM (0 minutes ago)
to amy.abernethy, Robert, robert.califf, Larry, Mintu
Dear Amy, Bob, Rob, Mintu (and Larry),
Thanks for your fascinating talk as new FDA commissioner and acting CIO. Have blogged a little about the email I sent all of you on Friday 9/6/19 :
'Stanford Center for Digital Health - A Conversation with Dr. Amy Abernethy, FDA Principal Deputy Commissioner, and Acting Chief Information Officer ... some brainstorming questions with regards to how World University and School might be of help to Dr. Abernethy in her new role - A) free-to-students' highest quality universal education, B) facilitating a single cryptocurrency with blockchain, distributed potentially via Universal Basic Income (UBI) experiments (partly to alleviate poverty), C) 'avatar bot electronic medical records' for all 7.5 billion people' -
https://scott-macleod.blogspot.com/2019/09/shoaling-and-schooling-stanford-center.html- and especially, brainstorming-wise, with regard to how World Univ & Sch might be of service to you in your new role at the FDA,
In what ways could World University and School become a kind of test platform for online clinical trials -
https://wiki.worlduniversityandschool.org/wiki/Clinical_Trials_at_WUaS_(for_all_languages) - eventually in all ~200 countries, and especially for speakers / people in all 7,111 known living languages online as well? Thank you so much.
Best regards, Scott
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https://twitter.com/WorldUnivAndSchMintu
agency intersects across many areas
here digital health
Deputy commissioner of FDA
acting CIO
Dukey
Journey in different stages
evidence based
At
Duke
how to accelerate clinical evidence generation?
2005-06
data
ipads
difficult to do work beyond boundaries
real time data was difficult
Flatiron
business incentives
oncologies
big pharma
set up by govt
Mintu
how can academic programs do better and faster?
Amy
solving a problem required all key people to be at table
all value each other
Amy core focus
how to use bio engineering
how can the FDA be prepared from a technical perspective
modernizing the FDA
Food is operationally complex especially?
modernization of FDA
Drug
technology to point way
What would that look like
clinical side
devices?
Amy
example
device space
how process is regulated in line with solution themselves
software as a device?
2020 legislation
continuous medical devices over time
for post-marketing requirements
Mintu
landscape of medicare data
cardiology example ...
better and better data as data gets commoditized
in the end
regional data?
or universal federated data?
Amy
1
medicare data > landscape is much bigger
2
real world evidence data set case
genetic underpinnings ...
3
pooling data across boundaries
have often been defined by the boundaries of individual health systems
some groups have begun to colesced
Mintu
data is commoditized
data's in the oil
superset data - which might mean cost might be coming down
Nation states or individual health organizations?
Mintu
evolution of software as medical device as tool
attacks on AI
what is the regulatory framework
Amy
leave this to CDRH
Good software principles are defined
Jeff Scheren who leads FDA device center
monitoring these within real world systems
datasets on which they are built
and the underlying bias they might have
Mintu
working with tech?
worked with Apple?
Amy
don't have clear patterns of how we related to the data tech industry
where they are stake holders
regulatory tool kits
re regulated space s non-regulated space
re movnig fast
move fast but keep us safe
risk informed models - CDRH have done this
Questions
Data ownership?
patients have little owneship - appropriate
FDA doesn't regulate who owns what
except for clinical trials data
mechanisms
local
who's transforming it
Cost?
cost effectiveness?
Mintu
cost of trials contineu to go up
1
multi-national studies
2
adaptable studies
where will we be with phase 3
is there a path
with technology
or
3rd stge trials
AI based adaptive trials
change question?
What's the FDA work force of tomorrow?
Notes
FDA Mission
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.Mar 28, 2018
What We Do | FDA
https://www.fda.gov› about-fda › what-we-do
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Thnx
@DrAbernethyFDA
@leftbundle
for your excellent
@StanfordCDH
talk & re Clinical Trials at WUaS https://wiki.worlduniversityandschool.org/wiki/Clinical_Trials_at_WUaS_(for_all_languages)… planned online in 7111 living languages https://wiki.worlduniversityandschool.org/wiki/Languages & ~200 countries https://wiki.worlduniversityandschool.org/wiki/Nation_States… in
https://wiki.worlduniversityandschool.org/wiki/World_University_Medical_School…
@WUaSPress
@HeartBobH
~
https://twitter.com/WorldUnivAndSch/status/1170094815532290050https://twitter.com/scottmacleod/status/1170100779669020672https://twitter.com/sgkmacleod/status/1170099366842920960https://twitter.com/WUaSPress/status/1170099555469127681
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Thnx @DrAbernethyFDA @leftbundle for your excellent @StanfordCDH talk & re Clinical Trials at WUaS https://wiki.worlduniversityandschool.org/wiki/Clinical_Trials_at_WUaS_(for_all_languages) planned online in 7111 living languages https://wiki.worlduniversityandschool.org/wiki/Languages & ~200 countries https://wiki.worlduniversityandschool.org/wiki/Nation_States in
https://wiki.worlduniversityandschool.org/wiki/World_University_Medical_School @WUaSPress @HeartBobH ~
https://twitter.com/scottmacleod/status/1170100779669020672
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Thnx @DrAbernethyFDA @leftbundle for your excellent @StanfordMed talk & re Clinical Trials at WUaS
https://wiki.worlduniversityandschool.org/wiki/Clinical_Trials_at_WUaS_(for_all_languages) planned online in 7111 living languages https://wiki.worlduniversityandschool.org/wiki/Languages & ~200 countries
https://wiki.worlduniversityandschool.org/wiki/Nation_States in @WUaSPress @HeartBobH >
https://scott-macleod.blogspot.com/2019/09/shoaling-and-schooling-stanford-center.html ~
https://twitter.com/WorldUnivAndSch/status/1170285038451118080
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Schooling:
Shoaling:
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