62nd Edition of the A.I. Healthcare Report
Dylan Reid(Moskowitz)
Government Affairs|Specialized in AI Healthcare|Health Policy and Tech
Important Announcement
I want to take this time to note that I will now be offering consulting services exclusively in A.I. healthcare for clients. I figured after 60+ editions that now is the time to start monetizing my knowledge. Do not worry the newsletter will remain free. Please direct message me for more information.
Main Ideas
This Week on The A.I. Healthcare Report
Welcome to the Sixty-Second of the AI Healthcare Report!
Welcome to the Sixty-Second Edition of the A.I. Healthcare Report! The Aggies edge out Bowling Green with a 26-20 victory and we are officially a little over one week until the MLB Playoffs. The Astros are on the verge of clinching the AL West.
Weekly Question
The FDA recently published an upcoming Digital Health Advisory Committee public advisory meeting.
The committee's goal is to provide advice and recommendations to the FDA on regulatory issues.
The committee will discuss the total product lifestyle suggestions for Generative AI-enabled devices.
What do you think the FDA should know about Generative AI-enabled devices?
The meeting will be held on November 20-21, 2024, from 9:00 a.m. to 6:00 p.m. EST and is open to the public.
For more information, please click here .
Healthcare Market Watch
Healthcare Policy Watch
The FDA has published draft guidance entitled "Considerations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs".
The draft guidance includes suggestions for those who intend to construct global clinical development programs for drugs to treat cancer via multiregional clinical trials (MRCTs) for marketing applications. The notice also expands upon current MRCT procedures.
Please submit comments by November 18, 2024.
The final guidance "Conducting Clinical Trials With Decentralized Elements" is now available and provides suggestions regarding conducting clinical trials with decentralized elements for drugs, biological products, and devices.
Please submit comments at any time.
The draft guidance examines the integration of randomized trials for drugs and biological products into routine clinical practice as is being published as part of the FDA's real-world evidence program (RWE), following mandatory actions published by the Federal Food, Drug, and Cosmetic Act, and the use of RWE in regulatory decision-making.
Please submit comments by December 17, 2024.
The FDA has indicated an upcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee. The main goal of the committee is to provide the FDA with advice and suggestions on regulatory issues.
The meeting will be held on October 29, 2024, from 8:00 a.m. to 5:00 p.m. EST and will be open to the public.
The FDA has issued the Fee Rate for using a priority review voucher for FY 2025.
The fee rate is determined by the costs of the agency in reviewing a human drug application designated as a priority review in the last fiscal year and the average costs of reviewing an application not subject to priority review in the last fiscal year.
The rate is effective on October 1st, 2024 until September 30, 2025.
Congressional Updates
H.R. 1513 Bill Update
The legislation has bill text, has been received in the Senate, and has been read twice and referred to the Senate Commerce, Science, and Transportation Committee.
The latest bill text is here .
For more information, please click here .
H.R. 3800 Bill Update
The legislation has bill text, has been received in the Senate, and has been read twice and referred to the Senate Finance Committee.
The latest bill text is here .
For more information, please click here .
H.R. 5391 Bill Update
Rep. Dan Crenshaw [R-TX-02] is the latest cosponsor of the bill.
For more information, please click here .
H.R. 6033 Bill Update
The legislation has bill text, has been received in the Senate, and has been read twice and referred to the Senate Health, Education, Labor, and Pensions Committee.
The latest bill text is here .
For more information, please click here .
H.R. 6205 Bill Update
Rep. Joseph Morelle [D-NY-25] is the latest cosponsor of the bill.
For more information, please click here .
H.R. 6936 Bill Update
Rep. Abigail Spanberger [D-VA-07] is the latest cosponsor of the bill.
For more information, please click here .
H.R. 7174 Bill Update
Rep. David Valadao [R-CA-22] is the latest cosponsor of the bill.
For more information, please click here .
H.R. 7307 Bill Update
Reps. Patrick Ryan [D-NY-18] and Dean Phillips [D-MN-03] are the latest cosponsors of the bill.
For more information, please click here .
H.R. 8575 Bill Update
Reps. Andrea Salinas [D-OR-06], Jimmy Gomez [D-CA-34], and Dan Crenshaw [R-TX-02] are the latest cosponsors of the bill.
For more information, please click here .
H.R. 8702 Bill Update
Reps. Brandon Williams [R-NY-22}, Zoe Lofgren [D-CA-18], Glenn Grothman [R-WI-06], and Val T. Hoyle [D-OR-04] are the latest cosponsors of the bill.
For more information, please click here .
领英推荐
H.R. 9402 Bill Update
Reps. Anna Eshoo [D-CA-16], Yadira Caraveo [D-CO-08], Brandon Williams [R-NY-22], and Brittany Petersen [D-CO-07] are the latest cosponsors of the bill.
For more information, please click here .
H.R. 9466 Bill Update
Reps. Anna Eshoo [D-CA-16], Ami Bera [D-CA-06], Suzanne Bonamici [D-OR-01], and Brittany Petersen [D-CO-07] are the latest cosponsors of the bill.
For more information, please click here .
H.R. 9475 Bill Update
Rep. Brittany Petersen [D-CO-07] is the latest cosponsor of the bill.
For more information, please click here .
H.R. 9497 Bill Update
The bill text is now available.
For more information, please click here .
S.5021 Bill Update
Sen. Jeff Merkley [D-OR] is the latest cosponsor of the bill.
For more information, please click here .
New Bills
H.R.9607 - To promote a 21st century artificial intelligence workforce and to authorize the Secretary of Education to carry out a program to increase access to prekindergarten through grade 12 emerging and advanced technology education and upskill workers in the technology of the future.
Sponsor: Rep. Barbara Lee [D-CA-12]
Cosponsor: Rep. Emmanuel Cleaver [D-MO-05]
The legislation promotes a 21st century artificial intelligence workforce and authorizes the Secretary of Education to carry out a program to increase access to prekindergarten through grade 12 emerging and advanced technology education and upskill workers in the technology of the future.
The latest action has been that the bill has been referred to the House Committees on Education and the Workforce and Science, Space, and Technology.
For more information, please click here .
H.R. 9626- To direct the Department of Defense to develop a plan for the establishment of a secure computing and data storage environment for the testing of artificial intelligence trained on biological data, and for other purposes.
Sponsor: Rep. Ro Khanna [D-CA-17]
The bill directs the Department of Defense to develop a plan for the establishment of a secure computing and data storage environment for the testing of artificial intelligence trained on biological data, and for other purposes.
The bill has been referred to the House Committee on Armed Services.
For more information, please click here .
S.5029-A bill to amend title XI of the Social Security Act to establish a research and development-intensive small biotech manufacturer exception from the Medicare drug price negotiation program.
Sponsor: Sen. Bill Cassidy [R-LA]
The legislation amends title XI of the Social Security Act to establish a research and development-intensive small biotech manufacturer exception from the Medicare drug price negotiation program.
The bill has been read twice and has been referred to the Senate Finance Committee.
For more information, please click here .
State Updates
Please register for the event with the link above.
The event will be held on September 27th at noon CST in Dallas and online.
Various A.I. initiatives at the UT University System.
These are details of the settlement of the Dallas-based A.I. Healthcare technology company Pieces Technologies.
Coming up
House
Committee: Small Business
Subcommittee: Innovation, Entrepreneurship, and Workforce Development
Date: September 25, 2024 (10:00 a.m.)
Committee: VA
Subcommittee:?Disability Assistance and Memorial Affairs, Economic Opportunity?,?Health, Full Committee
Senate
Committee: HELP
Date: September 24, 2024 (10:00 a.m.)
Committee: HELP
Subcommittee: Employment and Workplace Safety
Date: September 25, 2024 (2:00 p.m.)
What I Am Reading
Stanford Human-Centered Artificial Intelligence is a great resource for diving deeper into AI and Healthcare. I have provided the signup page for their free newsletter here .
I am currently reading Thinking, Fast and Slow by Daniel Kahneman.
For the physical book, click here .
Projects
Below are a few writing projects I have done.
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1 个月Awesome! Thanks for putting this together!