46th Edition of the A.I. Healthcare Report
Dylan Reid(Moskowitz)
?? Healthcare Policy & AI Strategist | Speaker ?? | Bridging Tech, Science & Policy | Tech-Savvy with AI & Coding Expertise | Advancing Healthcare Public Affairs & PR | Worked with Hevolution, EndoDNA, Guardant Health
Main Ideas
This Week on The A.I. Healthcare Report
Welcome to the Forty-Sixth Edition of the AI Healthcare Report!
We now have over 1,000 subscribers and welcome to the Forty-Sixth Edition of the A.I. Healthcare Report. Only 110 more days til college football! The Texas Rangers stand in second place in the AL West, while the Astros are next-to-last in the division.
With each issue, I hope we can learn from each other.
If you have updates for the newsletter or would like to continue the conversation, please email me at [email protected] or connect with me on LinkedIn here.
Weekly Question
The FDA released a notice announcing of a virtual, public meeting entitled “Listening Session: Optimizing FDA's Use of and Processes for Advisory Committees".
Do you think that Advisory Committees are useful in determining health policy? Why or why not?
The meeting will be held on June 13, 2024, from 9:00am-4:00pm.
Please submit requests to make oral presentations by May 13, 2024, at 3:00pm.
Please submit comments on the listening session by August 13, 2024.
For more information, please click here.
Healthcare Market Watch
Healthcare Policy Watch
The FDA announced a draft document called "Considerations for the Use of Human- and Animal-Derived Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry.”
Its objective is to provide manufacturers of Cell and Gene Therapies (CGT) and Tissue-Engineered Medical Products (TEMPs) with recommendations on the safety, quality, and identity of human and animal materials in these products.
Additionally, suggestions of chemistry, manufacturing, and control (CMC) regarding INDs of human and animal materials are also discussed.
Please submit comments by July 29, 2024.
The FDA published a draft document entitled "Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry"
The draft document provides sponsors of allogenic-cell based medical products suggestions for determining cell-based testing to support INDs or BLAs.
Please submit comments by July 29, 2024.
The FDA issued a final rule on the amending of its regulations that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The agency is also closing down its enforcement of general enforcement discretion of laboratory-developed tests (LDTs).
The rule is effective July 5, 2024.
Congressional Updates
H.R. 4755 Bill Update
The legislation has passed the House of Representatives and has been received in the Senate and has been read twice and referred to the Senate Commerce, Science, and Transportation Committee.
For more information, please click here.
H.R. 5547 Bill Update
Rep. Vern Buchanan [R-FL-16] is the latest cosponsor on the bill.
For more information, please click here.
H.R. 8075 Bill Update
Rep. Bill Posey [R-FL-08] is the latest cosponsor of the bill.
For more information, please click here.
S.3967 Bill Update
Senators Jeanne Shaheen [D-NH] and Cindy Hyde-Smith [R-MS] are the latest cosponsors of the bill.
For more information, please click here.
S.4122 Bill Update
Bill text has been released for the legislation.
For more information, please click here.
S.4139 Bill Update
Bill text has been released for the legislation.
For more information, please click here.
New Bills
H.R.8144 - To amend title III of the Public Health Service Act to include rural emergency hospitals in the definition of a covered entity for purposes of the 340B drug discount program.
Sponsor: Rep. Jack Bergman [R-MI-01]
Cosponsor: Rep. Debbie Dingell [D-MI-06]
The legislation amends title III of the Public Health Service Act to include rural emergency hospitals in the 340b drug discount program.
The bill has been referred to the House Committees on Energy and Commerce.
For more information, please click here.
H.R.8148 - To amend title XVIII of the Social Security Act to allow for the furnishing of audio-only telehealth services.
领英推荐
Sponsor: Rep. Randy Feenstra [R-IA-04]
Cosponsor: Rep. Zachary Nunn [R-IA-03]
The legislation amends title XVIII of the Social Security Act to allow for the expanded access of audio-only telehealth services.
The bill has been referred to the House Committees on Energy and Commerce and Ways and Means for a period of time determined by the Speaker.
For more information, please click here.
H.R.8227 - To amend title XVIII of the Social Security Act to remove in-person requirements under Medicare for mental health services furnished through telehealth and telecommunications technology.
Sponsor: Rep. Kevin Hern [R-OK-01]
Cosponsors: Reps. Susie Lee [D-NV-03], Nicole Malliotakis [R-NY-11], Brian Fitzpatrick [R-PA-01]
The legislation amends title XVIII of the Social Security Act to remove in-person requirements under Medicare for mental health services for telehealth and telecommunications technology.
The bill has been referred to the House Committees on Energy and Commerce and Ways and Means for a period of time determined by the Speaker.
For more information, please click here.
S.4238 - A bill to amend title III of the Public Health Service Act to direct the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to award grants to eligible entities to carry out construction or modernization projects designed to strengthen and increase capacity within the specialized pediatric health care infrastructure, and for other purposes.
Sponsor: Sen. Alex Padilla [D-CA]
Cosponsor: Sen. Bob Casey [D-PA]
The legislation amends title III of the Public Health Service Act to direct the Secretary of Health and Human Services to award grants to those attempting to strengthen and increase capacity for specialized pediatric healthcare infrastructure.
The bill has been read twice and has been referred to the Senate Committee on Health, Education, Labor, and Pensions.
For more information, please click here.
S.4247 - A bill to establish Federal research award reimbursement limits for indirect costs for institutions of higher education, and for other purposes.
Sponsor: Sen. Mike Lee [R-UT]
Cosponsors: Sens. Roger Marshall [R-KS], Josh Hawley [R-MO]
The legislation establishes Federal research award reimbursement limits for indirect costs for higher education institutions.
The bill has been read twice and has been referred to the Senate Committee on Health, Education, Labor, and Pensions.
For more information, please click here.
State Updates
Above is a list of those who are pushing the A.I. conversation forward, such as in healthcare.
Texas is currently exploring how to implement its statewide generative A.I. processes
Amanda Crawford, Texas Chief Information Officer, was quoted as saying the following:
“What we’ve done is we’re really exploring what are the concerns, how can we deploy it safely in government. They’re excited to be able to deploy it and really leverage what could really be a transformational technology for the better..."
Regarding generative A.I. Crawford continued by saying the following:
“We want to make sure that it’s accessible, and that whatever we’re designing, not only do we keep humans in the loop, but that we also design it with our constituents in mind..."
Coming up
House
May 8th
10:00 AM?|?2360 Rayburn HOB
Senate?
May 8th
10:00 AM?|?SD-124
Host:?Committee on Appropriations?| Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
10:00 AM?|?SD-608
Host: Committee on Budget
May 9th?
10:00 AM?|?SD-138
Host:?Committee on Appropriations?| Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
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.
Writing Projects
Below are a few writing projects I have done.
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