67th Edition of the A.I. Healthcare Report

67th Edition of the A.I. Healthcare Report

Important Announcements

My goal has always been constant. It is to challenge the conventional coverage and access arguments we hear in healthcare.

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.

I will also be providing my thoughts and analyses to paid subscribers on the "AI Healthcare Substack". There will be more details to follow.

The "AI Healthcare Substack" is here: https://aihealthcarethoughts.substack.com/

Also please follow the AI Healthcare Podcast LinkedIn Page here: https://www.dhirubhai.net/company/ai-healthcare-podcast/


Main Ideas

  • The FDA is extending the comment period for a notice that appeared in the Federal Register on September 20, 2024, for draft guidance for industry and FDA staff entitled "Chemical Analysis for Biocompatibility Assessment of Medical Devices.”
  • GSK spends $800 million for upgrades to a manufacturing site.
  • The FDA has announced an upcoming public advisory committee for the Vaccines and Related Biological Products Advisory Committee.
  • H.R. 9900 now has bill text.
  • Researchers at ASU are using AI to help with the diagnosis of myopic maculopathy.


This Week on The A.I. Healthcare Report

Welcome to the Sixty-Seventh Edition of the AI Healthcare Report!

Welcome to the Sixty-Seventh Edition of the A.I. Healthcare Report! The Longhorns squeaked past the Vanderbilt Commodores 27-24 and have dropped to number 6 in the College Football Rankings. The Aggies are now ranked number 10 after defeating the LSU Tigers 38-23. The Longhorns will face the Florida Gators on November 9th and the Aggies will face the South Carolina Gamecocks next week. A lot of exciting things happening in College Football. The LA Dodgers are leading the New York Yankees 2-0 in the World Series matchup.


Weekly Question

The FDA is extending the comment period for a notice that appeared in the Federal Register on September 20, 2024, for draft guidance for industry and FDA staff entitled "Chemical Analysis for Biocompatibility Assessment of Medical Devices.”

The FDA is extending the comment period after a request was made to allow more time for those interested to submit comments.

What comments would you add to this notice and why?

Please submit comments by December 19, 2024.

For more information, please click here .


Healthcare Market Watch

Pharma companies must adapt to keep pace with AI developments, say experts

GSK pumps up to $800m for US manufacturing site upgrade

Dyno and Roche collaborate on neurological gene therapies

The pulse of the medtech industry

J&J, Eli Lilly pad immunology profiles with trial readouts in new patient groups


Healthcare Policy Watch

1.Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adherence Potential and Patient Preference in Prescription Drug Promotion

The FDA has proposed a collection of information submitted to the Office of Management and Budget (OMB) for review.

The title of the information collection is called "Adherence Potential and Patient Preference in Prescription Drug Promotion".

Please submit comments by November 25, 2024.


2.Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

The FDA has announced an upcoming public advisory committee for the Vaccines and Related Biological Products Advisory Committee.

The goal of the advisory committee is to provide the FDA with suggestions on regulatory issues.

The public advisory committee will discuss Respiratory Syncytial Virus (RSV) Vaccine Safety in Pediatric Populations and progress on the Laboratory of Immunoregulation (LI) and Laboratory of Retroviruses (LR) research initiatives at CBER.

*A portion of the meeting will be closed to the public.

The meeting will be held virtually on December 12, 2024, from 8:30 a.m. to 5:30 p.m. EST.


3.Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List

The FDA has announced an upcoming public advisory committee for the Pharmacy Compounding Advisory Committee.

The goal of the advisory committee is to provide the FDA with suggestions on regulatory issues.

The meeting will be open to the public.

The meeting will take place at the FDA White Oak Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, and will be recorded for those not able to attend.

The meeting will be held on December 4, 2024, from 8 a.m. to 3 p.m. EST.


Congressional Updates

H.R. 3283 Bill Update

The bill has a cost analysis from the Congressional Budget Office (CBO). All this means is how much the legislation would cost if enacted and its impact on the federal budget.

For more information, please click here .


H.R. 7292 Bill Update

Rep. Vern Buchanan [R-FL-16] is the latest cosponsor of the bill.

For more information, please click here .


H.R. 7307 Bill Update

Reps. Josh Gottheimer [D-NJ-5] and Tom Suozzi [D-NY-3] are the latest cosponsors of the bill.

For more information, please click here .


H.R. 9900 Bill Update

The legislation now has bill text.

For more information, please click here .


H.R. 9892 Bill Update

The legislation now has bill text.

For more information, please click here .


H.R. 9903 Bill Update

The legislation now has bill text.

For more information, please click here .


H.R. 9979 Bill Update

The legislation now has bill text.

For more information, please click here .


H.R. 10006 Bill Update

The legislation now has bill text.

For more information, please click here .


S. 4495 Bill Update

The bill has a cost analysis from the Congressional Budget Office (CBO). All this means is how much the legislation would cost if enacted and its impact on the federal budget.

For more information, please click here .


S.5275 Bill Update

The legislation now has bill text.

For more information, please click here .


New Bills

H.R.10047 - To amend the Public Health Service Act to direct the Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, to award grants to support community-based programs for harm reduction services for individuals who use substances.

Sponsor: Rep. Rick Larsen [D-WA-02]

Cosponsor: Rep. Ann Kuster [D-NH-02]

The legislation amends the Public Health Service Act to direct the Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, to award grants to support community-based programs for harm reduction services for individuals who use substances.

The bill has been referred to the House Energy and Commerce Committee.

For more information, please click here .


H.R.10050 - To require the Secretary of Health and Human Services to conduct a study on pharmacy benefit manager audit practices.

Sponsor: Rep. Celeste Maloy [R-UT-02]

Cosponsors: Reps. Diana Harshbarger [R-TN-01] and Raja Krishnamoorthi [D-IL-08]

The legislation requires the Secretary of Health and Human Services to conduct a study on pharmacy benefit manager audit practices.

The bill has been referred to the House Energy and Commerce and Ways and Means Committees for a period of time determined by the Speaker.

For more information, please click here .


H.R.10058 - To amend title XIX of the Social Security Act to require coverage for certain individual with breast or cervical cancer under the Medicaid program.

Sponsor: Rep. Maxine Waters [D-CA-43]

Cosponsors: Reps. John Garamendi [D-CA-8], Adriano Espaillat [D-NY-13], Josh Gottheimer [D-NJ-5], Gerald Connolly [D-VA-11], Raúl Grijalva [D-AZ-7], and Bennie Thompson [D-MS-2]

The legislation amends title XIX of the Social Security Act to require coverage for certain individual with breast or cervical cancer under the Medicaid program.

The bill has been referred to the House Energy and Commerce Committee.

For more information, please click here .


H.R.10060 - To amend title XVIII of the Social Security Act to require the provision of certain information with respect to breast reconstruction surgery under the Medicare program.

Sponsor: Rep. Maxine Waters [D-CA-43]

Cosponsors: Reps. John Garamendi [D-CA-8], Adriano Espaillat [D-NY-13], Josh Gottheimer [D-NJ-5], Gerald Connolly [D-VA-11], Raúl Grijalva [D-AZ-7], Bennie Thompson [D-MS-2], and Andrea Salinas [D-OR-6]

The legislation amends title XVIII of the Social Security Act to require the provision of certain information with respect to breast reconstruction surgery under the Medicare program.

The bill has been referred to the House Energy and Commerce and Ways and Means Committees for a period of time determined by the Speaker.

For more information, please click here .


State Updates

Texas 2036 Newsletter Signup

Guidelines not policies: The University of Texas at San Antonio’s approach to gen AI

ASU researchers use AI to help people see more clearly

Researchers at ASU are using AI to help with the diagnosis of myopic maculopathy.

Professor Yalin Wang, leader of the project, states in the following quote below:

“People living in rural areas find it difficult to access sophisticated imaging devices and see physicians...“Once AI-powered technology becomes available, it will significantly improve the quality of life in worldwide populations, including those who live in developing countries.”


Coming up

No pertinent hearings this week


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 .

Fathom.org is also a great newsletter for AI news.

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.


Follow Me

Below are my social channels to read the AI Healthcare Report/listen to the AI HealthcarePodcast


All podcast episodes can be found on Apple Podcasts and Spotify too.



Ronald Haag II, MBA

Protean's Vision: Advanced Care/Support Across the Cancer Care Continuum. Let's have a Conversation and Change our World! Protean's AI-MAPS System Empowers Doctors to Do More!

3 周

Wow! Thank you Dylan for this great information! We especially appreciate your legislative coverage!

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