41st Edition of the A.I. Healthcare Report

After a brief hiatus for personal reasons, we are back! Thank you for understanding!?

Main Ideas:?

• The FDA Roundup Newsletter will be launching this upcoming Friday!
• Sen. Mark Warner [D-VA] introduces a bill that would create cybersecurity standards for advanced payment programs.
• The FDA provides updates to cybersecurity of medical devices.
• H.R. 5245 was reported favorably (and amended)out of the House Committee on Foreign Affairs.
• Sen. Roger Wicker [R-MS] introduces legislation that would provide community-based training opportunities for medical students in rural areas and medically under-served communities.
• A.I. helps one Central Texas Patient with his diabetes diagnosis.
• Banner Health expand its partnership with Regard AI.

This Week on The A.I. Healthcare Report

Welcome to the Forty-First Edition of the AI Healthcare Report!

Welcome to the Forty-First of the AI Healthcare Report. I wanted to take a second to recognize the amazing picture that my friend Daniel Maley produced with Dall-E. Check out his Linkedin and newsletter if you want more technical analysis on A.I. Only 152 more days until college football begins! Baseball is also right around the corner! Since this is the end of the month, we will be exploring A.I. initiatives in Texas and Arizona.

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

Recently, Sen. Mark Warner [D-VA] introduced S.4054, which is a bill that would create cybersecurity standards for advanced payment programs regarding security breaches.?

What do you see as a potential pro/con to this type of policy in the ongoing conversation of A.I. in healthcare?

For more information on the bill, please click here.

Healthcare Market Watch

Medicare to cover Novo’s obesity drug for some patients

FDA clears first-of-its-kind Duchenne drug for broad use

FDA grants orphan drug status to HI-Bio’s felzartamab for AMR

Mirador launches with $400m to develop precision therapies

BMS’ cell therapy Abecma gains EC approval for multiple myeloma

Healthcare Policy Watch

1.Manufacturing USA Institute Competition: AI for Resilient Manufacturing

The Office of Advanced Manufacturing within the National Institute of Standards and Technology published a notice of intent (NOI) announcing a Manufacturing USA Institute Competition focused on A.I. development.?

The NOI allows those to develop key relationships with multiple stakeholders.?

2.Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The FDA announces its draft guidance "Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act", which proposes updates to the final guidance of the agency "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.”

Please submit comments on the draft guidance by May 13, 2024.?

3.Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products; Draft Guidance for Industry; Availability

The FDA is announcing its draft guidance “Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products”, which provides recommendations to new drug applications (NDAs) and and abbreviated new drug applications (ANDAs) for non-prescriptive medications on minor labeling changes.?

Please submit comments on the draft guidance by May 13, 2024.?

4.Determination of Regulatory Review Period for Purposes of Patent Extension; DAURISMO

The FDA publishes the regulatory review period for DAURISMO.?

The drug is made by Pfizer and is used to treat acute myeloid leukemia (AML).?

Please submit comments by May 13, 2024.

5.Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act

The FDA establishes criteria for drug products and categories of drug products that present demonstrable difficulties for compounding (DCC).

Drug products and categories of drug products that appear on certain DCC lists cannot be granted certain statutory exemptions.?

Please submit comments by June 18, 2024.?

Congressional Updates

H.R. 5245 Bill Updates

The legislation was reported favorably (and amended)out of the House Committee on Foreign Affairs.

Reps. Dina Titus [D-NV-1], Michael Lawler [R-NY-17] are the latest cosponsors of the bill.?

For more information, please click here.

H.R. 5547 Bill Update

Reps. Adrian Smith [R-NE-3], Daniel Meuser [R-PA-09], Blake Moore [R-UT-01], and Mariannette Miller-Meeks [R-IA-1] are the latest cosponsors of the bill.?

For more information, please click here.

H.R. 6205 Bill Update

Rep. Katie Porter [D-CA-47} is the latest cosponsor on the bill.?

For more information, please click here.

H.R. 7056 Bill Update

Reps. Madeline Dean [D-PA-04] and Pete Aguilar [D-CA-33] are the latest cosponsors of the bill.?

For more information, please click here.

H.R. 7265 Bill Update

S.3779 is the companion bill in the Senate.

The sponsor of the companion bill is Sen. Brian Schatz [D-HI].?

For more information on the companion bill, please click here.

H.R. 7292 Bill Update

S.3744 is the companion bill in the Senate.?

The sponsor of the companion bill is Sen. Bill Cassidy [R-LA].

For more information on the companion bill, please click here.

New Bills

S.3967-A bill to amend title XVIII of the Social Security Act to make permanent certain telehealth flexibilities under the Medicare program

Sponsor: Sen. Tim Scott [R-SC]

Cosponsors: Sens. Brian Schatz [D-HI], Marsha Blackburn [R-TN], Tina Smith [D-MN], Dan Sullivan [R-AK], Raphael Warnock [D-GA], Roger Marshall [R-KS], and Angus King [I-ME]

The bill establishes certain telehealth flexibilities under Medicare to be permanent.

The legislation has been read twice and has been referred to the Senate Finance Committee.?

For more information, please click here.?

S.3968- A bill to amend the Public Health Service Act to provide community-based training opportunities for medical students in rural areas and medically under-served communities, and for other purposes.

Sponsor: Sen. Roger Wicker [R-MS]

Cosponsor: Sen. Bob Casey [D-PA]

The bill amends the Public Health Service Act [PHSA] to provide training for medical students in rural and under-served areas.?

The legislation has been read twice and has been referred to the Senate Health, Education, Labor, and Pensions Committee.?

For more information, please click here.

S.3975 - A bill to require companies to receive consent from consumers to having their data used to train an artificial intelligence system.

Sponsor: Sen. Peter Welch [D-VT]

Cosponsor: Sen. Ben Ray Lujan [D-NM]

The bill required companies to receive consent from customers to use their data for A.I. systems.?

The legislation has been read twice and has been referred to the Senate Commerce, Science, and Transportation Committee.?

For more information, please click here.

H.R. 7711- To amend title XVIII of the Social Security Act to make permanent certain telehealth flexibilities under the Medicare program.

Sponsor: Rep. Debbie Dingell [D-MI-06]

Cosponsor: Rep. Jack Bergman [R-MI-01]

The bill amends title XVIII of the Social Security Act (SSA) to make certain telehealth flexibilities under Medicare to be permanent.

The legislation was referred to the House Energy and Commerce and Ways and Means Committees for a period of time to be determined by the Speaker of the House.?

For more information, please click here.

H.R.7717 - To amend title XI of the Social Security Act to enhance pharmacy benefit manager transparency requirements.

Sponsor: Rep. Ruben Gallego [D-AZ-03]

The bill amends title XI of the SSA to increase transparency requirements for pharmacy benefit managers.?

The legislation was referred to the House Energy and Commerce and Ways and Means Committees for a period of time to be determined by the Speaker of the House.

For more information, please click here.

State Updates

AI helps diagnose Central Texas patient with rare form of diabetes

Cooper Myers, an Austin resident, tells his story about how A.I. has helped him with his diabetes diagnosis.

Myers asked Chat GPT about his diabetes with the following prompt:

"If my father is a skinny type 2, my grandfather is a skinny type 2 and I am a skinny type 1 with no antibodies, then could we have a different kind of diabetes?”

Chat-GPT suggested that Myers might have MODY (Maturity-Onset Diabetes of the Young), which is when the pancreas creates insulin, but it goes unused.?

Dr. Keta Pandit, Meyers' physician at Texas Diabetes and Endocrinology was quoted as saying the following regarding using A.I and other resources, such as Chat GPT:

“If that information is utilized in conjunction with your healthcare team, and to expedite care, or diagnosis or evaluation, I think that can be very usefu[l],”

Banner Health rolls out Regard's AI tool to streamline diagnoses, clinical documentation

Regard AI and Banner Health are building upon their existing partnership.?

Banner will implement Regard AI across its 33 acute-hospitals network in 6 states later in 2024.?

Susan Lee, D.O. and Banner's physician executive was quoted as saying the following:?

“Electronic medical records are all-encompassing, and there are good things to that and there are some challenges to that..."

Regarding the goal for clinicians, Lee continued by saying the following:

"We want the clinicians to feel like their time is well spent..."

Coming up

No hearings are scheduled 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.

FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies by Holly Fernandez-Lynch and I. Glenn Cohen is a great book for those who are interested in the history of the FDA and in regulating drugs and new technologies. Purchase the book here.

Writing Projects

Below are a few writing projects I have done.

• The Southern United States: A Case Study on AI and Healthcare Unions
• Dallas vs. Lubbock Obesity Rates: A mini-case Study of AI in Healthcare
• Avoiding a Cautionary Tale: Policy Considerations for Artificial Intelligence in Health Care Hearing: 11/8/23
• Case Study: AI in Healthcare in Mississippi with model built by Peter Skuta

Follow Me

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

• Youtube:@TheAIHealthcarePodcast

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

• Spotify Link: https://lnkd.in/ezH2yzEj
• Apple Podcasts Link:https://lnkd.in/efvkbkDh