54th Edition of the A.I. Healthcare Report

Main Ideas

• Abbvie acquires Celsius Therapeutics for $250 million.
• The FDA has requested the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995, specifically mentioning the Total Product Life Cycle Advisory Program Pilot.
• H.R. 8333 officially has a score from the Congressional Budget Office.
• Rep. David Schweikert [R-AZ-01] introduces legislation that directs the Secretary of Health and Human Services to issue guidance on payment under the Medicare program for certain items involving artificial intelligence.
• Texas hospital is leading the way in using holograms of doctors for patients.

This Week on The A.I. Healthcare Report

Welcome to the Fifty-Fourth of the AI Healthcare Report!

Welcome to the Fifty-Fourth Edition of the A.I. Healthcare Report! I hope everyone is enjoying their summer! I am trying to get to the golf course as much as I possibly can! We are now less than 60 days from college football! It was a hard-fought battle for the Aggies against the Volunteers! But do not fret...I believe the Aggies will be back. The Texas Rangers are still in third place in the AL West, while the Astros are still in second place in the division.

Weekly Question

The FDA recently published a notice regarding draft guidance for industry called “Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products.”

The draft guidance emphasizes key components of drug delivery performance information for devices, products that include device constituent parts, and delivery of a human drug, which includes biological products.

The notice mentions the FDA's recommendations related to drug design outputs for exhibiting and assessing drug delivery performance and to facilitate and streamline drug delivery devices.

Please submit comments on the draft guidance by September 30, 2024.

For more information, please click here.

Healthcare Market Watch

HCPs want AI to personalize, summarize medical education content: survey

New CKD drugs are promising, but need stronger efficacy data, kidney docs say: GlobalData

Alumis raises $250m in IPO as biotech stock stirs

AbbVie completes acquisition of Celsius Therapeutics for $250m

AI and stable funding environments are catalysts for biotech assets

Healthcare Policy Watch

1.Laboratory Developed Tests: Small Entity Compliance Guide; Guidance for Laboratory Manufacturers and Food and Drug Administration Staff; Availability

The FDA has published final guidance called “Laboratory Developed Tests: Small Entity Compliance Guide.”

The laboratory-developed tests (LDT) rule amended agency regulations that in vitro diagnostic products (IVDs) are products under the Federal Food, Drug, and Cosmetic Act (FD&C Act), specifically indicating that the manufacturer of the IVD is a laboratory.

The final guidance aims to phase out the FDA's general enforcement discretion for LDTs so that IVDs will fall under the same enforcement.

Please submit comments at any time.

2.Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Total Product Life Cycle Advisory Program Pilot

The FDA has requested the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995, specifically mentioning the Total Product Life Cycle Advisory Program Pilot.

CDRH launched the Total Product Life Cycle Advisory Program Pilot Program in 2023. The program is a joint agreement between the FDA and industry as part of the Medical Device User Fee Amendments for fiscal year (FY) 2023 through FY 2027, whose aim is to spur quicker innovation of medical devices of importance.

Please submit comments and suggestions by July 26, 2024.

3. Agency Information Collection Activities: Proposed Collection; Comment Request

The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget approve a revision of the collection project: “Medical Expenditures Panel Survey—Household and Medical Provider Components.”

The notice was originally published in the Federal Register on April 19, 2024, but there were no comments received after 60 days.

A 30-day extension was given for comments.

Please submit comments by July 31, 2024.

Congressional Updates

H.R. 5950 Bill Update

Rep. Zachary Nunn [R-IA-3] is the latest cosponsor of the bill.

For more information, please click here.

H.R. 7512 Bill Update

The bill officially has a score from the Congressional Budget Office.

For more information, please click here.

H.R. 7539 Bill Update

Reps. Josh Gottheimer [D-NJ-5] and Brendan Boyle [D-PA-2] are the latest cosponsors of the bill.

For more information, please click here.

H.R. 8075 Bill Update

Rep. Larry Bucshon [R-IN-8] is the latest cosponsor of the bill.

For more information, please click here.

H.R. 8333 Bill Update

The bill officially has a score from the Congressional Budget Office.

For more information, please click here.

H.R. 8412 Bill Update

Reps. Darren Soto [D-FL-9] and Juan Ciscomani [R-AZ-6] are the latest cosponsors of the bill.

For more information, please click here.

H.R. 8415 Bill Update

The bill has text made available to the public.

For more information, please click here.

H.R. 8702 Bill Update

Reps. Becca Balint [D-VT-At Large], Scott Peters [D-CA-50], David Valadao [R-CA-22], Brad Sherman [D-CA-32], Paul Tonko [D-NY-20], Grace Napolitano [D-CA-31], and Joyce Beatty [D-OH-3] are the latest cosponsors on the bill.

For more information, please click here.

S.4139 Bill Update

H.R. 8056 is the companion bill.

For more information, please click here.

New Bills

H.R.8816 - American Medical Innovation and Investment Act of 2024

Sponsor: Rep. Vern Buchanan [R-FL-16].

The bill amends title XVIII of the Social Security Act to provide for a cognitive impairment detection benefit under the Medicare program.

The latest action on the bill was that it ordered to be amended in the nature of the substitute with 40 Yeas and 0 Nays.

For more information, please click here.

H.R.8820 - To amend the Internal Revenue Code of 1986 to provide an above-the-line deduction for long-term care insurance premiums and to reduce certain tax credits.

Sponsor: Rep. Eric Burlison [R-MO-07]

The bill amends the Internal Revenue Code of 1986 to provide an above-the-line deduction for long-term care insurance premiums and to reduce certain tax credits.

The latest action on the bill was that it was referred to the House Ways and Means Committee.

For more information, please click here.

H.R.8832 - To direct the Secretary of Health and Human Services to issue guidance on payment under the Medicare program for certain items involving artificial intelligence.

Sponsor: Rep. David Schweikert [R-AZ-01]

Cosponsor: Rep. Kevin Hern [R-OK-01]

The bill directs the Secretary of Health and Human Services to issue guidance on payment under the Medicare program for certain items involving artificial intelligence.

The latest action on the bill was that it was 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.8861 - To amend the Federal Food, Drug, and Cosmetic Act to extend the destruction authority of the Secretary of Health and Human Services to articles that present a significant public health concern, and for other purposes.

Sponsor: Rep. Clay Higgins [R-LA-03]

Cosponsor: Rep. Troy Carter [D-LA-02]

The bill amends the Federal Food, Drug, and Cosmetic Act to extend the destruction authority of the Secretary of Health and Human Services to articles that present a significant public health concern.

The latest action on the bill was that it was referred to the House Energy and Commerce Committee.

For more information, please click here.

State Updates

Texas 2036 Newsletter Signup

Texas hospital is reportedly 1st in US to use holograms for doctor-patient visits

Crescent Regional Hospital in Lancaster, TX is leading the way in using holograms of doctors for patients.

Crescent Regional Hospital CEO, Raji Kumar, was quoted as saying the following:

"...,I'm super excited of being able to bring some of this technology to North Texas."

Steve Stirling, managing director of Holoconnects was quoted as saying the following:

"We can provide real-time, life-like access from distant locations which provide patients with access to levels of specialty care from anywhere in the world and also save doctors one of their most precious commodities -- time!"

The Intricacies of AI Policy and Governance (State Bar of Texas Annual Meeting 2024)

John Browning and Judge Roy Ferguson are interviewed on this podcast episode about AI Policy and Governance

Coming up

House

The House is scheduled to be out next week.

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Senate

The Senate is scheduled to be out next 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.

I am also reading a book called Superintelligence, which examines the potential power of intelligent machines.

For the book, click 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