52nd Edition of the A.I. Healthcare Report
Made by Daniel Maley with Dall-E

52nd Edition of the A.I. Healthcare Report

Main Ideas

  • The Federal Register recently published a notice regarding the implementation of interoperable systems and processes for enhanced drug distribution security requirements under the Food, Drug and Cosmetic Act (FD&C Act).
  • Santa Ana Bio secures $168m for inflammatory disease treatments
  • The Center for Drug Evaluation and Research (CDER) announced a special program called the "Emerging Drug Safety Technology Meeting"(EDSTM).
  • H.R. 6033 was ordered to be reported and amended 40-0 by the yeas and nays.
  • Sens. Maria Cantwell [D-WA] and Jerry Moran [R-KS] introduce legislation to develop artificial intelligence training resources and toolkits for United States small businesses.



This Week on The A.I. Healthcare Report


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

Welcome to the Fifty-Second Edition of the A.I. Healthcare Report! I hope every one of you is ready for summer! It is around the corner! We are now less than 70 days til college football! Congrats to the Aggies for beating the University of Florida. On to the University of Kentucky! The Texas Rangers still stand in second place in the AL West, while the Astros are still in third place 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 Questions

The Federal Register recently published a notice regarding the implementation of interoperable systems and processes for enhanced drug distribution security requirements under the Food, Drug and Cosmetic Act (FD&C Act).

What comments would you submit to the FDA regarding the matter?

Please submit comments by September 12, 2024.

For more information, please click here.


Healthcare Market Watch

AbbVie joins in latest gastrointestinal drug chase

Takeda signs option agreement with Ascentage for CML drug

Santa Ana Bio secures $168m for inflammatory disease treatments

FDA grants approval for Bristol Myers Squibb’s Augtyro for solid tumours

Pre-diabetes rates increase amidst a renaissance for type 2 diabetes research


Healthcare Policy Watch

1.Emerging Drug Safety Technology Meetings; Program Announcement

The Center for Drug Evaluation and Research (CDER) announced a special program called the "Emerging Drug Safety Technology Meeting"(EDSTM).

The meetings will be managed by staff in the CDER EDSTM program.

Furthermore, the meetings provide the opportunity for key stakeholders that have an approved application, support industry pharmacovigilance activities(PV), and meet the eligibility requirements the opportunity to meet with CDER staff to discuss the use of A.I. in PV research.

Please submit meeting requests starting on June 11, 2024.


2.Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

The FDA published a notice regarding pharmacy outsourcing facilities and other matters regarding human drug compounding, repacking, and other related activities.

Please submit comments by August 12, 2024.


3.Request for Nominations for Individuals and Consumer Organizations for Advisory Committees

The FDA is seeking nominations for individuals and consumer organizations for advisory committees in a voting/non-voting manner.

The agency requests the intent to participate must be in writing.

Please submit a letter of interest to the FDA by July 29, 2024.


4.Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use

The FDA has declared the accessibility of its administrative order (proposed order) “Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use.”

Please submit comments by July 29, 2024.


5.Notice of Availability and Request for Comments; National Nanotechnology Initiative Environmental, Health, and Safety Research Strategy: 2024 Update

The National Nanotechnology Coordination Office (NNCO) on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC) is seeking comment on the National Nanotechnology Initiative (NNI) Environmental, Health, and Safety (EHS) Research Strategy: 2024 Update.

Please submit comments by July 22, 2024.


Congressional Updates

H.R. 5547 Bill Update

Rep. Lloyd Smucker [R-PA-11] is the latest cosponsor on the bill.

For more information, please click here.



H.R. 6033 Bill Update

A mark-up session was held on the bill and was ordered to be reported and amended 40-0 by the yeas and nays.

For more information, please click here.


H.R. 6205 Bill Update

Reps. Greg Pence [R-IN-6], Melanie Stansbury [D-NM-1], Grace Meng [D-NY-6], and Debbie Wasserman Schultz [D-FL-25] are the latest cosponsors of the bill.

For more information. please click here.


H.R. 6213 Bill Update

Reps. Suzan K.DelBene [D-WA-1] and Collin Allred [D-TX-32] are the latest cosponsors of the bill.

For more information, please click here.


H.R. 6766 Bill Update

Rep. Barbara Lee [D-CA-12] is the latest cosponsor of the bill.

For more information, please click here.


H.R. 7265 Bill Update

Rep. Seth Moulton [D-MA-6] is the latest cosponsor of the bill.

For more information, please click here.


H.R 8267 Bill Update

The legislation now has bill text.

For more information, please click here.


H.R. 8333 Bill Update

The legislation now has bill text.

For more information, please click here.


S.146 Bill Update

Hearings were held with the Senate Committee on Banking, Housing, and Urban Affairs.

For more information, please click here.


S.150 Bill Update

The Congressional Budget Office (CBO) constructed a score for the bill.

The CBO predicts that the S.150 would reduce direct spending by $2.4 billion and increase revenues by $585 million over the years 2024-2034, for a decrease in the deficit of $3 billion.


S.4238 Bill Update

The legislation now has bill text.

For more information, please click here.


S.4276 Bill Update

The legislation now has bill text.

For more information, please click here.


S.4278 Bill Update

The legislation now has bill text.

For more information, please click here.


New Bills

H.R.8749 - To amend title XVIII of the Social Security Act to promote preparedness and Medicare beneficiary access to safer, more accurate sterile intravenous drug preparations through automated hospital infrastructure.

Sponsor: Rep. Mike Kelly [R-PA-16]

The bill amends title XVIII of the Social Security Act regarding Medicare beneficiaries to access safer, more accurate sterile intravenous drugs via automated hospital infrastructure.

The legislation has been referred to the House Committee on Ways and Means.

For more information, please click here.


H.R.8756 - To establish the Chief Artificial Intelligence Officers Council, Chief Artificial Intelligence Officers, and Artificial Intelligence Coordination Boards, and for other purposes.

Sponsor: Rep. Gerry Connolly [D-VA-11]

Cosponsor: Rep. Andrew Garbarino [R-NY-02]

The legislation establishes the Chief Artificial Intelligence Officers Council, Chief Artificial Intelligence Officers, and Artificial Intelligence Coordination Boards

The bill has been referred to the House Committee on Oversight and Accountability and the Committee on Science, Space, and Technology for a period of time determined by the speaker.

For more information, please click here.


S.4487-A bill to require the Secretary of Commerce to develop artificial intelligence training resources and toolkits for United States small businesses, and for other purposes.

Sponsor: Sen. Maria Cantwell [D-WA]

Cosponsor: Sen. Jerry Moran [R-KS]

The legislation requires the Secretary of Commerce to develop artificial intelligence training resources and toolkits for United States small businesses.

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

For more information, please click here.


S.4495-A bill to enable safe, responsible, and agile procurement, development, and use of artificial intelligence by the Federal Government, and for other purposes.

Sponsor: Sen. Gary Peters [D-MI]

Cosponsor: Sen. Thom Tillis [R-NC]

The bill establishes safe, responsible, and agile procurement, development, and use of artificial intelligence by the Federal Government.

The bill has been read twice and has been referred to the Senate Committee on Homeland Security and Governmental Affairs.

For more information, please click here.


State Updates

Texas 2036 Newsletter Signup

DeepScribe Collaborates with Texas Oncology to Provide AI Solution for Complex Patient Documentation

DeepScribe will work with Texas Oncology to reduce inefficiencies while strengthening the patient-physician relationship.

Steven Paulson, M.D., President and CEO of Texas Oncology was quoted as saying the following:

"Working with DeepScribe aligns perfectly with our mission to advance cancer care for all Texans..."

James Lindsey, IT strategy and innovation principal at Texas Oncology provided a technical perspective of the partnership with the following quote below:

“Texas Oncology’s customized instance of DeepScribe has been trained in the specific needs of oncologists and fine-tuned using actual provider input and patient visits. Safety and privacy were part of our main considerations, as well as how this data would be protected and secured.”

Scott Paulson, M.D., medical oncologist at Texas Oncology?Baylor Charles A. Sammons Cancer Center provided a clinical perspective of the partnership and his positive use of the technology with the following quote below:

“The notes are accurate and even capture billing codes that may have been missed or forgotten if providers come back to finish their documentation hours later. I can also focus on the patient during the visit, instead of my computer.”


Coming up

House

N/A, House is out of session

?

Senate

June 18th

10:00 AM

Homeland Security and Governmental Affairs

Hearings to examine origins of COVID-19, focusing on available evidence.

?

June 20th

9:00 AM

Health, Education, Labor, and Pensions

Hearings to examine the immediate and long-term challenges facing public school teachers, focusing on low pay, teacher shortages, and underfunded public schools.


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.


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.


Kinza Fatima

Top Voice in Corporate Communication | Business Development | Product Development | Author & Speaker

5 个月

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