53rd Edition of the A.I. Healthcare Report
Made by Daniel Maley with Dall-E

53rd Edition of the A.I. Healthcare Report

Main Ideas

  • There are benefits to the use of generative A.I. and clinical enrollment.
  • CMS, Office of the National Coordinator for Health Information Technology (ONC) recently published a final rule that revises the Medicare Prescription Drug Benefit (Part D) and ONC policies regarding electronic publishing and adoption of health information technology for use.
  • Sen. James Lankford [R-OK] is the latest cosponsor of S.4276.
  • Sen. Todd Young [R-IN] sponsors a bill that requires the Secretary of Commerce to conduct a public awareness and education campaign about the benefits and risks of A.I. for Americans.
  • Houston and Tempe are two cities to pay close attention to for A.I. healthcare innovation.


This Week on The A.I. Healthcare Report


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

Welcome to the Fifty-Third 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! The Aggies are facing a winner take all game today against the Tennessee Volunteers. The Texas Rangers have moved to third place in the AL West, while the Astros have moved up to second place in the division.

This issue will include both Texas and Arizona AI Healthcare news.

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 recently published a notice regarding consensus standards on meeting certain requirements of medical devices.

What comments would you submit on this matter?

Please submit comments at anytime.

For more information, please click here .


Healthcare Market Watch

Novo Nordisk unwraps phase 3 hemophilia A data, revealing how Roche rivalry may shake out

Study shows generative AI can speed up clinical trial enrollment for pennies per patient

Top 10 smartest deals in biopharma

Sarepta’s Elevidys secures US label expansion for DMD

Sanofi and Biovac partner to produce polio vaccines in Africa


Healthcare Policy Watch

1.Medicare Program; Medicare Prescription Drug Benefit Program; Health Information Technology Standards and Implementation Specifications

CMS, Office of the National Coordinator for Health Information Technology (ONC) recently published a final rule that revises the Medicare Prescription Drug Benefit (Part D) and ONC policies regarding electronic publishing and adoption of health information technology for use.

The rule is effective July 17, 2024.


2.Facility Readiness: Goal Date Decisions Under Generic Drug User Fee Amendments; Guidance for Industry; Availability

The FDA announced a final guidance called "Facility Readiness: Goal Date Decisions Under GDUFA.”

The final guidance is focused on a facility's readiness for inspection as seen on Form FDA 356h to set a new date for ANDAS.

Please submit comments at any time.


3.Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection; Guidance for Industry, Revision 1; Availability

The FDA published final guidance entitled “Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection.”

The final guidance provides context on what is to be done if a drug/device is deemed to be adulterated by owner/operator etc. at which the drug/device is made or limits an FDA investigation.

Please submit comments at any time.


4. Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 062

The FDA declares new modifications to the list of recognized standards of the FDA Modernization Act of 1997.

The new publication “Modifications to the List of Recognized Standards, Recognition List Number: 062” (Recognition List Number: 062) will assist manufacturers to help them meet certain standards for particular requirement requirements for medical devices.

Please submit comments at any time.


5.Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Committees

The FDA is requesting in-writing nonvoting industry representatives to notify the agency about serving on its public advisory committees for the Center for Drug Evaluation and Research (CDER).

A nominee might be self-nominated or nominated by an organization to serve as an industry representative.

Please submit the required materials by July 22, 2024.


Congressional Updates

H.R. 7292 Bill Update

Reps. Andrea Salinas [D-OR-6] and Thomas Suozzi [D-NY-3] are the latest cosponsors of the bill.

For more information, please click here .


H.R. 8702 Bill Update

Rep. Abigail Spanberger [D-VA-07] is the latest cosponsor of the bill.

For more information, please click here .


S.3641 Bill Update

Sen. Kyrsten Sinema [I-AZ] is the latest cosponsor of the bill.

For more information, please click here .


S.4276 Bill Update

Sen. James Lankford [R-OK] is the latest cosponsor of the bill.

For more information, please click here .


New Bills

S.4596 - A bill to require the Secretary of Commerce to conduct a public awareness and education campaign to provide information regarding the benefits of, risks relating to, and the prevalence of artificial intelligence in the daily lives of individuals in the United States, and for other purposes.

Sponsor: Sen. Todd Young [R-IN]

Cosponsor: Sen. Brian Schatz [D-HI]

The bill requires the Secretary of Commerce to conduct a public awareness and education campaign about the benefits and risks of A.I. for Americans.

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

For more information, please click here .



S.4575- A bill to amend the Older Americans Act of 1965 to require the Assistant Secretary for Aging to make available to States, area agencies on aging, and service providers information and technical assistance to support the provision of evidence-informed practices that are likely to improve health outcomes, and for other purposes.

Sponsor: Sen. Mike Braun [R-IN]

The bill requires the Assistant Secretary for Aging to make available to states and other entities information and technical assistance to support the provision of evidence-informed practices that are likely to improve health outcomes.

The legislation 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

Texas 2036 Newsletter Signup

Houston data scientist joins medical device startup amid AI evolution in the sector

Angela Wilkins joins the Starling Medical team.

She has had experience working at Baylor College of Medicine, co-founding Mercury Data Science (now Omniscience), and also as the Executive Director of the Ken Kennedy Institute at Rice University.

When talking about Houston becoming a big AI healthcare hub, she was quoted as saying the following:

"When we talk about the Houston innovation ecosystem, it's something we should be doing better at because we have so many startups and so many places that would like to use better technology to solve problems..."


No one left behind: AI-enabled support for aging vets

Arizona State University is one of the many institutions leading the way in AI healthcare innovation with the invention of edge devices for military veteran support.

The research is supported by a grant called "Edgecare".

Professor Ming Zhao, an associate professor of computer science and engineering in the School of Computing and Augmented Intelligence, was quoted as saying the following:

“The project is about helping veterans stay independent,” Zhao says. “But when they need help, they can get help.”

Professor Nicole Roberts, an associate professor of psychology in the School of Social and Behavioral Sciences (and for whom is working on the project with Zhao) provided her reasoning with the research:

"...“We now know that lack of social connection, as well as lack of exercise, mental stimulation and even sleep can increase dementia risk. So early tracking of cognitive and emotional changes can help veterans get care at earlier stages of cognitive decline.”


Coming up

House

June 26

3:00 pm???????

Improving Value-Based Care for Patients and Providers Committee on Ways and Means Subcommittee on Health


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.


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