45th Edition of the A.I. Healthcare Report
Dylan Reid(Moskowitz)
Government Affairs|Specialized in AI Healthcare|Health Policy and Tech
Main Ideas
This Week on The A.I. Healthcare Report
Welcome to the Forty-Fifth Edition of the AI Healthcare Report!
Welcome to the Forty-Fifth Edition of the AI Healthcare Report! Only 117 more days til college football begins! The Texas Rangers stand in second place in the AL West, while the Astros are still last in the division.
Since this is the last edition of the month, we will be including what is happening in A.I. Healthcare 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, the FDA released a notice requesting comments on promoting effective drug development which could be considered, investigated, and enacted by the Center for Drug Evaluation and Research (CDER) and the Office of Clinical Pharmacology (OCP).
What would you consider to be effective drug development and why for CDER and OCP to consider?
Please submit your comments by June 25, 2024.
For more information, please click here .
Healthcare Market Watch
Healthcare Policy Watch
This Federal Register notice is just a confirmation of the application from the National Association of Boards of Pharmacy (NABP) for continued Centers for Medicare and Medicaid Services Approval (CMS) of NABP for its Home Infusion Therapy (HIT) Treatment Program.
In 60 days of receipt of the application, CMS will declare a notice that mentions key details of the accreditation body and the request type.
Please submit comments by May 28, 2024.
The FDA has announced draft guidance for industry, IRBs, and clinical investigators called "Cancer Clinical Trial Eligibility Criteria: Laboratory Values.”
The draft guidance is one in a series that provides recommendations on eligibility requirements for clinical trials for investigational drugs by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER).
Suggestions for the inclusion of more diverse participants are also mentioned.
Please submit comments by June 25, 2024.
The FDA published a revised draft guidance called “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers.”
The objective of the revised draft guidance is to address questions and concerns posed by key stakeholders regarding promotional labeling and advertising for prescription biological reference products, biosimilar products, and interchangeable biosimilar products under the Public Health Service Act.
Please submit comments by June 24, 2024.
The FDA declared new draft guidance for industry entitled "Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling."
The goal of the draft guidance for industry is to aid new drug applications (NDAs) and abbreviated new drug applications (ANDAs) in constructing composition statements that are valid and a corresponding statement of labeling.
Please submit comments by June 28, 2024.
The FDA issues a notice about a public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee on regulatory issues.
The meeting is open to the public and will be held on May 24, 2024.
Congressional Updates
H.R. 4002 Bill Update
Rep. Suzan DelBene [D-WA-1] is the latest cosponsor on the bill.
For more information, please click here .
H.R. 6207 Bill Update
Rep. Brian Fitzpatrick [R-PA-1] is the latest cosponsor on the bill.
For more information, please click here .
H.R. 6881 Bill Update
Rep. James McGovern [D-MA-2] is the latest cosponsor on the bill.
For more information, please click here .
H.R. 6487 Bill Update
Rep. Chrissy Houlahan [D-PA-06] is the latest cosponsor on the bill.
For more information, please click here.
H.R. 7174 Bill Update
Rep. Brad Wenstrup [R-OH-02] is the latest cosponsor on the bill.
For more information, please click here .
H.R. 7539 Bill Update
Rep. Pete Sessions [R-TX-17] is the latest cosponsor on the bill.
For more information, please click here .
H.R. 7907 Bill Update
Bill text has been released for the legislation.
For more information, please click here .
H.R. 7939 Bill Update
Bill text has been released for the legislation.
For more information, please click here .
S.3967 Bill Update
The Senate Bill has a companion H.R. 7623 sponsored by Rep. Buddy Carter [R-GA-01].
For more information on the companion bill, please click here .
S.4111 Bill Update
Bill text has been released for the legislation.
领英推荐
For more information, please click here .
New Bills
S.4122 - A bill to amend title XIX of the Social Security Act to develop national quality standards for continuous skilled nursing services provided through Medicaid, and for other purposes.
Sponsor: Sen. JD Vance [R-OH]
Cosponsor: Sen. Maggie Hassan [D-NH]
The legislation amends title XIX of the Social Security Act to develop standards for continuous nursing services via Medicaid and for other reasons.
The bill has been read twice and has been referred to the Senate Finance Committee.
For more information, please click here .
S.4139 - A bill to amend the Workforce Innovation and Opportunity Act to establish a digital skills at work grant program.
Sponsor: Sen. Tim Kaine [D-VA]
The legislation amends the Workforce Innovation and Opportunity Act and establishes digital skills for work grant programs.
The bill has been read twice and has been referred to the Senate Health, Education, Labor, and Pensions Committee.
For more information, please click here .
H.R.8075 - To amend title XVIII of the Social Security Act to provide for Medicare coverage of staff-assisted home dialysis for certain hemodialysis and peritoneal dialysis patients and to ensure all patients are educated on modality options and receive the resources, information, and support to succeed on the modality of their choice, and for other purposes.
Sponsor: Rep. Carol Miller [R-WV-01]
Cosponsors: Reps. Mariannette Miller-Meeks [R-IA-01], Marilyn Strickland [D-WA-10], Earl Blumenauer [D-OR-03]
The legislation mend title XVIII of the Social Security Act and gives Medicare coverage of staff-assisted home dialysis for certain patients.
The bill has been referred to the House Committees on Energy and Commerce, and Ways and Means for a time to be determined by the Speaker of the House.
For more information, please click here .
H.R. 8106-To amend title XIX of the Social Security Act to increase transparency and expand coverage options with respect to home and community-based services under a Medicaid waiver.
Sponsor: Rep. Cathy McMorris-Rodgers [R-WA-05]
Cosponsor: Rep. Frank Pallone [D-NJ-06]
The legislation reforms title XIX of the Social Security Act to increase the transparency of coverage and access needs for home and community-based services that qualify for Medicaid.
The bill has been referred to the House Committee on Energy and Commerce.
For more information, please click here .
State Updates
Collective Health Expands into Plano, a Dallas suburb.
Ali Diab, CEO of Collective Health, was quoted as saying the following:
"This expansion allows us to continue our commitment to deliver a premier health benefits experience for our newest members, including employees at H-E-B, Daikin, and Academy Sports + Outdoors.”
Diab also relayed the following:
“We’ve seen tremendous growth in the region, and we’ll continue to support employers’ desire for innovative and value-maximizing health benefit plan solutions that they can be proud of..."
Assuming approval by the Board of Regents, the University of Arizona will be offering a bachelor's degree in A.I.
Currently, the U of A has a $162 million deficit.
Given the reason for submission, the following was quoted:
"The programs submitted have relatively little to no new associated costs due to existing faculty already in place, will generate revenue and are in emerging academic fields where timing is important."
The W.P. Carey School of Business is launching a Master of Science in Artificial Intelligence in Business (MS-AIB).
Ohad Kadan, who is the Charles J. Robel Dean and W.P. Carey Distinguished Chair in Business was quoted as saying the following:
"There is no doubt that AI is quickly becoming a vital business skill. We are excited to meet the needs of students and employers through our new graduate degree program within our top-ranked information systems department..."
The program will be held on its main campus in Tempe and aims to help students launch their careers in A.I.
The University of Arizona's Health Sciences Arizona Stimulation Technology and Education Center is aiming to bridge the gap between A.I. and traditional medical education.
The bot, whose name is Artificial Intelligence Medical History Evaluation Instrument [AIMHEI] aims to enhance the educational experience for medical professionals.
Dr. Allen Hamilton, MD, FACS, who is the Executive Director of ASTEC and a Regents Professor of Surgery at the U of A College of Medicine in Tucson was quoted as saying the following about [AIMHEI]:
“We hope it will function as the ultimate coaching tool because it not only streamlines the coaching of the medical interviewing process, but also makes it uniquely personalized for each student while saving valuable time for both faculty and students. It offers individualized coaching with targeted feedback, allowing students to refine their medical interview skills with precision.”
Coming up
House
April 30th
10:00 AM?|?2123 Rayburn HOB
Host:?Committee on Energy and Commerce ?| Subcommittee on Health
10:30 AM?|?2358-C Rayburn HOB
Host:?Committee on Appropriations ?| Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Senate
May 2nd
10:00am |?SD-430
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
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