66th Edition of the A.I. Healthcare Report
Dylan Reid(Moskowitz)
Government Affairs|Specialized in AI Healthcare|Health Policy and Tech
Important Announcements
My goal has always been constant. It is to challenge the conventional coverage and access arguments we hear in healthcare.
I want to take this time to note that I will now be offering consulting services exclusively in A.I. healthcare for clients. I figured after 60+ editions that now is the time to start monetizing my knowledge. Do not worry the newsletter will remain free. Please direct message me for more information.
I will also be providing my thoughts and analyses to paid subscribers on the "AI Healthcare Substack". There will be more details to follow.
The "AI Healthcare Substack" is here: https://aihealthcarethoughts.substack.com/
Also please follow the AI Healthcare Podcast LinkedIn Page here: https://www.dhirubhai.net/company/ai-healthcare-podcast/
Main Ideas
This Week on The A.I. Healthcare Report
Welcome to the Sixty-Sixth Edition of the AI Healthcare Report!
Welcome to the Sixty-Sixth Edition of the A.I. Healthcare Report! The Longhorns fell to the Georgia Bulldogs 30-15 and have dropped to number 5 in the College Football Rankings. The Aggies are still at 14. The Longhorns will face the Vanderbilt Commodores and the Aggies will face the LSU Tigers next week. A lot of exciting things happening in College Football. Not to mention we are in the middle of an exciting baseball playoffs season!
Weekly Question
The FDA recently released final guidance entitled "Requests for Reconsideration at the Division Level Under GDUFA.”
The final guidance provides suggestions on processes for applicants of abbreviated new drug applications (ANDAs) who wish to consider a reconsideration at the division level or original signatory authority.
What comments or concerns do you have about the final guidance?
For more information, please click here.
Healthcare Market Watch
Healthcare Policy Watch
The FDA has published final guidance for industry called “Temporary Policies for Compounding Certain Parenteral Drug Products.”
As of October 10, 2024, HHS Secretary Xavier Becerra that the destruction of Hurricane Helene in North Carolina, Florida, Georgia, Tennessee, and South Carolina and Hurricane Milton in Florida constitute a public health emergency.
Hurricane Helene greatly impacted the operations of one of the biggest manufacturers in particular intravenous and peritoneal dialysis solutions.
The final guidance document emphasizes the FDA's regulatory and enforcement priorities regarding the compounding of certain parental drug products by outsourcing facilities, State-licensed pharmacies, and Federal facilities not registered with the FDA as outsourcing facilities.
Please submit comments at any time.
The FDA has announced the publication of final guidance for industry called “Core Patient-Reported Outcomes in Cancer Clinical Trials".
The notice provides recommendations to sponsors regarding the collection of core patient-reported outcomes in cancer clinical trials and related instrument selection and trial design.
The final guidance emphasizes patient-reported outcomes (PRO), specifically for anti-cancer therapies for survival, tumor responses, or delay of the progression of malignancy.
Please submit comments at any time.
The FDA is sending a notice correcting a final rule called "Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments” that appeared in the Federal Register on September 20, 2024.
The final rule omitted the effective date of a provision in the regulatory text.
The effective date is February 3, 2025.
Congressional Updates
H.R. 5391 Bill Update
Rep. Neal Dunn [R-FL-02] is the latest cosponsor of the bill.
For more information, please click here.
H.R. 7164 Bill Update
Reps. Mary Sattler Peltola [D-AK-At Large], Michael Lawler [R-NY-17], and Terri Sewell [D-AL-07] are the latest cosponsors of the bill.
For more information, please click here.
H.R. 8575 Bill Update
Reps. Don Bacon [R-NE-02] and Adam Schiff [D-CA-30] are the latest cosponsors of the bill.
领英推荐
For more information, please click here.
H.R. 8702 Bill Update
Reps. Garret Graves [R-LA-06] and Michael Lawler [R-NY-17] are the latest cosponsors of the bill.
For more information, please click here.
H.R. 9607 Bill Update
The legislation now has bill text.
For the bill text, please click here.
S. 5206 Bill Update
The legislation now has bill text.
For the bill text, please click here.
S.5222 Bill Update
The legislation now has bill text.
For the bill text, please click here.
New Bills
H.R.9996 - To amend title 38, United States Code, to make certain improvements to the laws relating to patient advocacy for patients who receive health care furnished by the Department of Veterans Affairs, and for other purposes.
Sponsor: Rep. Rudy Yakym [R-IN-02]
The bill amends title 38, United States Code, to make certain improvements to the laws relating to patient advocacy for patients who receive health care furnished by the Department of Veterans Affairs, and for other purposes.
The legislation has been referred to the House Veterans' Affairs Committee.
For more information, please click here.
H.R.10006 - To amend title XVIII of the Social Security Act to improve transparency with respect to the suspension of Medicare payments pending an investigation into a credible allegation of fraud.
Sponsor: Rep. Josh Harder [D-CA-09]
The bill amends title XVIII of the Social Security Act to improve transparency with respect to the suspension of Medicare payments pending an investigation into a credible allegation of fraud.
The legislation has been 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.
State Updates
Check out this podcast episode by Rice University's Baker Institute for Public Policy about improving patient outcomes while decreasing spending.
Coming up
No pertinent hearings 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.
Fathom.org is also a great newsletter for AI news.
I am currently reading Thinking, Fast and Slow by Daniel Kahneman.
For the physical book, click here.
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
All podcast episodes can be found on Apple Podcasts and Spotify too.