58th 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 Fifty-Eighth of the AI Healthcare Report!
Welcome to the Fifty-Eighth 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 possible! Just a friendly reminder that I will be out on vacation during the first week of August and there will be no edition that first week of the month. We are now less than 30 days from college football! The Texas Rangers are still in third place in the AL West, while the Astros are in first place. August Recess begins this week!
Weekly Question
The FDA published a recent notice announcing draft guidance for industry called "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers."
The draft guidance answers to FAQs posed by applicants and other key stakeholders regarding post-approval manufacturing changes to biosimilar and interchangeable products under the Public Health Service Act.
Please submit comments by September 23, 2024.
For more information, please click here.
Healthcare Market Watch
Healthcare Policy Watch
The FDA has extended the comment period on a notice that first appeared on June 26, 2024.
The notice requested comments on its “Information Technology (IT) Strategy” and “Customer Experience (CX) Strategy."
Please submit comments by August 30, 2024.
The FDA has announced the issuance of Emergency Use Authorizations for certain medical devices during COVID-19.
The announcement follows the February 4, 2020 decision by the Secretary of Health and Human Services as amended on March 15, 2023, that there is a public health emergency or a significant threat of one.
The FDA has established a public docket that will aid in determining how to best advance the development of new biosimilar biological products as part of the Biosimilar User Fee Act of 2022.
Please submit comments by October 23, 2024.
Final guidance for industry by the FDA has been announced called "“Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products."
The guidance is intended to provide sponsors and other parties with considerations regarding using of EHRs or medical claims data in supporting regulatory decisions for effectiveness or safety.
The notice finalizes the draft guidance that was originally published on July 25, 2024.
The Pulmonary-Allergy Drugs Advisory Committee has been renewed for an additional two years beyond the charter expiration date.
The new charter will be in effect until May 30, 2026.
Congressional Updates
H.R. 1024 Bill Update
Rep. Jerrold Nadler [D-NY-12] is the latest cosponsor of the bill.
For more information, please click here.
H.R. 3565 Bill Update
Rep. Wiley Nickel [D-NC-13] is the latest cosponsor of the bill.
For more information, please click here.
H.R. 5183 Bill Update
Rep. Raúl Grijalva [D-AZ-7] is the latest cosponsor of the bill.
For more information, please click here.
H.R. 6020 Bill Update
The legislation was put on the Union Calendar No. 509, which means that is a bill that is relevant to raising revenues, government spending, or government property and is considered for a potential vote.
H.R. 7076 Bill Update
10+ Democrats are the latest cosponsors of the bill.
For more information, please click here.
H.R. 7164 Bill Update
Del. Eleanor Holmes Norton [D-DC-At Large] is the latest cosponsor of the bill.
For more information, please click here.
H.R. 7307 Bill Update
Rep. Yadira Caraveo [D-CO-8] is the latest cosponsor of the bill.
For more information, please click here.
H.R. 8075 Bill Update
Rescom. Jenniffer González-Colón [R-PR-At Large] is the latest cosponsor of the bill.
Recommended by LinkedIn
For more information, please click here.
H.R. 8412 Bill Update
Rep. Yadira Caraveo [D-CO-8] is the latest cosponsor of the bill.
For more information, please click here.
S.4697 Bill Update
Sen. Jon Ossoff [D-GA] is the latest cosponsor of the bill.
For more information, please click here.
New Bills
S.4729 - A bill to amend the Older Americans Act of 1965 to establish a pilot program for family caregivers for individuals with Alzheimer's disease or a related disorder with neurological and organic brain dysfunction.
Sponsor: Sen. Ed Markey [D-MA]
The bill amends the Older Americans Act of 1965 to establish a pilot program for family caregivers for individuals with Alzheimer's disease or a related disorder with neurological and organic brain dysfunction.
The legislation has been read twice and has been referred to the Senate Health, Education, Labor, and Pensions Committee.
For more information, please click here.
S.4739 - A bill to advance research to achieve medical breakthroughs in brain tumor treatment and improve awareness and adequacy of specialized cancer and brain tumor care.
Sponsor: Sen. Richard Blumenthal [D-CT]
Cosponsors: Sens. Mike Rounds [R-SD], John Barrasso [R-WY], Jack Reed [D-RI]
The legislation advances research to achieve medical breakthroughs in brain tumor treatments and improves awareness and adequacy of specialized cancer and brain tumor care.
The legislation 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.9127 - To amend title III of the Public Health Service Act to include territorial disproportionate share hospitals as covered entities under the 340B drug discount program.
Sponsor: Del. Gregorio Kilili Camacho Sablan [D-MP-At Large]
Cosponsor: Del. James Moylan [R-GU-At Large]
The legislation amends title III of the Public Health Service Act to include territorial disproportionate share hospitals as covered entities under the 340B drug discount program.
The bill has been referred to the House Energy and Commerce Committee.
For more information, please click here.
H.R.9141 - To amend the Internal Revenue Code of 1986 to expand eligibility for health savings accounts, and for other purposes.
Sponsor: Rep. Kat Cammack [R-FL-03]
Cosponsors: Reps. Lori Chavez-DeRemer [R-OR-05] and Thomas Kean [R-NJ-07]
The legislation amends the Internal Revenue Code of 1986 to expand eligibility for health savings accounts, and for other purposes.
The bill has been referred to the House Ways and Means Committee.
For more information, please click here.
State Updates
Coming up
House
Not in session next week.
Senate
Wednesday, Jul 31, 2024
10:00 AM – SD-562
Business meeting to consider S.4776, to amend the Older Americans Act of 1965 to authorize appropriations for fiscal years 2025 through 2029, S.4762, to amend the Public Health Service Act to reauthorize programs and research relating to autism, S.4755, to reauthorize traumatic brain injury programs, and other pending calendar business.
Thursday, Aug 01, 2024
9:30 AM – SD-106
Business meeting to markup an original bill entitled, "Energy and Water Development and Related Agencies Appropriations Act", an original bill entitled, "Department of Defense Appropriations Act", an original bill entitled, "Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act", an original bill entitled, "Department of Homeland Security Appropriations Act", and an original bill entitled, "Financial Services and General Government Appropriations Act".
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 also am looking forward to reading Collaboration Effect on Profit: Overcoming Founder's Syndrome to Achieve Sustainable Success.
For the 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.