56th 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-Sixth of the AI Healthcare Report!
Welcome to the Fifty-Sixth 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! We are now less than 40 days from college football! The Texas Rangers are still in third place in the AL West, while the Astros are still in second place in the division. We are also two weeks away from August Recess when Congress will not be in session for the entire month.
Weekly Question
The FDA published a notice regarding a proposed collection of a reclassification petition for medical devices.
The public has 60 days to comment.
Please submit comments by September 9, 2024.
What comments would you submit to the FDA regarding the matter?
For more information, please click here.
Healthcare Market Watch
Healthcare Policy Watch
The FDA has announced a revised draft guidance for industry called "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers".
The draft guidance revises and replaces "Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” released in June 2014.
The revised draft guidance is not final nor in effect at this time.
Please submit comments by September 9, 2024.
The FDA has published draft guidance entitled "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products".
The draft guidance provides suggestions to industry and content of a use-related risk analysis (URAA) and how it can be used during product development and market applications.
Please submit comments by September 9, 2024.
With the Clinical Trials Transformation Initiative (CTTI), the FDA seeks patient advocates interested in joining the Patient Engagement Collaborative (PEC).
The PEC works directly with the FDA's Patient Affairs Staff, Office of Clinical Policy and Programs (OCPP), Office of the Commissioner at FDA, and is hosted by CTTI.
Topics of the PEC include patient engagement and new models of collaboration between stakeholders.
Applications will be accepted until August 8, 2024, or until 75 applications are received.
A recent notice published by the FDA informed the public that SPEVIGO is undergoing the process of a regulatory review period and is being made public by the agency as is required by law.
SPEVIGO is used to treat those who have generalized pustular psoriasis and is manufactured by Boehringer Ingelheim.
Please submit comments by September 9, 2024.
Congressional Updates
H.R. 5173 Bill Update
Rep. Larry Bucshon [R-IN-8] is the latest cosponsor of the bill.
For more information, please click here.
H.R. 7056 Bill Update
Reps. Salud Carbajal [D-CA-24], John Garamendi [D-CA-8], Ruben Gallego [D-AZ-3], and Lucy McBath [D-GA-7] are the latest cosponsors of the bill.
For more information, please click here.
H.R. 7292 Bill Update
Rep. Claudia Tenney [R-NY-24] is the latest cosponsor of the bill.
For more information, please click here.
H.R. 8333 Bill Update
Reps. Thomas Suozzi [D-NY-3] and Darin LaHood [R-IL-16] are the latest cosponsors of the bill.
For more information, please click here.
H.R. 8575 Bill Update.
Reps. Jeff Van Drew [R-NJ-2]. Michael Lawler [R-NY-17], Yvette Clarke [D-NY-9], and Grace Napolitano [D-CA-31] are the latest cosponsors of the bill.
For more information, please click here.
H.R. 8588 Bill Update
Rep. Josh Gottheimer [D-NJ-5] is the latest cosponsor of the bill.
For more information, please click here.
领英推荐
S.113 Bill Update
Sen. Ralphael Warnock [D-GA] is the latest cosponsor of the bill.
For more information, please click here.
S.2691 Bill Update
Sens. Mark Warner [D-VA] and Susan Collins [R-ME] are the latest cosponsors of the bill
For more information, please click here.
New Bills
H.R. 8939- To amend the Communications Act of 1934 to establish technical and procedural standards for artificial or prerecorded voice systems created through generative artificial intelligence, and for other purposes.
Sponsor: Rep. Rick Allen [R-GA-12]
The legislation amends the Communications Act of 1934 to establish technical and procedural standards for artificial or prerecorded voice systems created through generative artificial intelligence.
The bill has been referred to the House Energy and Commerce Committee.
For more information, please click here.
H.R.8964 - To amend the HITECH Act to allow an individual to obtain a copy of such individual's protected health information at no cost unless certain circumstances apply, and for other purposes.
Sponsor: Rep. Bill Foster [D-IL-11]
Cosponsors: Reps. Raúl Grijalva [D-AZ-07], Gregory Meeks [D-NY-05], and Joyce Beatty [D-OH-03].
The bill amends the HITECH Act to allow an individual to obtain a copy of such individual's protected health information at no cost unless certain circumstances apply.
The bill has been referred to the House Energy and Commerce Committee.
For more information, please click here.
S.4635 - A bill to require a report and updated guidance on continued risk management for pharmaceutical supply chains of Department of Defense.
Sponsor: Sen. Gary Peters [D-MI]
Cosponsor: Sen. Joni Ernst [R-IA]
The bill requires a report and updated guidance on continued risk management for pharmaceutical supply chains of Department of Defense.
The bill and been read twice and has been referred to the Senate Armed Services Committee.
For more information, please click here.
S.4697 - Healthcare Cybersecurity Act of 2024
Sponsor: Sen. Jacky Rosen [D-NV]
Cosponsor: Sens. Todd Young [R-IN] and Angus King [I-ME]
The bill enhances the cybersecurity of the Healthcare and Public Health Sector.
The bill has been read twice and has been referred to the Senate Homeland Security and Governmental Affairs Committee.
For more information, please click here.
State Updates
AI in trauma care innovations is speeding up in Texas.
Amina Qutub, associate professor in the Department of Biomedical and Chemical Engineering at UTSA, was quoted as saying the following:
"We hope we are a pilot that people can use as an exemplar of how AI can make the most of data sets. And so, while we’re building it for Texas, we imagine it will be a model that’s used across the nation and internationally..."
Coming up
House
The House is not scheduled to be in session next week.
Senate?
The Senate is not scheduled to be in session next 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.
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
All podcast episodes can be found on Apple Podcasts and Spotify too.