The AI Healthcare Report: 8/25/23
Dylan Reid(Moskowitz)
?? Healthcare Policy & AI Strategist | Speaker ?? | Bridging Tech, Science & Policy | Tech-Savvy with AI & Coding Expertise | Advancing Healthcare Public Affairs & PR | Worked with Hevolution, EndoDNA, Guardant Health
Welcome to the Fourteenth Edition of the AI Healthcare Report!
College Football starts this Saturday! Is anyone else excited?! There is now only a 1 game- difference between the Rangers and the Astros in the AL West. Tickets for Rodeo Houston are now available for purchase?here.
If this is your first time here, I welcome you. Please read the last issue of the newsletter?here.
With each issue, I hope we can learn from each other.
If you would like to continue the conversation, please email me at [email protected] or connect with me on LinkedIn?here. Please feel free to also share this newsletter with people in your network and have them subscribe. Also, come check out my website landing page here when you get the chance.
Let us dive in!
Weekly Question
Health Resources and Services Administration (HRSA) announces that they are seeking input from the public before submitting an Information Collection Request (ICR) to the Office of Management and Budget (OMB) on the Office for the Advancement of Telehealth (OAT)'s Evidence-Based Telehealth Network Program. OAT aims to increase the quality of healthcare services with telehealth initiatives. What are your thoughts?
Please add your thoughts to the comment section below. There is not a right or wrong answer.
The deadline to submit comments is October 17th.
The Federal Register notice is here.
Workshop To Enhance Clinical Study Diversity; Public Workshop; Request for Comments
The FDA has published a notice of an open workshop called "Workshop To Enhance Clinical Study Diversity", which is required under the Food and Drug Omnibus Reform Act of 2022 (FDORA) to hold public workshops and receive input from stakeholders on clinical diversity.
The deadline to submit comments is January 29th.
The Federal Register notice is here.
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry; Extension of the Comment Period
The FDA is extending the comment period for guidance on the “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry,", which appeared in the Federal Register on July 14th.
The deadline to submit comments is November 13th.
The Federal Register notice is here.
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Alternative Form of Hearing
The FDA announces an alternative hearing regarding the Center for Drug Evaluation and Research's (CDER's) approving ITCA 650 (exenatide in DUROS device) new drug application (NDA) submitted by Intarcia Therapeutics, Inc. The hearing meets FDA criteria as an alternative form of hearing.
The Federal Register notice is here.
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The FDA announces a future public meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The aim of the meeting is to provide the FDA with regulatory issues.
The Federal Register notice is here.
Codecademy ML/AI Engineering Certificate
I am in the process of working towards the Codecademy ML/AI Engineering Certificate program. The program is $350 annually. With the certificate, I plan to combine my AI policy and engineering knowledge when examining healthcare models.
Texas Tribune Festival Speakers Announced
From September 21st to September 23rd in Austin, the Texas Tribune is hosting TribFest, where movers and shakers of state public policy come together to discuss initiatives and ideas in the Lone Star State. The full speaker list has been announced. To purchase tickets, please click?here.
Federal Legislation
H.R. 5245- To amend the State Department Basic Authorities Act of 1956 to require certain congressional notification prior to entering into, renewing, or extending a science and technology agreement with the People's Republic of China, and for other purposes.
Sponsor: Rep. Andy Barr [R-KY-06]
Cosponsors: Reps. Neal Dunn [R-FL-02] and Robert Wittman [R-VA-01]
The bill aims to require congressional notification when working with the People's Republic of China on science and technology agreements. There has not been any bill text released, but I am tracking this bill. For more information, please click here.
S.2691, S.2714, H.R.3831, and H.R. 5173 Bill Updates
In the Eleventh Edition of the AI Healthcare Report, S. 2691 sponsored by Sen. Brian Schatz [D-HI] was mentioned. The bill text has been released. A few key details of the bill are below:
(1) ESTABLISHMENT.—Not later than 90 days after the date of enactment of this section, the Director of the National Institute of Standards and Technology (in this section referred to as the ‘‘Director’’), in coordination with the heads of other relevant Federal agencies, shall form a working group to assist platforms in identifying AI-generated content.?
(2) MEMBERSHIP.—The working group shall include members from the following:?
(A) Relevant Federal agencies.?
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(B) Developers of generative artificial intelligence systems.
(C) Private sector groups engaged in developing content detection standards.?
(D) Social media platforms.?
(E) Academic and other relevant entities.?
(F) Any other entity determined appropriate by the Director.?
(3) DUTIES.—Not later than 1 year after the date on which the Director establishes the working group under paragraph (1), the working group shall publish a framework that includes—?
(A) technical standards for AI-generated content detection technology to assist platforms in identifying image, video, audio, and multimedia AI-generated content;?
(B) guidelines and best practices for platforms to implement such technical standards; ?
(C) recommendations for detection practices for non-audiovisual AI-generated content,
(4) REPORT TO CONGRESS.—Not later than 1 year after the date on which the Director establishes the working group under paragraph (1), the Director shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the framework published under paragraph (3), together with recommendations for legislative or administrative action determined appropriate by the Director.?
The bill text of S. 2691 is here.
Additionally, the Eleventh Edition mentioned S. 2714 mentioned by Sen. Martin Heinrich [D-NM]. The legislative text has been released. A few key details of the bill are below:
(1) DEFINITION.—In this subsection, the terms ‘NAIRR’, ‘National Artificial Intelligence Research Resource’, ‘Operating Entity’, ‘Program Management Office’, and ‘resources of the NAIRR’ have the meanings given the terms in section 5601.?
2) ESTABLISHMENT.—There is established within the Interagency Committee a Steering Subcommittee for the National Artificial Intelligence Research Resource (referred to in this section as the ‘NAIRR Steering Subcommittee’).
(3) CHAIR AND ASSISTANT CHAIRS.—the Director of the Office of Science and Technology Policy. The Director of the Office of Science and Technology Policy may establish assistant chairs of the NAIRR Steering Subcommittee based on members of the NAIRR Steering Subcommittee rotating into the assistant chair positions on a predetermined schedule.
(4) MEMBERSHIP.—The Director of the Office of Science and Technology Policy shall select members of the Interagency Committee to serve on the NAIRR Steering Subcommittee that the Director determines—?
?‘‘(A) have substantial expertise;
?‘‘(B) have substantially funded or conducted artificial intelligence research and development; or
?‘‘(C) have some other significant relationship with the NAIRR. ‘‘
(5) CHANGES TO NAIRR STEERING SUBCOMMITTEE COMPOSITION.—Not less frequently than once a year, the Director of the Office of Science and Technology Policy shall review the composition of the NAIRR Steering Subcommittee and update such composition, which may include adding or removing members from the NAIRR Steering Subcommittee, if necessary. ‘‘
(6) SUBCOMMITTEES AND WORKING GROUPS.—The NAIRR Steering Subcommittee may establish subcommittees, working groups, or other permanent or temporary bodies of certain members of the NAIRR Steering Subcommittee.?
The bill text for S.2714 is here.
In the Sixth Edition of the AI Healthcare Report, H.R. 3831 sponsored by Rep. Ritchie Torres [D-NY-15] was mentioned. Rep. Dan Goldman [D-NY-10] is the latest cosponsor of the bill.
In the Twelfth Edition of the AI Healthcare Report, H.R. 5173 by Rep. August Pfluger [R-TX-11] was discussed. The bill text for the legislation has been released. A few key details are below:
Section 60102(o)(2) of the Infrastructure Investment and Jobs Act (47 U.S.C. 1702(o)(2)) is amended by inserting after ‘‘Act’)’’ the following: ‘‘, except for section 552 of that title (commonly referred to as the ‘Freedom of Information Act’)’’.
The bill text for H.R. 5173 is here.
State Legislation
What I am reading
I am reading Possible Minds: Twenty-Five Ways of Looking at AI, which examines the history of AI and its different applications.
Coming up
August Recess is here, which means no committees are scheduled to meet for hearings.
Helpful Resources
Well shared ??OAT aims to increase the quality of healthcare services with telehealth initiatives.The FDA has published a notice of an open workshop called "Workshop To Enhance Clinical Study Diversity".