The AI Healthcare Report: 9/22/23
Dylan Reid(Moskowitz)
Government Affairs|Specialized in AI Healthcare|Health Policy and Tech
Welcome to the Eighteenth Edition of the AI Healthcare Report! The Aggies are playing the Auburn Tigers tomorrow at noon EST. Hopefully, we will get into the rankings again after this week after beating Auburn. The Rangers are now only a 0.5 games back from the Astros. Tickets for Rodeo Houston are now available for purchase?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
Rep. Mike Carey [R-OH-15] was quoted from the Ways and Means Committee Hearing on Flawed Implementation of the No Surprises Act as saying the following:
"Do you have any concerns that patient access to care, which is already in jeopardy due to the health care workforce challenges that we face, will be diminished due to the implementation of this law at all?”
How would you use AI to make it easier for patients to find the doctor that they need? There is no right or wrong answer. Please submit your thoughts below.
Friendly Reminder
The Senate HELP Committee AI White Paper by RM Cassidy is here .
Please submit feedback and comments to [email protected] by TODAY!
Writing Projects
Below are a few writing projects I have done and a few working papers.
Case Study: Working Paper on AI in Healthcare in Jackson, MS
Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence; Draft Guidance for Industry; Availability
The FDA announces its draft guidance for industry entitled "Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence." The guidance follows up from its 2019 draft guidance and the 1998 guidance “Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products”. While nothing has changed since 1998, counsel from the FDA is needed to better understand "well-controlled clinical investigations" and its evidence.
Please submit comments by December 18, 2023.
The Federal Register link is here .
Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry; Availability
The FDA declares its draft guidance for industry “Regulatory Considerations for Prescription Drug Use-Related Software." The guidance is based upon the drug labeling authority of the FDA regarding related software implemented on behalf of a drug sponsor with a prescription, prescription-drug lead, or a drug-device combination product.
Please submit comments by December 18, 2023.
The Federal Register link is here .
Food and Drug Administration Information Technology Strategy; Request for Comments
The FDA publicizes its IT strategic plan “FDA Information Technology Strategy”. As part of its duty on user fees and Omnibus bill requirements, the agency will construct a strategic plan by September 29, 2023.
Please submit comments by October 30, 2023
The Federal Register link is here .
Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies; Guidance for Industry, Investigators, and Institutional Review Boards; Availability
Final guidance has been completed by the FDA titled “Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” The guidance aims to help sponsors of clinical trials of medical products when there are major disasters or public health emergencies.
The Federal Register link is here .
Scientific Challenges and Opportunities To Advance the Development of Individualized Cellular and Gene Therapies; Request for Information
The FDA and the Center for Biologics Evaluation and Research (CBER) is soliciting information regarding scientific challenges in and opportunities in individualized cellular and gene therapies. From the responses gathered, the FDA plans to use the information for upcoming meetings that would help determine future courses of action.
Please submit comments by November 20, 2023.
The Federal Register link 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.
Federal Legislation
S. 2855- A bill to modernize and streamline the permitting process for broadband infrastructure on Federal land, and for other purposes.
Sponsor: Sen. John Barrasso [R-WY]
Cosponsor: Sen. Krysten Sinema [I-AZ]
The legislation increases coverage and access for broadband internet to those who do not have access to the internet by making the permitting process more efficient. The latest action on the bill is that it has been read twice and referred to the Committee on Energy and Natural Resources.
S. 2799- A bill to direct the Secretary of Health and Human Services to establish an Office of Rural Health, and for other purposes.
Sponsor: Sen. Cindy Hyde-Smith [R-MS]
Cosponsor: Sen. Jeff Merkley [D-OR]
The legislation aims to make an Office of Rural Health at HHS. The bill has been read twice and has been referred to the Committee on Health, Education, Labor, and Pensions. A few key details of the bill are below:
(1) Serving as the primary point of contact in the Centers for Disease Control and Prevention on matters pertaining to rural health.?
(2) Assisting the Director of the Centers for Disease Control and Prevention in conducting, coordinating, and promoting research regarding public health issues affecting rural populations, and in disseminating the results of such research.?
(3) Working with all personnel and offices of the Centers for Disease Control and Prevention to develop, refine, coordinate, and promulgate policies, best practices, lessons learned, and innovative, successful programs to improve care and services (including through telehealth) for rural populations.?
(4) Coordinating and supporting rural health research, conducting and supporting educational outreach, and disseminating evidence-based interventions related to health outcomes, access to health care, and lifestyle challenges, to prevent death, disease, injury, and disability, and promote healthy behaviors in rural populations.?
领英推荐
The link to the bill is here .
S. 2871- A bill to advance Federal Government innovation through the implementation and use of multi-cloud computing software technology, and for other purposes.
Sponsor: Sen. Steve Daines [R-MT]
Cosponsor: Sen. Jacky Rosen [D-NV]
The bill enacts a framework for the adoption of multi-cloud computing software technology in the federal government. The bill has been read twice and has been referred to the Committee on Homeland Security and Government Affairs.
H.R.5541 - TREAT Act
Sponsor: Rep. Bob Latta [R-OH-05]
Cosponsor: Rep. Debbie Dingell [D-MI-06]
The TREAT Act aims to provide temporary licensing for telehealth and interstate healthcare. The bill has been referred to the Energy and Commerce Committee. A few key details of the bill are below:
?(b) SCOPE OF TELEHEALTH SERVICES.—Telehealth services authorized by this section are mental health services provided to any patient regardless of whether the health care professional has a prior treatment relationship with the patient, provided that, if the health care professional does not have a prior treatment relationship with the patient, a new relationship may be established only via a written acknowledgment or synchronous technology.?
(c) INITIATION OF TELEHEALTH SERVICES.—Before providing telehealth services authorized by this section, the health care professional shall—
(1) verify the identification of the patient receiving health services;
(2) obtain oral or written acknowledgment from the patient (or legal representative of the patient) to perform telehealth services, and if such acknowledgment is oral, make a record of such acknowledgment; and?
(3) obtain or confirm an alternative method of 4 contacting the patient in case of a technological failure.
?(d) WRITTEN NOTICE OF PROVISION OF SERVICES.—As soon as practicable, but not later than 30 days 8 after first providing services pursuant to this section in a jurisdiction other than the jurisdiction in which a health care professional is licensed, certified, or otherwise authorized, such health care professional shall provide written notice to the applicable licensing, certifying, or authorizing authority in the jurisdiction in which the health care professional provided such services…
The link to the bill is here .
H.R.5547 - Maintaining Investments in New Innovation Act
Sponsor: Rep. Wiley Nicke; [D-NC- 13]
Cosponsors: Reps. John Joyce [R-PA-13] and Donald Davis [D-NC-1]
The legislation provides protections to genetically target technologies. The bill has been referred to the Committees on Energy and Commerce and Ways and Means for a period to be determined by the Speaker of the House. A few key details of the bill are below:
Section 1192(e) of the Social Security Act (42 U.S.C. 1320f–1(e)) is amended—?
(1) in paragraph (1)(A)(ii), by inserting ‘‘(or, in the case of an advanced drug product (as defined in paragraph (4)), 11 years)’’ after ‘‘7 years’’; and?
?(2) by adding at the end the following new paragraph: ‘‘
(4) ADVANCED DRUG PRODUCT DEFINED.—?
For purposes of paragraph (1)(A)(ii), the term ‘advanced drug product’ means a drug that incorporates or utilizes a genetically targeted technology (as defined in section 529A(c)(2) of the Federal 15 Food, Drug, and Cosmetic Act) that may result in the modulation (including suppression, up-regulation, or activation) of the function of a gene or its associated gene product.’’.?
The link to the bill is here .
H.R.5526 - Seniors’ Access to Critical Medications Act of 2023
Sponsor: Rep. Diana Harshbarger [R-TN-01]
Cosponsors: Rep. Debbie Wasserman-Schultz [D-FL-25], Chuck Fleischmann [R-TN-03], Donald Davis [D-NC-01], Mariannette Miller-Meeks [R-IA-01], Troy Balderson [R-OH-12], Bill Johnson [R-OH-06]
The legislation aims to clarify the in-office ancillary in-services exception to the physician self-referral prohibition for drugs under Medicare. The bill has been referred to the Committees on Energy and Commerce and Ways and Means for a period to be determined by the Speaker of the House. A few key details of the bill are below:
(a) IN GENERAL.—Section 1877(b)(2) of the Social 7 Security Act (42 U.S.C. 1395nn(b)(2)) is amended by adding at the end the following new sentence: ‘‘With respect to services consisting of drugs, and any supplies necessary to administer such drugs, furnished on or after May 11, 2023, the requirement that such drugs and supplies be furnished in accordance with subparagraph (A)(ii) 13 in order to qualify as a case described in this paragraph shall not apply.’’.?
(b) WITHDRAWAL OF FAQS.—The Secretary of Health and Human Services shall remove the frequently asked questions and answers published on the website of the Centers for Medicare & Medicaid Services on September 20, 2021, and May 19, 2023, which prohibit or seek to prohibit the arrangement described in the amendment made by subsection (a) and those frequently asked questions and answers shall be deemed to have never been published.?
The link to the bill is here .
State Legislation
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 .
Coming up
Date: September 27th, 2023 at 3:30pm
Helpful Resources