Health

Washington D.C. — House Energy and Commerce Health Subcommittee Chair Brett Guthrie (R-KY) delivered the following opening remarks at today’s Health Subcommittee hearing titled “Understanding How AI is Changing Health Care.” “I would like to thank our witnesses for being here today. This hearing could not be timelier, as our Committee and the Congress as a whole look at issues regarding artificial intelligence, it’s important that we shine a light specifically on the role that AI could play in solving some of our most significant health care problems. “These emerging technologies are already changing the way in which clinicians care for their patients and how researchers conduct clinical trials. “As AI continues to drive innovation in health care, it is essential that Congress examine the meaningful benefits and any potential unintended consequences that these technologies could have. “The potential benefits from artificial intelligence are seemingly without limit. Future technologies could help our health care system save lives by better predicting potential diagnoses and could help us reduce redundancies in our system. “We have already seen this play out in real time over the past several years and have watched unimaginable advances in health care as a result of generative AI.” REAL WORLD AI SUCCESS IN HEALTH CARE   “For example, there are already numerous success stories in using AI for pharmaceutical research and development to get treatments to market sooner. This was the case in the AI-assisted research by MIT scientists that found that the drug Halicin could be used as an effective antibiotic. “We now have multicancer screening diagnostic tools that use AI to help detect early-stage cancers, and AI is even being used in operating rooms to augment existing processes to improve patient outcomes. “However, this is not to say that we should let the use of these technologies go without guardrails. “Over the next several months and years policymakers and those in the health industry will need to answer some fundamental questions regarding the role AI will play in our health care system, including:  “Are the technologies trained with supervised AI using human-generated inputs to drive outcomes? “Are these technologies trained with unsupervised AI that’s generating outcomes based off human behavior to ease everyday decision-making for health care consumers? “Or are these technologies trained with reinforced AI in which humans are rewarding the systems for the outputs generated?   “Those are very complex and difficult things we need to explore as we move forward. “In each of these use cases, it is important to remember that every decision comes with a cost—both human and financial. Wearable devices that are constantly monitoring someone’s heart rate, calorie intake and out-take, and sleep patterns in addition to other metrics that can help lead to healthier lifestyles, and in some cases, to predicting extreme cardiac events or even strokes.”  ENSURING APPROPRIATE GUARDRAILS TO DEPLOY AI SAFETY AND EFFECTIVELY   “In the event of using user data to predict better lifestyle habits, how are we ensuring this user data is secure and ensuring that consumers have full control over this information and not being used or sold without their consent? “In the event of predicting a major health event, are there protocols that should be considered to ensure individuals aren’t taking unnecessary trips to the Emergency Room and potentially incurring significant health care debt as a result? “In closing, I support the real possibilities AI can bring to our health care system, and most importantly, to patients. “We should give the technology the license to coexist alongside clinicians, patients, and innovators as well as regulators while also remaining vigilant of how this technology is being used. “I look forward to the discussion today.” 

Washington D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) delivered the following opening remarks at today’s Health Subcommittee hearing titled “Understanding How AI is Changing Health Care.” A NATIONAL DATA PRIVACY STANDARD   “This is now the fourth hearing that the Energy and Commerce Committee has held across our subcommittees on the subject of artificial intelligence.   “Artificial intelligence has the potential to transform every aspect of our lives—for better or for worse.  “It’s critical that America—not China—is the one addressing AI’s challenges and leading in this technology’s development and deployment.   “The best way to start is by laying the groundwork to protect people’s information with a national data privacy standard.   “This is a foundational first step towards a safe and prosperous AI future, in health care and beyond.  “I look forward to continuing to discuss how we can improve privacy protections for Americans as we incorporate AI tools into our lives, and I’m proud of each of our subcommittee chairs for leading on this important issue.” OPPORTUNITIES FOR AI IN HEALTH CARE “AI has a unique role to play in the future of health care.  “AI could help find the next breakthrough cure or improve our ability to catch deadly diseases earlier.    “We are already seeing that artificial intelligence can be used to aid in the assessment of medical imaging, which one of our witnesses will discuss in detail.  “Additionally, AI is reducing administrative burdens on health care providers.  “We have all heard from the providers in our districts about the burden of necessary but cumbersome paperwork, how this often leads to burnout for our doctors and nurses, and how it eats up time that they could spend providing actual patient care.   “For just about my entire tenure in Congress, one of the top issues that we’ve struggled with has been finding ways to cut paperwork and redundancies in our health care system so that we can let doctors do what doctors do best: treat their patients.  “For years, we’ve nibbled around the edges of this issue, but the future of AI could be transformative and will hopefully let doctors be doctors instead of administrative staff. We’ll hear more from Dr. Schlosser from HCA on how this is being tested out in their hospitals.”  CONCERNS WITH AI IN HEALTH CARE “To be clear, AI will not solve all the problems with the American health care system.  “One concern that we have frequently heard is the potential for human biases to be implicitly baked into AI technologies.  “The first piece of health care legislation that this Committee advanced this year was my bill to ban the usage of Quality Adjusted Life Years—or QALYs—which are discriminatory measures that are used by federal payers to deny health care services to people with disabilities and chronic illnesses.   “If AI is reliant on QALYs or other similar measures when assisting in clinical decision making, our most vulnerable will be left behind.  “No one here wants to advocate for discrimination, and we need to be conscious of how federal programs and AI technologies incorporate these types of biases and what we should be thinking about in this area.” WINNING THE FUTURE “I’ll close by saying that I’m optimistic about the promise of many of these technologies.   “I think these technologies can make a difference in the lives of patients, and this Committee needs to lead the way in supporting innovation.  “For American to lead, we must strike the right balance with AI, one that gives businesses the flexibility to remain agile as they develop these cutting-edge technologies, while also ensuring its responsible use.   “A national standard for the collection and handling of data will provide businesses, health care providers, and every American with clear and understandable protections wherever they are.  “Today’s hearing will hopefully shed more light on the current landscape of AI in health care and hopefully provide us with further insight on next steps that we should take to continue supporting patients.”

Letter comes ahead of Director Cohen’s testimony before Oversight Subcommittee Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight subcommittee Republicans, today wrote to Centers for Disease Control and Prevention Director Mandy Cohen, who is slated to testify before the Oversight Subcommittee tommorrow, November 30. KEY LETTER EXCERPTS :  “ The Centers for Disease Control and Protection’s (CDC) failure to communicate accurate information in real-time during the COVID-19 pandemic has undermined public trust in the agency. If the CDC is to regain credibility with the American people, it must be transparent and forthcoming with the information it has on public health threats facing our nation. “It is widely known that China thwarted international efforts, including efforts by the CDC, to respond to the burgeoning COVID-19 crisis as it began to unfold in China. Even the World Health Organization (WHO), which has long been criticized for being overly accommodating to the Chinese Communist Party (CCP), has called China’s decision to withhold information from the early days of the COVID-19 pandemic ‘simply inexcusable.’ “The WHO has now called on China to provide epidemiologic and clinical information, as well as laboratory results, on the reported pneumonia clusters among children, in addition to information on recent trends of known pathogen circulation. It would be an abdication of the CDC’s duty to the American people if it allows China to repeat its misdeeds from the COVID-19 pandemic. The American people should not have to rely on the unaccountable and untrustworthy WHO to communicate information about Chinese public health threats. Further, we cannot allow the CCP to block the CDC from accessing the information it needs to protect Americans and assist in appropriate public health response efforts.”  The Chairs requested bi-weekly briefings and answers to the following questions by December 13, 2023:  Has the CDC engaged with or interacted with its Chinese counterparts with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia?  If yes, when did the CDC and its Chinese counterparts first interact with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? Who initiated this interaction?  At any point did the CDC’s Chinese counterparts withhold information or fail to respond to the CDC in a timely manner with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? Please detail each instance and the topic of inquiry that prompted such failure to respond in a timely manner. What specific information, if any, has the CDC sought from China with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? What specific information, if any, has the CDC received from China with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? Please detail the length of time it took China to respond to each inquiry for information. What specific response efforts, if any, has the CDC offered to take part in with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia?  What specific response efforts, if any, has the CDC taken part in, is actively taking part in, or plans to take part in with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia?  Has specific information on the outbreak been communicated to relevant federal agencies and/or key stakeholders, including:  The Administration for Strategic Preparedness and Response (ASPR);  The U.S. Food and Drug Administration (FDA);  The National Institutes of Health (NIH); The Surgeon General; Department of Defense; Other Federal entities; and/or  State and local public health officials CLICK HERE to read the letter.

Letter comes ahead of Director Cohen’s testimony before Oversight Subcommittee Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight subcommittee Republicans, today wrote to Centers for Disease Control and Prevention Director Mandy Cohen, who is slated to testify before the Oversight Subcommittee tommorrow, November 30. KEY LETTER EXCERPTS :  “ The Centers for Disease Control and Protection’s (CDC) failure to communicate accurate information in real-time during the COVID-19 pandemic has undermined public trust in the agency. If the CDC is to regain credibility with the American people, it must be transparent and forthcoming with the information it has on public health threats facing our nation. “It is widely known that China thwarted international efforts, including efforts by the CDC, to respond to the burgeoning COVID-19 crisis as it began to unfold in China. Even the World Health Organization (WHO), which has long been criticized for being overly accommodating to the Chinese Communist Party (CCP), has called China’s decision to withhold information from the early days of the COVID-19 pandemic ‘simply inexcusable.’ “The WHO has now called on China to provide epidemiologic and clinical information, as well as laboratory results, on the reported pneumonia clusters among children, in addition to information on recent trends of known pathogen circulation. It would be an abdication of the CDC’s duty to the American people if it allows China to repeat its misdeeds from the COVID-19 pandemic. The American people should not have to rely on the unaccountable and untrustworthy WHO to communicate information about Chinese public health threats. Further, we cannot allow the CCP to block the CDC from accessing the information it needs to protect Americans and assist in appropriate public health response efforts.”  The Chairs requested bi-weekly briefings and answers to the following questions by December 13, 2023:  Has the CDC engaged with or interacted with its Chinese counterparts with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia?  If yes, when did the CDC and its Chinese counterparts first interact with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? Who initiated this interaction?  At any point did the CDC’s Chinese counterparts withhold information or fail to respond to the CDC in a timely manner with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? Please detail each instance and the topic of inquiry that prompted such failure to respond in a timely manner. What specific information, if any, has the CDC sought from China with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? What specific information, if any, has the CDC received from China with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? Please detail the length of time it took China to respond to each inquiry for information. What specific response efforts, if any, has the CDC offered to take part in with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia?  What specific response efforts, if any, has the CDC taken part in, is actively taking part in, or plans to take part in with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia?  Has specific information on the outbreak been communicated to relevant federal agencies and/or key stakeholders, including:  The Administration for Strategic Preparedness and Response (ASPR);  The U.S. Food and Drug Administration (FDA);  The National Institutes of Health (NIH); The Surgeon General; Department of Defense; Other Federal entities; and/or  State and local public health officials CLICK HERE to read the letter.

Washington, D.C. — In a final warning to the Food and Drug Administration (FDA), House Energy and Commerce Committee Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, threatened to issue a subpoena for documents related to risky research conducted at FDA facilities. The letter follows two previous requests for documents regarding experiments involving virus manipulation, which the FDA has acknowledged occurred in some of its research studies.   November 9, 2023  The Honorable Robert M. Califf, M.D., MACC  Commissioner  U.S. Food and Drug Administration  10903 New Hampshire Avenue  Silver Spring, MD 20903  Dr. Califf,  The Committee sent the U.S. Food and Drug Administration (FDA) a letter on March 27, 2023, regarding FDA-funded research that may pose significant biosafety or biosecurity risks. Following the FDA’s insufficient response on May 26, 2023, we sent a follow up letter on June 29, 2023. To date, the FDA has only produced 29 pages of the charter documents for the Institutional Biosafety (IBC) and the Dual Use Research of Concern (DURC) review panel, which were not sent until October 20, 2023. Having not received an adequate response to our follow-up letter, we are sending a formal document request to obtain information needed for our oversight that we requested in the June 29 letter.  Pursuant to Rules X and XI of the U.S. House of Representatives, please provide the following by November 28, 2023:  All coronavirus research studies referenced in the January 31, 2023, email. All studies that have undergone Institutional Biosafety Committee (IBC) review at the FDA since October 1, 2013, and all documents related to the IBC reviews of these studies.   All studies that have undergone Dual Use Research of Concern (DURC) review at the FDA since October 1, 2013, and all documents related to the DURC reviews of these studies.   All policies and/or procedures related to the IBC and DURC processes.   In the May 26, 2023, response letter, the FDA stated that the Center for Biologic Evaluation and Research (CBER) research studies involving coronaviruses and viral manipulation of SARS-CoV-2 “underwent applicable Institutional Biosafety Committee (IBC) review, including attestation by the principal investigator (PIs) regarding Dual Use Research of Concern (DURC) screening.” The FDA added “[n]one of these studies rose to the level of DURC review.” Please provide all documents related to these statements.  In the May 26, 2023, response letter, the FDA stated that a Center for Drug Evaluation and Research (CDER) laboratory performs studies to monitor and evaluate seasonal influenza virus resistance to clinically relevant antivirals. Please provide all documents related to these studies, including the IBC and DURC applications and approvals.   In the May 26, 2023, response letter, FDA stated that FDA requires “any research associated with hazardous biological agents and toxins (HBATs) be subject to full IBC review.” Please provide all documents since October 1, 2013, associated with HBATs, including documents related to full IBC review.  In the May 26, 2023, response letter, the FDA stated that “[s]ince September 2015, and prior to the establishment of the DRP, the FDA’s IBC application process required the attestation of all PIs concerning the nature of their work as it related to DURC policies.” Please provide a copy of the IBC application with the attestation requirement, and all documents related to the establishment of the attestation requirement.  All documents related to all extramural research that have gone through the FDA IBC and/or DURC review since September 1, 2015.    Thus, to carry out our Constitutional responsibilities of oversight, if the FDA does not produce the requested documents by November 23, 2023, it will be necessary to issue a subpoena for documents since the FDA has delayed its response and the committee has a right to obtain these materials to aid in its legislative activities and to ensure that the Executive Branch is complying with the law.  If you have any questions, please contact the Majority Committee staff at (202) 225-3641. Thank you for your attention to this request.  CLICK HERE to view the letter.  CLICK HERE to read the March 27, 2023. letter.  CLICK HERE to read the June 29, 2023, letter. 

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, sent a letter to the Substance Abuse and Mental Health Services Administration. The letter to Assistant Secretary and Administrator Delphin-Rittmon, which is the second follow up from the Committee, serves as the final notice before the Committee will be forced to issue a subpoena. KEY EXCERPTS :  “[…] SAMHSA still has not yet provided the full accounting for billions of dollars in expenditures as requested.”  […]  “Since SAMHSA apparently is not addressing our requests for expenditure information, we now request documents. The Committee’s document requests are specific and reasonable and seek to get full accountability for SAMHSA funds. Unfortunately, SAMHSA has repeatedly not provided requested information about expenditures, nor have any legal reasons been provided for not yet providing the requested information and documents.”  The Chairs requested the following documents by November 27, 2023:  The most recent copies of each state’s Payment Management System and Federal Financial Report draw-down reports for COVID supplemental funding. The most recent copies of Payment Management System and Federal Financial Report draw-down reports for each of the following programs that received COVID-19 supplemental funds: Certified Community Behavioral Health Clinics (CCBHCs); Suicide Prevention Programs; Project AWARE; Tribal Behavioral Health Grants; Substance Use Prevention, Treatment, & Recovery Services Block Grant; Community Mental Health Services Block Grant; National Childhood Traumatic Stress Network; and Community Based Substance Use Disorder Services The most recent copies of each state’s Payment Management System and Federal Financial Report draw-down reports for 9-8-8 crisis care funding.  CLICK HERE to read the full letter.  CLICK HERE to read the Chairs’ April 5, 2023, letter on Covid Spending, Suicide Hotline Rollout, Support for Treating Serious Mental Illness, and New Office of Recovery. CLICK HERE to read the Chairs’ August 10, 2023, follow up letter.