THIS WEEK’S DOSE

• Senate HELP Committee Releases HIPAA Modernization White Paper: Sen. Cassidy (R-LA), Ranking Member of the Senate Health, Education, Labor & Pensions (HELP) Committee, released a white paper entitled “Strengthening Health Data Privacy for Americans: Addressing the Challenges of the Modern Era.”
• House Creates Bipartisan AI Task Force: The task force will explore how Congress can ensure that the United States continues to lead the world in artificial intelligence (AI) innovation while considering guardrails that may be appropriate.
• ARPA-H Announces Women’s Health Focus: The Advanced Research Projects Agency for Health (ARPA-H) announced the Sprint for Women’s Health, committing $100 million toward research and development.

CONGRESS

Senate HELP Committee Releases HIPAA Modernization White Paper. The white paper discusses three categories of potential health data privacy legislative action:

1. Updates to the existing Health Insurance Portability and Accountability Act (HIPAA) framework
2. Health data in areas where regulation may be unclear, including intake services, the removal of health data from HIPAA, patient-generated wellness data, sensor-generated data and direct-to-consumer-collected genetic data
3. Data outside of HIPAA

In September 2023, Sen. Cassidy released a request for information (RFI) posing more than 35 questions to stakeholders on ways to improve privacy protections for health data to safeguard sensitive information. The RFI helped inform the themes and legislative proposals in this white paper. The paper does not discuss specific next steps, although it alludes to working with the HELP Committee to advance legislation.

House Creates Bipartisan AI Task Force. Speaker of the House Johnson (R-LA) and House Democratic Leader Jeffries (D-NY) announced the creation of a bipartisan task force on AI. The task force consists of 24 members representing key committees of jurisdiction, with 12 appointed by each party leader. It will be jointly led by Chair Obernolte (R-CA) and Co-Chair Lieu (D-CA) and is tasked with producing a comprehensive report that will include guiding principles, forward-looking recommendations and bipartisan policy proposals developed in consultation with committees of jurisdiction.

Rep. Obernolte, who serves on the House Energy and Commerce Committee and has been active in health policy this year, specified in the announcement that the report is expected to detail the regulatory standards and congressional actions necessary to protect consumers and foster continued investment and innovation in AI. The timing of the report was not specified.

ADMINISTRATION

ARPA-H Announces Women’s Health Focus. The Sprint for Women’s Health commits $100 million toward research and development in women’s health. ARPA-H will seek funding proposals with innovative, evidence-based ideas from a diverse mix of scientific community members. According to the release, awardees will develop unconventional approaches and innovative avenues to advance high-impact biomedical research.

In the coming weeks, specific topics developed by ARPA-H program managers will be announced as part of a new request for solutions funding opportunity. The forthcoming request for solutions will solicit ideas for novel groundbreaking research and development to address women’s health, as well as opportunities to accelerate and scale tools, products and platforms with potential for commercialization to improve women’s health outcomes. Multiple awards under this request for solutions are anticipated. Exact award amounts depend on meeting aggressive milestones, typical to the ARPA-H model. Awardees and potential additional funding opportunities will be announced later in the year.

The ARPA-H Sprint for Women’s Health will be conducted in collaboration with the Investor Catalyst (IC) Hub of ARPANET-H, the agency’s nationwide health innovation network that connects people, innovators and institutions to improve health outcomes. Organizations interested in becoming a part of the IC Hub can learn more on the IC Hub website.

QUICK HITS

• House Energy & Commerce Members Urge FDA to Advance Clinical Trial Diversity Efforts. Ranking Member Pallone (D-NJ), Health Subcommittee Ranking Member Eshoo (D-CA), and Oversight and Investigations Subcommittee Ranking Member Castor (D-FL) wrote to US Food and Drug Administration (FDA) Commissioner Robert M. Califf, MD, calling on the agency to move forward with guidance to improve the diversity of populations represented in clinical trials.
• Administration Awards $5.1M in Support of LGBTQI+ Youth and Families. The Substance Abuse and Mental Health Services Administration announced four awards totaling $5.1 million for family counseling and support for lesbian, gay, bisexual, transgender, queer/questioning, intersex+ youth and their families. The awardees will engage LGBTQI+ youth and their families to prevent risk of health conditions and promote well-being for LGBTQI+ youth by establishing tailored family counseling and support programs.
• GAO Releases Report on Student Veteran Mental Health. The US Government Accountability Office (GAO) reviewed US Department of Veterans Affairs (VA) documentation and data for fiscal years 2017 – 2022 on mental healthcare use and diagnoses, and interviewed 12 student veterans identified by a veterans service organization. GAO recommended that VA communicate comprehensive information on when and how to implement a Veterans Integration to Academic Leadership program across its healthcare systems on a regular basis. VA concurred with GAO’s recommendation.
• GAO Releases Maternal Health Report. GAO found that maternal mortality and other adverse outcomes associated with pregnancy or childbirth worsened significantly in 2020 and 2021 compared to 2018 and 2019, and disparities in outcomes persisted throughout the pandemic. GAO recommended that the US Department of Health and Human Services (HHS) ensure that the Maternal Health Blueprint’s performance measurement strategy follows key practices. GAO also recommended that the Centers for Disease Control and Prevention establish quantitative targets for the Perinatal Quality Collaborative program’s near-term goals. HHS concurred with GAO’s recommendations and noted plans to address them.

NEXT WEEK’S DIAGNOSIS

The Senate is scheduled to be in session next week, while the House is scheduled to be in recess part of the week, returning to session on February 28, 2024 – two days before the first of two upcoming appropriations deadlines. At the committee level, the House Energy and Commerce Health Subcommittee will hold a legislative hearing on rare disease bills, and the Senate Budget Committee will hold a hearing on reproductive health.