Yesterday, the White House’s Make America Healthy Again (MAHA) Commission, led by the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. released its inaugural health report titled, Make Our...more
Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more
2/13/2025
/ Artificial Intelligence ,
Chevron Deference ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
Investment ,
Investors ,
Legislative Agendas ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Machine Learning ,
Medical Devices ,
Medicare Advantage ,
Popular ,
Prescription Drugs ,
Private Equity ,
Regulatory Agenda ,
Regulatory Reform ,
SCOTUS ,
Technology Sector ,
Trump Administration
As the new year begins, change is afoot inside the Beltway as the 119th Congress gets underway and Washington prepares for President Trump’s second administration. While change is bringing uncertainty on some fronts, health...more
1/6/2025
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Consolidated Appropriations Act (CAA) ,
DEA ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Federal Funding ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Over The Counter Drugs (OTC) ,
Pharmacy Benefit Manager (PBM) ,
Policies and Procedures ,
Trump Administration
AdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based...more
Most presidents spend the first days of their administration reversing the policies of their opposite party predecessor and laying the groundwork for their own policies with a series of executive orders. President Trump is...more
11/15/2024
/ Artificial Intelligence ,
China ,
Department of Health and Human Services (HHS) ,
Deregulation ,
Diversity and Inclusion Standards (D&I) ,
Environmental Policies ,
EU ,
Immigration ,
International Emergency Economic Powers Act (IEEPA) ,
Liquid Natural Gas ,
National Security ,
NGOs ,
Policies and Procedures ,
Tariffs ,
Tax Cuts and Jobs Act ,
Trade Act of 1974 ,
US Trade Policies
Last year, both Congress and the Biden-Harris administration noticeably increased their attention on Artificial Intelligence (AI). Key congressional committees explored AI implications for health care & life sciences, and the...more
1/5/2024
/ AHRQ ,
Algorithms ,
Artificial Intelligence ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Transparency
Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more
1/2/2024
/ Appropriation ,
Artificial Intelligence ,
Clinical Laboratories ,
Congressional Oversight ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Drug Pricing ,
Fiscal Year ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Medicare ,
Mental Health ,
Pharmaceutical Industry ,
Price Transparency ,
Proposed Rules ,
Supply Shortages
Key Points -
President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more
11/13/2023
/ Abbreviated New Drug Application (ANDA) ,
Artificial Intelligence ,
Critical Infrastructure Sectors ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HITECH Act ,
Joe Biden ,
Life Sciences ,
Machine Learning ,
ONC ,
Popular
Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more