In July, the Senate Armed Services Committee passed its version of the FY 2025 National Defense Authorization Act (NDAA), which would make substantial changes to the rules for determining the “country of origin” of drugs for...more
Efforts to curtail U.S. reliance on biotechnology companies in the People’s Republic of China (PRC) and prevent certain data of U.S. persons from being provided to the Chinese Communist Party (CCP) have come to the fore this...more
On April 26, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS) finalized updates to regulations implementing Section 1557 of the...more
Life sciences and health care companies are heavily regulated under the rigorous standards of the U.S. Food and Drug Administration to ensure high levels of quality and patient safety. However, companies seeking to advance...more
The U.S. Federal Trade Commission (FTC) staked out its role in policing the potential competition and consumer protection implications of generative AI technologies’ use of copyrighted materials in comments submitted in the...more
President Joe Biden signed a sweeping executive order on artificial intelligence (AI) spurring broad U.S. government action on AI safety, security, and trust and reinforcing Congressional interest in AI....more
The rapid growth of AI and its ramifications for nearly all aspects of society and the economy is placing increasing pressure on the U.S. and European governments to proactively set regulations and guardrails for this nascent...more
On April 11, the U.S. Department of Health & Human Services (HHS) Office of the National Coordinator (ONC) posted a proposed rule entitled, “Health Data, Technology, and Interoperability: Certification Program Updates,...more
While the Medicare statute provides access to healthcare services for our nation’s elderly and disabled populations, it also can serve to foreclose access for those populations when an item or service does not fall within one...more
The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently hosted a one-day virtual public workshop entitled,...more
On February 13-14, 2023, the Centers for Medicare & Medicaid Services (CMS) convened a virtual panel of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to evaluate changes to the criteria for clinical...more
On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant drug pricing-related provisions. The bill generally revives many of the drug pricing provisions...more
At our recent Health Care AI Law and Policy Summit, Hogan Lovells partner Melissa Bianchi moderated a panel discussion on the state of the health care AI industry. Joined by representatives from the American Medical...more
At our recent Health Care AI Law and Policy Summit, Hogan Lovells partner Stuart Langbein moderated a panel discussion on AI policy and reimbursement issues. Joined by representatives from CMS Medicare Administrative...more
Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: FDA warns...more
This morning, the U.S. House passed drug pricing legislation as part of the Build Back Better Act (BBBA) (specifically the Rules Committee version available here and the manager’s amendments available here). In prelude to...more
The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the Republican-led H.R. 19, the “Lower Costs, More Cures Act of 2021” and a reintroduced...more
4/26/2021
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