Cybil Roehrenbeck

Nov 12, 2024 | jdsupra.com | Cybil Roehrenbeck

In the wake of the biggest American political comeback in more than 100 years, stakeholders in the health industry are asking themselves: What does this portend for health policy—patients, providers, manufacturers, and insurers? This memorandum, prepared before the majority for the U.S. House of Representatives has been determined, provides a high-level overview of the ‘What’ and ‘When’ we can expect in health policy over the coming months and next two years. Deep FDA Reform.

Apr 12, 2024 | jdsupra.com | Melissa Bianchi |Beth Roberts |Cybil Roehrenbeck

On May 1-2, Hogan Lovells is hosting its annual Health Care AI Law and Policy Summit, an informative and interactive program where our thought leaders and industry guests will address a variety of topics including new and emerging health care AI policies and regulatory considerations, implications for ethics and consumer safety, developments in the U.S., UK, and EU, and more. You can register for the Summit online here.

Apr 12, 2024 | lexology.com | Melissa Bianchi |Beth Roberts |Cybil Roehrenbeck

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 innovative health-related AI technologies must also be mindful of U.S. federal and state policy developments impacting their products and services.

Apr 17, 2023 | jdsupra.com | Cybil Roehrenbeck

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, Algorithm Transparency, and Information Sharing.” The Notice of Proposed Rulemaking (NPRM) includes proposals to "promote greater trust in the predictive decision support interventions (DSIs) used in healthcare to…enable users to determine whether predictive DSI is fair,...

Mar 28, 2023 | jdsupra.com | Melissa Bianchi |Cybil Roehrenbeck |Victoria Wallace

To its credit, the Centers for Medicare & Medicaid Services (CMS) is working to provide access to innovative technology where it can. For example, in the CY 2023 hospital outpatient rulemaking, CMS created a pathway to separate payment for AI-based diagnostic services, and the agency is expected to issue rulemaking providing a pathway to temporary transitional coverage for certain innovative technologies this Spring.