On April 25, 2024, the U.S. Food and Drug Administration (FDA) issued and requested public comment on a revised draft guidance (Draft Guidance) providing recommendations related to promotional labeling and advertising that manufacturers, packers, and distributors (collectively “Firms”) should consider
Trends in Transformation
Trends in Transformation, published by Crowell & Moring LLP, focuses on legal and regulatory developments affecting the healthcare sector. The blog covers topics such as Medicare and Medicaid payment systems, hospital and long-term care facility reimbursement policies, healthcare innovation strategies, public health emergency responses, and federal and state government roles in healthcare delivery. It also addresses issues related to healthcare quality reporting, digital modernization in healthcare, nutrition and public health policy, and the impact of natural disasters on healthcare systems. The blog provides updates on legislative and administrative actions influencing healthcare providers, payers, and policy stakeholders.
Latest from Trends in Transformation - Page 4
The Trusted Exchange Framework and Common Agreement (TEFCA) and State Data Exchange is Moving Forward in 2024
Health data exchange and interoperability have entered a new chapter in the U.S. In 2016, the 21st Century Cures Act (Cures Act) included a requirement that the Office of the National Coordinator for Health Information Technology (ONC) create a Trusted…
AHRQ Outlines Principles and Recommendations to Advance Digital Healthcare Equity
On April 18, 2024, the Department of Health and Human Services’ (HHS’) Agency for Healthcare Research and Quality (AHRQ) issued the Digital Healthcare Equity Framework (the Framework) to guide users and stakeholders to consider equity throughout the entire lifecycle when…
AHRQ Outlines Principles and Recommendations to Advance Digital Healthcare Equity
On April 18, 2024, the Department of Health and Human Services’ (HHS’) Agency for Healthcare Research and Quality (AHRQ) issued the Digital Healthcare Equity Framework (the Framework) to guide users and stakeholders to consider equity throughout the entire lifecycle when…
An Overview of the ACO Primary Care Flex (ACO PC Flex) Model
In March 2024, the Centers for Medicare & Medicaid Services (CMS) released a new voluntary model called the ACO Primary Care Flex Model (ACO PC Flex Model). This model focuses on primary care delivery within the Medicare Shared Savings Program…
Taking a Closer Look at ONC’s AI Transparency Regulations
In recent years, organizations have been developing and using predictive models, which are powered by artificial intelligence (AI) and machine learning (ML) technologies, for numerous use cases in clinical and health care settings, including to aid in clinical decision-making. Currently,…
Senate HELP Committee Ranking Member Issues Health Data Privacy Policy Recommendations
On February 21, Senator Bill Cassidy (R-LA), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a report to propose policy recommendations to revise the Health Insurance Portability and Accountability Act of 1996 (HIPAA) framework and…
Senate HELP Committee Ranking Member Issues Health Data Privacy Policy Recommendations
On February 21, Senator Bill Cassidy (R-LA), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a report to propose policy recommendations to revise the Health Insurance Portability and Accountability Act of 1996 (HIPAA) framework and…
ONC Releases an Updated Draft of Their 2024–2030 Federal Health IT Strategic Plan
The Office of the National Coordinator for Health Information Technology (ONC) released a draft of their 2024–2030 Federal Health IT Strategic Plan (Draft Strategic Plan) on March 27, 2024, updating the 2020-2025 Federal Health IT Strategic Plan. In collaboration…
CMS Issues Guidance on HIPAA-Compliant Secure Texting Platforms
On February 8, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a quality standard memorandum (Memorandum) clarifying that hospitals and critical access hospitals (CAHs) may transmit patient information and orders via text message under certain conditions. Although Computerized…