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OOn May 24, 2025, Robert F. Kennedy, Jr. and the Make America Healthy Again (MAHA) Commission are expected to submit the Make our Children Healthy Again Assessment to President Trump as required by the President’s February 13 Executive Order (EO) establishing the Commission.[1] The EO directed Secretary Kennedy and the MAHA Commission to assess potential contributors to childhood chronic disease in America, focusing on the American diet, absorption of toxic material, medical treatments, lifestyle, environmental factors, Government policies, and food production technique.Continue Reading MAHA’s Vision for Healthier Diets: Awaiting Concrete Steps and Assessing Challenges 

This year, thousands of individuals in Southern California were impacted by the Palisades Fire and Eaton Fire. The fires were the second and fourth most destructive in the state’s history.[1] In 2024, millions of individuals in the southeastern United States were impacted by Hurricanes Helene and Milton. These hurricanes made landfall less than two weeks apart, establishing a new record for the shortest interval between two significant hurricanes in Florida.[2] The Southern California wildfires and Hurricanes Helene and Milton exemplify the pattern of increasingly severe and frequent natural disasters attributed to a changing climate. Such climate-related disasters have profound implications for healthcare systems, underscoring the necessity for coordinated efforts between federal and state governments to ensure the continuity of healthcare services and access to medical care. As a result of the Southern California wildfires, over 700 people were evacuated from nursing homes and other care facilities.[3] In Florida alone, over 350 healthcare facilities were evacuated as a preventative measure against Hurricane Milton.[4] Hundreds of other healthcare facilities throughout the region faced evacuations, closures, and damage as result of the hurricanes. Preparedness and swift response measures at all levels of government are essential to safeguard lives in the face of natural disasters.Continue Reading The Role of Federal and State Governments in Maintaining Healthcare During Natural Disasters

The Centers for Medicare & Medicaid Services (CMS) Innovation Center (the Innovation Center) published its data-sharing strategy, which seeks to further enable data sharing while ensuring proper security, risk management, and privacy obligations. The strategy outlines the Innovation Center’s approach to identifying data sharing needs across Innovation Center models and highlights the importance of data in developing and testing innovative healthcare payment and service delivery models.Continue Reading CMS Innovation Center Outlines Data Sharing Principles

On July 25, the Department of Health and Human Services (HHS) announced a number of organizational changes, including renaming the Office of the National Coordinator for Health Information Technology (ONC) to the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (ASTP/ONC), among other actions. These organizational changes reflect heightened focus to provide oversight and issue policies governing the use of individuals’ health data and the development of artificial intelligence (AI) technologies. It also demonstrates HHS’ aim to address recent cyberattacks against the healthcare sector entities.Continue Reading HHS Reorganizes ONC and Bolsters AI Leadership

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 Exchange Framework and Common Agreement (TEFCA) for nationwide health information exchange.  Seven years later, on December 12, 2023, ONC announced that the nationwide health data exchange governed by TEFCA is operational. At the signing event, many Department of Health and Human Services (HHS) officials celebrated the announcement including Secretary Xavier Becerra, Deputy Secretary Andrea Palm, and National Coordinator for Health Information Technology, Micky Tripathi.Continue Reading The Trusted Exchange Framework and Common Agreement (TEFCA) and State Data Exchange is Moving Forward in 2024

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 implementing digital healthcare solutions. AHRQ also released a separate implementation guide (the Guide) to outline best practices and examples to implement the Framework. The Framework’s guiding principles provide a clear purpose for the Framework and development of its domains while the separate Guide provides actionable steps on how to implement the Framework.

Digital healthcare developers and vendors, health systems, health plans, and clinical providers should review the Framework and Guide to assess equity during each phase of the digital healthcare lifecycle for digital health technologies. Specifically, the Framework recommends that these stakeholders should consider the Framework’s principles and recommendations to address the accessibility, purpose, security, privacy features, usability, and safety concerns applying to digital solutions.Continue Reading AHRQ Outlines Principles and Recommendations to Advance Digital Healthcare Equity

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, healthcare AI systems and tools have both clinical and administrative applications, namely monitoring patients, recommending treatments, predicting health trajectories, recording clinical notes, optimizing operational processes, and supporting population health management.

The Department of Health and Human Services (HHS) and federal agencies have been developing policies to advance transparency and manage risks for the development and use of AI/ML-powered health care technologies. Most recently, the Office of the National Coordinator for Health Information Technology (ONC) issued regulations that addresses predictive models and health AI systems.Continue Reading Taking a Closer Look at ONC’s AI Transparency Regulations

On November 28, Crowell Health Solutions published a white paper outlining several policy recommendations to advance widespread adoption of decentralized clinical trials (DCTs). The white paper titled, “Advancing Adoption of Decentralized Clinical Trials: Rationale, Current State, and Policy Recommendations” examines the current environment on decentralized and hybrid clinical trials, including a discussion on benefits and challenges that DCTs may pose; existing legislation and regulation; and background on programs and policies that can be leveraged to support DCT adoption.Continue Reading Crowell Health Solutions Examines the Adoption of Decentralized Clinical Trials and Provides Policy Recommendations

Rapid developments and competition in artificial intelligence (AI) will drive proliferation of new AI technologies in health care in the coming years, along with a number of legal and ethical issues.

ChatGPT 3.5 created a huge splash, rife with controversy, when it was released in November 2022. Launched by the San Francisco-based startup OpenAI, ChatGPT is a natural language processing (NLP) model (a type of machine learning (ML)), that automatically learns and recognizes patterns. ChatGPT uses a neural network architecture to generate human-sounding responses to questions, providing users with large amounts of potentially useful information in seconds. According to a recent review, ChatGPT demonstrated that it was capable of passing all three parts of the U.S. Medical Licensing Exam (USMLE), which tests medical students on topics including the basic sciences, clinical knowledge and patient treatment and diagnosis, without any specialized training. ChatGPT also showed proficiency in medical charting, diagnosing, and performing nonclinical tasks. OpenAI recently launched ChatGPT 4.0, which offers expanded capabilities and improved performance on various professional and academic assessments.Continue Reading AI in Health Care: AI Bill of Rights, Future Regulations, and What Business Should Consider Now