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 with 25 other federal organizations, the purpose of this strategic Plan is to create overall

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 Provider Order Entry (CPOE) continues to be the preferred method of order entry, healthcare team

In September 2023, the Centers for Medicare & Medicaid Services (CMS) released a new state total cost of care (TCOC) model called the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model. This model follows in the footsteps of other successful state total cost of care (TCOC) models to improve health care spending, improve

The ever-changing healthcare policy landscape will witness at the federal level regulatory changes driven by the need to transform healthcare delivery, quality and innovation. Looking forward in 2024, this summary examines a number of healthcare innovation topics that have seen significant policy activity in recent years and that are relevant to healthcare stakeholders, including providers,

On January 30, the Centers for Medicare & Medicaid Services’ (CMS’) Innovation Center announced that sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT) Access Model, a model for eligible states and pharmaceutical manufacturers designed to improve Medicaid beneficiaries’ access to cell and gene therapies.

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

On October 24, 2023, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (“MHRA”) jointly released a publication identifying five guiding principles for predetermined change control plans (“PCCP”) for machine learning-enabled medical devices (“MLMD Guiding Principles”).

On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued final guidance entitled, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring,” (the Final Guidance) to provide clarification on its enforcement policies and premarket review expectations for certain non-invasive remote monitoring devices used for patient monitoring at the conclusion of

On December 22, 2023, FDA issued final guidance–Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. This final guidance is aimed at sponsors and others who may be involved in remote data acquisition for clinical trials to evaluate medical products. As digital health technologies (DHTs) used for remote data acquisition are playing