Expanded Information Block Rules Go into Effect
Podcast: Interoperability: The Provider Perspective - Diagnosing Health Care
Podcast–Interoperability: How Far We’ve Come and Where We’re Going - Diagnosing Health Care
The New Information Blocking Rule: What It Means For Hospices
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
On January 29, 2026, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (“ASTP/ONC”) released the Draft United States Core Data for Interoperability Version 7...more
Our Health Care Group reviews recent developments signaling a shift toward more active enforcement of the 21st Century Cures Act’s information blocking requirements and what digital health entities should expect in 2026....more
The Health Insurance Portability and Accountability Act (HIPAA) has long been the cornerstone of patient privacy and data protection. Among its most patient-centric provisions is the Right of Access rule, which guarantees...more
The FDA released updates to two guidance documents on January 6: General Wellness: Policy for Low Risk Devices (General Wellness) and Clinical Decision Support Software (CDS). FDA did not issue a traditional press release;...more
On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) software. The January 2026 guidance supersedes the previous, and less detailed,...more
On January 6, 2026, the US Food and Drug Administration (FDA) issued two revised guidance documents relating to general wellness products (General Wellness Guidance) and clinical decision support software (CDS Software...more
On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support Software (2026 CDS Software Guidance)....more
The United States Food and Drug Administration (FDA) issued revisions this month to its guidance documents "Clinical Decision Support Software" (CDS Guidance) and "General Wellness: Policy for Low Risk Devices" (General...more
On December 29, 2025, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more
On January 6, the Food and Drug Administration (FDA) updated its guidance documents on Clinical Decision Support (CDS) software and general wellness products, and withdrew its guidance on the adoption of international...more
In a September 3 Press Release, the U.S. Department of Health and Human Services (HHS) announced that it is increasing efforts to curb information blocking. This was quickly followed by a September 4 Enforcement Alert issued...more
Federal enforcement of information blocking rules has entered a new era. On September 3, the US Department of Health and Human Services (HHS) issued a press release announcing a “crackdown” on the “harmful practice” of...more
The US Department of Health and Human Services (HHS) announced, on September 3, 2025, a major enforcement initiative targeting “information blocking” – the practice of restricting access, exchange, or use of electronic health...more
The US Department of Health and Human Services (HHS) announced its intent to begin actively enforcing the information blocking regulations adopted under the 21st Century Cures Act, in a press release on September 3, 2025, and...more
FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more
On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more
In September 2022, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Clinical Decision Support Software,” representing a shift from what was proposed in the 2019 draft guidance. The guidance document is...more
On May 13, 2021, MITRE Corporation, a non-profit that provides engineering and technical guidance for the federal government, published a long-awaited report proposing a National Strategy for Digital Health (the “Report”)....more
The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more
You’d be forgiven in the current climate of coronavirus and election season, to name just a couple hot issues of the day, for missing two recent announcements from the FDA about its digital health program. On September 14,...more
The Department of Health and Human Services released its draft 2020-2025 Federal Health IT Strategic Plan for public comment. This article outlines the goals of the plan, as well as challenges in healthcare that ONC hopes the...more
NOTE FROM THE EDITORS - Welcome to the first issue of "Vital Signs"—a refreshed and reframed revival of Jones Day's Digital Health Law Update, given our long-standing commitment, experience, and leadership in digital...more
The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more
This post is the first in a series of three in which we recap the Food and Drug Administration’s somewhat difficult year, having spent the majority of it without a permanent Commissioner and facing a slew of political and...more
Digital health offers huge potential for improving care and alleviating the increasing burden on our over-stretched healthcare systems. However, its uptake remains slow and varies significantly across the EU....more