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
HHS Ramps Up Enforcement Against Information Blocking- 2025 marks a significant turning point in federal enforcement against “information blocking” in healthcare. In a series of announcements this September, the U.S....more
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
We were told it would arrive, heard it was on the brink, and now it is here. In the opening session of the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy (ASTP) 2026 Annual...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
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
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
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
On September 3, 2025, the U.S. Department of Health and Human Services (HHS) announced that HHS would increase resources to enforce the information blocking prohibition under the 21st Century Cures Act. Generally, the...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
On December 17, 2024, 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 August 5, 2024, the Office of the National Coordinator for Health Information Technology— now known as the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (“ASTP/ONC”) within the...more
On June 31, 2024, the Department of Health and Human Services (“HHS”) published a final rule establishing penalties for healthcare providers who violate the information blocking rules implemented under the 21st Century Cures...more
Healthcare providers are facing penalties for blocking access to a patient’s electronic health information under a new Biden administration rule. On June 24, the U.S. Department of Health and Human Services (HHS)...more
Last week, HHS published its final rule outlining disincentives for certain healthcare providers that have committed information blocking (the Final Rule). The Final Rule also provides information related to OIG’s...more
The United States Department of Health and Human Services (HHS) has now established disincentives for certain health care providers if found by the Office of Inspector General (OIG) to have committed information blocking...more
The Office of the National Coordinator for Health Information Technology (ONC) released the anticipated Common Agreement Version 2.0 on April 22, 2024. Since 2016, the ONC has been working to implement the requirements of the...more
The public comments are in! The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) are now reviewing the 136 comments they received on a proposed...more
On October 30, 2023, the Department of Health and Human Services (HHS) released a proposed rule establishing penalties for healthcare providers who violate the information blocking rules implemented under the 21st Century...more
The U.S. Department of Health and Human Services (HHS)—through the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC)—recently published a...more
The U.S. Department of Health and Human Services (“HHS”) on October 30, 2023, issued a Notice of Proposed Rulemaking (“NPRM”) to establish penalties for healthcare providers found to have committed information blocking. This...more
On October 30, 2023, the U.S. Department of Health and Human Services (HHS) released a proposed rule (Proposed Rule) to establish disincentives for healthcare providers that engage in information blocking under the 21st...more
In 2020, when the U.S. Department of Health and Human Services (HHS) published its Final Rule to implement the information blocking prohibitions of the 21st Century Cures Act, HHS left healthcare providers wondering what...more
On November 1, 2023, the U.S. Department of Health and Human Services (HHS) published a proposed rule titled “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information...more