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
The Centers for Medicare & Medicaid Services (CMS) released its Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies on Jan....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 April 18, the Office of the National Coordinator for Health Information Technology (ONC) formally published its proposed rule titled Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm...more
On November 4, 2020, the US Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) published an interim final rule with comment period in the Federal Register that...more
In an effort to provide additional relief to a health care system strained by the COVID-19 pandemic, the Office of the National Coordinator for Health IT (“ONC”) released an Interim Final Rule with Comment Period (“IFC”) on...more
On October 29, 2020, the Office of the National Coordinator for Health Information Technology (ONC) announced it was delaying the compliance deadlines for information blocking and other health IT provisions initially...more
As promised, here is a summary of some key provisions in CMS’ proposed rule relating to the Medicare Advantage and Part D programs for contract years 2021 and 2022. CMS is soliciting comments on a number of issues and we urge...more
On February 5, 2020, the Centers for Medicare and Medicaid Services (CMS) proposed removing long-standing prohibitions and eligibility restrictions that had barred many individuals with End-Stage Renal Disease (ESRD) from...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
The Medicaid program generally has more generous coverage rules for children than for adults. For example, under the Early and Periodic Screening, Diagnostic and Testing (EPSDT) provisions of the Medicaid statute, if a...more
On October 17, 2019, the Department of Health & Human Services (HHS) published two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that, if...more
The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more
On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more
• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions. • The revised draft guidance on CDS further elaborates on how to make CDS...more
The U.S. Food and Drug Administration (FDA) continues advancing regulatory policies tailored to the digital health community. On September 26, 2019, the agency issued a series of guidance documents that interpret several of...more
The Office of the National Coordinator for Health Information Technology (ONC) recently released a proposed rule aimed at promoting the interoperability of health information technology and enabling access to electronic...more
On March 4, 2019, HHS published a proposed rule, which includes a request for public comment on the implications of requiring providers to make public disclosures of price information for the services they perform. The 21st...more
On February 11, 2019, CMS issued a proposed rule, to improve access to electronic health information (the Proposed Rule). The Proposed Rule results from the 21st Century Cures Act (the Cures Act), in which CMS and the Office...more
On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more
As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more
Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Roadmap” addresses continued focus on digital health, among other priorities,...more
On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Clinical and Patient Decision Support Software” (“CDS Guidance”). According to FDA Commissioner Scott Gottlieb, M.D., the CDS...more
On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more