CMS

On July 30, 2025, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) announced a new Health Technology Ecosystem Initiative—a collaborative effort between government and industry to unlock innovation by modernizing healthcare data flows among patients, providers, payers, and technology platforms. The new initiative does not contemplate any new regulations; instead, it is a CMS-led effort intended to empower and accelerate innovation by the private sector through (i) the development of public digital infrastructure and data standards and (ii) voluntary commitments from industry to deliver new technology solutions based on a common data-sharing framework.

It is too early to predict how successful the Health Technology Ecosystem will be—the stubborn prevalence of data silos, lack of interoperability between systems, and challenges with using data for secondary purposes have long been a hurdle to innovation—yet, with 60 organizations, including leading tech firms, already pledging support for the new initiative, the broader industry may see this as an occasion for renewed focus and expanded efforts to bring health technology solutions to market at scale. For life sciences and digital health companies, this new initiative may present a strategic opportunity to better serve patients, empower providers, improve real-world evidence generation, and support innovation leading to better healthcare outcomes. Continue Reading What Life Sciences and Digital Health Companies Need to Know About CMS’s New Health Technology Ecosystem Initiative

On September 15, 2021, CMS published a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule (“MCIT/RN Rule”), which was published on January 14, 2021 and was set to take effect on December 15, 2021.  The MCIT/RN Rule would have…
Continue Reading CMS Proposal Would Impact Coverage of Innovative Digital Health Technologies

On April 21, 2020, the Department of Health and Human Services (“HHS”) announced that, as a response to the COVID-19 public health emergency, it will exercise enforcement discretion to “permit compliance flexibilities” regarding the implementation of the interoperability final rules issued on March 9th, 2020.  This joint announcement was made…
Continue Reading HHS Announces Enforcement Discretion Over the Implementation of Interoperability Final Rules Due to COVID-19 Public Health Emergency

On April 19, 2019, the Department of Health and Human Services (HHS) announced a 30-day extension to the comment period for two rules proposed by the HHS Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), originally published on March…
Continue Reading Update: HHS Extends Comment Period for Interoperability Proposed Rules

Digital health record

On March 4, 2019, the Department of Health and Human Services (HHS) published two proposed rules to improve patient access to personal health data. The two rules, issued by the HHS Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC),…
Continue Reading Patient Access to Electronic Health Data at the Forefront of Two HHS Proposed Rules

On February 29, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a State Medicaid Directors Letter (SMDL) that expands the scope of expenditures eligible for the 90 percent federal match for activities to promote the use of a health information exchange (HIE) and the adoption of certified electronic health record (EHR) technology by Medicaid providers.

Specifically, this updated guidance permits States to claim the enhanced match for expenditures that promote coordination of care between entities eligible for EHR incentive payments and other Medicaid providers who may not necessarily qualify for such payments.   This SMDL supersedes earlier guidance that did not permit the enhanced match for these activities.Continue Reading CMS Expands Scope of Enhanced Match for Promotion of Health IT

Last week, the chairmen and ranking members of the Senate Committee on Health, Education, Labor, and Pensions and the Senate Committee on Finance sent a letter to Andy Slavitt, Acting Administrator for the Centers for Medicare & Medicaid Services (“CMS”), and Jocelyn Samuels, Director of the Health and Human Services (“HHS”) Office for Civil Rights (“OCR”), requesting information on how HHS “is working to support and protect victims of medical identity theft” in order to “assess the adequacy of current efforts.”
Continue Reading Senators Request Information from HHS About Medical Identity Theft Efforts