Cures Act

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Two recent federal cases are providing insight into what to expect in state court litigation related to information blocking, defined in the 21st Century Cures Act (Cures Act) as a practice that interferes with the access, exchange, or use of electronic health information. 

On March 12, 2025, the Fourth Circuit upheld the Maryland District Court’s preliminary injunction for the plaintiff in Real Time Medical Systems Inc. v. PointClickCare Technologies, 131 F.4th 205 (2025).  In sum, the Fourth Circuit agreed with the District Court that PointClickCare’s “use of indecipherable CAPTCHAs and choice to block certain users is illegal under the information-blocking provision of the federal Cures Act, which supports [Real Time’s] unfair competition claims” under Maryland law.  The Fourth Circuit relied in part on Intus Care, Inc. v. RTZ Assocs., Inc., Case No. 24-cv-01132, 2024 U.S. Dist. LEXIS 100190 (June 5, 2024), where a District Court judge found that a violation of the Cures Act would constitute an “independently wrongful” act sufficient to support a claim for intentional interference with prospective economic advantage under California law, even though the Cures Act lacks a private right of action.Continue Reading Recent Federal Cases on Information Blocking Violations Pave Way for State Court Claims and Shed Light on Manner Exception

On January 18, 2022, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the entity chosen as a contracting partner, The Sequoia Project, Inc., published the long-awaited Trusted Exchange Framework and Common Agreement (TEFCA) for health information exchange. In simple terms, TEFCA is a framework that health information networks (HINs) may enter into to share health data with other HINs, individuals, and entities. The stated goal of TEFCA is to develop uniform policies and technical requirements to scale health information exchange nationwide and ensure that HINs, health care providers, health plans, individuals, and other stakeholders can access real-time, interoperable health information.
Continue Reading ONC Releases a Framework for Nationwide Health Information Exchange

Last week, the Center for Medicare & Medicaid Services (CMS) finalized long-awaited regulations on Interoperability and Patient Access (the “CMS Rule”) to require Medicare Advantage plans, Medicaid and Children’s Health Insurance Program (CHIP) managed care plans, state agencies, and Qualified Health Plan (QHP) issuers on federally-facilitated exchanges (“CMS Payers”) to provide patients easy access to their claims and encounter information, as well as certain clinical information, through third-party applications of their choice. On the same day, the Office of the National Coordinator for Health Information Technology finalized its rules on Interoperability, Information Blocking, and the ONC Health IT Certification Program (the “ONC Rule”) related to the 21st Century Cures Act (Cures Act). The CMS Rule and ONC Rule have far-reaching impacts.

As individuals and organizations covered by the rules are considering how they may facilitate their access to health information to support patients, health care providers, and others, it is important to understand when provisions in the rules will be effective and timing and what acts may constitute violations of these rules.  To help clients get familiar with these deadlines, we are providing this summary chart of compliance requirements and applicable deadlines to help your organization prepare for upcoming enforcement of the ONC Rule and the CMS Rule.  For legal advice tailored to the specific needs of your organization, please reach out to Jodi Daniel, head of the firm’s Digital Health Practice at jdaniel@crowell.com.

As you read the chart, you should keep the following in mind:Continue Reading Compliance Reference Chart for ONC and CMS Interoperability Rules