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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 June 24, 2024, the Department of Health and Human Services (“HHS”) released a final rule (“Disincentives Final Rule”) establishing disincentives for certain healthcare providers that have committed information blocking. The information blocking disincentives directly impact Medicare-enrolled healthcare providers or suppliers including hospitals, critical access hospitals, MIPS-eligible clinicians, and ACOs. The Disincentives Final Rule has been submitted to the Office of the Federal Register for publication and will become effective 30 days after Federal Register publication.Continue Reading Healthcare Providers Who Engage in Information Blocking Will Face Disincentives Described in an HHS Final Rule    

On December 13, 2023, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.Continue Reading ONC Releases Final Rule on Information Blocking and Health IT Certification Program Updates, Including Requirements Related to AI

On January 19, 2022, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published the Trusted Exchange Framework and Common Agreement (TEFCA) for health information exchange. The Trusted Exchange Framework established a set of non-binding, foundational principles for trust policies and practices to help facilitate…

The Russia-Ukraine conflict is increasing the risk of ransomware attacks and other cyber threats for U.S. companies, and those in the health care industry may be targeted. In a recent analyst note from the Department of Health & Human Services (“HHS”), HHS describes the cyber capabilities of Russia, one of the world’s major cyberpowers, and analyzes two malware variants most likely to impact the U.S. health care and public health sector.
Continue Reading Increased Cyber Risk for Health Care Organizations Due to the Russia-Ukraine Conflict

This article was originally published in Corporate Compliance Insights.

Both your company’s data supply chain and its physical version have fundamentally similar business risks. Given the consequences of unethical practices along both, enterprises can no longer ignore how data is sourced, how it is managed or where it is going.

While many organizations go to great lengths to monitor their physical supply chain, their data supply chain often gets short shrift. For any company interacting with large sets and various streams of information, this can represent a significant exposure to risk.

Since the first investigation under the U.S. FCPA concerning a third party acting on behalf of a U.S. company was initiated nearly 40 years ago, upholding integrity in global supply chains has garnered attention. Rightfully so, as compounding risks in physical production and movement of goods abound upstream (e.g., forced labor, conflict materials, environmental impact) and downstream (e.g., bribery, fraud, misuse).
Continue Reading Is Your Data Supply Chain Ethical? Don’t Restrict Due Diligence to Physical Operations.

Last week, the Office of the National Coordinator for Health Information Technology (ONC)  published an Interim Final Rule: Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency (Interim Final Rule) providing needed relief to entities working toward compliance.  In the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Rule), issued on May 1, 2020, ONC defines the entities that are subject to the rule’s provisions. ONC refers to these entities as Actors. Actors include health care providers, health IT developers of certified health IT, Health Information Exchanges (HIEs), and Health Information Networks (HINs). The Interim Final Rule provides these Actors with “additional flexibilities” to implement the provisions of the ONC Rule including updated compliance dates.  ONC explained that the extension is due to the outbreak of COVID-19 public health emergency; however, this will also provide ONC with additional time to provide answers to the numerous questions that the agency has received as Actors work toward compliance. ONC is accepting comments on this rule, as is typical for an interim final rule. These comments must be submitted to regulations.gov by January 4, 2021.

The Interim Final Rule extends “the applicability date for the information blocking provisions and compliance dates and timeframes for certain Program requirements, including compliance dates for certain 2015 Edition health IT certification criteria and Conditions and Maintenance of Certification requirements.” See CMS and ONC Enforcement Deadlines Chart for more information about compliance dates for the ONC Rule.

Information BlockingContinue Reading ONC Issues Interim Final Rule Extending Compliance Dates for the Information Blocking and the ONC Health IT Certification Program

On April 30, 2020, the Centers for Medicare and Medicaid Services (CMS) announced a second round of regulatory waivers and rule changes in an interim final rule with comment (IFC) that added significant flexibilities for the coverage of telehealth services furnished by a broader set of eligible clinicians and in nontraditional health settings during the…

This week CMS continued its rapid response—average approval takes less than a week—to review and approve Social Security Act Section 1115(c) Appendix K and Section 1135 waivers to facilitate state Medicaid programs’ efforts to address the COVID-19 pandemic. CMS approved waiver applications from Colorado, Connecticut, Delaware, Hawaii, Idaho, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts,…

On March 23, the Centers for Medicare and Medicaid Services (CMS) approved Section 1135 waiver requests submitted by the California Department of Health Care Services (DHCS) as part of its response to the COVID-19 pandemic.  The waiver requests were submitted by DHCS on March 16 and March 19, 2020.

As discussed in a previous blog post, Section 1135 authorizes the U.S. Department of Health and Human Services to waive federal Medicare, Medicaid, and Children’s Health Insurance Program requirements in order to respond to a public health or national emergency. As of March 24, CMS had approved Section 1135 waivers related to the COVID-19 pandemic from 13 different states.

With the approval granted by CMS, DHCS is permitted to take the following actions in regards to its Medicaid program (Medi-Cal), effective retroactively to March 1 and to extend until the end of the public health emergency:Continue Reading CMS Approves Medi-Cal Section 1135 Waivers