Search results for: "information blocking"

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 June 27, 2023, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“OIG Final Rule”) that implements statutory provisions for its enforcement of the information blocking penalties created by the 21stCentury Cures Act (“Cures Act”) and assessment of civil money penalties (“CMPs”) of up to $1 million per violation of information blocking for certain individuals or entities subject to the information blocking requirements.

Continue Reading HHS-OIG Releases Final Rule Implementing Information Blocking Penalties

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 Blocking

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

The federal government has spent billions to promote adoption and “meaningful use” of health information technology (HIT). There is growing government interest in ensuring that HIT is used to support patient care, but doing so requires electronic exchange of information. Congress, the Department of Health and Human Services (HHS), and States have taken action to identify and prevent “information blocking”—interference with the exchange or use of electronic health information—by health care providers, hospitals, technology developers, and service providers. And there likely will be more guidance, statutory and regulatory changes, and enforcement by federal agencies and states in the coming year.

Congress Requests Information and Takes Action

On December 21, 2014, Congress raised concerns about health information blocking, claiming that such activities “frustrate Congressional intent” under the Health Information Technology for Economic and Clinical Health (HITECH) Act, “devalue taxpayer investments,” and make HIT “less valuable and more burdensome” to hospitals and health care providers. Congress urged the Office of the National Coordinator for Health Information Technology (ONC) at HHS to certify only HIT that does not block health information exchange. Congress also requested ONC publish a detailed report on the scope of health information blocking and a strategy to address it, within 90 days.

Continue Reading Health Information Blocking Leads to New Requirements and May Lead to Enforcement Actions

On April 10, ONC released its Report to Congress on Health Information Blocking (the “Report”).  Here is a brief summary of the report, the full text of which is available here.

ONC has stated that its views health information blocking as frustrating the goals of HITECH and the Meaningful Use initiative.  ONC defines information blocking as conduct which:

  1. Interferes with the ability of authorized persons or entities to exchange electronic health information; and
  2. is done knowingly with the intent to block information exchange; and
  3. is not justified by reasonable business, technological, or public policy reasons.

ONC recognizes that there may legitimate reasons why EHR systems are not interoperable.  The Report focuses on the non-legitimate reasons, and highlights the following behavior:

  1. Contract terms which restrict individuals’ access to their EHR;
  2. Charging prices or fees for data exchange, portability, and interfaces which make exchanging EHR cost prohibitive;
  3. Developing health IT in “non-standard” ways which may increase the costs of sharing health information (particularly when interoperability standards have been adopted);
  4. Developing health IT in ways which may “lock in” users or their data, leading to fraud, waste or abuse, or otherwise impede innovation in health information exchange.

The Report is careful to explain that ONC would weigh such practices against legitimate considerations whether they are technological, regulatory, or economic in nature.

Continue Reading ONC Releases Report to Congress on Health Information Blocking

Federal policy efforts to advance health data exchange and interoperability are continuing to change rapidly. The latest changes are the publication of two final rules by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) finalizing parts of the Health Data, Technology, and Interoperability (HTI-2) Proposed Rule. These rules adopt requirements regarding the Trusted Exchange Framework and Common Agreement (TEFCA) (HTI-2 Final Rule), and create a new Information Blocking exception under Protecting Care Access (HTI-3 Final Rule), published on December 16th and 17th, respectively.

Continue Reading End of Year Regulations on Interoperability

In recent years, organizations have been developing and using predictive models, which are powered by artificial intelligence (AI) and machine learning (ML) technologies, for numerous use cases in clinical and health care settings, including to aid in clinical decision-making. Currently, healthcare AI systems and tools have both clinical and administrative applications, namely monitoring patients, recommending treatments, predicting health trajectories, recording clinical notes, optimizing operational processes, and supporting population health management.

The Department of Health and Human Services (HHS) and federal agencies have been developing policies to advance transparency and manage risks for the development and use of AI/ML-powered health care technologies. Most recently, the Office of the National Coordinator for Health Information Technology (ONC) issued regulations that addresses predictive models and health AI systems.

Continue Reading Taking a Closer Look at ONC’s AI Transparency Regulations

The ever-changing healthcare policy landscape will witness at the federal level regulatory changes driven by the need to transform healthcare delivery, quality and innovation. Looking forward in 2024, this summary examines a number of healthcare innovation topics that have seen significant policy activity in recent years and that are relevant to healthcare stakeholders, including providers, plans, electronic health record (EHR) vendors and health technology companies.

Stakeholders should use this summary to examine existing regulatory and compliance gaps, prepare their organizations to comply with forthcoming federal regulations, and keep apprised of federal funding opportunities. For more information on these policy developments, please contact the professionals listed below, or your regular Crowell contact.

Continue Reading Healthcare Policy Developments to Watch in 2024