HHS Announces Crackdown on “Information Blocking” Violations

September 9, 2025September 24, 2025 WyattLLP Electronic Health Records, Health Information Technology 21st Century Cures Act, CEHRT, EHR, electronic medical records, Health data access, HHS, information blocking enforcement, ONC

By: Kathie McDonald-McClure

The 21^st Century Cures Act of 2016 (Cures Act) was passed by Congress and signed into law by President Obama on December 13, 2016. The Cures Act seeks to ensure access, exchange, and use of electronic health information. The Act mandated the U.S. Department of Health and Human Services (HHS) to establish rules prohibiting “information blocking” by developers of certified electronic health information technology (CEHRT), healthcare providers, health information networks (HINs), and health information exchanges (HIEs).

HHS, during the first Trump Administration, proposed and finalized initial information blocking rules for CEHRT developers and healthcare providers. The rules were initially set to take effect in November 2020 but were delayed due to the COVID-19 pandemic. The Biden Administration HHS announced that there would be no further delays and those initial information blocking rules became effective on April 21, 2021. These rules are applicable to developers of CEHRT and healthcare providers as well as HINs and HIEs. See 45 C.F.R. Part 171—Information Blocking and see our April 6, 2021 article discussing these complex rules, “Information Blocking Rule Effective April 5, 2021: Are Providers Ready?”

The next mandate under the Cures Act was to establish civil monetary penalties (CMPs) for CEHRT developers and “appropriate disincentives” for healthcare providers who violate the information blocking rules. The Biden Administration HHS Office of Inspector General (OIG) proposed and finalized the CMPs of not more than one million dollars per violation for CEHRT developers who commit information blocking. Those rules became effective September 1, 2023. See 42 C.F.R. Part 1003 Subpart N.

The Biden Administration HHS also proposed and finalized the disincentives for certain healthcare providers who run afoul of the information blocking rule. These disincentives became effective on July 31, 2024. See 45 C.F.R. 171.1000.

On September 3, 2025, HHS, under the direction of Secretary Robert F. Kennedy, Jr., announced a crackdown on information blocking violations. The announcement states that the Cures Act was “published” during the first Trump Administration despite being signed into law by President Obama. The announcement goes on to say that “[i]nformation blocking was not a priority under the Biden Administration” despite the implementation of penalties and disincentives for violations.

Nevertheless, it is important to note the intent of HHS under Secretary Kennedy to prioritize enforcement of the information blocking rules. The announcement summarizes the penalties and disincentives for information blocking violations. The disincentives for hospitals, critical access hospitals, and clinicians are not as straightforward as the CMPs for CEHRT developers because they are tied to Medicare payment formulas. Although not detailed in the HHS announcement, we discuss the disincentives in more depth in our July 3, 2024 article, “HHS Adds New Teeth to Information Blocking Law for Health Care Providers.”

Looking for assistance in navigating compliance and avoiding the pitfalls associated with the information blocking rules? We work with our clients regarding their policies and procedures related to compliance with information blocking, HIPAA and other data privacy and security laws and regulations. If you are looking for assistance in this area, contact Kathie McDonald-McClure at (502) 562-7526 or Margaret Levi Young at (859) 288-7469. To learn more about Wyatt’s health care, data privacy and cyber security practice, visit the following Wyatt website pages: Wyatt Data Privacy & Cyber Security and Wyatt Health Care.

HHS Adds New Teeth to Information Blocking Law for Health Care Providers

July 3, 2024October 17, 2024 Kathie McDonald-McClure Cures Act and Program Interoperability, Electronic Health Records, Health Information Technology, HITECH Law, Meaningful Use Accountable Care Organizations, ACOs, civil penalties, Critical Access Hospitals, eligible hospitals, health information blocking, Health Information Technology, meaningful use of certified EHR, Medicare, Merit-based Incentive Payment System, MIPS, MSSP, ONC, Promoting Interoperability Program, Shared Savings Program

by Margaret Young Levi, Kathie McDonald-McClure, and Drayden Burton (Wyatt Summer Associate)

On July 1, 2024, the U.S. Department of Health and Human Services (HHS) published a final rule entitled “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking,” 89 Fed. Reg. 54662 (Final Rule) establishing “disincentives” for health care providers who commit information blocking. Importantly, the 21^st Century Cares Act explicitly delegated the authority to HHS to establish “appropriate disincentives” for information blocking through notice and comment rulemaking. 42 U.S. Code § 300jj–52(b)(2)(B). Previously, on October 23, 2023, HHS published its proposed rule seeking comments on the proposed appropriate disincentives (Proposed Rule).

In general, “information blocking” means knowingly and unreasonably interfering with, preventing, or materially discouraging the access, exchange, or use of “electronic health information” (EHI) unless such blocking is required by law or permitted by regulatory exceptions. To learn more about information blocking and the permitted exceptions, see our article “Information Blocking Rule Effective April 5, 2021: Are Providers Ready?,” which provides an overview of the Rule’s key elements and requirements. The prohibition on information blocking went into effect on April 5, 2021, but until now did not contain any penalties for health care providers who engage in information blocking. Previously, on June 27, 2023, the HHS Office of Inspector General (HHS-OIG) established civil monetary penalties of up to $1 million per information blocking violation by developers of certified health information technology and for health information networks (HINs) and health information exchanges (HIEs). (88 Federal Register 42820).

This Final Rule adds some teeth, aiming to ensure that individuals and their health care providers always have access to the individual’s health information. Some of the comments that HHS had received to its Proposed Rule supported disincentives that incentivize an exchange of EHI across care settings on the basis that this will lead to better patient outcomes. In issuing its Final Rule HHS stated, “When health information can be appropriately accessed and exchanged, care is more coordinated and efficient, allowing the health care system to better serve patients.”

The “Disincentives”

The Final Rule establishes certain “disincentives” for several categories of health care providers that HHS-OIG finds to have engaged in activities that interfere with or prevent access to EHI that constitute information blocking. These disincentives are as follows:

INFORMATION BLOCKING RULE EFFECTIVE APRIL 5, 2021: ARE PROVIDERS READY?

April 6, 2021July 15, 2021 WyattLLP Cures Act and Program Interoperability, Health Information Technology 21st Century Cures Act, electronic health information, health information blocking, ONC, patient right of access

By Kathie McDonald-McClure and Margaret Young Levi

The Information Blocking Final Rule, a provision of the 21st Century Cures Act geared towards ensuring access, exchange and use of electronic health information (EHI), was published on May 1, 2020, and became effective on June 20, 2020. However, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health IT (ONC) extended the compliance effective dates for the Final Rule several times over the last year—and most providers were hopeful that it would be extended once again—but there are no more delays. Information Blocking compliance is now effective, as of April 5, 2021. Health care providers should take immediate steps to ensure compliance.

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Stages 1, 2, And Now 3, Meaningful Use Criteria

April 17, 2015 Margaret Young Levi Electronic Health Records, Health Information Technology, HITECH Law, Meaningful Use CEHRT, Centers for Medicare & Medicaid Services, CMS, EHR, Health Information Technology, Meaningful Use, Medicaid Electronic Health Record, Medicare Electronic Health Record, ONC

The Centers for Medicare & Medicaid Services (“CMS”) proposed Meaningful Use criteria to implement Stage 3 and allow eligible professionals, eligible hospitals and critical access hospitals (“CAHs”) to qualify for incentive payments (or avoid downward payment adjustments) under the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program implemented by the Health Information Technology for Economic and Clinical Health (“HITECH”) Act of 2009. Then CMS made changes to Stage 1 and Stage 2 Meaningful Use criteria to better align with the proposed Stage 3 criteria just two weeks later.

On March 30, 2015, CMS published a long-awaited proposed rule which, if finalized, would implement Stage 3, making changes to the objectives and measures of meaningful use for providers effective in Continue reading →

HHS Announces Dramatic Increase in Adoption of Electronic Health Records

May 23, 2013March 12, 2014 Kathie McDonald-McClure Electronic Health Records, Eligible Professional Incentives, Health care reform, Health Information Technology, HITECH Law, Hospital EHR Incentives, Meaningful Use, Physician EMR Stimulus ARRA, Electronic Health Records, Health Information Technology, HITECH Act, linkedin, meaningful use of certified EHR, ONC

On May 22, 2013, Kathleen Sebelius, Secretary of the United States Health & Human Services Department, announced that over 50 percent of doctors and over 80 percent of hospitals are making a “meaningful use” of electronic health records (EHRs) and have received incentives for such use. By comparison, in 2008, just nine percent had adopted EHRs. Secretary Sebelius credits the “dramatic increase” in adoption of EHRs to the Health Information Technology for Economic and Clinical Health Act (HITECH Act) that was passed as part of the American Recovery and Reinvestment Act of 2009 (ARRA). The HITECH Act awards incentives to eligible professionals (physicians) and hospitals who make a “meaningful use” of EHR technology that has been certified by the HHS Office of National Coordinator of Health Information Technology (ONC). The HHS press release with further information is available here.