The Department of Health and Human Services’ (HHS') investigation unit and health IT offices are stepping up enforcement of information blocking committed by providers, health IT developers and health information exchanges, the department announced Wednesday.
The news comes as President Donald Trump’s HHS is trying to improve the flow of patient health information by securing voluntary commitments by 60 major healthcare and tech companies to advance interoperability.
A press release from the department says Secretary Robert F. Kennedy Jr. has “directed increased resources” to investigate and enforce information blocking rules.
The Office of the Assistant Secretary for Technology Policy (ASTP/ONC) has already begun to review reports of information blocking and provide technical assistance to the HHS’ Office of Inspector General (OIG) to assist its investigations, Assistant Secretary Thomas Keane, M.D., said in a statement.
Certified health IT developers and health information networks could face penalties of up to $1 million per violation or have their certifications terminated. Medicare and Medicaid providers could be subject to disincentives under those programs, the HHS wrote.
“Information blocking was not a priority under the Biden Administration,” the HHS said. “That changed under President Trump and Secretary Kennedy.”
Commenters on the ASTP/ONC and the Centers for Medicare and Medicaid Services’ (CMS') May request for information on health technology noted that information blocking is still common among healthcare entities, despite it being explicitly prohibited in the 2016 21st Century Cures Act.
Several comment letters stated that EHR companies and other health IT developers have incentives to not share data because it is a valuable “competitive advantage,” as the Connected Health Initiative wrote. Data are “trapped in a limited number of competing vendor ecosystems,” Premier said in its comment letter to the agencies.
Premier wrote that large EHR companies force digital health tools to undergo rigorous technical and procedural processes to connect their applications, which is a form of anticompetitiveness with their own native applications.
“Unblocking the flow of health information is critical to unleashing health IT innovation and transforming our healthcare ecosystem,” said Deputy Secretary of Health and Human Services Jim O’Neill. “We will take appropriate action against any health care actors who are found to be blocking health data for patients, caregivers, providers, health innovators, and others.”
In addition to the voluntary pledges signed by the private sector in July, the CMS unveiled a new voluntary interoperability framework. Healthcare organizations that align with the interoperability framework will be designated CMS Aligned Networks.
“Patients must have unfettered access to their health information as guaranteed by law. Providers and certain health IT entities have a legal duty to ensure that information flows where and when it’s needed,” acting Inspector General Juliet T. Hodgkins said in a statement. “HHS-OIG will deploy all available authorities to investigate and hold violators accountable. We are committed to enforcing the law and protecting patients’ access to health information.”
The HHS urged patients and innovators to report information blocking to the agency.