21st Century Cures Act: Implementation Update

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The Office of the National Coordinator for Health IT (ONC) has come under fire for what some consider a slow implementation of the 21st Century Cures Act (Cures Act), which was passed in 2016. The Cures Act was designed to help accelerate medical product development and bring new innovations and advances to patients in need more efficiently.

The Cures Act authorized $500 million over the course of nine years to help the United States Food and Drug Administration (FDA) cover the cost of implementing the law. The ONC has laid the groundwork to release information blocking regulations, improve patient health data access, promote interoperability, among other objectives outlined in the Cures Act. In December 2018, Donald Rucker, MD, provided testimony to the House Committee on Energy & Commerce Subcommittee on Health regarding the steps ONC is taking to ensure the directives and goals of the Cures Act are reached in the near future.

“The Cures Act directs the HHS Secretary to adopt standards and policies that advance health IT to enable and stimulate the trusted exchange of electronic health information,” explained Rucker. “The Cures Act, thus, materially advances our mission to enable patients’ records to follow them when and where they need it.”

ONC established the Health IT Advisory Committee (HITAC) in January 2018 to support the flow of information and provide recommendations to the National Coordinator about achieving the goals set forth in the Act. The establishment of this committee specifically fulfills provision 4003(e) of the Cures Act.

ONC is also working to increase connectivity by establishing the Trusted Exchange Framework and Common Agreement (TEFCA.) The Cures Act called for a trusted exchange framework and common agreement, which will help to expand health data exchange nationwide. In January 2018, ONC released the first draft of TEFCA and gathered public comment from stakeholders across the healthcare sector. “ONC received more than 200 comments on the draft, and plans to release an updated draft for public comment in the coming months,” said Rucker.

ONC also expects TEFCA will support community exchange efforts and improve interoperability for patients with behavioral health conditions such as substance use disorders and mental illness. “Health information networks, as intrinsically local resources, are positioned to more effectively connect patients with the clinical services and social supports they need,” noted Rucker.

ONC has also made progress toward implementing an EHR Reporting Program in accordance with Section 4002 of the Cures Act. The EHR Reporting Program will provide publicly available, comparative information on certified health IT products.

ONC received 77 public comment submissions in response to its request for information (RFI) to inform the development of reporting criteria and other components of the program.

Combined, these resources and regulations will help to ensure patients, providers, and other stakeholders can exchange and use health information without special effort. “In summary, ONC has made great progress towards implementing key provisions of the 21st Century Cures Act,” according to Rucker. “These actions will maximize the potential of health IT and result in improved care and reduced cost.”

Further progress continues to be made in regular intervals, with the proposed rule to implement the “information blocking” prohibition released earlier this month.

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