The 21st Century Cures Act: Updates and News

The 21st Century Cures Act is a federal law that promotes interoperability and the free exchange of health information. It requires healthcare providers and payers to give patients access to electronic healthcare records without delay or expense. Specifically, vendors should be able to provide United States Core Data for Interoperability (USCDI) information electronically via application program interfaces (APIs) that can be accessed on mobile health apps. The Office of the National Coordinator of Health IT (ONC) Information Blocking Rule and the Centers for Medicare and Medicaid Services (CMS) Interoperability and Patient Access Rule are the implementing regulations for the 21st Century Cures Act. Since this act became law in late 2016, the compliance deadline for the information blocking regulations applicability was April 5, 2021. At the end of 2022, there were three updates to the law.

As defined in the 21st Century Cures Act, information blocking is a practice that interferes with, prevents, or materially discourages the access, exchange, or use of electronic health information (EHI). Healthcare providers and software developers accused of information blocking could be investigated by the Office of Inspector General (OIG). All healthcare providers and payers must comply with the act and recent updates.

All EHI now falls under the Cures Act rule and must be made available upon authorized request from patients, providers, payers, and health information systems. Beginning October 6, 2022, the definition of “information blocking” in 45 CFR 171.103 no longer limits what is considered EHI to the data elements represented in the USCDI.

As of December 31, 2022, electronic health records (EHR) vendors were to have the criteria outlined by health level 7 (HL7), Fast Healthcare Interoperability Resources (FHIR), standardized APIs, and other implementation specifications completed. By December 31, 2023, EHI export capability must be made available through APIs upon authorized request. 170.315(b)(10) criterion for Electronic Health Information export is also considered part of the 2015 Edition Cures Update; however, its compliance date is December 31, 2023.

Learn more about how Stericycle provides tools and resources for organizations to manage HIPAA compliance.

How does the 21st Century Cures Act impact medical research?

The Cures Act reduces administrative burdens and makes it easier for data sharing among National Institutes of Health-supported research. The act also improves privacy for research volunteers.

How does the 21st Century Cures Act address mental health?

The act calls for the following funding for mental health: $1 billion to states to address the opioid epidemic, $30 million for suicide prevention, $12.5 million for expanded crisis response capabilities, and $5 million for the identification and treatment of maternal depression.

How does the 21st Century Cures Act affect the regulation of medical devices?

The Breakthrough Devices Program hopes to provide patients and providers with faster access to medical devices by speeding up the assessment and review process while maintaining the proper standards to gain market approval and clearance.

How does the 21st Century Cures Act affect the FDA approval process?

As described in Section 3033 of the 21st Century Cures Act, Regenerative Medicine Advanced Therapy (RMAT) expedites the approval of certain drugs that are intended to “treat, modify, reverse, or cure a serious life-threatening disease or condition.”

What is the role of the 21st Century Cures Act to the National Institutes of Health (NIH)?

The act gives NIH the tools and resources to advance biomedical research, from foundational basic research studies to advanced clinical trials. The NIH will receive $4.8 billion in funding over the next ten years.

How is the 21st Century Cures Act funded?

There is an FDA Innovation Account in which the FDA receives provisions to carry out the act and plan the allocation of certain funds from fiscal year (FY) 2017 to FY 2025.