Did You Know? The Recently Passed 21st Century Cures Act Includes Significant Health IT Regulations

Within the recently signed bill, The 21^st Century Cures Act, is a powerful set of regulations about interoperability, EHR certification, health information exchange, information blocking, and more.

The 21^st Century Cures Act bill was enacted after being signed by former President Obama on December 13, 2016. The Act provides funding through 2026 for the Cancer Moonshot project, Precision Medicine, brain and stem cell research, and opioid crisis funding for states, in addition to streamlining research processes for new drug therapies, clinical trials and vaccines, and for antimicrobial resistance monitoring and research.

Section 4, which starts on page 125 of the bill, is where things get interesting for Health Information Technology. The law sets out to improve electronic health record (EHR) use and oversight and move the dial on nationwide data interoperability. It includes previously unseen strong language on encouraging interoperability of EHRs, discouraging information blocking, reducing physician documentation burden, as well as creating a reporting system on EHR usability. Here are some highlights (direct quotes are from the text of the final bill):

EHR Certification – the bill establishes new requirements for health IT interoperability through EHR certification rules with the expectation of facilitating better data transfer between disparate systems. For example, it calls for the use of a national API standard that covers authentication, security, auditability, and deeper data interoperability. “One year after the enactment of Cures, the Secretary through rule making, shall require that a health information technology developer or entity does not take any action that constitutes information blocking, does not prohibit or restrict communications, has published application programming interfaces (API), has successfully tested the real world use of the technology for interoperability, has provided the Secretary with certain performance attestations, and has submitted reporting criteria.”

Information Blocking – new certification rules must ensure a health IT developer does not engage in intentional information blocking, or they could face fines of up to $1 million. The bill defines information blocking  as “likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information; and if conducted by a health information technology developer, exchange, or network, such developer, exchange, or network knows, or should know, that such practice is likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information; or if conducted by a health care provider, such provider knows that such practice is unreasonable and is likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information.”  

Meaningful Use and Quality Programs – calls for HHS to evaluate current programs with the intention to reduce administrative burden and spur increased technology adoption. “…establish a goal with respect to the reduction of regulatory or administrative burdens (such as documentation requirements) relating to the use of electronic health records.” The bill also includes language supporting specialists and other providers who traditionally have not had EHRs available for incentive program participation.

Electronic Health Record Reporting Program – calls for a group of stakeholders to set reporting standards for interoperability, security and EHR certification. “The Secretary shall award grants, contracts or agreements to independent entities to collect the information required to be reported. Includes the authorization of $15 million to support the ONC’s certification process.”

Interoperability – The bill defines interoperability as follows:

• “Enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user”
• “Allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law”
• “Does not constitute information blocking”

It includes new language instructing HHS to convene “public-private and public-public partnerships to build consensus and develop or support a trusted exchange framework, including a common agreement among health information networks nationally.” Upon consensus, the framework will be published and a list of those in common agreement will be published within two years.

The Bottom Line - All of this being said, a new administration is in place, including a new Secretary of HHS, who will be tasked with interpreting the language in this bill. So it remains to be seen how impactful the act will be on Health IT and the other areas covered within. But many are hopeful and welcome the stronger language included in the bill. The 21^st Century Cures Act will certainly be interesting to follow in the years to come.

Additional Resource: College of Healthcare Information Management Executives (CHIME) crosswalk of Health IT Provisions in the Committee Print of the 21st Century Cures Act (dated November 25, 2016), H.R. 6 (21st Century Cures Act) and S. 2511 (Improving Health Information Technology Act)