A New Day for Interoperability – The Information Blocking Regulations Start Now

Micky Tripathi and Steven Posnack | April 5, 2021

Enacted by Congress over four years ago through Section 4004 of the 21st Century Cures Act (Cures Act) and implemented through a final rule released over one year ago, the time has come for the benefits of the Cures Act’s information blocking provision to swing into full gear.

Starting today, April 5th, 2021, the following participants in health care will need to follow the law: 1) health care providers, 2) health IT developers of certified health IT, and 3) health information networks/health information exchanges. That said, all health care stakeholders will benefit, including many of these types of participants in the form of more readily available EHI when and where it is needed most. Through the Cures Act, Congress defined “information blocking” and established penalties for those who engage in practices that interfere with the access, exchange, or use of “electronic health information” (EHI). The law excludes practices required by applicable law(s) or if they meet an “exception” established by the HHS Secretary.

For the next 18 months (through October 5th, 2022) a smaller subset of EHI is in scope. Specifically, the EHI that cannot be “blocked” is limited to the data elements represented in the United States Core Data for Interoperability (USCDI Version 1). This initial 18-month period and limited scope gives the regulated community time to grow more experienced with the information blocking regulation, including when and how to meet an “exception,” before the full scope of the regulation’s EHI definition comes into effect. Of course, those who are able to share more EHI than is represented by the USCDI Version 1 need not wait to begin doing so. Similarly, as a way to prepare for October 2022, we strongly encourage the regulated community to make all EHI available as if the scope of EHI were not currently limited.

ONC will continue to release education materials and communicate with stakeholders about the information blocking regulations. We remain closely partnered with the HHS Office of Inspector General with respect to information blocking investigations and civil monetary penalties (for which a final rule is still pending) as well as HHS broadly when it comes to disincentives for health care providers.

It’s important to keep in mind that the submission of an information blocking complaint informs enforcement efforts. As a result, your input matters. Submitting a complaint is easy and starts with going to HealthIT.gov’s feedback and inquiry portal and clicking on “Report Information Blocking.”

For updates on information blocking, please sign up for ONC’s weekly emails and continue to visit HealthIT.gov for educational resources, including answers to frequently asked questions.