21st Century Cures Act – Information Blocking Regulations*

Previous Vyne Dental Updates

Background

The Assistant Secretary for Technology Policy / Office of the National Coordinator of Health IT (ASTP/ONC) adopted regulations to implement the information blocking prohibition under the 21st Century Cures Act. The regulations are meant to promote interoperability and ensure patients, providers and others with a permissible purpose under applicable law can access, exchange, and use electronic health information (EHI) without unreasonable barriers. Dentists—like other health care providers—are directly impacted, both as actors subject to the regulations and as users of software and other technology to access, exchange and use EHI.

What is "Information Blocking"?

Information blocking refers to any act or omission by a regulated “actor” that is likely to prevent, materially discourage or otherwise inhibit access to, exchange of, or use of EHI (if the actor has the level of knowledge that it is likely to interfere required by the regulations)—unless a legal exception applies. These “actors” include:
  • Health care providers (including dental practices)
  • Health IT developers of certified health IT (e.g., EHR and other software vendors with a product certified by ASTP/ONC’s Health IT Certification Program)
  • Health Information Exchanges (HIEs) and Health Information Networks (HINs)
Source: https://www.healthit.gov/topic/information-blocking

What is an "HIE"/"HIN"?

Under the regulations, a HIN/HIE is an individual or entity that “…permits, enables, or requires the use of any technology or services for access, exchange, or use of electronic health information” among more than two unaffiliated individuals or entities (other than the entity itself) that are enabled to exchange with each other for treatment, payment, or health care operations (as such terms are defined by HIPAA), regardless of whether the individuals or entities are subject to HIPAA.

Sources:

What counts as Electronic Health Information (EHI)?

ASTP/ONC aligns EHI with the HIPAA “designated record set,” which includes medical and billing records and other records used to make decisions about individuals.

Source: https://www.healthit.gov/topic/information-blocking

Practical Takeaways for Dental Practices

  • You and your patients have rights to access and receive EHI electronically without unreasonable delays or barriers.
  • Certified health IT developers and HIN/HIEs must not engage in any act or omission likely to interfere with EHI access, exchange, or use (if they know or should know that it is likely to interfere) unless a specific legal exception applies—and they must meet all conditions of that exception.
  • Review software contracts and API availability; confirm that your vendor supports electronic access and export consistent with their obligations under the regulations.

How Do I Report Information Blocking to the ASTP/ONC?

Information blocking claims can be submitted online through ASTP/ONC’s Report Information Blocking Portal

(https://inquiry.healthit.gov/support/plugins/servlet/desk/portal/6).

* This document is not intended to provide legal advice. If you have questions regarding your obligations under the information blocking regulations, you should consult an attorney.