The US Department of Health and Human Services’ (“HHS”) Office of National Coordinator for Health IT (“ONC”) recently extended a few key compliance deadlines relevant to developers of certified health IT products, healthcare providers, and health information networks and exchanges (HIEs/HINs). Specifically, ONC pushed back certain requirements related to certification of certified health IT products and Information Blocking found in the ONC Cures Act Final Rule (ONC Rule), a rule that promotes seamless and secure access, exchange, and use of electronic health information through standardized health IT requirements. HHS stressed that it has extended these compliance deadlines to provide the healthcare industry additional time to implement the ONC Rule as the healthcare industry continues to grapple with the myriad challenges presented by COVID-19.
Developers of certified health IT are required to certify their products under the ONC Health IT Certification Program (“Program”). The Program now incorporates numerous new administrative and technical requirements outlined in the ONC Rule. The updated compliance deadlines give developers of certified health IT more time to update their currently certified products or build new products to comply with the new certification requirements, as well as more time to test those products. These developers also have additional time to attest under the Program that their products are compliant with specific conditions (known in the industry as the Conditions and Maintenance of Certification (“COC”)) that were updated by the ONC Rule.
Additionally, under the updated deadlines, developers of certified health IT, as well as healthcare providers and HIEs/HINs, have more time to comply with the new Information Blocking obligations required under the ONC Rule. Information Blocking is defined as any practice that is likely to “interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.” There are eight narrow exceptions to these practices that allow an entity to engage in this type of behavior, most notably where the practice is intended to prevent harm, safeguard the security of electronic health information, or safeguard the privacy of the individual’s electronic health information.
The following is a summary of some key deadlines:
|Developers of certified health IT, healthcare providers, and HIEs/HINs cannot engage in Information Blocking.||April 5, 2021|
|Developers of certified health IT must attest that they comply with the CoC that were updated by the ONC Rule.||May 1, 2022|
|All products certified under the Program must align with the ONC Rule’s new technical certification requirements.||December 31, 2022 (except with respect to a requirement related to electronic health information exports, which is not required until December 31, 2023)|
|Developers of certified health IT must successfully test their certified health IT under real world conditions.||Initial Plan for testing due December 14, 2021; Initial Results of testing due March 15, 2023|
For more information regarding the specific deadline updates, please see HHS’s official press release regarding the changes.
We anticipate that the updated compliance deadlines will be a welcome change given the many technical and compliance challenges presented by the ONC Rule. With this extra breathing room, now is the ideal time for companies to evaluate their compliance posture with respect to the ONC Rule and begin to develop strategies for adopting and implementing the new requirements under the ONC Rule, as implementation will require consultation with technical and legal teams. Beckage attorneys will continue to follow the evolving regulatory compliance guidance on deadlines and substantive requirements to assist clients in the health IT and healthcare industry as they navigate these and other new regulatory requirements. Beckage attorneys are uniquely experienced to help health organizations and tech companies of all sizes to navigate the complicated maze of legal and practical considerations raised by these and other health law regulations. Please do not hesitate to reach out if you are interested in discussing the ONC Rule’s potential impact on your business.
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