This has been a busy year for the ONC Health IT program! In case you missed anything, we’ve put together a recap of some regulatory highlights:
- The Office of the National Coordinator (ONC) official release the Enhanced Oversight and Accountability final rule (81 FR 72442-44; and 45 CFR 170.581) at the tail end of 2016, but the impact was large in 2017. Under this rule, the ONC established a larger role in their oversight for accredited test labs (ATLs) and added new regulations of authorized certification bodies (ACBs).
- Main points for developers in this update are the institution of the ONC Certification Ban and direct review. 580 focuses on direct review. This means that the ONC can directly take over surveillance or a complaint against a certified product when warranted.
- In 45 CFR 170.581, the ONC instituted the Certification Ban. This ban occurs when a product is:
- Terminated by ONC under the ONC Health IT Certification Program;
- Withdrawn from the ONC Health IT Certification Program by an ONC-ACB because the health IT developer requested it to be withdrawn when the health IT developer’s health IT was the subject of a potential non-conformity or non-conformity as determined by ONC;
- Withdrawn by an ONC-ACB because of a non-conformity with any of the certification criteria; or
- Withdrawn by an ONC-ACB because the health IT developer requested it to be withdrawn when the health IT developer’s health IT was the subject of surveillance for a certification criterion or criteria, including notice of pending surveillance.
- The certification of a health IT developer’s health IT subject to the prohibition of this section may commence once the following conditions are met.
- A health IT developer must request ONC’s permission in writing to participate in the ONC Health IT Certification Program.
- The request must demonstrate that the customers affected by the certificate termination or withdrawal have been provided appropriate remediation.
- ONC is satisfied with the health IT developer’s demonstration under paragraph (b)(2)of this section that all affected customers have been provided with appropriate remediation and grants reinstatement into the ONC Health IT Certification Program.
- In September 2017, ONC mandated that 30 out of 55 criteria are now tested based on a self-declaration method in an effort to reduce regulatory burden.
- In efforts to reduce industry-wide burden, ONC mandated that 30 out of 55 criteria are now tested based on a self-declaration method. Additionally, surveillance is still a critical part of the certification program. In an effort to provide additional flexibility for focusing our surveillance efforts, ONC has exercised enforcement discretion with respect to the implementation of randomized surveillance of certified health IT products. By doing so, ONC has relaxed the requirement that ONC-ACBs must conduct random surveillance on at least 2% of certified products each year. Learn more
For questions or more information, contact us at EHR@drummondgroup.com.