New CMS rule requires hospitals, not vendors, to do annual safety self-checks: 5 details

Jackie Drees - Tuesday, September 14th, 2021

CMS recently updated regulations for its Medicare Promoting Interoperability program to require eligible hospitals to complete an annual self-assessment of their EHRs using ONC-sponsored safety guidelines. 

Five details: 

1. In the Aug. 13 action, CMS said hospitals participating in the interoperability program must finish ONC's Safety Assurance Factors for EHR Resilience Guides beginning in 2022. 

2. ONC developed the SAFER guidelines in 2014 and later revised them in 2016. Each SAFER guide comprises 12 to 29 recommended practices to help providers decrease the risk of patient harm caused by EHRs. 

3. In a 2019 study published in JAMA, researchers found that 39.5 percent of EHR-related products under surveillance had "nonconformities" with existing EHR certification regulations that were linked to potential patient harm, according to a Sept. 10 JAMA viewpoint article. 

4. While implementing the new safety guidelines is a big step for improving patients' well-being, hospitals will need help from their EHR vendors moving forward to comply with CMS' new rules, according to Dean Sittig, PhD, biomedical informatics professor at UTHealth, and Hardeep Singh, MD, health policy, quality and informatics program chief at Michael E. DeBakey VA Medical Center's innovation center. 

5. In the JAMA viewpoint article, Drs. Sittig and Singh argued that CMS should add annual SAFER assessment by EHR developers to its interoperability program criteria so that the vendors test how their products hold up against the safety requirements. 

"The annual EHR developer assessment process should be transparent and carried out by teams consisting of EHR designers, developers, implementers and trainers," Drs. Sittig and Singh wrote.