Autoscoring Certification: Sleep Stage Pilot Program

The AASM is excited to announce a two-year pilot certification program for autoscoring sleep software! The pilot certification is limited to sleep stage scoring in the adult population. The certification program’s purpose is to independently verify the performance of autoscoring systems.

Benefits of the AASM Autoscoring Certification for software companies:

  • The pilot will enable increased transparency to users of autoscoring solutions by supplying an independent evaluation of real-world performance, thus building confidence among accredited facilities.
  • Prestige of being certified by AASM, a trusted source for setting standards in the field of sleep medicine.
  • Demonstrates to the sleep community that your software is equivalent or better than human scorers in the staging of polysomnography.
  • Software that achieves certification will be given a digital and physical certificate that can be used for promotional purposes and will be listed on AASM’s website to assure AASM members that the software has passed AASM requirements for certification.

Currently Certified Autoscoring Software Programs

Software: Sleepware G3 with Somnolyzer v4.0.2.0., Company: Philips RS North America, LLC

FAQs

Companies, who can operate throughout the United States, that have autoscoring software that can provide stage scoring from the analysis of in-lab polysomnograms. The autoscoring software must have received FDA 510(k) clearance or proof that an application has been submitted and is in process with the FDA. Additional eligibility criteria can be found in the certification standards.

No, any software that can analyze a sleep study and meets certification standards is eligible for certification. The autoscoring software must be able to analyze raw, unscored, full-night polysomnography records in European Data Format (“EDF”). Additional eligibility criteria can be found in the certification standards.

After a company submits an Eligibility Checklist, and eligibility has been determined, staff will email the eligible company an Application, Guide, Standards, and Certification & License Agreement. Applications will be accepted from 2/13/2023 through 3/31/2024. Applications will be processed in the order they are received. Applicants that earn certification will be announced on a quarterly basis.

We announce those who obtained certification roughly every quarter. We will make all efforts to process as many certification applications as possible before each quarterly announcement. As this is a pilot program, we are still determining processing timelines and cannot guarantee that an applicant will be reviewed prior to any quarterly announcement. Currently, we estimate that the certification process, from the date an application is accepted until the autoscoring software has completed validation testing, will take between 8-12 weeks. Applicants will be prioritized in the order the complete application is received.

The certification standards list the requirements that must be met to pass certification. If a software passes, the applicant is given a digital and physical certificate that can be used for promotional purposes and a license to utilize the autoscoring certification mark for promotional purposes. Recognition of the software’s certification will be listed on AASM’s website.

To validate the robust level of performance necessary for certification, AASM assembled a group of 11 highly skilled and experienced scorers who scored over 100 diverse records from numerous institutions. This highly skilled group of individuals consists of 9 sleep technologists and 2 physicians, several of whom serve on AASM’s Sleep ISR adult gold standard panel. View the full list of scorers

The certification will be valid for two years from the date of issue and will state the version number of the software.

Software that does not meet minimum accuracy thresholds will be provided with a private and confidential report highlighting these discrepancies. During the pilot period, there will only be one chance for a company to retry a failed certification attempt. The retry attempt will be charged $7,500 USD.

Contact the AASM Autoscoring Certification staff at certification@aasm.org to request an Eligibility Checklist. Eligible companies will be sent an Application, Guide, Standards, and Certification & License Agreement.

For additional information and to request an Eligibility Checklist, please contact the AASM Autoscoring Certification staff at certification@aasm.org or (630) 737-9780.