Presentations and Recording from the May 25, 2017 RAPID Phase II / III Working Group Meeting are now available on the event page.
Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration
Conclusion: The demonstration provided proof of concept that UDIs can be incorporated into provider and enterprise electronic information systems and used as the index key to combine device and clinical data in a database useful for device evaluation. Keys to success and challenges to achieving this goal were identified. Fundamental informatics principles were central to accomplishing the system of systems model.
This Work Group is tasked with:
· Defining criteria that identify high risk implants
· Developing an API to be used to query the GUDID for the items that meet this criteria
The work of this group ties directly to the X12 proposal to include Device Identifiers (DI) in the claims forms and comments to the FDA recommending a more refined list of high risk implants whose DI would be included in claims, as opposed to all items/all DIs.
The LUC High Risk Implant Work Group Charter can be found at: http://www.ahrmm.org/resources/learning-udi-community/pdfs/work-groups/high-risk-criteria-implants-work-group-summary-statement-103116.pdf.
Please contact AHRMM (firstname.lastname@example.org) with questions or if you are interested in joining this important Working Group or visit the Learning UDI Community website at: http://www.ahrmm.org/resources/learning-udi-community/index.shtml for information about other LUC Working Groups.
“The Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) today released the 2017 Interoperability Standards Advisory (ISA). The ISA catalogues key information about standards and implementation specifications – such as whether they are required by any federal programs or how widely used they are – to help enhance information sharing for key clinical data, including medication lists, immunization records, and test results.”
Reade the latest FDA blog post from Jeffrey Shuren, MD, JD, Director of FDA’s Center for Devices and Radiological Health