HIMSS News

HIMSS Submits Comments to FDA on Health IT Uses in Clinical Research

January 4, 2016


In a December 28th letter to Dr. Stephen Ostroff, the Acting Commissioner of Food and Drug at the Food and Drug Administration ( FDA), HIMSS submitted comments to the Using Technologies and Innovative Methods To Conduct Food and Drug Administration-Regulated Clinical Investigations of Investigational Drugs; Establishment of a Public Docket request for comment.

In the letter, HIMSS appreciated the opportunity to leverage our members' expertise in developing comments, and looks forward to establishing a dialogue with the FDA on the continued advancement and improvement of incorporating technologies and innovative methods into clinical research. HIMSS remains supportive of ensuring that technology and innovative methods are used to carry out clinical investigations. HIMSS offers its commitment to finding the right technologies that support clinical research, but also are integral to new, innovative care delivery processes.

HIMSS strongly discourages any federal agency from dictating specific technology tools that providers should be using in a particular care delivery model or to conduct research. HIMSS notes that technologies for clinical research include: electronic health records (EHRs), telehealth services (including remote patient monitoring), health information exchange services, and tools in patient engagement, population health management, and data aggregation and analytics; and it should be up to the provider to determine its technology requirements and decide which technologies they should use for their particular circumstances.

HIMSS is committed to be being a resource to FDA on the continued advancement and improvement of incorporating technologies and innovative methods into clinical research.

View Final Comments

Posted Under: Policy Center