The AHA today commented on the Food and Drug Administration’s draft guidance for industry and FDA staff on clinical decision support software as part of the agency’s efforts to implement Section 3060(a) of the 21st Century Cures Act. AHA expressed concern that “FDA’s interpretation of certain criteria could result in many existing CDS algorithms being subject to the FDA approval process and ultimately slow the pace of innovation and development of new algorithms to support better patient care and outcomes.” In its letter, AHA shared specific recommendations with FDA and said it “looks forward to working with the FDA to ensure the agency’s regulatory approach to implementing Section 3060(a) is consistent with the language and intent of the Cures Act and prioritizes patient safety while at the same time allowing hospitals and health systems to continue to implement innovative decision support tools.”

Related News Articles

Headline
The AHA’s Society for Health Care Strategy & Market Development Aug. 21 announced Donna Teach, chief marketing and communications officer for Nationwide…
Perspective
Public
The job description for the ideal health care leader in coming years might read something like this:Wanted: Bold, compassionate innovator who unites clinical…
Headline
The National Institutes of Health Aug. 5 issued guidance to researchers on the use of artificial intelligence for the research application process. According…
Headline
The AHA’s Next Generation Leaders Fellowship July 29 announced its 36 fellows for the class of 2026, who will each work with mentors to address a specific…
Headline
The American Society for Health Care Engineering July 28 announced the recipients of its annual member awards during the 2025 Health Care Facilities Innovation…
Headline
AHA Chair-elect Marc Boom, M.D., president and CEO of Houston Methodist, and AHA Immediate-past Chair Joanne Conroy, M.D., president and CEO of Dartmouth…