Sep 14, 2011

Mobile medical app-related issued explicitly not covered by the recent FDA guidance’s scope include wireless safety, applying quality systems to software and regulatory requirements for clinical decision support (CDS) software. The agency has disclosed plans to address these issues in separate guidances, but has provided no further details on those plans.

The FDA mobile apps workshop, however, devoted two panel discussions on September 13th to the issue of how to potentially classify and regulate CDS tools—but efforts to clarify possible regulatory approaches to these technologies resulted in a slew of questions and few answers.

Dr. Kristen Meier, mathematical statistician at the FDA, cited various examples of CDS systems performing tasks as simple as BMI calculations and as complex as directing biopsy sites. Considerations of safety, effectiveness and intended use should inform regulatory pathways for particular CDS products, Meier suggested, as well as the following factors:

  • The level of impact of a CDS product on a patient’s health condition
  • The degree of acceptance of a CDS product among clinical practitioners
  • The ability to identify and correct erroneous output from a CDS product

Dr. Richard Katz of George Washington University and Dr. Michael Segal of SimulConsult argued that FDA regulation of CDS products should depend also on levels of user and product sophistication, and whether the product and its data sources are stand-alone or not. A critical factor, Katz added, is whether a CDS product is prescriptive or non-prescriptive; prescriptive functions introduce higher levels of risk into the clinical equation, and so warrant closer regulatory scrutiny.

Panelists broadly argued against a single, one-size-fits-all regulatory approach to CDS. Dr. Satish Mishra of medical app review website, and Dr. Wendy Nilsen of the National Institute of Health both contended that attempting to regulate all CDS systems and apps uniformly would not work, and that more complex CDS should meet different standards of safety and effectiveness than simpler CDS.  

Regulation of CDS systems could prove even more challenging in cases where vendors have “black-boxed” their technologies as proprietary products; providing transparency into how their systems work could result in competitive disadvantage, according to panelists including Dr. Meier of the FDA and SimultConsults’s Dr. Segal. Indeed, argued Segal, requiring too much transparency from CDS providers could in some cases scare off these firms’ investors and potentially stifle innovation in the CDs sector. A “modest and incremental” approach would best mitigate these potential issues, Segal suggested.

Obviously the FDA’s decision to delay guidance on regulating CDS was well-founded. Crafting a regulatory process able to address an issue of this complexity will take some time, and not likely make all parties concerned happy.


  • Stewart Eisenhart