FDA’s Recent Update to the Digital Health Policy Navigator

December 21, 2022By Véronique Li, Senior Medical Device Regulation Expert & Philip Won & Lisa M. Baumhardt, Senior Medical Device Regulation Expert

In our previous blog post, we provided a flowchart for the Digital Health Policy Navigator’s process so that our blog readers can quickly review the seven steps in determining whether their product’s software functions may be potentially the focus of FDA oversight. Two days after the blog post, FDA updated the Digital Health Policy Navigator to improve access to the tool through the webpage and add examples to the clinical decision support software policy considerations in Step 6.  These include the following examples of software functions that meet Criterion 3 of clinical decision support software (section 520(o)(1)(E)(ii) of the Federal Food, Drug, and Cosmetic Act):

  • Evidence-based clinician order sets for an HCP to choose from, tailored for a particular condition, disease, or clinician preference;
  • Matching patient-specific medical information from records or reports to reference information (e.g., clinical guidelines);
  • Contextually relevant reference information about a disease or condition;
  • Drug-drug interaction and drug-allergy contraindication notifications to avert adverse drug events;
  • Drug formulary guidelines;
  • Duplicate testing or prescription production prevention notification (e.g., medication reconciliations and test reconciliations);
  • Reminders for preventive care or clinician’s orders; and
  • Patient data reports and summaries (e.g., discharge papers).

Besides the newly included examples above, no other changes were made to the Digital Health Policy Navigator. As a result, the flowchart we created is still current and can be downloaded here.

Categories: Medical Devices