Last year the Federal Drug Administration (FDA) announced plans to release new guidance documents that define and expand the types of clinical decision support (CDS) systems it will regulate. In July of 2011, the FDA released for comment purposes a draft guidance specifically addressing mobile health applications. What this means is that the FDA’s seal of approval may soon be coming to a health app on your smartphone!

The FDA has been regulating CDS systems for a long time, but precise guidelines have not exactly been easily available. Historically, the FDA has regulated primarily software systems that are connected to medical devices or considered an accessory to a medical device. The regulation of stand-alone CDS systems depends on their function. Specifically, the FDA does not regulate electronic health record (EHR) systems unless they provide diagnostic functions or certain analytic capabilities. Simple EHR systems fall under the purview of the Health Insurance Portability and Accountability Act (HIPAA) which is not governed by the FDA (we’ll address HIPAA in separate future post).

The types of CDS systems that the FDA currently regulates in some capacity include the following:

  1. Accessory software that adds functionality to a medical device (eg, peripheral software that reads bloods sugar levels from a glucometer and provides an alert if it’s high)
  2. Certain calculators that produce actionable results or provide drug dosing information
  3. Systems that provide medication reminders
  4. Advanced analytics systems that analyze physiological data for diagnostic or therapeutic purposes (eg, an ECG or an ABG analyzer)
  5. Software that stores, transmits, or converts physiological data (not general EHR information which falls under HIPAA).
  6. Software that displays interpreted or processed medical data (could be as simple as graphing certain statistical medical trends)

Whether a particular piece of CDS software is in fact regulated depends on a number of factors that have not all been explicitly spelled out by the FDA to date (this is the intent of the upcoming guidance). Factors that are likely to cause regulation include the following:

  • Software that provides real-time, active or online monitoring of patient functions
  • Software that has the capability to generate an alarm condition that are not already generated on a medical device
  • Software that manipulates data and subjects it to decision tree algorithms, or that attracts attention to imminent hazard conditions
  • Software that provides or suggests individualized treatment information for a specific patient based on data entered for that patient
  • Software that addresses serious conditions or suggests immediate steps for potentially life-threatening conditions (for example, a software whose output based on an ECG input is SHOCK NOW!)

As is very apparent, the scope of this regulation is quite broad and its requirements are rather vague and subjective; basically, it is ultimately up to the FDA to decide if a particular piece of CDS software merits premarket review and regulatory approval. Even things such as simple medical calculators on websites (or in apps) may require FDA approval under certain circumstances. Given the ubiquity of such calculators across the Web and in mobile applications, it will be interesting to see how the FDA plans to implement such a plan.

A number of industry coalitions have been formed to give industry a voice in this area and help provide some guidance to the FDA for rational regulation. These include the following: