The senate slaps the FDA’s hand on health app regulation

In October 2013, a month after the the FDA released its guidance on regulating mHealth apps, a bipartisan group of lawmakers introduced the SOFTWARE Act, which defines three different categories of mHealth software: medical, clinical, and health. Under the SOFTWARE Act, only medical software would require FDA approval. According to a Forbes article on the SOFTWARE Act, "medical software" is software that directly changes the functioning of the body, or would do so if followed, or includes the use of a regulated therapy without physician involvement. In February 2014, the Senate introduced the PROTECT Act, which would further limit the FDA's regulatory reach into mHealth. 



According to the announcement, "Under current law, the [FDA] can use its definition of a medical device to assert broad regulatory authority over a wide array of low-risk health IT, including mobile wellness apps, scheduling software and electronic health records." 

In a mobihealthnews post, Bradley Merrill Thompson, a healthcare attorney, outlined which apps would no longer be regulated. Thompson suggests that the PROTECT Act may go too far. Here's a summary of some the examples cited by Thompson:


  • Consumer Use Melanoma Apps: an app that analyzes pictures of moles to determine cancer risk
  • Sports Concussion Injury Apps: an app that analyzes posture sway to determine concussion status
  • Drug Dose Calculators: an app that guides patients to take the appropriate drug dose
  • Disease Managers for Patients: an app that guides patients to appropriate behavior change for disease management
  • Emergency Care Predictive Analytics Software: software that analyzes multiple variables to recommend a course of treatment for emergency care providers
  • Hospital Patient Monitoring Software: software that alerts care providers when a patient's health is deteriorating
  • Radiation Dose Calculator: software that analyzes multiple data sources to determine appropriate radiation dosages
  • Burn Victim Fluids Assessment: software that analyzes how patients respond to fluid therapy over time increments

Bottom Line

While some oversight is needed to protect patients from faulty screening and diagnoses, we should recognize that our current system is far from perfect. Venture Capitalist Vinod Khosla illustrates the imperfection of the expert-driven system that we use today:

The healthcare industry is in the very beginning of a generation-long period of change. Before making a call on regulatory hoops, let's make sure we make an honest appraisal of the veracity of our current system and clearly evaluate the risk of putting the brakes on emerging innovation.