Bradley Merrill Thompson
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, wrote an article titled “8 Types of Medical Apps a Senate Bill Asks FDA to Stop Regulating.”
Following is an excerpt:
Here are a few thoughts from Thompson on which types of apps would no longer be regulated:
When reading the list below of examples of software that the PROTECT Act would remove from FDA regulation, it’s important to understand that the items on this list are presently regulated by FDA, and have been so since they were first marketed in some cases many years ago.
High Risk CDS
Many of the following examples flow from one simple principle. A good indicator of risk for CDS is when the user is substantially dependent on the software for clinical decision-making. Those situations can arise in many different contexts, but generally involve a serious or life-threatening disease or condition.
The following list is illustrative of types of software that are (1) CDS and (2) would become no longer regulated by FDA under the PROTECT Act.