Dive Brief:
- The House has introduced a bill, dubbed The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, which would regulate medical apps, as well as clinical decision support, EMRs and other health technologies.
- The bill would give the FDA the power to regulate apps which were developed to be used as accessories to regulated medical devices such as medical image readers for smartphones or tablets.
- It would also give the agency oversight over apps which can turn mobile devices into regulated medical devices, such as apps allowing a smartphone to conduct ECG testing.
Dive Insight:
This bill is long overdue. With apps increasingly serving the purpose of medical devices, or working in tandem with such devices, it's logical for the FDA to get involved in regulating them. Right now, the medical apps market is in ferment, with new and powerful options emerging at breakneck speed. Regulating these apps -- which, admittedly, will bring no joy to entrepreneurs -- is a necessary step towards legitimizing their use, and ultimately, encouraging their development.