The burgeoning industry of “Femtech”—technology designed to serve women’s health needs—dwells in nebulous territory from a compliance standpoint. On one hand, these applications and/or wearables are developed by technology companies without the regulatory burdens associated with, say, healthcare organizations. On the other, these companies collect, analyze, and store data related to women’s health, which sounds a lot like a healthcare company to some.
So, where does the line exist between a technology company and healthcare, and how are compliance practitioners supposed to know when their organization wanders from one industry into another? That’s the question regulators and executives are grappling with, and one we’ll attempt to untangle.
