The intersection of software, technology, and health care and the proliferation of software as a medical device in the health care arena has become common place and has spurred significant innovations. The term Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” The Food and Drug Administration (FDA) has already cleared a significant amount of SaMD, including more than 500 algorithms employing artificial intelligence (AI).
In response to this rapid innovation, Foley has launched its Software as a Medical Device Series to help navigate the issues that plague digital health companies, investors, clinicians and other organizations that utilize software and medical devices. Our contributors will address various considerations including technology, data, intellectual property, licensing, and contracting.
