Developer Perspectives on Potential Harms of Machine Learning Predictive Analytics in Health Care: Qualitative Analysis.

Even though MLPA developers recognized that their products can harm patients, public, and even health systems, robust procedures to assess the potential for harms and the need for mitigation do not exist. Our findings suggest that, to the extent that new oversight paradigms rely on self-regulation, they will face serious challenges if harms are driven by features that developers consider inescapable in health care and business environments. Furthermore, effective self-regulation will require MLPA developers to accept responsibility for safety and efficacy and know how to act accordingly. Our results suggest that, at the very least, substantial education will be necessary to fill the "principles-to-practice" gap.