ABSTRACT
Diabetes Technology Society (DTS) convened a meeting about the US Food and Drug Administration (FDA) Digital Health Software Precertification Program on August 28, 2018. Forty-eight attendees participated from clinical and academic endocrinology (both adult and pediatric), nursing, behavioral health, engineering, and law, as well as representatives of FDA, National Institutes of Health (NIH), National Telecommunications and Information Administration (NTIA), and industry. The meeting was intended to provide ideas to FDA about their plan to launch a Digital Health Software Precertification Program. Attendees discussed the four components of the plan: (1) excellence appraisal and certification, (2) review pathway determination, (3) streamlined premarket review process, and (4) real-world performance. The format included (1) introductory remarks, (2) a program overview presentation from FDA, (3) roundtable working sessions focused on each of the Software Precertification Program's four components, (4) presentations reflecting the discussions, (5) questions to and answers from FDA, and (6) concluding remarks. The meeting provided useful information to the diabetes technology community and thoughtful feedback to FDA.
Subject(s)
Certification , Diabetes Mellitus/therapy , Medical Informatics/standards , Software/standards , United States Food and Drug Administration , Artificial Intelligence , Humans , Machine Learning , Medical Informatics Applications , Models, Organizational , Product Surveillance, Postmarketing , Program Development , Societies, Medical , Software Validation , United StatesABSTRACT
In the more recent literature on cosmological evolutions of the universe, the cosmic vacuum energy has become a nonrenouncable ingredient. The cosmological constant Lambda, first invented by Einstein, but later also rejected by him, presently experiences an astonishing revival. Interestingly enough, it acts like a constant vacuum energy density would also do. Namely, it has an accelerating action on cosmic dynamics, without which, as it appears, presently obtained cosmological data cannot be conciliated with theory. As we are going to show in this review, however, the concept of a constant vacuum energy density is unsatisfactory for very basic reasons because it would claim for a physical reality that acts upon spacetime and matter dynamics without itself being acted upon by spacetime or matter.
