The 21st Century Cures Act (H.R. 6) was a focal point at the NIH/SPIE Biophotonics from Bench to Bedside workshop (see p. 47). In addition to addressing the FDA's drug approval process, the Act extends NIH funding over the next five years, with a focus on innovative technologies, early feasibility studies, and patient-reported outcomes.
The Act would mean approximately $2 billion in new funding each year from 2016 to 2020 and an overall $112 billion, explained event co-chair Bruce Tromberg in his welcome address. This spending would be the subject of scrutiny, but Tromberg sees many opportunites for biophotonics and biomedical optics. He said the Act's emphasis on health, wellness, and disease prevention; reduction in regulatory burden for class I and II devices; strengthening of the "innovation ecosystem"; and support for basic science, technology, and discovery aligns nicely with the capabilities and growth of these technologies.
Tromberg noted that biophotonics developers will be challenged to translate optics terminology to clinical language; demonstrate links between quantitative optical measurements and clinical outcomes/cost-effectiveness; and integrate new source and detector technologies into wearable/portable devices. He also said that advanced technologies and consumer devices will expand the impact of biophotonics in clinical settings and to the home, that "dual use" of devices may expand, and that wearables will dramatically accelerate discovery of new endpoints.
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