Sonya Makhni1, Ashish Atreja1, Amy Sheon2, Brian Van Winkle3, John Sharp4, Neil Carpenter3. 1. Icahn School of Medicine at Mount Sinai, New York, New York, USA. 2. Case Western Reserve University, Cleveland, Ohio, USA. 3. LifeBridge Health, Baltimore, Maryland, USA. 4. Kent State University, Kent, Ohio, USA.
Abstract
BACKGROUND: The Network of Digital Evidence (NODE) was formed to further advance the field of health information technology (HIT) and evidence-based digital medicine at different healthcare institutions nationwide. As the NODE network reviewed the state of the field, it was noted that despite substantial financial and human capital investments, the processes and results of HIT innovation seem chaotic and subpar, especially in comparison to the more well-established drug and device industries. During the course of this white paper, we will explore the causes for this observed phenomenon as well as propose possible solutions to improve the state of HIT. METHODS: We compared the entire process of discovery, proof of concept, Food and Drug Administration (FDA) review, and postmarket monitoring and distribution/implementation of HIT innovations to the equivalent processes for drugs and devices. Whereas drug and device innovations are subject to a standardized pipeline of production, HIT innovations are not held to equivalent standards. CONCLUSIONS: As a result, HIT lags behind the more mature drug and device industries in producing effective and reliable products. This leads to an inefficient use of already scarce healthcare resources. The authors believe that the HIT industry must adopt many of the mechanisms implemented by the drug and device industries as dictated by their innovation pipelines of discovery, proof of concept, FDA review, and postmarket monitoring and distribution/implementation. We propose an eight-point plan to fundamentally evolve the HIT lifecycle, including reforms for institutions such as neutral government agencies, new health system boards and management systems, modified incentive structures, improved relationships with financial investors and start-ups, patient engagement, and enhanced mechanisms to improve HIT adoption.
BACKGROUND: The Network of Digital Evidence (NODE) was formed to further advance the field of health information technology (HIT) and evidence-based digital medicine at different healthcare institutions nationwide. As the NODE network reviewed the state of the field, it was noted that despite substantial financial and human capital investments, the processes and results of HIT innovation seem chaotic and subpar, especially in comparison to the more well-established drug and device industries. During the course of this white paper, we will explore the causes for this observed phenomenon as well as propose possible solutions to improve the state of HIT. METHODS: We compared the entire process of discovery, proof of concept, Food and Drug Administration (FDA) review, and postmarket monitoring and distribution/implementation of HIT innovations to the equivalent processes for drugs and devices. Whereas drug and device innovations are subject to a standardized pipeline of production, HIT innovations are not held to equivalent standards. CONCLUSIONS: As a result, HIT lags behind the more mature drug and device industries in producing effective and reliable products. This leads to an inefficient use of already scarce healthcare resources. The authors believe that the HIT industry must adopt many of the mechanisms implemented by the drug and device industries as dictated by their innovation pipelines of discovery, proof of concept, FDA review, and postmarket monitoring and distribution/implementation. We propose an eight-point plan to fundamentally evolve the HIT lifecycle, including reforms for institutions such as neutral government agencies, new health system boards and management systems, modified incentive structures, improved relationships with financial investors and start-ups, patient engagement, and enhanced mechanisms to improve HIT adoption.
Authors: John M Jakicic; Kelliann K Davis; Renee J Rogers; Wendy C King; Marsha D Marcus; Diane Helsel; Amy D Rickman; Abdus S Wahed; Steven H Belle Journal: JAMA Date: 2016-09-20 Impact factor: 56.272