LAUSR

The widespread global interest in electronic health records (EHRs) has created an impression that the requisite engagement of caregivers, providers, patients, and the institutions that rely on EHRs is well-established and in place (Pagliari et al., 2007). Meaningful Use regulation is similarly well-intended but also gives the impression that proper linkages are in place and that the relationships are optimized to create value. The point made a decade ago that “inevitability does not mean easy transition” (Blumenthal and Tavenner, 2010) is still true today. For pediatrics this is especially true. While recent legislation has obligated pharmaceutical sponsors and manufacturers (PhRMA) to be more proactive in the planning, design, and conduct of pediatric clinical trials in populations that would stand to benefit from potential new medicines, the totality of data that would support meaningful dosing guidance as well as long-term safety experience is still lacking (Barrett et al., 2018). As the assumption that adult and pediatric disease progression is similar is often not valid, bridging experiments and trials are likewise not always appropriate with the default scenario that dosing in children is heavily reliant on the adult experience. EHRs have the potential to generate meaningful real-world data (RWD) in children if a mechanism can be adopted that both captures the relevant outcome data and decision support systems built on such data become a part of the practice of medicine and not just a reference.