The field of digital health, and its meaning, has evolved rapidly over the last 20 years. For this article we followed the most recent definition provided by FDA in 2020. Emerging solutions offers tremendous potential to positively transform the healthcare sector. Despite the growing number of applications, however, the evolution of methodologies to perform timely, cost-effective and robust evaluations have not kept pace. It remains an industry-wide challenge to provide credible evidence, therefore, hindering wider adoption. Conventional methodologies, such as clinical trials, have seldom been applied and more pragmatic approaches are needed. In response, several academic centers such as researchers from the Institute of Global Health Innovation at Imperial College London have initiated a digital health clinical simulation test bed to explore new approaches for evidence gathering relevant to solution type and maturity. The aim of this article is to: (1) Review current research approaches and discuss their limitations; (2) Discuss challenges faced by different stakeholders in undertaking evaluations; and (3) Call for new approaches to facilitate the safe and responsible growth of the digital health sector.

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A systematic analysis of Hospital Episodes Statistics (HES) data was done to determine the effects of the 2017 WannaCry attack on the National Health Service (NHS) by identifying the missed appointments, deaths, and fiscal costs attributable to the ransomware attack. The main outcomes measured were: outpatient appointments cancelled, elective and emergency admissions to hospitals, accident and emergency (A&E) attendances, and deaths in A&E. Compared with the baseline, there was no significant difference in the total activity across all trusts during the week of the WannaCry attack. Trusts had 1% more emergency admissions and 1% fewer A&E attendances per day during the WannaCry week compared with baseline. Hospitals directly infected with the ransomware, however, had significantly fewer emergency and elective admissions: a decrease of about 6% in total admissions per infected hospital per day was observed, with 4% fewer emergency admissions and 9% fewer elective admissions. No difference in mortality was noted. The total economic value of the lower activity at the infected trusts during this time was £5.9 m including £4 m in lost inpatient admissions, £0.6 m from lost A&E activity, and £1.3 m from cancelled outpatient appointments. Among hospitals infected with WannaCry ransomware, there was a significant decrease in the number of attendances and admissions, which corresponded to £5.9 m in lost hospital activity. There was no increase in mortality reported, though this is a crude measure of patient harm. Further work is needed to appreciate the impact of a cyberattack or IT failure on care delivery and patient safety.