Digital health stands poised to transform cardiovascular medicine, much as echocardiographic imaging has upended stethoscope-based auscultation for diagnosis. Work published in 2021 has advanced this hope, and engaged an ever-widening group of stakeholders, critical to ensure proper evaluation of this important technology that may touch so many lives. Digital health's great promise in no small measure stems from its ability to endow extant medical tests (ECG, fundoscopy, and imaging) and electronic health record data, which are known to practitioners and integrated into workflows, with new superpowers, and to draw massively scalable data from wearables into the fold. This integration will accelerate adoption and impact care.
Before the promise of digital health can bear fruit to improve human health, a major gap must be addressed—the paucity of clinical trials to address outcomes. The 'black box' issue and lack of explainability are widely discussed concerns that may not be solved in the short term, but may be mitigated or overcome with robust evidence from prospective clinical trials. Data management processes to prevent overwhelming an already taxed healthcare system are mandatory. Further development of novel hybrid regulatory strategies, recognizing software as a medical device coupled to consumer hardware, are pre-requisites to exponentially driving data availability. With broad input from clinicians, industry, regulators, and patients; attention to privacy and human rights; diligent testing, validation and oversight; and prospective trial data, digital health promises an exciting and healthy future, as opposed to a brave new world.
The authors thank the following for their contributions to the preparation of the manuscript: Dr Anastasia Xintarakou, Mr Philip Lees, and Ms Alexandra Kourlampa. Thanks also to Professors E. Peyster and S. Khurshid for permission to use the figures.
Eur Heart J. 2022;43(4):271-279. © 2022 Oxford University Press
Copyright 2007 European Society of Cardiology. Published by Oxford University Press. All rights reserved.