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      Digital health: a path to validation


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          Digital health solutions continue to grow in both number and capabilities. Despite these advances, the confidence of the various stakeholders — from patients and clinicians to payers, industry and regulators — in medicine remains quite low. As a result, there is a need for objective, transparent, and standards-based evaluation of digital health products that can bring greater clarity to the digital health marketplace. We believe an approach that is guided by end-user requirements and formal assessment across technical, clinical, usability, and cost domains is one possible solution. For digital health solutions to have greater impact, quality and value must be easier to distinguish. To that end, we review the existing landscape and gaps, highlight the evolving responses and approaches, and detail one pragmatic framework that addresses the current limitations in the marketplace with a path toward implementation.

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          Most cited references15

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          Mobile medical and health apps: state of the art, concerns, regulatory control and certification

          This paper examines the state of the art in mobile clinical and health-related apps. A 2012 estimate puts the number of health-related apps at no fewer than 40,000, as healthcare professionals and consumers continue to express concerns about the quality of many apps, calling for some form of app regulatory control or certification to be put in place. We describe the range of apps on offer as of 2013, and then present a brief survey of evaluation studies of medical and health-related apps that have been conducted to date, covering a range of clinical disciplines and topics. Our survey includes studies that highlighted risks, negative issues and worrying deficiencies in existing apps. We discuss the concept of ‘apps as a medical device’ and the relevant regulatory controls that apply in USA and Europe, offering examples of apps that have been formally approved using these mechanisms. We describe the online Health Apps Library run by the National Health Service in England and the calls for a vetted medical and health app store. We discuss the ingredients for successful apps beyond the rather narrow definition of ‘apps as a medical device’. These ingredients cover app content quality, usability, the need to match apps to consumers’ general and health literacy levels, device connectivity standards (for apps that connect to glucometers, blood pressure monitors, etc.), as well as app security and user privacy. ‘Happtique Health App Certification Program’ (HACP), a voluntary app certification scheme, successfully captures most of these desiderata, but is solely focused on apps targeting the US market. HACP, while very welcome, is in ways reminiscent of the early days of the Web, when many “similar” quality benchmarking tools and codes of conduct for information publishers were proposed to appraise and rate online medical and health information. It is probably impossible to rate and police every app on offer today, much like in those early days of the Web, when people quickly realised the same regarding informational Web pages. The best first line of defence was, is, and will always be to educate consumers regarding the potentially harmful content of (some) apps.
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            What it will take to achieve the as-yet-unfulfilled promises of health information technology.

            A team of RAND Corporation researchers projected in 2005 that rapid adoption of health information technology (IT) could save the United States more than $81 billion annually. Seven years later the empirical data on the technology's impact on health care efficiency and safety are mixed, and annual health care expenditures in the United States have grown by $800 billion. In our view, the disappointing performance of health IT to date can be largely attributed to several factors: sluggish adoption of health IT systems, coupled with the choice of systems that are neither interoperable nor easy to use; and the failure of health care providers and institutions to reengineer care processes to reap the full benefits of health IT. We believe that the original promise of health IT can be met if the systems are redesigned to address these flaws by creating more-standardized systems that are easier to use, are truly interoperable, and afford patients more access to and control over their health data. Providers must do their part by reengineering care processes to take full advantage of efficiencies offered by health IT, in the context of redesigned payment models that favor value over volume.
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              Origin and uses of primum non nocere--above all, do no harm!

              Ryan Smith (2005)
              The so-called Hippocratic injunction to do no harm has been an axiom central to clinical pharmacology and to the education of medical and graduate students. With the recent reexamination of the nature and magnitude of adverse reactions to drugs, the purposes of this research and review were to discover the origin of this unique Latin expression. It has been reported that the author was neither Hippocrates nor Galen. Searches of writings back to the Middle Ages have uncovered the appearance of the axiom as expressed in English, coupled with its unique Latin, in 1860, with attribution to the English physician, Thomas Sydenham. Commonly used in the late 1800s into the early decades of the 1900s, it was nearly exclusively transmitted orally; it rarely appeared in print in the early 20th century. Its applicability and limitations as a guide to the ethical practice of medicine and pharmacological research are discussed. Despite insufficiencies, it remains a potent reminder that every medical and pharmacological decision carries the potential for harm.

                Author and article information

                NPJ Digit Med
                NPJ Digit Med
                NPJ Digital Medicine
                Nature Publishing Group UK (London )
                13 May 2019
                13 May 2019
                : 2
                : 38
                [1 ]Armstrong Institute for Patient Safety and Quality, 750 E Pratt St, 15th Floor, Baltimore, MD 21202 USA
                [2 ]Johns Hopkins Medicine, Department of Medicine, Division of Gastroenterology, 1800 Orleans St, Baltimore, MD 21287 USA
                [3 ]ISNI 0000 0004 0630 1170, GRID grid.474430.0, Health Technologies, National Health Mission Area, , The Johns Hopkins University Applied Physics Lab (APL), ; 11100 Johns Hopkins Road, Laurel, MD 20723 USA
                [4 ]ISNI 0000 0001 2171 9311, GRID grid.21107.35, Johns Hopkins Bloomberg School of Public Health, , JHU Global mHealth Initiative, ; 615N. Wolfe St, Baltimore, MD 21205 USA
                [5 ]ISNI 0000 0001 2192 2723, GRID grid.411935.b, The Johns Hopkins Hospital, Department of Neurology, ; 1800 Orleans St, Baltimore, MD 21287 USA
                © The Author(s) 2019

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

                : 4 January 2019
                : 12 April 2019
                Review Article
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                © The Author(s) 2019

                health policy,technology
                health policy, technology


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