Mathews Simon C, McShea Michael J, Hanley Casey L, Ravitz Alan, Labrique Alain B, Cohen Adam B
Armstrong Institute for Patient Safety and Quality, 750 E Pratt St, 15th Floor, Baltimore, MD 21202 USA.
Johns Hopkins Medicine, Department of Medicine, Division of Gastroenterology, 1800 Orleans St, Baltimore, MD 21287 USA.
NPJ Digit Med. 2019 May 13;2:38. doi: 10.1038/s41746-019-0111-3. eCollection 2019.
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.
数字健康解决方案在数量和功能上都在持续增长。尽管取得了这些进展，但从患者、临床医生到支付方、行业和监管机构等各类利益相关者对医学的信心仍然相当低。因此，需要对数字健康产品进行客观、透明且基于标准的评估，以便为数字健康市场带来更高的清晰度。我们认为，一种以最终用户需求为导向，并在技术、临床、可用性和成本领域进行正式评估的方法是一种可能的解决方案。为了使数字健康解决方案产生更大影响，质量和价值必须更易于区分。为此，我们审视了现有格局和差距，突出了不断演变的应对措施和方法，并详细阐述了一个务实的框架，该框架解决了市场当前的局限性，并提供了一条实施路径。
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