Digital health innovation is expected to transform healthcare, but it also generates ethical and societal concerns, such as privacy risks, and biases that can compound existing health inequalities. While such concerns are widely recognized, existing regulatory principles, oversight methods and ethical frameworks seem out of sync with digital health innovation. New governance and innovation best practices are thus needed to bring such principles to bear with the reality of business, innovation, and regulation.

To grant practical insight into best practices for responsible digital health innovation, we conducted a qualitative study based on an interactive engagement methodology. We engaged key stakeholders (n = 46) operating at the translational frontier of digital health. This approach allowed us to identify three clusters of governance and innovation best practices in digital health innovation: i) inclusive co-creation, ii) responsive regulation, and iii) value-driven innovation. Our study shows that realizing responsible digital health requires diverse stakeholders’ commitment to adapt innovation and regulation practices, embracing co-creation as the default modus operandi for digital health development. We describe these collaborative practices and show how they can ensure that innovation is neither slowed by overregulation, nor leads to unethical outcomes.

数字健康创新有望改变医疗保健，但它也会产生道德和社会问题，例如隐私风险以及可能加剧现有健康不平等的偏见。尽管这些担忧得到了广泛认可，但现有的监管原则、监督方法和道德框架似乎与数字健康创新不同步。因此，需要新的治理和创新最佳实践，以使这些原则适应商业、创新和监管的现实。

为了对负责任的数字健康创新的最佳实践提供实际见解，我们基于交互式参与方法进行了定性研究。我们 与数字健康转化领域的主要利益相关者（ n = 46）进行了合作。这种方法使我们能够确定数字健康创新中的三组治理和创新最佳实践：i）包容性共同创造，ii）响应性监管，以及iii）价值驱动的创新。我们的研究表明，实现负责任的数字健康需要不同利益相关者致力于调整创新和监管实践，将共同创造作为数字健康发展的默认运作方式。我们描述了这些协作实践，并展示了它们如何确保创新既不会因过度监管而减慢，也不会导致不道德的结果。