Digital health technologies (DHTs) can transform neurological assessments, improving quality and continuity of care. In the United States, the Food & Drug Administration (FDA) oversees the safety and efficacy of these technologies, employing a detailed regulatory process that classifies devices based on risk and requires rigorous review and post-market surveillance. Following FDA approval, DHTs enter the Current Procedural Terminology, Relative Value Scale Update Committee, and Centers for Medicare & Medicaid Services coding and valuation processes leading to coverage and payment decisions. DHT adoption is challenged by rapid technologic advancements, an inconsistent evidence base, marketing discrepancies, ambiguous coding guidance, and variable health insurance coverage. Regulators, policymakers, and payers will need to develop better methods to evaluate these promising technologies and guide their deployment. This includes striking a balance between patient safety and clinical effectiveness versus promotion of innovation, especially as DHTs increasingly incorporate artificial intelligence. Data validity, cybersecurity, risk management, societal, and ethical responsibilities should be addressed. Regulatory advances can support adoption of these promising tools by ensuring DHTs are safe, effective, accessible, and equitable.

中文翻译：

---

探索美国神经数字健康技术的监管环境

数字健康技术 (DHT) 可以改变神经评估，提高护理质量和连续性。在美国，食品和药物管理局 (FDA) 负责监督这些技术的安全性和有效性，采用详细的监管流程，根据风险对设备进行分类，并要求进行严格的审查和上市后监督。 FDA 批准后，DHT 进入当前程序术语、相对价值量表更新委员会以及医疗保险和医疗补助服务中心的编码和评估流程，从而做出承保和支付决策。 DHT 的采用面临着快速的技术进步、不一致的证据基础、营销差异、模糊的编码指导和可变的健康保险覆盖范围的挑战。监管机构、政策制定者和付款人需要开发更好的方法来评估这些有前景的技术并指导其部署。这包括在患者安全和临床有效性与促进创新之间取得平衡，特别是在 DHT 越来越多地融入人工智能的情况下。应解决数据有效性、网络安全、风险管理、社会和道德责任。监管进步可以确保 DHT 的安全、有效、可访问和公平，从而支持这些有前途的工具的采用。