Busis Neil A, Marolia Dilshad, Montgomery Robert, Balcer Laura J, Galetta Steven L, Grossman Scott N
Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA.
NYU Langone Health System, New York, NY, USA.
NPJ Digit Med. 2024 Apr 12;7(1):94. doi: 10.1038/s41746-024-01098-5.
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.
数字健康技术（DHTs）可以改变神经学评估方式，提高护理质量和连贯性。在美国，食品药品监督管理局（FDA）负责监管这些技术的安全性和有效性，采用详细的监管程序，根据风险对设备进行分类，并要求进行严格审查和上市后监测。获得FDA批准后，DHTs进入现行程序术语、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估值流程，从而做出覆盖范围和支付决定。DHTs的采用面临着技术快速进步、证据基础不一致、营销差异、编码指导不明确以及医疗保险覆盖范围多变等挑战。监管机构、政策制定者和支付方需要制定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，尤其是随着DHTs越来越多地融入人工智能。数据有效性、网络安全、风险管理、社会和道德责任都应得到解决。监管方面的进步可以通过确保DHTs安全、有效、可及和公平来支持采用这些有前景的工具。
