Issued2026-02-03

Public Law 119-75 / H.R. 7148, Sec. 6216 – Report on Wearable Medical Devices

Enacted LawFederal

Summary

Directs the Comptroller General of the United States to conduct a technology assessment and submit a report to Congress on wearable medical devices used to support clinical decision-making. The report must address the capabilities and limitations of these devices, their potential to accurately prescribe treatments, the benefits and challenges of artificial intelligence in augmenting those capabilities, and policy options to enhance benefits and mitigate risks.

Healthcare Implications

Creates a federal review pathway for AI-enabled wearable medical devices used in or around clinical decision-making. The provision does not impose direct obligations on healthcare providers, developers, FDA, CMS, or payers, but the required report could inform future congressional oversight and policy development around AI-enabled wearables, clinical decision support, and treatment recommendations.

Impact Level

Low

Keywords

Transparency & Governance; Clinical Quality & Efficacy; Safety & Risk

Stakeholders

Regulators & Government; Developers & Vendors; Providers & Health Systems