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Striking a Balance: Innovation, Equity, and Consistency in AI Health Technologies

Striking a Balance: Innovation, Equity, and Consistency in AI Health Technologies

However, the lack of comprehensive regulatory guidance has led to the force-fitting of novel innovations into existing categories, leading to ambiguous boundaries between medical devices and consumer electronics. This results in added ambiguity for innovators seeking to share valuable product concepts. What is lacking is a comprehensive approach to evaluating medical benefits, risks, and evidence that can be universally applied across different product categories, product types, and regulatory regimes [3].

Eric Perakslis, Kimberly Nolen, Ethan Fricklas, Tracy Tubb

JMIR AI 2025;4:e57421

Patient Health Record Protection Beyond the Health Insurance Portability and Accountability Act: Mixed Methods Study

Patient Health Record Protection Beyond the Health Insurance Portability and Accountability Act: Mixed Methods Study

These categories correspond to the 15 underlying values based on the description of the breach report in the dataset: access controls, communication, data breach, data privacy, electronic communication, employee management, IT, PHI, policies, privacy, procedures, regulatory compliance, risk management, security, and security breach.

Hemang Subramanian, Arijit Sengupta, Yilin Xu

J Med Internet Res 2024;26:e59674

Regulating AI in Mental Health: Ethics of Care Perspective

Regulating AI in Mental Health: Ethics of Care Perspective

Surprisingly, these aspects are almost entirely absent from recent regulatory and ethical guidance and debate. This article argues that the responsible AI approach—which is the dominant ethics approach ruling most regulatory and ethical guidance—is insufficient because it does not refer to AI’s impact on human relationships. This reinforces a narrow concept of accountability and responsibility of companies developing AI.

Tamar Tavory

JMIR Ment Health 2024;11:e58493

Regulatory Issues in Electronic Health Records for Adolescent HIV Research: Strategies and Lessons Learned

Regulatory Issues in Electronic Health Records for Adolescent HIV Research: Strategies and Lessons Learned

Experts have identified multiple key ethical and regulatory challenges unique to pragmatic trials, including the necessity for harmonization among collaborating institutional review boards (IRBs) [16], and the need to streamline the regulatory oversight process [14,16].

Sara Shaw Green, Sung-Jae Lee, Samantha Chahin, Meardith Pooler-Burgess, Monique Green-Jones, Sitaji Gurung, Angulique Y Outlaw, Sylvie Naar

JMIR Form Res 2024;8:e46420