21st Century Cures Act: ethical recommendations for new patient-facing products. (25th July 2022) - Durieux, Brigitte N
Abstract: Background: Recent legislation ensuring patient access to their electronic health records represents a promising national commitment to patient empowerment. Access and interoperability rules seek to empower individuals as well as increase opportunities for data sharing by hospitals, apps, and other parties for research and innovation. However, there are trade-offs between data accessibility and oversight. Some third-party apps may not be covered by federal regulations, and receiving records directly from individuals may render some services in possession of health data. To promote consumer trust, these services should follow ethical standards regardless of regulatory status. Actionable Principles: This Perspective proposes 3 actionable principles, grounded in medical ethics, for services making use of health data: services should (1) provide informed, dynamic, regular consent, including control over data sharing, (2) promote inclusivity and equity, and (3) intentionally focus on consumer trust and the perception of value in the service provided.