
AI in Health Care and the FDA’s Blind Spot
A Novel Study Shows That Large Language Models Act Like Medical Devices in Clinical Care Scenarios
Blog Post
In the fast-paced world of digital health, turning an innovative idea into a trusted product demands not only technical expertise but also a deep commitment to ethical regulation and consumer-oriented policies.
Consider products that allow a caregiver to passively surveil an older adult, remotely monitoring their location and activities. While these technologies were designed to enhance safety, they often fail to account for the values and privacy concerns of older adults themselves, limiting their adoption and efficacy.
A recent article from Senior Fellows Emily Largent, Jason Karlawish, and Anna Wexler provides product developers across the digital health life cycle with recommendations for emphasizing ethical and regulatory concerns and accounting for environmental impact. These recommendations can help address disparities and safeguard user data while fostering innovation in mobile health apps, electronic medical records, telemedicine, wearable devices, and more.
Below, we summarize the article’s four key points:
As the digital health landscape expands, developers must be held accountable throughout the product-development life cycle, ensuring that digital tools reach their potential to improve health outcomes equitably.
To learn more about common issues within digital health and how stakeholders can address ethical and regulatory concerns, see the full article here.
The study, “From an Idea to the Marketplace: Identifying and Addressing Ethical and Regulatory Considerations Across the Digital Health Product-Development Lifecycle ,” was published on July 25, 2024 in BMC Digital Health. Authors include Emily Largent, Jason Karlawish, and Anna Wexler.
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