product liability

            On April 28, 2022, Covington convened experts across our practice groups for the Covington Robotics Forum, which explored recent developments and forecasts relevant to industries affected by robotics.  One segment of the Robotics Forum covered risks of automation and AI, highlights of which are captured here.  A full recording of the Robotics Forum is available…

In light of the rapidly expanding field of medical software technology, and its recognition that traditional approval mechanisms for hardware-based medical devices may not be well suited to regulating such technology, FDA is piloting a new, streamlined regulatory approach for digital health technologies. The initiative, currently a “working model” and known as the Software Precertification Program, is meant to encourage the development of health and medical software, including potentially software using artificial intelligence.

As currently envisioned, the Precertification Program creates a voluntary, organization-based approach to FDA review of digital health software. FDA will pre-certify organizations as having a “culture of quality” based on FDA’s review of the software developer’s R&D and monitoring systems. Under the working model, pre-certified organizations could submit less information in premarket submissions to FDA than currently required or may qualify for an exemption from premarket review by FDA.
Continue Reading AI Update: Medical Software and Preemption

Algorithms define online shopping, allowing for individualized product recommendations driven by customer data. To date, this technology has spurred little litigation. Few if any courts have explicitly ruled on responsibilities related to AI-driven product recommendation software.

Still, developers should be aware of potential legal risks from this novel technology. For example: What happens if AI recommends a product to a shopper and the product injures the shopper because of a defect? Can the shopper bring a product liability claim — such as for strict liability or negligence — against the algorithm’s developer? Although there is limited precedent on this issue, the risk appears limited.
Continue Reading Covington AI/IoT Update: Product Liability Risks for AI-Facilitated Shopping