Information different patients need or want about cybersecurity risk varies, so communicating clearly is always key.

Many devices in current use were marketed before manufacturers were required to demonstrate safety and effectiveness.

This issue invites clinicians, researchers, device representatives, and patient-safety champions to consider how to exercise sufficient caution without stifling innovation.

Device innovation has potential to improve patient outcomes over time, yet prospective benefits must be considered in light of risks.

This series of 5 color oil on canvas sketches includes a sequence of images and illuminates one patient’s postoperative experiences.

Financial relationships are common, and ethical questions rightly emerge about how conflicts of interest compromise investigators’ approaches to research.

A history of device oversight by the US Food and Drug Administration traces regulatory changes in response to injuries caused by Dalkon Shield intrauterine devices.

Heightened caution, improved physician and patient communication, and equitable access are key priorities.

The AMA Code of Medical Ethics offers guidance for balancing need for safety with demand for innovation.

If the safe-and-effective standard for judging devices’ potential as therapy or enhancement is inadequate, one might wonder whether BCI regulation should be overseen by the FDA.