Devices
On tap today: FDA convenes artificial womb panel
We're seeing some progress in the world of artificial wombs — enough so that the Food and Drug Administration is convening a two-day panel, starting today, to discuss how to evaluate their safety and effectiveness, and ethical issues associated with clinical trials, Lizzy Lawrence tells us.
A handful of research teams have been developing the technology underlying artificial wombs, intended to save babies born too soon by replicating the uterine environment. Closest to human trials is a team at the Children's Hospital of Philadelphia, which built a bag filled with sterile fluid connected to oxygen and nutrition tubes. Researchers are targeting babies born at less than 28 weeks — less than 2% of preterm births.
While the technology is potentially lifesaving, testing will be difficult. It's not easy to anticipate premature births, so researchers would have only a short window during which to obtain consent from the pregnant person, among other challenges.
Read more from Lizzy here, and stay tuned for more from the panel.
Device shows promise controlling postpartum bleeding
A study out of Columbia suggests that a new intrauterine device could control postpartum hemorrhage, a major cause of maternal mortality.
The device, which uses low-level suction to encourage uterine contractions, previously showed promise in a smaller study, controlling blood loss among patients experiencing relatively minor bleeding.
But the new study, which covered 800 people across 16 hospitals, found that it controlled hemorrhaging across 93% of patients who had a vaginal birth and 84% of patients who had a C-section. Researchers are continuing to study the device, including how it compares to other treatments for postpartum hemorrhage.
"Until we have more data, we're using the new intrauterine device after medications have been tried," said Dena Goffman, lead author on the study.
Privacy How a regulatory loophole compromises patient privacy
Gaps in federal privacy protections may be especially harmful for patients seeking help and treatment online for substance use disorder, including through goal-setting apps, drink trackers, provider directories or even telehealth treatment programs. While these sites and services could be hugely beneficial to patients, there's not much regulation to stop the groups operating them from gathering sensitive information about visitors — and that data could eventually lead to arrest or prosecution, lawyer and health privacy expert Jacqueline Seitz writes for STAT.
Seitz is part of a movement urging the Health and Human Services Department and the Federal Trade Commission to strengthen privacy protections for substance use disorder patients by calling up a regulation called 42 CFR Part 2, which establishes certain privacy protections for substance use disorder records. Those agencies could, for instance, publicly affirm that Part 2 can also protect online privacy. The FTC could also take action against drug use, addiction and recovery apps that compromise users' privacy, just as it has for reproductive and mental health apps, Seitz wrote.
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