Abortion
Telehealth providers stay nimble amid regulatory uncertainty
A handful of online abortion medication providers told me they were anxiously awaiting the Supreme Court's ruling on mifepristone last week — a decision that risks dramatically altering their operations by limiting the types of medication they could dispense via mail. Mifepristone is often used in combination with misopristol to end a pregnancy, though misopristol can also be used on its own.
While the nation's highest court maintained access to mifepristone in the short term by putting a hold on a Texas district court decision that would remove the drug from the market, telehealth abortion providers like Wisp and Hey Jane say they're ready to adapt. As my colleague Sarah Owermohle reports, the case is headed to an appeals court which will address the case in the next few weeks.
In the event of a limit, Wisp said it was prepared to transition to a misopristol-only protocol — a change that could take the Bay Area company a few weeks.
Kiki Freedman, head of Hey Jane, which has continued to offer mifepristone, said her team was encouraged by the Supreme Court decision. "Access to medication abortion should never have been jeopardized in the first place, but we know these baseless attacks are far from over," Freedman said.
cybersecurity
How cyber threats could impact surgeries
Late last week, STAT's Lizzy Lawrence was at the CyberMed Summit, where FDA tech leaders, cybersecurity experts, and cyber safety advocates mingled wearing name badges printed on floppy disks.
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By far the most illustrative part of the event, Lizzy reports, was the live clinical simulation, where the audience watched over Zoom as a George Washington University emergency medicine resident attempted to treat patients in the midst of a fake cybersecurity attack. He had to figure out how best to treat a stroke patient without a working CT scanner, and take care of a patient in cardiac arrest without a catheter lab. Without the CT scan, for example, he had to guess based on patient behavior whether the stroke resulted from a clogged blood vessel or a brain bleed. Blood thinners would treat the clogged vessel, but fatally worsen the bleed.
Another highlight: a panel on how medical device regulation fits into the country's security strategy. The FDA's Suzanne Schwartz discussed FDA's plan with its new cybersecurity authorities enshrined in the omnibus, and the agency's Jessica Wilkerson cautioned that securing legacy devices is a complex, ongoing issue.
electronic health records
Bad news for Oracle: VA's health record overhaul on pause
The federal government's multi-year, multi-billion dollar health records software boondoggle has hit yet another snag: The Veterans Affairs Department said last week it was halting deployments of health record technology provided by Oracle — which recently acquired bid winner Cerner — to focus on improving its function at handful of sites that currently use the software.
VA officials struck a conciliatory tone in a department press release. Veterans and clinicians said the EHR software "is not meeting expectations – and we're holding Oracle Cerner and ourselves accountable to get this right," VA Secretary Denis McDonough said.
"For the past few years, we've tried to fix this plane while flying it – and that hasn't delivered the results that veterans or our staff deserve," the VA's Neil Evans said.
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