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Harmonia Healthcare's chief scientific officer, Marlena Fejzo, Ph.D., will also leverage her groundbreaking discovery of the hormone associated with HG to drive innovations in prognostics, prevention and treatments. Harmonia Healthcare, a new provider focused on specialty women’s health, has opened a clinic in New Jersey to treat hyperemesis gravidarum (HG).  HG can bring nausea and vomiting during pregnancy severe enough to prevent proper food intake and can lead to weight loss, dehydration and ultimately hospitalization. It can cause complications for mothers and their babies and is estimated to affect up to nearly 11% of pregnant women. Harmonia’s new clinic will offer evidence-based treatments and educate patients on the latest science around HG. Its offerings include medication and vitamin infusion, electrolyte replacement plans, prescription management, diagnostic bloodwork and telehealth. A second clinic is planned to open in New York City this fall. The clinic does not require referrals.   Its chief scientific officer, Marlena Fejzo, Ph.D., a women’s health researcher with lived experience of HG, will also leverage her and colleagues' groundbreaking discovery of the hormone associated with the condition—GDF15—to drive innovations in prognostics, prevention and treatment. Fejzo was a 2023 Fiercest Women in Life Sciences awardee.  “We really want to fix the broken care model in women’s health and improve care,” Fejzo told Fierce Healthcare. “We hope to expand this to be the future of care for these undertreated and underdiagnosed diseases.”  Harmonia’s online platform will offer educational resources and eventually telehealth, though women should still ideally first come into the clinic in person. The current status quo for women with HG is unacceptable and costly, Fejzo says. If they end up in an emergency room, they are treated with fluids or antiemetic drugs and released. But because HG causes persistent nausea and vomiting, women need persistent medication management, Fejzo argues. If they are discharged without a prescription, many will inevitably wind up back in the hospital again; 60% of women have multiple hospital visits, per Fejzo.  And, while HG is starting to be diagnosed properly more often, Fejzo said, it can still be misdiagnosed or not diagnosed at all.  “A lot of people think that it’s just regular nausea and vomiting and that everything’s going to be fine … when actually there are really adverse outcomes associated with HG for the mother and the baby,” Fejzo said.  During a recent conference, Fejzo said she discovered ER doctors affiliated with Harvard discharge HG patients without a prescription. Their justification for it was that the medications might make them tired, and then they would have to miss work. “That’s a real misunderstanding of HG,” Fejzo said, adding that if Harvard-affiliated docs are doing it, “I assume it is common.”  RELATED: New study finds cause and potential treatment for dangerous morning sickness Part of the reason Fejzo believes this is happening is due to a famous historic incident known as the thalidomide disaster. After women being treated with thalidomide for nausea had babies with birth defects, it launched a widespread hesitancy to prescribe medications during pregnancy, Fejzo said. There also remains a misguided belief that HG is psychological or resolves on its own.  And because HG typically starts early in pregnancy, many women see ER docs before even seeing their obstetrician, meaning many providers may not be aware of how sick their patients have really been. Obstetricians are also generally not trained to ask their patients about their levels of nausea and vomiting—and patients, too, may not talk about it, Fejzo explained. To address this, Harmonia will be monitoring women receiving medication management and coordinating with their other providers, like OB-GYNs, midwives and doulas. The goal is to intervene as early as possible with more aggressive treatment before the condition spirals out of control. The best medications for HG being prescribed off-label include Zofran, Phenergan and Reglan, according to Fejzo. Yet doctors usually begin with doxylamine and pyridoxine, as recommended by the American College of Obstetricians and Gynecologists, which Fejzo says are “pretty much a placebo for HG.”  By serving patients with HG, Harmonia will have the infrastructure in place to run clinical trials on potential new treatments, Fejzo said. She is already advising NGM Bio, which recently announced it is interested in testing its drug NGM120 in HG patients.  While Fejzo doesn’t anticipate challenges with patients getting their scripts filled, Harmonia providers will educate patients on how to have conversations with pharmacists in case they do run into pushback. In recent years, pharmacists have sometimes refused to fill opioid prescriptions with doses they perceived as too high or poorly monitored by the prescriber. One of the country’s only other clinics in this space, Alabama’s Morning Sickness Clinic, claims its model has led to a 95% reduction in ER visits and a 90% decrease in total cost of care. Its co-founder, an emergency medicine physician, is one of Harmonia’s clinical advisers.  Harmonia eventually hopes to expand to serve other under-researched women’s health conditions. While the company does not currently plan to pursue formal health system partnerships, it hopes that its clinics will come to be known locally as the go-to expert for these conditions.  And, while it isn’t yet, Harmonia plans to be working with commercial and Medicaid insurance plans by the end of this year.

While the world frets over legal and clinical perils of the growing use of artificial intelligence in healthcare, cybersecurity may have become the IT genie already out of the bottle. Attacks on healthcare information systems are accelerating at an extraordinary pace, according to numerous reports. In one evaluation, a threat analyst for the cybersecurity firm Emsisoft found that cyberattacks on hospital systems last year nearly doubled from those of 2022, rising from 25 to 46. Those 46 systems represented a total of 141 affected hospitals. The paydays for criminal hackers and ransom seekers have gotten bigger too, with the average payout jumping from $5,000 in 2018 to $1.5 million in 2023. Another report said that about one in three Americans were affected by health-related data breaches in 2023. Increasing costs and healthcare cybersecurity worries have sparked draft national legislation aimed at boosting protections within the U.S. Department of Health and Human Services (HHS) purview. The bipartisan “Strengthening Cybersecurity in Health Care Act” by four senators would require the HHS to perform routine evaluations of its systems and deliver biannual reports on practices and progress. As an example of the severity of threats facing institutions, a ransomware gang last month gave a Chicago safety-net hospital two days to cough up $900,000 or else face a leak of its patient data. Another Chicago facility, Lurie Children’s Hospital, was forced to take its networks offline earlier this month in response to a likely ransomware attack. The response resulted in limited access to medical records and impaired phone and email communications. Hospitals and large health systems aren’t the only victims. A Colorado ophthalmology group experienced an attack affecting 6,000 patients, while the operator of more than 100 fertility clinics nationwide has proposed a $5.75 million settlement to resolve a data breach exposing the data of about 900,000 patients. And a respiratory homecare provider has proposed a $7.25 million settlement of a class action lawsuit over a breach affecting nearly 3 million patients. Meanwhile, Florida prosecutors have charged a 21-year-old with leading a scamming ring that allegedly hacked into doctors’ electronic prescribing accounts and wrote tens of thousands of bogus orders for addictive drugs. Officials say the scheme mainly involved oxycodone, promethazine, and codeine. The latter two can be used to create a recreational drug known as sizzurp or purple drank. Attacks not only increase dangers of drug misuse and medical mistakes but also expose patients to public embarrassment. Last year a leak at a Pennsylvania health network led hackers to post cancer patient photos to the dark web. Officials linked the action to Black Cat, a ransomware gang associated with Russia. A warning from HHS alleged that the group has demanded ransoms as high as $1.5 million per incident. In response to the wave of attacks, in January HHS unveiled a set of healthcare-specific cybersecurity performance goals aimed at helping the healthcare sector prioritize key security safeguards. The proposed “Strengthening Cybersecurity” legislation pending in the U.S. Senate would supplement those goals by requiring HHS to submit to Congress a report every two years describing how the agency is identifying and addressing vulnerabilities. Editor’s Note: This article first appeared in the Healthcare Docket newsletter. Click here to subscribe and read the full newsletter.