CommonSpirit Health: Ransomware attack responsible

 Updated Oct. 13 at 10:00 a.m.

CommonSpirit Health is now characterizing the interruption of IT services across several of its hospitals as a ransomware attack.

In the week since it disclosed an "IT security incident" that forced EHR shutdowns and appointment cancelations, the Catholic health giant said Wednesday that it has notified law enforced and tapped "leading cybersecurity specialists" to support its a forensics investigation. 

"Upon discovering the ransomware attack, CommonSpirit took immediate steps to protect our systems, contain the incident, begin an investigation and ensure continuity of care," the system said in an emailed statement. "Patients continue to receive the highest quality of care, and we are providing relevant updates on the ongoing situation to our patients, employees and caregivers. Patient care remains our utmost priority and we apologize for any inconvenience this matter has created."

CommonSpirit said its facilities are following pre-established system outage protocols that include taking certain systems, such as its EHRs, offline. 

The Chicago-based system operates 142 hospitals and over 2,200 sites of care within 21 states. It has seen system interruptions across several states including Nebraska, Tennessee, Texas, Washington and Iowa as a result of the attack.

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Updated Oct. 7 at 1:12 p.m.

Following the confirmation from CommonSpirit Health that a cybersecurity incident has disrupted medical systems in numerous but unidentified locations, reports from patients and health providers has revealed the ongoing effect of the attack that reportedly began Monday.

CommonSpirit confirmed in a statement to Fierce Healthcare that IT outages are taking place as a precautionary measure and that some patient’s may be notified regarding changes to appointments.

Subsidiaries of CommonSpirit have reported being affected by the attack including CHI Health facilities in Nebraska and Tennessee, Seattle-based Virginia Mason Franciscan Health providers, MercyOne Des Moines Medical Center, Houston-based St. Luke's Health and Mich.-based Trinity Health System.

The first reports of outages came on Tuesday from CHI Health and Virginia Mason Franciscan Health. CHI health reportedly later delayed surgeries.

"We drive to Bergan Mercy, go in the procedure center, walk up to the front counter, and I'm like 'I'm here to check-in,' and there was some stammering and stuttering and they're like, 'Well all the procedures have been canceled today,'" a CHI Health patient who reported that upon arriving at a CHI facility on Oct. 3 learned that their colonoscopy was canceled told NBC. 

Seattle-based Virginia Mason Franciscan Health providers St. Michael Medical Center and St. Anthony Hospital also reported being affected.

A caregiver reported to the KitSap Sun that staff at St. Anthony Hospital were unaware of her sister’s appointment and could not “put anything in the computer.” She reported observing staff using a makeshift paper system of record keeping and phones to communicate with providers and payers.

MercyOne Des Moines Medical Center also had to shut down its EHR system and other IT systems. Ambulances were reportedly rerouted to other medical facilities for a brief time on Oct. 3.

A nurse at the Houston-based St. Luke's Health told a local news outlet that some facilities are fully paper charting, with some patients' lab work not being processed, and appointments being canceled.

Livonia, Mich.-based Trinity Health System has also taken IT systems offline, including its EHR system. A spokesperson from Trinity told NBC.

CommonSpirit Health is managing an IT security incident affecting some of its facilities in multiple regions, the company said in a statement to Fierce Healthcare.

The number of facilities affected is still undisclosed as is the security of patient data following the incident which reportedly began Monday.

“As a result of this incident, we have rescheduled some patient appointments in some of our communities,” CommonSpirit’s statement said. “Patients will be contacted directly by their provider and/or care facility if their appointment is impacted.”

The Chicago-based health system is one of the largest in the country, operating 142 hospitals and over 2,200 sites of care within 21 states.

“As a precautionary step we have taken certain IT systems offline, which in some of our divisions includes electronic health record systems and other systems,” the statement said. “Our facilities are following existing protocols for system outages and taking steps to minimize the disruption.”

CommonSpirit’s Nebraska-based subsidiary CHI Health has reported outages in all of its Omaha hospitals—Lakeside Hospital, Creighton University Medical Center, Bergan Mercy and Immanuel Medical Center.

Two CHI Health hospitals in Chattanooga, Tennessee, moved some systems offline including electronic health records, according to a statement from CHI Memorial.

The Seattle-based Virginia Mason Franciscan Health has also reported being impacted by the outage. VMFH operates hospitals and clinics in the Puget Sound region, including St. Joseph Medical Center in Tacoma. Patients were reportedly unable to access the online patient portal, MyChart.

“We take our responsibility to ensure the privacy of our patients and IT security very seriously,” the statement said.  

CommonSpirit is one of many notable nonprofit health systems reporting significant losses for the most recent fiscal year. The health system, which was formed in a 2019 merger of Catholic Health Initiatives and Dignity Health, reported $1.85 billion in losses in 2022.

The Catholic organization recently appointed Wright Lassiter, formerly of Henry Ford Health, as its new CEO and successor to Lloyd Dean.

https://www.fiercehealthcare.com/health-tech/commonspirit-health-reported-it-security-incident-affecting-facilities-wash-neb-and

Sony, Lexie Hearing roll out first batches of over-the-counter hearing aids

 With less than a week to go until the FDA’s long-awaited rule takes effect enabling hearing aids to be sold over the counter, consumer tech makers are lifting the curtain on their first entries in the brand-new medical device category.

The tech giant Sony, as well as Lexie Hearing—which took over Bose’s direct-to-consumer hearing aid division earlier this year—unveiled new models of their self-fitting hearing aids this week.

Consumers will be able to buy those and other eligible devices in stores and online, no prescription or medical exam needed, once the FDA rule takes effect on Oct. 17. Finalized in mid-August, it established a new category of devices aimed at making hearing aids more affordable and easily accessible to the approximately 30 million U.S. adults who could benefit from them. Currently, according to the FDA, only about 20% of that group uses the devices, which are priced on average between $1,000 and $4,000.

The rule covers only air-conduction hearing aids—which are worn in or behind the ear and don’t require a surgical implant—and applies to adults with mild to moderate hearing impairment, while those with severe hearing loss or under the age of 18 will continue to require a prescription.

Sony’s CRE-C10 and CRE-E10 earbud-like devices, which the tech giant debuted Wednesday, mark its first foray into the hearing health market and the first products of a partnership with hearing aid maker WS Audiology that was announced last month.

The CRE-C10 hearing aids, priced at $1,000, run on standard size 10 batteries—six of which are included with the initial order—giving the devices a battery life of up to 70 hours of continuous use, per Sony. They’ll be available for purchase via Sony’s website and retailers like Amazon and Best Buy beginning this month.

The CRE-E10 model, meanwhile, runs on rechargeable batteries that boast 26 hours of continuous use per charge. It’s equipped with Bluetooth technology, allowing users to stream audio from their iOS devices through their hearing aids. Those upgraded features, of course, carry an upgraded price: $1,300 for the pair and their wireless charging case, which will go on sale later this winter.

Both of Sony’s OTC hearing aids connect to its Hearing Control app, where users can set up the devices and adjust the fit and volume levels. They can also continue to visit the app as needed to adjust volume and other settings based on different environments and other changes in their hearing needs; both models are also designed to automatically adjust based on a user’s surroundings.

Lexie’s B2 hearing aids—which carry the “Powered by Bose” label—are similar to Sony’s upgraded CRE-E10 model. The devices are equipped with a rechargeable battery that lasts up to 18 hours after each three-hour charge. Lexie’s offerings, too, can be self-adjusted using the paired Lexie app, where users can tweak treble and bass frequencies and switch other settings based on changes in their environment.

The receiver-in-canal hearing aids are priced quite a bit lower than Sony’s own rechargeable option—at $999—and will be available for purchase in more than 11,000 pharmacy and retail locations, both online and brick-and-mortar, as soon as next week, the devicemaker announced Tuesday.

The handoff of Bose's hearing device business to Lexie earlier this year came amid the total elimination of Bose’s consumer healthcare division in March, marking a sputtering end to Bose’s once-lauded expansion into health tech.

That short-lived exploration peaked in 2018 with FDA clearance for its SoundControl hearing aids, but it was all downhill from there: They didn’t officially launch in the U.S. until mid-2021—with the rollout further hampered by the lack of a definitive over-the-counter FDA ruling—and were discontinued just a year later amid the Lexie handoff.

https://www.fiercebiotech.com/medtech/sony-bose-partner-lexie-roll-out-first-batch-over-counter-hearing-aids-fda-ruling

Novo Nordisk's Wegovy gets a surprise endorsement from Twitter's soon-to-be owner Elon Musk

 How do you solve a problem like Elon Musk? Well, when it comes to his weight, there seems to be a simple answer: Novo Nordisk’s Wegovy.

Musk, who runs several major companies including SpaceX and electric car firm Tesla and is now set—after a long legal tussle—to buy Twitter, said on the social media platform in response to a question about his recent weight loss that it was down to “Fasting” and, in a later tweet, "And Wegovy.”

Wegovy is Novo Nordisk’s injectable form of GLP-1 drug semaglutide, the ingredient in its diabetes franchise Ozempic and Rybelsus.

The FDA approved Wegovy last summer for chronic weight management in adults with obesity or who are overweight with at least one weight-related condition (such as high blood pressure, Type 2 diabetes or high cholesterol) with a BMI of 27 or more or in those with a BMI of 30 or greater in general.

While some nice free advertising for Novo, it isn’t clear whether Musk should, according to the drug's approval, in fact be using the drug. For that reason, these kinds of unexpected endorsements can be a double-edged sword for companies.

In fact earlier this year, a report out by Variety claimed that a number of celebrities are paying big bucks to use Ozempic but in a slightly different dose to tap its weight-loss effects.

Musk is not a spokesperson for the company and a Novo Nordisk spokesperson told Fierce Pharma Marketing that "we were not aware of Elon Musk’s use of Wegovy before he shared this information publicly."

Wegovy’s approval could be a boon for obesity drugs, which have been few and far between despite there being a potentially lucrative market.

Heart safety concerns have hampered many meds over the past 20 years, but Wegovy appears to be bucking the trend, making $1.2 billion last year as it racks up sales.

It does, however, have a potential rival in Eli Lilly’s tirzepatide, but just this month got a rolling submission off to the FDA for obesity. The drug was approved earlier this year for Type 2 diabetes approval and is branded as Mounjaro.

https://www.fiercepharma.com/marketing/novo-nordisks-wegovy-gets-surprise-endorsement-twitters-soon-be-new-owner-elon-musk

'LGBTQ voting bloc set to make up almost 1 in 5 voters by 2040': Human Rights Campaign

 The LGBTQ voting bloc is poised for considerable growth over the next two decades, wielding considerable influence in determining what the future will look like for the nation’s political landscape.

In a report published Thursday by the Human Rights Campaign (HRC), a national LGBTQ advocacy group, and Bowling Green State University in Ohio, it’s estimated that LGBTQ adults — already accounting for a sizable proportion of the electorate, at 11.3 percent — will make up 14 percent of eligible voters by 2030.

By 2040, nearly 18 percent of eligible voters in the U.S. will identify as LGBTQ, according to the report, which uses publicly available Census Bureau data and demographic projections from the University of Virginia.

HRC Interim President Joni Madison on Thursday said the role LGBTQ voters already play in elections will grow in the coming years to “fundamentally reshape the American electoral landscape,” particularly in battleground states and swing districts.

In several consequential red states including Georgia, Texas and Arizona, the proportion of LGBTQ voters is expected to nearly double between 2020 and 2040, surpassing national levels.

That’s likely to tip the scales toward Democrats in those states, turning once reliably Republican strongholds into more evenly divided battlegrounds. A 2020 Williams Institute report found that half of LGBTQ adults in the U.S. are registered Democrats (another 15 percent are Republicans, 22 percent are Independents and 13 percent identify with another party or are unsure with which party they most identify).

In states including Nevada and Colorado, the proportion of the voting eligible population identifying as LGBTQ will exceed an estimated 20 percent by 2040, according to Thursday’s report.

Nationally, the share of eligible voters that identify as LGBTQ is already up from 2020, when 10.8 percent of the adult population said they were LGBTQ. That’s in no small part tied to the coming of age of young adults in Gen Z, with 27 percent of that generation (born between 1997 and 2003) identifying as LGBTQ, according to Thursday’s report.

A February Gallup poll similarly found that more than 20 percent of Gen Z adults identify as either gay, lesbian, bisexual or transgender, nearly doubling since 2017, when only the leading edge of that generation (born between 1997 and 1999) had reached adulthood.

Thursday’s HRC report comes on the heels of a record-breaking year for state bills aiming to restrict the rights of LGBTQ people, particularly transgender youth. The state legislatures of no less than 40 states this year considered measures to curtail access to gender-affirming health care, bar transgender athletes from competing on sports teams consistent with their gender identity and restrict how LGBTQ issues and identities are talked about at school or the workplace, according to Freedom for All Americans, which tracks state-level legislation affecting the LGBTQ community.

More than 50 percent of registered LGBTQ voters planning to vote in the midterms in a February GLAAD poll said they are “extremely motivated” to vote this November, recognizing that these elections are underscored by an increasingly hostile climate toward LGBTQ people in state legislatures nationwide.

While the fight over LGBTQ rights this year has primarily been fought at the state level, federal lawmakers have begun to wade into the issue.

In August, Rep. Marjorie Taylor Greene (R-Ga.) introduced the first piece of federal legislation to outlaw gender-affirming care for minors nationwide, seeking to make it a felony — punishable by up to 25 years in prison — to provide gender-affirming care to youth under 18.

Greene’s bill is co-sponsored by more than 40 House Republicans and Republican Senate candidates J.D. Vance of Ohio and Blake Masters of Arizona have pledged to back the measure if they are elected in November.

House Minority Leader Kevin McCarthy (R-Calif.) has promised to bring up a bill to prevent transgender athletes from competing in women’s sports if Republicans win the House majority.

https://thehill.com/changing-america/respect/diversity-inclusion/3686612-lgbtq-voting-bloc-set-to-near-one-in-five-voters-by-2040-human-rights-campaign-says/

Philips expands rollout of its ClarifEye augmented reality surgical navigation solution to Japan

 

• International University of Health and Welfare, Mita Hospital, Tokyo, employs Philips’ augmented reality (AR) surgical navigation solution to treat first patients in Japan, helping to bring the patient benefits of minimally-invasive spine surgery to Japan’s aging population

• New data published in European Spine Journal on the clinical use of ClarifEye showed a 98% accuracy of pedicle screw placement during minimally invasive procedures, comparable to values reported in literature for other navigation and robotic systems

 Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced expanded rollout of its augmented reality (AR) surgical navigation solution - ClarifEye - to Japan, highlighting positive results in the first patients treated by the International University of Health and Welfare, Mita Hospital (Tokyo, Japan) using this innovative 3D AR solution. Installed on a Philips interventional X-ray system in a hybrid operating room at Mita Hospital, ClarifEye helped the hospital’s orthopedic surgeon Dr. Ken Ishii to successfully treat patients with spinal stenosis (narrowing of the spaces in the spine) and scoliosis (sideways curvature of the spine) via minimally-invasive image-guided procedures.

Due to its aging population, the number of spine surgeries performed each year in Japan continues to increase. Lumbar spinal canal stenosis, the most common spinal disease, is currently found in approximately 10.8% of the country’s 70-79 year olds [1]. In patients with severe symptoms, surgical procedures are typically performed, including excision of the compressed area and fixation of the bone with screws or other fixtures. Traditionally, these fixation devices have been placed through a large incision with direct observation of the affected vertebra. However, they are now increasingly being placed via minimally-invasive procedures performed through small incisions, minimizing bleeding and soft tissue damage, reducing postoperative pain, and making treatment available to patients at risk from the trauma of open surgery. Philips’ augmented reality surgical navigation solution - ClarifEye - combines 2D and 3D visualizations at low X-ray dose with 3D AR navigation into one system. It enables surgeons to define and navigate critical trajectories for precise device placement while avoiding damage to fragile neurological and vascular structures close to the patient’s spine.

https://finance.yahoo.com/news/philips-expands-rollout-clarifeye-augmented-080000908.html

BeiGene upped at Leerink, Guggenheim

Oct-13-22 Upgrade SVB Leerink Mkt Perform → Outperform $177 → $200

Oct-13-22 Upgrade Guggenheim Neutral → Buy $205

https://finviz.com/quote.ashx?t=BGNE&p=d

Prime Medicine sets IPO terms, which could value the biotech at up to $1.7 billion

 Prime Medicine Inc. has set terms for its initial public offering, in which the Massachusetts-based biotechnology company, which utilizes gene-editing technology to develop therapies for a wide spectrum of diseases, looks to raise up $160.2 million. The company said it is offering 8.9 million shares in the IPO, which is expected to priced between $16 and $18 a share. With 94.34 million shares expected to be outstanding after the IPO, the pricing could value the company at up to $1.70 billion. The stock is expected to list on the Nasdaq under the ticker symbol "PRME." J.P. Morgan, Goldman Sachs, Morgan Stanley and Jefferies are the underwrites. The company recorded a net loss of $65.7 million on no revenue for the six months ended June 30, after a loss of $92.1 million on no revenue in the same period a year ago. The company is looking to go public at a time that the Renaissance IPO ETF has tumbled 11.1% over the past three months, while the iShares Biotechnology ETF has slipped 2.3% and the S&P 500 has declined 4.1%.

https://www.morningstar.com/news/marketwatch/20221013484/prime-medicine-sets-ipo-terms-which-could-value-the-biotech-at-up-to-17-billion