Short takes: Legrand acquires Enovation, FDA nixes Cue Health’s Covid tests, Ascension confirms ransomware attack–who did it? (updated), beware of ‘vishing’ courtesy of ChatGPT

Legrand Care acquires Enovation. Enovation is a Netherlands-based digital health company with a connected care platform for care monitoring across prevention, early detection, medication checks, and remote healthcare. Its customer base includes ambulances, pharmacies, clinics, hospitals, and home care. With distribution in healthcare organizations across 18 countries, including Scottish Digital Telecare [TTA 11 Aug 2021], it will join the equally international Legrand’s Assisted Living and Healthcare (AL&HC) business unit with Intervox, Neat, Tynetec, Jontek, and Aid Call. Acquisition cost was not disclosed. Release   Legrand and Tynetec are long-time supporters of TTA.

The hammer drops on embattled Cue Health. The US Food and Drug Administration (FDA) has invalidated Cue Health’s Covid-19 Tests for Home and OTC Use and for the authorized lab test version. Home users were advised to discard unused kits in household trash. Both consumers and providers were advised to retest if symptoms persisted after a negative test result. This followed an FDA inspection of their operations that determined that unauthorized changes to the test kit design were made along with failures in performance testing. A Warning Letter was issued to Cue on 9 May. The company has not yet responded. FDA Safety Communication

Cue was one of many biotech manufacturers that marketed Covid-19 point of care/lab, and home testing kits after obtaining Emergency Use Authorizations (EUA) in 2020 and 2021. It exploded in size and went public in September 2021 at $200 million and $16/share with a valuation of $3 billion. Today HLTH shares trade on NasdaqCM at a little bit over $0.13. Their headquarters facilities in San Diego that once had 1,500 employees must be a lonely place, as the company reported another layoff of 230 employees, about half of remaining staff, after earlier layoff rounds of 245 in February and 880 in 2023. Their remaining test is one for Mpox on a EUA. Two other tests developed for flu and RSV are still under FDA review.  Cue Health’s financial reports for 2023 were dismal with revenue down to $71 million, an 85% reduction versus 2022, and a net loss of $373.5 million. Recent reports indicate that the company will refocus on marketing its Cue Health Monitoring System. Management and board changes have also been drastic, with a CEO change in March (Yahoo Finance) and the CFO departing this past Monday. MedTech Dive

Ascension Health finally acknowledged that its cyberattack was ransomware-based. On Saturday 11 May, their website event update confirmed that the cyberattack was ransomware. The Saturday and Monday 13 May updates also confirm that system operations will continue to be disrupted with no timetable set for restoration to normal status. Impacted systems include their EHR, MyChart, and some hospitals are diverting emergency care. The update page now has 12 regional updates and a general + patient FAQ. Update: in these states, Ascension’s retail pharmacies cannot fill prescriptions: Florida, Wisconsin and the District of Columbia. Their website recommends that patients bring paperwork and prescription containers. Lab and imaging results are delayed. Since the hospitals are on manual systems, overall there are delays in admissions–bring documentation. And the class-action suits have started, with reports that three have been filed already. Healthcare IT News

Who dunnit? DataBreaches.net reported over the weekend that Ascension’s hack has been attributed to interestingly named ransomwareistes Black Basta. Late last week, the US Cybersecurity and Infrastructure Security Agency (CISA) issued an alert on Black Basta. It’s another charming ransomware-as-a-service (RaaS) with bad news affiliates like BlackCat/ALPHV wreaking havoc on over 500 organizations globally. No word on whether Ascension has paid ransom. 

Speaking of cybersecurity, now something else to worry about–‘vishing’. This is ‘voice phishing’, another generative AI-facilitated hack that uses snippets of a human voice to pose as people or representing organizations via phone call or voicemail. Not enough? There’s ‘smishing’–SMS or text phishing which can invade your phone with all sorts of nasty messages. These attacks, according to cybersec firm Enea, are up twelve-fold since the launch of ChatGPT. Vishing, smishing, and phishing (email) attacks have increased by a staggering 1,265%. 76% of enterprises lack sufficient voice and messaging fraud protection. Can we go back to the 1990s? 2000s? When we worried about “Nigerian princes” email scams? Becker’s, Enea survey report