...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... Continue Reading
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News roundup: UHG CEO’s Bad Day at Capitol Hill; Kaiser’s 13.4M data breach; Walgreens’ stock beatup; Cigna writes off VillageMD; Oracle Cerner shrinks 50%; Owlet BabySat gets Wheel; fundings for Midi, Trovo, Alaffia, Klineo
...Witty’s Senate testimony statement, House testimony statement Speaking of data breaches, Kaiser Permanente reported a big one to Health and Human Services (HHS). This relates to ad tracker information shared with third-party advertisers such as Google, Microsoft, and X. Kaiser used it in secured areas of their website and mobile apps. Information disclosed could be name and IP. Kaiser reported it on 12 April but only disclosed on 25 April that 13.4 million records may have been affected. The ad trackers have since been removed. TechCrunch, FierceHealthcare Walgreens stock not recovering. April was WBA’s worst month in five years and... Continue Reading
Weekend reading: 23andMe’s exploding plastic inevitable fate–and what might have been
...2023 debut and their in-house drug discovery moved only two out of 50 into early-stage human trials. The GSK deal expired and was not renewed. 23andMe was also torching through cash. [TTA 2 Feb]. The thick and sticky icing on the cake was 23andMe’s antagonistic response to the breached customers, blaming them for recycling passwords and using multiple features they offered [TTA 19 Jan]. This was rightfully blasted in the industry and the subject of multiple consumer class-action lawsuits. In this Editor’s opinion, 23andMe’s ship must pass between the Scylla and Charybdis of financial choices. Splitting up a near-worthless company... Continue Reading
News roundup: Congress hammers absent UHG on Change cyberattack–and more; 10% unhinged at Hinge Health; Steward Health nears insolvency; Two Chairs $72M Series C
UnitedHealth Group facing direct Congressional criticism–and didn’t show up to answer it. The House Energy and Commerce Committee held a hearing yesterday on the BlackCat/ALPHV cyberattack on UHG/Optum’s Change Healthcare systems. Representatives of the American Hospital Association, which we noted led the earliest efforts to assess the situation, help health systems, and then lobby Health and Human Services to assist providers, the College of Healthcare Information Management Executives, and the Healthcare Sector Coordinating Council testified to a restive group of House representatives. Though reports have said that UHG had previously briefed the committee and CEO Andrew Witty will appear before... Continue Reading
News roundup: Now Clover Health faces delisting; BlackCat/ALPHV affiliate with 4TB of data puts it up for sale; $58M for Biolinq’s ‘smallest blood glucose biosensor’
...and four others, for a total since 2014 of $254 million. Crunchbase Current blood glucose sensors penetrate the skin with tiny needles. The Biolinq biosensor uses electrochemical sensors to measure glucose levels from the intradermal space just beneath the surface of the skin, on top of the capillary layer avoiding scarring. To access the intradermal layer, the sensors must be “200 times smaller than a human hair filament” according to Biolinq CEO Rich Yang. It also can combine blood glucose information with relative levels of activity in one device to eventually measure other analytes. The device as currently designed displays... Continue Reading
Opinion: Further thoughts on Teladoc, Amwell, and the future of telehealth–what happens next?
...work with her then-employer in early 2020 that the population health platform they had introduced already had integrated HIPAA-compliant telehealth platforms as a module–all that was needed to get the practices up and running on it–and coding correctly. Health systems now integrate telehealth into their patient portals. EHRs even for the small practice market now have integrated telehealth. As mentioned, specialized telehealth such as telemental health took off during the pandemic and, after a cleanout period, have largely stayed with us. Asynchronous telehealth has also become acceptable to consumers. (Interestingly, the leading asynchronous diagnoses are for hypertension and respiratory diseases... Continue Reading
News roundup: Amwell faces NYSE delisting; Walmart Health slows Health Centers, except Texas; Novosound’s ultrasound patent; Eko’s Low EF AI; Universal Brain; Elizabeth Holmes in ‘Dropout’ + update
...available on Hulu. Or if you have a VPN, you can set it to a UK-based server and sign up for BBC iPlayer. The only recent (January) news about Ms. Holmes is that the Department of Health and Human Services (HHS) Office of Inspector General (OIG) banned her and Sunny Balwani from all Federal health programs for 90 years, which does strike one as overkill as beyond their reasonable lifetimes. Ars Technica Based on a Reddit posting on a pop culture chat, celeb Jen Shah, also at FPC Bryan, and Holmes were snapped ‘hanging out’ in the yard. Shah was... Continue Reading
ATA requests expediting of revised proposed rule on controlled substance telehealth prescribing; announces Nexus 2024 meeting 5-7 May
ATA and 200 organizations request from DEA a revised proposed rule on controlled substance teleprescribing–stat. The American Telemedicine Association (ATA), in a 2 April letter (PDF link) with over 200 signatories, requests that the DEA quickly issue a revised proposed rule for industry comment. Last October, the Drug Enforcement Administration (DEA) and Health and Human Services (HHS) extended for the second time pandemic flexibilities for prescribing controlled substances through 2024. The proposed rule issued in May had 38,000 comments, which overwhelmed DEA and HHS. The two agencies were unable to come up with a revised proposed rule by end of... Continue Reading
Short takes: PocketHealth, Brightside fundings; VA OIG reports hit Oracle Cerner; Change cyberattack/legal updates; UHG-Amedisys reviewed in Oregon; Optum to buy Steward Health practices
...American Hospital Association, Senators and House Representatives are jumping all over Health and Human Services (HHS) to ensure that payments are made to Medicare, Medicaid, and Medicare Advantage plans–as well as calls for investigating UnitedHealth. Becker’s, FierceHealthcare As expected, UHG’s acquisition of Amedisys home health is running into more opposition at the state level. In this case, it’s the Oregon Health Authority (OHA) that will be conducting a full review. The Department of Justice (DOJ) has been investigating the acquisition on antitrust grounds almost since it was announced in June 2023. Shareholders approved the $3.3 billion buy the following September,... Continue Reading
2023 US data breaches topped 171M records, up 187% versus 2022: Protenus Breach Barometer
2023’s US healthcare data breaches hit an all time high, both in reported breaches and number of records affected. Protenus, which publishes an annual Breach Barometer, uses multiple data sources including Health and Human Services’ public breach tool. The numbers are shocking for both: HHS 2023 reported 725 reports and about 135 million records Protenus‘ numbers are significantly higher: 1,161 reports and 171,139,241 breached records. In 2022, the totals were respectively 1,138 reports affecting a total of 59,664,152 breached records. Breached records were up 187% in 2023. The variance in reporting is due to factors including not knowing the true... Continue Reading
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