News roundup: Precision’s $102M raise, more on BCI; Withings clears BPM Pro 2; Nebraska 1st state to sue Change/UHG, related insider trading update; VA Oracle go-lives may resume; ATA intros CODE; ClearDATA HITRUST certified

December 19, 2024 | by

One more funding. A competitor of Elon Musk’s Neuralink, Precision Neuroscience. closed their Series C at $102 million. This round was led by General Equity Holdings, with participation from firms including B Capital; Duquesne Family Office, the investment firm of Stanley F. Druckenmiller; and Steadview Capital, bringing their total funding to $155 million. The total brings them according to their release as one of the best-funded brain-computer interface (BCI) company after Neuralink, whose funding is unknown. The funding will be used to advance its clinical research and expedite development of its cutting-edge brain implant. 

Precision is the developer of the Layer 7 Cortical Interface to treat motor paralysis. At the time of their last funding in January 2023, this Editor noted that their difference was to treat neurological illnesses and events such as stroke, traumatic brain injury, and dementia. Their focus remains largely there: severe spinal cord injury, stroke, ALS. So far, the investigational device has been tested its device in 27 patients through research partnerships and was designated by FDA as a Breakthrough Device.

More on BCI in this must-read article by Timmy Broderick for STAT. The upcoming issues around BCI now center around the engagement of CMS (Centers for Medicare and Medicaid Studies) for coding, coverage, and payment for devices after the investigational stage; privacy issues about neural data; and continued support after implantation. This last one is acute as these companies are young. There has already been the example of Second Sight’s bankruptcy, leaving subjects stranded with useless retinal devices in their eyes. BCI to this Editor will develop through 2025–and be a major focus of investment by 2026-2027.

Withings gains FDA clearance, intros BPM Pro 2. A professional-level product for hypertension and chronic heart failure (CHF) targeted to care teams to connect with their patients, the FDA clearance covers blood pressure and pulse rate measurement in adults with arm circumferences of 9 to 17 inches (22 cm to 42 cm) or 16 to 20 inches (40 to 52 cm). What is really interesting about the connected (Wi-Fi, cellular, BT) device is that care teams can program the device through the Patient Insights feature for the patient to interact with the device in real time. Through a small screen, it asks questions that help to track the patient’s condition, reinforce medication adherence, and assess their satisfaction. It also has a Retake Measure feature to retake a reading if results exceed predetermined thresholds and increases accuracy. Withings plans to upgrade the device to take a 1-lead ECG to detect atrial fibrillation; this is a separate clearance and expected to become available in 2025. The device is not yet CE Marked. Withings was named a CES 2025 Innovation Awards Honoree in the Digital Health category. (Photo, Withings website) Release, Mobihealthnews, MedCityNews

UHG’s Mound of Misery multiplies with Nebraska’s Change Healthcare lawsuit, plus separate but related insider trading. 

  • Nebraska became the first state to sue UnitedHealth Group, Optum, and Change Healthcare over those affected by the late February ALPHV/BlackCat hack of Change’s systems. In Nebraska alone, it affected 575,000 individuals. (It is actually hard to find someone who was not affected by the hacking of the leading exchange for major claims clearing and payments.) Nebraska’s attorney general Mike Hilgers is suing because of the company’s carelessness in handling data and, even worse, in its slow notification of those affected. Our Readers will recall that Change/UHG initially tried to push off notification on healthcare providers. When HHS threw the ball back to Change [TTA 5 June], notices didn’t go out until August-September. The charges in state law center on consumer law: financial data protection and consumer protection statutes, deceptive trade practices, and Federal standards on privacy (HIPAA, and HIT protection. The lawsuit was filed by the AG in the District Court of Lancaster County, Nebraska. Nebraska Examiner
  • The Change acquisition and later problems were possibly the catalyst for stock sales by senior/C-level UHG executives, including UnitedHealthcare CEO Brian Thompson. The $300 million Hollywood (Florida) Firefighters Pension Fund initiated a class action lawsuit alleging that the sales were made while the Department of Justice (DOJ) was considering an anti-trust action against UHG that would revisit the so-called ‘firewall’ between it and Change.  The complaint specifically mentions that UHG executives were aware of it as early as October 2023. The Wall Street Journal revealed the investigation on 27 February 2024–the same time as the Change breach was revealed, cracking the stock almost immediately. Executives including Thompson ($15 million), UHG CEO Andrew Witty, and board chairman Stephen Hemsley ($102 million) were named. The class action covers the period for stock purchased between 14 March 2022 and 27 February 2024. UHG has until 1 March 2025 to answer the complaint. Healthcare Finance News  (This is likely to affect the settlement of the Thompson estate–Ed.)

VA confirms that additional Oracle EHR implementations may go live in 2025, after 18 months of dead stop. The Oracle Cerner EHR is reportedly ‘running better’ at the current six sites where it is operating: five VA only (including 20 community clinics and about 100 support sites), and the sixth at Lovell jointly with the Military Health System (MHS). The restart of EHR Modernization (EHRM) was confirmed earlier during budget hearings by Kurt DelBene, assistant secretary for information and technology and chief information officer. Crash and lag downtimes are reduced by half and incident tickets by 60% since the last updates in August.  Timing remains indefinite for 2025 (FY ends 30 September 2025) but current VA Secretary Denis McDonough confirmed that primarily VA staff will continue to work on it under the Trump Administration. “The overwhelming majority of VA professionals who work on EHRM will be working on EHRM on January 21st, just as they were on January 19th,” McDonough said at an 11 December press conference. Federal News Network

Short takes:

  • The American Telemedicine Association (ATA) launched its new ATA Center of Digital Excellence (CODE) last week. CODE is constructed as an alliance with leading health systems for the development and implementation of digital health best practices that prioritize patient-centered care, equitable access, and improved clinical and operational outcomes. Tools span enhancement of workflows and patient engagement to improve healthcare accessibility. ATA release
  • ClearDATA’s CyberHealth platform and cloud managed services have earned Certified status by HITRUST for information security. ClearDATA provides healthcare specific managed cloud security, compliance and operations solutions. HITRUST, the Health Information Trust Alliance, is a non-profit that sets standards for data organizations through the HITRUST CSF framework. Release

News roundup: GE Healthcare warns on ultrasound vulnerabilities, Geisinger leverages Best Buy/Geek Squad for RPM, telehealth aids NYC shelter homeless, Fay raises $25M, ClearDATA’s AWS distinction, Validic’s MedTech award

May 16, 2024 | by

GE Healthcare warns hospitals and clinics on cybersecurity vulnerabilities in ultrasound devices. On their Product Security Portal, GE Healthcare issued three Coordinated Security Vulnerability Disclosures affecting:

  • a software application implementation called kiosk mode vulnerable to local breakouts
  • the Common Service Desktop (CSD) component vulnerable to command injection and path traversal
  • EchoPAC Software Only (SWO), EchoPAC TurnKey, and ImageVault products, vulnerable to unencrypted communication, unencrypted database and hardcoded, unencrypted credentials

These primarily affect the Vivid line of ultrasound devices. Cybersec firm Nozomi Networks Labs found vulnerabilities in the system that could be exploited to gain administrative privileges and recommended that ultrasound devices 1) not be left unattended and 2) block incoming connections to workstations that have the clinical software installed and are connected to unprotected networks. Healthcare Dive

Geisinger partners on patient monitoring with healthcare devices delivered by Best Buy/Geek Squad. For the past two years, Geisinger Health, now part of Risant Health, has been using Geek Squad to deliver and activate remote patient monitoring (RPM) devices such as blood-pressure cuffs, weight scales, thermometers, and glucose meters for those in active care management. The results of early pilots are: 50% faster time to activation of devices, 19% higher rate of patient adherence to using a wearable device, and an 18% reduction in technical issues reported. The ConnectedCare 365 program is now being used by 14 clinical programs for patients in acute care episodes, those in pre-surgical or post-acute transition, and those receiving low to complex management of their chronic conditions. 27,000 Geisinger patients have used remote technology since 2010, including 3,000 using the Best Buy—formerly Current Health—platform. An interesting but logical linkup of healthcare and retail services. JAMA Network

NYC’s homeless shelter telehealth program. Since 2020, NYC Health + Hospitals Corporation (HHC) and the New York City Department of Social Services (DSS) have worked together to bring HHC’s Virtual ExpressCare to homeless shelters. In the past year (January 2023 to April 2024), over 5,000 shelter residents across all 600+ shelters have used the program. The shelters use telephones, tablets, and computers provided by DSS to connect residents with Virtual ExpressCare physicians. DSS and other agencies share responsibility for all technical needs, including ensuring WiFi access and equipment cleaning. The program is also extended to shelter staff. Of the primarily (70%) black and Latino residents using the service, nearly half were uninsured, with an additional 5 percent were covered through the NYC Care program. mHealth Intelligence

Nutritional health startup Fay raises $25 million.  The Series A round was led by Forerunner Ventures with participation from General Catalyst and 1984. The virtual network of registered dietician nutritionists emerging from stealth is additionally backed by founders at Grow Therapy and Maven Clinic. Fay’s network of nutritionists are available nationwide and work with insurance plans to provide consumers with nutritional plans covering 30 specialties/conditions, such as eating disorders, diabetes, kidney disease, weight management, gut health, general preventative care, and others. Currently, they work with United Healthcare, CVS Aetna, Blue Cross, Anthem, Cigna, Optum, and Humana. The advantage for dieticians is to build their private practice with Fay’s “business in a box”.   Release

On the cybersecurity front, ClearDATA has achieved Amazon Web Services (AWS) Level 1 Managed Security Service Provider (MSSP) Competency. This required meeting operational and technical AWS quality standards for managed security services. They are one of only 62 firms to be so designated and the only one in healthcare. ClearDATA is a comprehensive provider of cloud, compliance, and security services and software for providers, payers, biopharma, and healthcare solutions. Release 

Validic was selected as “Best Remote Patient Monitoring Solution” in the 8th annual MedTech Breakthrough Awards program conducted by MedTech Breakthrough. Validic was one of the earliest companies (2010) in the RPM/IoT area with data integrated into EHRs for personalized care at scale. Since 2010, it has served 400,000 enrolled patients and 7,000 referring providers. Release