Nanowear’s ‘smart clothing’ in NY/NJ hospital trials to monitor patients for early-stage COVID. Is it the Year of the Sensor?

Nanowear, a NYC-based developer of cloth-based nanosensors and monitoring systems, has entered a clinical trial collaboration with two major NY/NJ-area hospital systems to test for vital signs which may be predictive of an advancing case of COVID-19. 

The goal of the investigative teams at Hackensack Meridian Health, the largest health system in north and central New Jersey with 17 hospitals plus 500 patient care sites, and Maimonides Medical Center of Brooklyn, affiliated with Northwell Health, is to determine and assess patients for early signs of the ‘cytokine storm’ in the heart and lungs which indicates inflammation within the circulatory system, often leading to severe complications and death in COVID patients. The clinical trial will monitor patients with confirmed or suspected COVID-19. The release is not specific as to whether the garment will be issued to patients monitored solely in the hospital or inclusive of patients still at home.

Nanowear’s SimpleSENSE adjustable undergarment continuously captures key physiological signs related to the onset of COVID–real-time ECG, systolic and diastolic blood pressure, blood flow hemodynamics, respiration, lung volume and fluid, and temperature. The vital signs are then transmitted via a mobile app to a physician portal for monitoring and interpretation.  

The garment test is also significant as it is a contactless monitoring system–highly applicable to contagious diseases.

Last July, SimpleSENSE launched in a heart failure management clinical trial with Penn State Hershey Medical Center in Pennsylvania and Hackensack Meridian. The patented cloth-based nanotechnology sensors can capture up to 120 million data points per patient per day. The HF management trial was designed to validate and provide a pathway to clear its own diagnostic algorithm generated from the garment. The SimpleSENSE device and mobile platform have been submitted to FDA for Class II 510(k) clearance.  Also mHealth Intelligence.

This may be the Year of the Sensor. Human contact is out, remote monitoring is in. Earlier this week, we covered Philips integrating BioIntelliSense‘s BioSticker into its RPM systems. During 2018-2019, we profiled Doncaster UK-based MediBioSense, which uses the VitalPatch from VitalConnect. They recently announced that an enhanced VitalPatch suitable for seven-day use and body temperature sensing received CE Class IIa medical certification as well as FDA clearance. We last covered them when MBS adopted the Blue Cedar app security system in 2018, but based on their website press section, much has happened since in extending their sensor-based technologies. This Editor will try to catch up with Simon Beniston of MBS.

The last news roundup for 2019: ACA mandate unconstitutional, more $ for health research, PartnersHealthcare rebrands, Hackensack Meridian pays ransom, breaches>heart attack deaths, telepsychiatry merger, more

Well, it’s happy trails for 2019, until we meet again in 2020, paraphrasing a well-known Roy Rogers tune (Roy was a movie and TV cowboy singer in the US; his eponymous roast beef sandwich chain was an advertising client for one of this Editor’s first jobs). So we’ll round up the news as we and I trust most of our Readers will be off for most of the next two weeks to be observing the holidays with family, friends, de-stressing, defrosting, or attempting to catch up on work while it’s quiet before January Madness hits. It’s hard to believe that This Year of Grace is almost over.

Breaking News: In a somewhat split decision, the Fifth Circuit Court of Appeals ruled Wednesday evening that the (Un) Affordable Care Act’s (ACA)’s individual insurance mandate, compelling everyone to signup Or Else, is unconstitutional. Congress zeroed out the mandate charge in 2018’s tax law. A decision regarding severability of the mandate from the ACA law has been remanded to the District Court. FierceHealthcare, Healthcare Dive

Also here in the US, we have both an impeachment of a President (a House action which will fail utterly in the Senate, and regarded by ordinary folks as a political annoyance) and a Federal budget running out on Friday that hardly anyone notices because it’s been extended since October by two continuing resolutions (CRs). The new budget that has to be signed by President Trump on Friday is, according to this POLITICO report today, chock full of health research dollars for NIH, the All Of Us genomics initiative directed by Eric Dishman, the Patient-Centered Outcomes Research Institute, or PCORI. and more. There’s some coal dust in the stocking for the national patient identifier initiative. Separately, CMS’ Blue Button 2.0 is offline due to a bug.

PartnersHealthCare rebranding, investing $100 million. Now called Mass General Brigham to better align with its parents (Massachusetts General Hospital and Brigham and Women’s Hospital, the Boston Globe reported that MGB will be spending $100 million for the first 18 months of a digital health initiative to improve the patient experience and the efficiency of care. Much will be around patient convenience, for example the ability to book appointments online, communicate with care providers via video and text, and providing online access to their medical records through OpenNotes. Efficiency initiatives will be focused on analytics and AI to manage patient flow and track revenue. The strategic plan and rebranding is promoted as a five-year project. Partners has been a pioneer in the field, with other large health systems following such as Novant Health (NC) and Mount Sinai (NY) with innovative partnerships and investments. FierceHealthcare

Hackermania in Hackensack continues. TTA reported last week that local New Jersey media identified Hackensack Meridian Health had been the victim of a ransomware attack starting on 5 December. The health system confirmed on Friday that it was a ransomware attack and they paid an undisclosed sum covered by insurance. The attack forced them back to paper records in all 17 of their hospitals, so with the insurance–and against law enforcement advice–they decided to pay up. Asbury Park Press, Healthcare IT News,Health IT Securitywhich also mentions the November attack on Oahu (Hawaii) Cancer Center. International hacker and ransomware attacks on vulnerable healthcare organizations are the subject of these year-end roundups: CISOMag, Becker’s Hospital Review.

Cyberbreaches increase fatal heart attacks? A Vanderbilt University study has also traced an uptick in patient mortality after heart attack to delayed care due to breaches. A survey of 3,000 Medicare-certified hospitals, about 10 percent of which had experienced a data breach, led to 36 additional deaths per 10,000 heart attacks. Krebs On Security blog

Short takes: the Sutter Health-Aetna partnership is adding home visits via Heal and telemedicine via 98point6 in Sutter’s Northern California area….Medtronic snapped up eating behavioral health startup Klue to reinforce a hybrid closed loop system to simplify diabetes management….Telepsychiatry is still niche, but InSight Telepsychiatry and Regroup Telehealth, two of the larger companies in the field, agreed to combine to be the single largest with a few hundred centers. Both American Well and Teladoc are encroaching on this area. 

We wish our Readers a Festive Holiday Season, whether you celebrate the week of Hanukkah, Christmas, Kwanzaa, or

another holiday. Rest, reflect, and our best wishes for a happy, healthy New Year. We will be off except for perhaps an occasional article until after 2 January.