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

July 24, 2020 | by

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.

MediBioSense partners with MRIGlobal for Department of Defense health monitoring system

March 10, 2018 | by

Doncaster, UK-based MediBioSense Ltd. [TTA 23 Jan, 17 Feb] is partnering with Kansas City’s MRIGlobal to develop a wireless health monitoring system for the US Department of Defense Combating Terrorism Technical Support Office (CTTSO). The limited information in the release indicates that the joint project will provide technology integration and development services for CTTSO. The system “will provide medical grade health monitoring data and allow for real-time decisions to protect health.”

MediBioSense is the developer of the monitoring platform for and global distributor of the VitalPatch, originally developed by VitalConnect. MRIGlobal is a contract research organization for government, academia, and industry that works in the areas of national security, defense, health, and energy. In health, they develop solutions in in vitro diagnostics, infectious diseases, and ‘global biological engagement.’

CTTSO’s website description: “Identify and develop capabilities to combat terrorism and irregular adversaries and to deliver these capabilities to DoD components and interagency partners through rapid research and development, advanced studies and technical innovation, and provision of support to U.S. military operations.”

Which makes this new development quite interesting in what the VitalPatch may be detecting–and possibly a little hush-hush!

How do digital health partnerships happen? Where do you go with them? Views from a developer and an app security provider.

February 17, 2018 | by

This Editor recently covered a partnership between Doncaster UK’s MediBioSense Ltd.and San Francisco-based Blue Cedar, where Blue Cedar’s app security system will protect information from MediBioSense’s app through to the provider database. I was curious how two physically distant small companies, even in this global healthcare business, found each other, as well as how MediBioSense (MBS) adopted a US-developed sensor from VitalConnect. To find out more, I spoke with the company CEOs, Simon Beniston of MBS and John Aisien of Blue Cedar. Their respective experiences led me to three takeaways which are applicable to early-stage companies–wherever they are located.

Past business dealings of the principals and keeping connections ‘warm’ matter a great deal–when the time is right to partner. Both companies had a combination of people and past experience in common. “I had some interaction with Simon during my time at Mocana, the company from which Blue Cedar spun out.” Mr. Aisien noted. “Our sales leadership in the UK continued to be in touch with Simon, and as we continued to execute on our business plan and focused on healthcare, the relationship strengthened. Simon’s role as a healthcare global app developer made him even more attractive as a partner.” For Mr. Beniston considering Blue Cedar as a security partner, it was a combination of contacts and people he knew already, “driven by the realization that while our data was fairly secure by design, I was cognizant of the fact that data protection requirements were growing in the European market with GDPR (General Data Protection Regulation). As a forward-thinking company, we wanted to get to this early on. Given this, the partnership between MediBioSense and Blue Cedar was a perfect fit.”

MediBioSense’s relationship with VitalConnect is also unusual in that MediBioSense developed their platform that monitors data for the VitalPatch. Mr. Beniston founded the company because he believed that healthcare was where mobile technologies, his prior field, could make a real difference and be joined to the use of biosensors and wearables. His knowledge of the platform and app were thus from the ground up. “We then went on to ensure that their [Blue Cedar’s] technology fit with our technology and the testing was successful. We could then go to healthcare companies and tell them that we have data protection covered. It gives us a competitive edge.”

The right partnerships build use cases, look forward to where their businesses can go in meeting customer needs, and are a step ahead of their clients. Mr. Aisien: “What Simon is doing is a wonderful example of using digital channels to improve healthcare outcomes and reduce costs. We think it’s a great proof point of the value of our app-centric approach as it relates to security in healthcare. MediBioSense’s app will be running on devices which are outside of the control of the entity using VitalPatch to capture [the patient’s] data. It’s not practical or economic for that entity to manage the device.”

When asked about whether healthcare users and developers are finally seeing the light about app security, Mr. Aisien acknowledged that it is developing. “The knowledge of the criticality of protecting oneself against security threats is unquestionably there and has been for awhile. With the increased use of digital channels–mobile, IoT, wearables–to improve business and reduce risks, the growth, the understanding, and most importantly, the funding are there. App-centric security continues to evolve because while other approaches like securing the whole device or containerization are technically sound, they are not necessarily economic or practical for all use cases. What makes universal sense is to download the app that already has the requisite levels of security in it.”

This is what attracted Mr. Beniston to use an app-based security approach for MediBioSense. “Historically it’s always been a device approach such as MDM [mobile device management]. One of our key USPs, when we approach our clients, is that one of the big expenses, aside from the VitalPatch, is hardware. One of our strengths is that our platform and interface can work on a consumer mobile device. We can utilize what your clinicians and patients already have in their pockets. They can use what they have, and to date, we haven’t seen any interference with mobile devices.”

He added, “We were surprised that even today, some are saying about GDPR that ‘we’ll wait until it happens’. That’s hiding your heads in the sand! (more…)

MediBioSense and Blue Cedar take a new approach to secure medical wearable data (UK/US)

January 23, 2018 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2018/01/VitalPatch_Header_Photo_Tablet.jpg” thumb_width=”150″ /]Doncaster UK-based MediBioSense Ltd. has partnered with San Francisco-based Blue Cedar to protect their VitalPatch app on smartphones and tablets. MediBioSense uses VitalPatch in their MBS HealthStream system marketed in the UK in acute care and long-term care setting. Blue Cedar is securing the app through their patented code-injected technology which protects the VitalPatch-collected data from the app to the provider database. The system with Blue Cedar’s security is available directly from MediBioSense.

VitalPatch is a single-use adhesive biosensor patch applied to the patient’s chest (see left above). It monitors eight vital signs and activity signs: heart rate, respiration, ECG, heart rate variability, temperature, body posture including fall detection/severity, and steps as an indicator of activity. MediBioSense contracted with the US-based developer, VitalConnect, to sell the system in the UK. VitalPatch is US FDA-cleared (Class II) and CE Marked for the EU.

One impetus, according to the release (PDF), is the GDPR (General Data Protection Regulation), the pan-European/UK data-protection law slated to take effect in May. This not only applies to European Union citizens’ personal data but also requires reports on how organizations safeguard that data. 

Blue Cedar, which this Editor has previously profiled [TTA 3 May 17], has developed code-injection technology that secures data from the app to the provider location on their servers or in the cloud. It secures the app without the device being managed. Devices have their own vulnerabilities when it comes to apps even when secured, as 84 percent of cyberattacks happen at the application layer (SAP). Blue Cedar’s security also enables tap-and-go from an icon versus multiple security entries, thus quick downloading from app stores or websites. For companies, the secured app provides granular analytic reports about users, app usage, devices, and operating systems which are useful for GDPR requirements.

Blue Cedar’s latest release of app security is Enforce, to secure existing mobile apps using in-app embedded controls to enforce a broad range of security policies. It is sold on the Microsoft Azure cloud platform and is primarily targeted to the value-added reseller (VAR) market. 

All the more reason to use all means to secure devices and apps. When as of last week Allscripts‘ EHR for e-prescribing was hit with a ransomware attack (FierceHealthcare), yet another hospital (Hancock Regional in Indianapolis) paid $5,000 to hackers to get back online (Digital Health), and Protenus/DataBreaches.net tracks a breach a day [TTA 29 Dec 17], cybersecurity has become Job #1 for anyone in the healthcare field. (And Big Healthcare now votes for security. Protenus today announced their $11 million Series B led by Kaiser Permanente Ventures and F-Prime Capital Partners. Release.)

BeVITAL: French telehealth, American multi-reading biosensor

April 27, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/HealthPatch.jpg” thumb_width=”150″ /]Paris-based telehealth company BePATIENT has partnered with Silicon Valley biosensor company Vital Connect for a remote patient monitoring system dubbed BeVITAL. The unusual part is that the Vital Connect sensor, HealthPatchMD, is about the size of a standard bandage–it adheres to the skin by the heart–and transmits multiple vital signs including single-lead ECG, heart rate, RR interval, heart rate variability, respiratory rate, skin temperature, body posture, fall detection and activity including steps. The BePATIENT PC/mobile telehealth platform has a patient facing mobile app (‘Fast Path’) app, currently available in the Apple App Store, with a clinician-facing reporting module. BeVITAL has been piloted already in Europe for post-discharge monitoring of over 80 surgical patients in clinical studies at five hospitals, with two more deployments this summer. In the Americas, the two post-discharge pilots will concentrate on heart failure, in the US at John Muir Medical Center in Walnut Creek and Concord, California and at the Hospital Infantile De Las Californias, Tijuana, Mexico. The latter study will be run by Scripps Translational Science Institute in San Diego.

BePATIENT’s platforms and ‘digital health modules’ are largely used in France, Europe and Australia, and also integrate devices from iHealth, Withings and fitness tracker Fitbit. The Vital Connect Platform is FDA-cleared, CE-marked and Ninsho Certified (Japan). In addition to the HealthPatchMD biosensor, which is reusable up to 500 times, they developed the single-use VitalPatch biosensor marketed in the US and Europe, and being tested by Philips for at-risk hospital patients (ZDNet). Release, KTVU News