Why information security should be every hospital CEO's No. 2 priority (at least right now)

Healthcare IT News | April 11, 2019

Health systems have been underinvesting in information security for a decade, some even longer, but the threat landscape has now reached a critical point. Hackers, cybercriminals and nation states are increasingly sophisticated, and have access to the same cutting-edge machine learning technologies that security teams use to protect their data. Malware has been weaponized. Grimly, there’s no end in sight. But how to get from today’s underfunded and risk-filled reality to a more secure future state in short order? It starts with moving infosec higher up on the CEO’s agenda – something that will in all likelihood be a difficult maneuver, but a transformative one. Crafting plans for a new robotic surgery facility? Splurging on modern imaging systems or creating an artificial intelligence command center? Exciting, but you might want to backburner those projects – yes, even ones with a clear path to ROI – and, instead, apply enough resources to finally strengthen your information security posture first.

Spotlight

Crowdsourcing, mobile apps, even robotics have become familiar, but their novel uses in healthcare keep multiplying. Inventors, entrepreneurs, and strategic thinkers are developing interactive products that offer instant diagnostics, link patients in remote locations to distant clinical care, and partnering robots with surgeons in the operating room. They are also looking for ways to scale these breakthroughs for use in low-resource environments. How is technology being leveraged in service of healthcare? What’s new in cybermedicine, how will it change lives, and how do we share “wow” products more broadly?


Other News
FUTURE OF HEALTHCARE

SandboxAQ and Mount Sinai Health System Collaborate on Data Protection

Sandbox AQ | March 24, 2022

Sandbox AQ, an enterprise SaaS company leveraging quantum tech and AI, announced a collaboration with Mount Sinai Health System to launch Post-Quantum Cryptography solutions, a broad security technology solution to protect patient data against current and future cybersecurity threats. Sandbox has developed SaaS-based enterprise modules that incorporate the latest encryption protocol standards recently ratified by NIST (National Institute of Standards and Technology). Through Sandbox AQ, Mount Sinai Health System will incorporate PQC protocols into its network to provide increased security for millions of customers and their sensitive data. "Our collaboration with Sandbox AQ propels our security and technology strategies forward, enabling us to deliver advanced, secure cutting-edge products to our patients. Protecting patient data against cyber threats is incredibly important to us." Kristin Myers, Executive Vice President and Chief Information Officer at Mount Sinai Health System and Dean for Information Technology at Icahn School of Medicine at Mount Sinai "Quantum technology will quickly render today's RSA-based encryption obsolete, which is why it's imperative that we protect the world's sensitive data now against the next generation of cyberattacks," said Jack D. Hidary, CEO of Sandbox AQ, which officially launched today. "Mount Sinai is one of the first healthcare systems planning to implement PQC protocols into its health network to protect its customers and transform its business. We look forward to collaborating with them on this project." About SandboxAQ Sandbox AQ is an enterprise SaaS company delivering solutions at the nexus of quantum tech and AI. Based in Palo Alto, the inspiration for Sandbox AQ and some of the team originated at Alphabet Inc. in 2016. Sandbox AQ launched as an independent, venture-backed entity in 2022. About Mount Sinai Health System The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. We advance medicine and health through unrivaled education and translational research and discovery to deliver care that is the safest, highest-quality, most accessible and equitable, and the best value of any health system in the nation. The Health System includes approximately 7,300 primary and specialty care physicians; 13 free-standing joint-venture centers; more than 410 ambulatory practices throughout the five boroughs of New York City, Westchester, and Long Island; and more than 30 affiliated community health centers. The Mount Sinai Hospital is ranked in U.S. News & World Report's "Honor Roll" of the top 20 U.S. hospitals and among the top in the nation by specialty: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Urology, and Rehabilitation. Mount Sinai Kravis Children's Hospital is ranked in U.S. News & World Report's "Best Children's Hospitals" among the country's best in four out of 10 pediatric specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked among the Top 20 nationally for ophthalmology. The Icahn School of Medicine at Mount Sinai is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report's "Best Medical Schools," aligned with a U.S. News & World Report "Honor Roll" Hospital, and No. 14 in the nation for National Institutes of Health funding. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and top five globally, and Mount Sinai Morningside as top 20 globally, and "The World's Best Specialized Hospitals" ranks Mount Sinai Heart as No. 1 in New York and No. 4 globally and the Division of Gastroenterology as No. 3 globally, and the Division of Pulmonary Medicine as No. 6 globally.

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DIGITAL HEALTHCARE

UniDoc Partners with AMD Global Telemedicine

UniDoc | February 04, 2022

UniDoc Health Corp., an innovator in the telehealth sector, is pleased to advise on a commercial master distribution agreement (the “Agreement”) with Massachusetts-based AMD Global Telemedicine Inc. (“AMD Global”) for the provision of specialized products and services critical to ongoing commercialization efforts. As a pioneer of virtual care technology, and an industry leader in telehealth solutions, AMD Global has been providing quality healthcare solutions for over 30 years with product sales and registered deployments in 100+ countries. The agreement adds AMD Global as a UniDoc key supplier of telehealth solutions including virtual care software platforms, integrated medical devices, and telemedicine bundled kits. The products and services will be purposed and integrated into the UniDoc Virtual Care Solutions Model (“VCSM”), which will offer a proprietary, customizable, and comprehensive telehealth solution based on a variety of integrated physical enclosures, kiosks, and related configurable packaging designed to deliver web-based services and analytical tools in combination with access to a developing network of healthcare providers, pharmacies, and hospitals. All AMD Global products and telehealth technologies are built to provide high performance and quality, are easy to use and maintain, and operate dependably even in difficult environments. AMD Global is ISO 13485:2003 certified and runs an FDA registered facility operating within good manufacturing telemedicine best practices guidelines. The AMD platform provides UniDoc with immediate access to FDA & Health Canada approved devices (FDA Certified; ISO 13485; and FDA GMP – including all HIPPAA privacy and compliance) which support and help propel the Company’s fast-track plans for commercialization. Mr. Eric Bacon, President of AMD Global Telemedicine Inc. states, we are very pleased to have this opportunity to work with the UniDoc team. Their dedication, passion and commitment are outstanding and adds great value to their ability to drive ahead, overcome obstacles, and keep focused on achieving results. Their offering is unique in its vision and feasibility to scale. We are excited to have been chosen as UniDoc’s provider of choice for their telehealth technology needs today as well as help them extend and develop their telehealth portfolio going forward.” “We are so very delighted to have this opportunity to work with AMD Global as a key vendor of critical components and services. When we began this venture, we found a very short list of suppliers who so clearly fit our needs and timelines. It didn’t take long to determine that AMD’s medical grade instruments are integrated into high quality software. Additionally, AMD completely met our needs when it came to ensuring all required certification and compliance requirements were already in place. To everyone’s credit on both sides, the synergies were readily apparent, and it didn’t take long to come to an agreement. I’m confident that this arrangement will prove instrumental in unlocking the value of this exciting venture together.” UniDoc CEO Antonio Baldassarre About UniDoc Health Corp. UniDoc is developing a telehealth solution which is being designed as a self-contained remote virtual clinic within a private kiosk for patients to undergo full consultations as if they were present in a physician’s office. Telehealth opens the doors to a large segment of the population challenged by access, experience or understanding of online computer technology. It is the Company’s belief that physical accessibility is the key to its business proposition. UniDoc is dedicated to unlocking shareholder value by delivering an excellent product and sophisticated commercial network within an expedited timeframe.

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HEALTH TECHNOLOGY

Texas Children's Hospital And Baylor College of Medicine COVID-19 Vaccine Technology Secures Emergency Use Authorization In India

Texas Children Hospital | December 29, 2021

Texas Children's Hospital and Baylor College of Medicine announced today that CORBEVAX™, a protein sub-unit COVID-19 Vaccine, whose technology was created and engineered at its Center for Vaccine Development (CVD), has received Emergency Use Authorization (EUA) approval from the Drugs Controller General ofIndia(DCGI)to launch inIndiawith other underserved countries to follow. Dubbed "The World's COVID-19 Vaccine", it uses a traditional recombinant protein-based technology that will enable its production at large scales making it widely accessible to inoculate the global population. The initial construct and production process of the vaccine antigen was developed at Texas Children's Hospital CVD, led by co-directors Drs. Maria Elena Bottazzi and Peter Hotez and in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialization team, to Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE). CORBEVAX™ after completing two Phase III clinical trials involving more than 3000 subjects was found to be safe, well tolerated and immunogenic: CORBEVAX™ demonstrated superior immune response in comparison with COVISHIELD™ vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant. CORBEVAX™ vaccination also generated significant Th1 skewed cellular immune response. CORBEVAX™ nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of >90% for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies. CORBEVAX™ nAb GMT against the Delta strain indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies. While none of the subjects who took CORBEVAX™ or COVISHIELD™ had serious adverse events, CORBEVAX™ had 50 percent fewer adverse events than COVISHIELD™. In the continuous monitoring of phase II studies, CORBEVAX™ showed high persistence of immune response as indicated by <30% drop in nAb GMT till 6 months second dose as compared to >80% drop observed with majority of the vaccines. "Protein-based vaccines have been widely used to prevent many other diseases, have proven safety records, and use economies of scale to achieve low-cost scalability across the world," said Dr. Maria Elena Bottazzi, Professor and Associate Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Our decade-long studies advancing coronavirus vaccine prototypes has led to the creation of this vaccine, which will fill the access gap created by the more expensive, newer vaccine technologies and that today are still not able to be quickly scaled for global production." The need for safe, streamlined, low-cost vaccines for middle- to low-income countries is central to the world's fight against the COVID-19 pandemic. Without widespread vaccination of populations in the Global South, additional virus variants will arise, hindering the progress achieved by currently available vaccines in the United States and other Western countries. "This announcement is an important first step in vaccinating the world and halting the pandemic. Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low- and middle-income countries face against the delta variant," said Dr. Peter Hotez, Professor and Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Widespread and global vaccination with our Texas Children's-Baylor-BE vaccine would also forestall the emergence of new variants. We have previously missed that opportunity for the alpha and delta variant. Now is our chance to prevent a new global wave from what might follow." "Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world. With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality. We deeply appreciate Texas Children's Hospital Center for Vaccine Development, Baylor, CEPI, the Bill and Melinda Gates Foundation, and the government of India for their continuous support and cooperation during this journey. The combined efforts & unceasing support demonstrate that we can collectively overcome any challenge". Mahima Datla, Managing Director, Biological E. Limited ABOUT TEXAS CHILDREN'S HOSPITAL Texas Children's Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children's hospital in Texas, and among the top in the nation, Texas Children's has garnered widespread recognition for its expertise and breakthroughs in pediatric and women's health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for pediatric research; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children's Hospital West Campus, a community hospital in suburban West Houston; and Texas Children's Hospital The Woodlands, the first hospital devoted to children's care for communities north of Houston. The organization also created Texas Children's HealthPlan, the nation's first HMO for children; has the largest pediatric primary care network in the country, Texas Children's Pediatrics; Texas Children's Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that's channeling care to children and women all over the world. Texas Children's Global Health program leads efforts that advance health care equity through innovative collaboration in care, education and research for underserved populations globally. Texas Children's Hospital is affiliated with Baylor College of Medicine. ABOUT TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT Texas Children's Hospital Center for Vaccine Development is one of the leading vaccine development centers in the world. Established in Washington DC as the Sabin Vaccine Institute Product Development Partnership (PDP) in the year 2000 and after relocating to the Texas Medical Center in 2011, it rebranded as Texas Children's Center for Vaccine Development. For the past two decades it has acquired an international reputation as a non-profit PDP, advancing vaccines for poverty-related neglected tropical diseases (NTDs) and emerging infectious diseases of pandemic importance. In addition, it builds and strengthens capacity for vaccine development locally and with foreign nations and leads global efforts to guide and influence vaccine policy and advocacy through "vaccine diplomacy" as an international bridge for peace and vaccine development capacity. ABOUT BCM VENTURES Baylor College of Medicine Ventures is the commercial engine of the health sciences university, created to support the translation of academic knowledge and intellectual assets for the benefit of society. We do this by engaging university innovators, entrepreneurs and industry to fully develop ideas along their best commercial path. We foster a culture of commercialization and engage with industry to identify market opportunities for collaborative ventures. ABOUT BIOLOGICAL E. LIMITED Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio. In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

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MEDICAL DEVICES

Extremity Medical Files Patent Infringement Lawsuit Against Nextremity Solutions, Zimmer Biomet Holdings and Zimmer, Inc.

Extremity Medical, LLC | April 07, 2022

Extremity Medical, LLC, a global medical device company focused on the development of innovative implants and instruments for upper and lower extremities, announcedthat it filed a lawsuit against Nextremity Solutions, Inc.; Zimmer Biomet Holdings, Inc.; and Zimmer, Inc., alleging infringement of an Extremity Medical patent* for its intraosseous fixation platform arising from the marketing of the InCore® Lapidus System by these companies. The complaint was filed in the U.S. District Court for the District of Delaware. Extremity Medical has amassed an intellectual propertyportfolio that includes 49 patents in the U.S. and several foreign countries. The novel and patented technology of Extremity’s intraosseous fixation platform provides surgeons with a zero-profile solution for fusion and fixation of bones within the upper and lower extremities, with the ability to be implanted through minimal incisions. This technology is currently marketed globally by Extremity under the trade names IO FiX, IO FiX Plus, IO FiX 2.0, IO Freedom, CarpalFiX, ApeX and XMCP. “Extremity Medical has invested a tremendous amount of effort and resources in research and development to create innovative technology to improve the lives of patients and meet surgeons’ needs. Our intellectual property is a critical component in making such advancements possible and we are committed to protecting it,” Matthew Lyons, Extremity Medical Chief Executive Officer, Founder and Chairman of the Board About Extremity Medical, LLC Extremity Medical, was founded in 2008, and is a privately-held medical device company based in Parsippany, NJ. The company is known for creating innovative implants and instruments for upper and lower extremity orthopedic procedures, including fusion and motion preservation. The company is focused on developing solutions for challenging cases that promote better outcomes, especially in patients with poor bone quality.

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Spotlight

Crowdsourcing, mobile apps, even robotics have become familiar, but their novel uses in healthcare keep multiplying. Inventors, entrepreneurs, and strategic thinkers are developing interactive products that offer instant diagnostics, link patients in remote locations to distant clinical care, and partnering robots with surgeons in the operating room. They are also looking for ways to scale these breakthroughs for use in low-resource environments. How is technology being leveraged in service of healthcare? What’s new in cybermedicine, how will it change lives, and how do we share “wow” products more broadly?

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