Vendor Management Needed in Light of NRC Health Ransomware Attack

HealthITSecurity.com | February 27, 2020

Last week, NRC Health became the latest vendor to report it fell victim to a ransomware attack, which locked the company out of its computer systems as it worked to recover. Given its massive list of healthcare clients, the cyberattack could become a massive data breach. NRC Health sells software to about 9,000 healthcare organizations, or about 75 percent of the 200 largest hospital chains in the US. Its clients include Cedars Sinai, Adventist Health, Providence Health, and a host of others, according to its website. In total, the vendor collects data from over 25 million US and Canadian consumers each year. While the vendor continues to recover and investigate the incident, security leaders have stressed what the incident could mean for patient privacy. But the NRC Health cyberattack sheds light on a greater concern to healthcare organizations: How can covered entities and other providers rein in their control over the vast number of vendors with which they interact, some of which are unknown?

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HEALTH TECHNOLOGY

Antengene Announces ATG-101 Granted Orphan Drug Designation by the U.S. FDA

Antengene Corporation Limited | September 19, 2022

Antengene Corporation Limited a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, announced that ATG-101, the company's in-house developed novel PD-L1/4-1BB bispecific antibody, has been granted an Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This ODD will help Antengene facilitate regulatory communication with the FDA, accelerate the clinical development and the future registration of ATG-101. At present, no PD-L1/4-1BB bispecific antibody has been approved for the treatment of pancreatic cancer worldwide. Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. Orphan Drug Designations by the U.S. FDA are meant to support the development of drug candidates that could potentially bring substantial therapeutic benefits to patients with rare diseases and to provide incentives to the subsequent development, registration and commercialization to designated drugs. Those incentives include tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, and 7-year market exclusivity in the U.S. regardless of the patent status of the designated drug. Pancreatic cancer is a highly malignant type of gastrointestinal cancer. According to the statistics by the World Health Organization (WHO), pancreatic cancer was ranked 13th and 7th globally by its incidence and mortality rates in 2012. In 2018, the U.S. reported over 55,000 newly- diagnosed pancreatic cancer cases and 44,330 related deaths. Whereas still defined as an orphan disease currently, it is projected that by 2030, pancreatic cancer will become the second most common cause of cancer-related deaths. ATG-101 is a novel PD-L1/4-1BB bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile. In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that had progressed on anti-PD-1/L1 treatment. Furthermore, ATG-101 has also shown an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies. ATG-101 is the first PD-L1/4-1BB bispecific antibody entering clinical development in Australia and is currently being evaluated in clinical studies in Australia, China, and the U.S. "We are very encouraged by this Orphan Drug Designation from the U.S. FDA and are hopeful that ATG-101 will offer a novel therapeutic to patients with pancreatic cancer. As Antengene's first in-house developed asset with global rights, ATG-101 has already entered clinical development in Australia, China, and the U.S. We will strive to accelerate the global clinical development of ATG-101 in efforts to provide a new treatment option to patients around the world." Dr. Bo Shan, Antengene's Chief Scientific Officer About Antengene Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a broad and expanding pipeline of 15 clinical and preclinical assets, of which 10 are global rights assets, and 5 came with rights for Asia Pacific markets including the Greater China region. To date, Antengene has obtained 24 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® already approved in mainland China, South Korea, Singapore and Australia.

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FUTURE OF HEALTHCARE

Verizon Business and Visionable expand connected healthcare partnership

Visionable and Verizon | September 22, 2022

Verizon Business and Visionable, a leading health technology company based in the U.K., announced that they are expanding their partnership which will enable both companies to work on a range of connected healthcare solutions, via Visionable’s patented technology powered by Verizon’s 5G Ultra Wideband and 5G Edge network, in the U.S. Verizon and Visionable are working together on a secure next-generation digital healthcare collaboration platform that enables healthcare professionals to access data, collaborate and share resources within the APAC and EMEA regions. The partnership seeks to address some of healthcare’s biggest challenges including connecting frontline responders to specialist doctors during emergencies and enabling access to community-led care for patients needing long-term support. “The healthcare industry generates a massive amount of data, but its ability to make good use of that data has long been hampered by network architectures that cannot handle it efficiently, securely, or cost-effectively. Through the combination of 5G and Edge computing, healthcare facilities and professionals will have access to secure near-real-time connectivity creating a new link between doctor and patient. As a result, illnesses could someday be diagnosed and treated more quickly, and medical costs could potentially decrease,” Scott Lawrence, Senior Vice President for Verizon Global Solutions Today’s announcement follows the launch of Visionable’s private-5G enabled Connected Healthcare Center in the U.K. in May. The center showcases the benefits of next-generation connectivity and collaboration across a patient’s care journey from urgent and emergency care to virtual wards to in-person care and rehabilitation, supported by Verizon private 5G. “Our partnership provides real-time connectivity and productivity, when and where it counts and costs. Together with Verizon, we endeavor to support our healthcare teams by enabling them to bring healthcare to the patient wherever they are,“ said Alan Lowe, CEO and Co-Founder of Visionable. This engagement is part of Verizon’s continued strategy to partner with customers, startups, universities, and large enterprises to explore how 5G can disrupt and transform nearly every industry. This includes Verizon’s strategic partnership with Emory Healthcare in Atlanta where Verizon is collaborating with Emory Healthcare to help spur the development of healthcare solutions powered by 5G Ultra Wideband. Today’s announcement builds on the company’s network-as-a-service foundation and supports its growing private networks, mobile edge compute and business solutions. About Visionable Visionable is a UK company that is helping make connected healthcare a reality in the UK and around the world. Driven by the belief that affordable, high-quality, timely healthcare is a basic human right that should be accessible to all, Visionable’s patented, real-time & multi-streaming technology enables critical remote decision-making by clinicians wherever they are located have created their own proprietary clinical collaboration platform. This enables the hospital to come to the patient and for healthcare teams to collaborate freely across multiple locations. Visionable is trusted by 25% of the top 100 UK hospitals, 100 more than 90 NHS organisations, 46 and 34 NHS Trusts., over 16,000 NHS staff. Visionable’ s specialist advisory board includes Lord Victor Adebowale, previous NHS board member, Mike Farrar, ex-NHS Chief Executive and leader of the North West England Strategic Authority and Dr Junaid Bajwa, practising physician and MSD’s Digital Accelerator’s Global Lead for Strategic Alliances. About Verizon Verizon Communications Inc. (NYSE, Nasdaq: VZ) was formed on June 30, 2000 and is one of the world’s leading providers of technology and communications services. Headquartered in New York City and with a presence around the world, Verizon generated revenues of $133.6 billion in 2021. The company offers data, video and voice services and solutions on its award-winning networks and platforms, delivering on customers’ demand for mobility, reliable network connectivity, security and control.

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HEALTH TECHNOLOGY

Software Identifies Unreported Mental Health Issues in Teens

Advanced Metrics | August 26, 2022

Advanced Metrics and Samaritan Counseling Center today announced the release of QUALO Behavioral Health, a cloud-based software designed to proactively screen teens for mental and emotional wellbeing. "An easy to implement mental health screening strategy gives schools a targeted opportunity to engage and empower students who need connected to community resources because they are struggling with feelings of depression, anxiety, and suicidal thoughts." Steve Schedler, Samaritan Counseling QUALO Behavioral Health software revolutionizes teen mental health screening by innovatively simplifying the entire screening process. The software guides youth through industry standard screening tools to understand their current emotional wellbeing. Mental health professionals are immediately provided with data supporting an "at-risk" or "not at risk" identification and are guided through an intentional follow-up process. "With the mental health crisis facing teens today, we knew it was critical to develop a software that supports teen's mental well-being and normalizes conversations about mental health. We designed this software so schools can implement it independently or through collaboration with an outside agency. Either way, the platform will support students, inform administrators, and enhance any mental health strategy a school is implementing." Steven Herr PhD, Advanced Metrics Advanced Metrics is a Software as a Service company dedicated to improving the health of individuals and communities through science informed software and human centered data analysis. Advanced Metrics designed QUALO, a comprehensive web-based solution, to empower human service organizations to deliver services that generate quality life outcomes. TeenHope is a student mental and emotional wellbeing education and screening program in Lancaster, PA. TeenHope is supported by Samaritan Counseling Center, which provides professional counseling, consultation and education for individuals, couples, businesses, and clergy.

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HEALTH TECHNOLOGY

HeartBeam Announces FDA Submission of HeartBeam AIMI™ Product

HeartBeam, Inc. | August 17, 2022

HeartBeam, Inc. a developmental stage digital healthcare company with a proprietary ECG telemedicine technology for heart attack detection, announced it has submitted a 510(k) application to the US Food and Drug Administration for its HeartBeam AIMI™ platform technology for use in diagnosing heart attacks. “The 510(k) submission of our first product, based on our platform technology, is an important milestone toward commercialization and underscores our continued progress toward making the HeartBeam AIMI platform widely available to help Emergency Department physicians correctly and expeditiously diagnose patients with chest pain or other symptoms of a heart attack. I am proud of the HeartBeam team for their commitment to achieving this critical step in bringing the Company’s technology to market. We look forward to working through the FDA review process toward our goal of clearance for the US market.” Branislav Vajdic, PhD, HeartBeam CEO and founder The HeartBeam AIMI platform technology is anticipated to assist health care professionals in identifying patients who present with chest pain to facilitate rapid detection of a heart attack and determine an appropriate treatment regimen. Chest pain is the second most common reason for an emergency department visit with high costs associated with these visits. The goal of HeartBeam’s technology is to offer more accurate heart attack detection to triage patients and expedite treatment. HeartBeam AIMI is software as a medical device with a 510(K) regulatory pathway. The HeartBeam algorithm used in an emergency department setting slots into existing physician workflow, leverages existing 12-lead ECG hardware and provides the attending physician with an instant comparison of the patient’s baseline and symptomatic ECG for their consideration in the patient’s diagnosis. This will allow physicians to quickly determine if a patient needs intervention or can be discharged which helps manage patient flow. Jon Hunt, PhD, HeartBeam Executive Vice President and Chief Business Officer, added, “Our FDA approval process doesn’t require any human or animal trials, so there is good reason to believe that we will receive FDA clearance for a limited market release by end of 2022 and full commercial roll-out in Q1 2023. While the FDA conducts its regulatory review, our team will focus on executing key components of its commercialization plan and subscription revenue model. We continue to engage in positive discussions with strategic institutions, including academic centers, regional healthcare systems and regional community hospital systems that can utilize our products. We look forward to approval and offering our HeartBeam AIMI platform in an expected $500 million total addressable market.” About HeartBeam, Inc. HeartBeam, Inc. is a development stage digital healthcare company with proprietary ECG telemedicine technology that will redefine the way high risk cardiovascular patients are diagnosed in an ambulatory setting at any time and any place. Its breakthrough solution employs a reusable, credit card sized, 3D vector ECG recording device and cloud-based software capable of assisting a physician in diagnosing a wide range of cardiovascular disease. HeartBeam is initially focusing on a huge unmet need of helping diagnose heart attacks in patients outside of a medical institution. No single lead ECG technology can offer this value to patients and their physicians. This underserved market is several times larger than the cardiac arrhythmia detection market based on the prevalence of patients with coronary artery disease at high risk of heart attack.

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People with osteoporosis are at increased risk of suffering a life-changing bone fracture. An osteoporosis and fragility clinic at Queen City Regional Medical Clinic in Spearfish, SD, focuses on this issue.

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