BY JIM HAMMERAND Henry Schein (Nasdaq: HSIC)+ said today that it is working to bring its ecommerce platform back up after more problems related to its cyberattack. The medical device manufacturer and distributor said last week that its ecommerce platform and other applications were unavailable and that “the threat actor from the previously disclosed cyber incident has claimed responsibility.” Today, the company said its ecommerce platform is back online in the U.S. and was expected to be restored in Canada and Europe “shortly.” Henry Schein said it continued to take orders via alternate methods previously communicated to customers, and continued shipping products. Earlier this month, the company warned customers and suppliers that their sensitive information may have been exposed in the cyberattack. Henry Schein first disclosed the cyber security incident in October. A ransomware gang known as BlackCat/ALPHV later said they encrypted the company’s systems and stole 35 TB of ...
About 44% of people in jail and 37% of people in prison have a mental illness. In addition, 63% of people in jail and 58% of people in prison have a substance use disorder. Yet, support is often lacking for this population. This was the topic of discussion on a recent panel of behavioral health experts at the Behavioral Health Tech 2023 conference in Phoenix. When asked what the healthcare industry should know about the intersection between the justice system and mental health, one panelist said that numerous players work with the incarcerated population and there needs to be better collaboration. “There are so many organizations — city-based, state-based, nationally-based — that are assisting this community,” said Darren Webb, CEO of Mindset, which helps those with mental illness and their caregivers apply for Social Security Disability benefits. “We’ve gone to partner with jails and we wouldn’t even know that there ...
Dive Brief Henry Schein, a medical and dental supplies company, is still recovering from a cybersecurity incident last month that took some of its systems offline. In a letter to its customers, the company disclosed on Monday that a data breach occurred, but “we do not have all the details of what data may have been compromised.” Customer bank accounts and credit card numbers may have been affected. Henry Shein also issued a letter to its suppliers, writing that the company is “aware that the bank account information for a limited number of suppliers was misused.” CEO Stanley Bergman told investors on a Monday earnings call that the company is working to bring its e-commerce platform back online this week, and that the incident primarily affected its dental and medical distribution operations in North America and Europe. Dive Insight Henry Schein lowered its sales expectations for its 2023 fiscal year, ...
Voice pathology refers to a problem arising from abnormal conditions, such as dysphonia, paralysis, cysts, and even cancer, that cause abnormal vibrations in the vocal cords (or vocal folds). In this context, voice pathology detection (VPD) has received much attention as a non-invasive way to automatically detect voice problems. It consists of two processing modules: a feature extraction module to characterize normal voices and a voice detection module to detect abnormal ones. Machine learning methods like support vector machines (SVM) and convolutional neural networks (CNN) have been successfully utilized as pathological voice detection modules to achieve good VPD performance. Also, a self-supervised, pretrained model can learn generic and rich speech feature representation, instead of explicit speech features, which further improves its VPD abilities. However, fine-tuning these models for VPD leads to an overfitting problem, due to a domain shift from conversation speech to the VPD task. As a result, the ...
From time to time, the FDA convenes an outside group of experts to weigh in on an experimental drug or medical device, or to offer insight on a scientific matter that raises questions. The FDA has 49 committees and panels oriented around various therapeutic areas and modalities. As regulatory submissions increasingly include digital components, the agency wants to ensure it is adequately informed about these technologies. It’s adding a digital health advisory committee charged with providing that perspective. The FDA expects the new advisory committee will become fully operational in 2024. It will discuss technologies such as artificial intelligence and machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. In addition, topics covered by this new committee could include decentralized clinical trials, patient-generated health data, and cybersecurity. The committee will consist of a core nine voting members, including the chair. Members serve terms of up ...
Mike Hollan Klein discusses how recent FDA draft guidelines will impact the use of SaMD in the life sciences industry. David Klein CEO and co-founder Click Therapeutics FDA recently released draft guidelines regarding the use of software as a medical device (SaMD), which determines when the software should be included on the drug’s label. David Klein, CEO of Click Therapeutics, spoke with Pharmaceutical Executive about the impact these guidelines could have on the industry. Pharmaceutical Executive: What work are you doing with SaMD? David Klein: We are a science led biotech and tech company developing SaMD to be prescription treatments. That includes prescription digital therapeutics and discovering developing them in a way where they could potentially work independently or in conjunction with pharmacotherapies in order to lead to better clinical and economic outcomes. PE: The FDA just issued some updated guidelines regarding SaMD, how do you think the industry will ...
A study conducted by researchers at University College London and published in Cell revealed that if the protein mechanisms of COVID-19 variants are similar to those of other coronaviruses, it could potentially make identifying coronaviruses viruses with pandemic potential easier. The researchers looked at both the innate and adaptive immune systems – the two parts that form the human immune system. Innate immunity acts as the first line of defence. It is present from birth and tries to prevent infection spreading through a rapid response. Adaptive immunity, developing throughout our lives, enables us to recognise future pathogens by learning from past infections. The study, which focused on the ability of the most infectious COVID-19 variants to overcome our innate immune systems, found that variants could increase the production of proteins called Orf6, Nucleocapsid (N) and Orf96, to defeat our first line of defence. As a result, the virus has evolved ...
IBM has announced a data breach of Janssen’s CarePath platform and has started informing affected customers. The Janssen CarePath portal provides patients and healthcare professionals in the US with information regarding insurance coverage, out-of-pocket costs, and prescribing information at no cost to the users. The number of highest grossing Janssen drugs are included in the platform such as Darzalex (daratumumab) and Stelara (ustekinumab) which generated $2.5bn and $3.2bn in US sales in H1 2023, respectively, as per the company’s Q2 2023 financial report. Data breaches at the top pharma companies are nothing new, as companies such as Merck & Co (MSD), Roche, and AstraZeneca have all been hacked in the past. Data breaches cost the companies an average of $5m to remediate, as per IBM’s 2020 data breach report. The Janssen CarePath systems provider, IBM, indicated that the stolen data may have contained information provided as part of the Janssen ...
A technical flaw has resulted in “unauthorized access” to personal information at Johnson & Johnson’s Janssen CarePath patient assistance program, IBM reported on Wednesday. After an internal investigation, IBM was unable to determine how many accounts were affected, or the exact information that may have been compromised. The company is reaching out to all Janssen CarePath customers “out of an abundance of caution,” the tech giant said in a statement. The Janssen program helped more than 1.16 million U.S. patients access medications in 2022 alone, according to the drugmaker’s website. The free initiative facilitates access by helping patients navigate health insurance, plus provides information to get patients started on and stay on treatment. The program also provides options to manage out-of-pocket costs. By IBM’s account of events, J&J first became aware of a technical loophole in the Janssen CarePath system. Once informed, IBM, which manages the service, “promptly remediated the ...
Dive Brief A plaintiff has accused Medtronic of sharing user data for its InPen diabetes management system with companies including Google. The lawsuit alleges that Medtronic’s MiniMed business used digital platforms to acquire “a treasure trove of personal data” and shared the information with third parties to increase revenue and profits. According to the plaintiff in the proposed class action lawsuit, the disclosures to Google are “particularly problematic” because his use of Gmail meant his personal information was “automatically linked to his real identity.” Dive Insight The case centers on the app that accompanies Medtronic’s smart insulin pen. Medtronic created the app to help patients record their insulin doses, receive reminders and share data with their healthcare team. The use of the data is covered by Medtronic’s notice of privacy practices. According to the lawsuit, the company has used the data in ways that are beyond the terms covered in ...
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