[Editor’s note: This article has been updated to include the White House’s announcement.]
President Joe Biden nominated Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration on Friday.
If confirmed, Califf, a cardiologist who also led the FDA during the last year of President Barack Obama’s administration, will step into a position that has been vacant for months.
“Dr. Robert Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” said Biden in a statement.
“As the FDA considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the FDA,” he continued.
WHY IT MATTERS
The FDA has lacked a Senate-confirmed leader since Biden took office in January of this year. The current acting commissioner, Janet Woodcock, can only legally serve until November 15 if Biden does not nominate anyone.
Califf, who has been a paid consultant for multiple large pharmaceutical companies, is currently senior advisor at Verily Life Sciences and Google Health. He and Biden also collaborated on the president’s Cancer Moonshot Initiative.
Califf would have a busy to-do list as FDA responds to the COVID-19 crisis, with new decisions to make about vaccines and antivirals. The agency is considering expanding eligibility for Pfizer and Moderna booster shots for all adults, for example.
Observers told Politico that they expected Califf to be confirmed again by the Senate, which approved his last nomination 89 to four.
THE LARGER TREND
The FDA has in recent months also fine-tuned its policies around software in medical devices.
This past week, the agency published a long-awaited draft for its Content of Premarket Submissions for Device Software Functions, aimed at replacing an outdated guidance first issued in 2005.
The new draft, said Bakul Patel, director of the FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health, “describes the information that the FDA considers important during its evaluation of the safety and effectiveness for device software with one or more device functions, including both software in a medical device and software as a medical device.”
The document followed the agency’s release of “guiding principles” for artificial intelligence and machine learning device development in October.
ON THE RECORD
“Rob Califf is a good choice,” said Dr. Aaron S. Kesselheim, a professor of medicine at Harvard Medical School, to the Washington Post‘s Laurie McGinley. “Califf certainly spent the vast majority of his early career working on clinical trials … and understands the value of rigorous data.”
“I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making,” said Biden in his Friday statement. “Dr. Califf had strong bipartisan support in the Senate in 2016, and I urge the Senate to swiftly confirm Dr. Califf so he can continue the important work being done at this critical moment.”
Source Here: healthcareitnews.com
Apple Sues NSO Group, Accusing It of Spying on Users in New Lawsuit
Apple announced this week that it was suing NSO Group, an Israeli surveillance technology company, in federal court for allegedly accessing users’ devices without authorization.
In addition to damages, the tech giant is seeking to block NSO Group from accessing or using any Apple products, or developing spyware that could be used on Apple products in the future.
“State-sponsored actors like the NSO Group spend millions of dollars on sophisticated surveillance technologies without effective accountability,” said Craig Federighi, Apple’s senior vice president of software engineering, in a statement. “That needs to change.”
Apple devices are “the most secure consumer hardware on the market,” he contended, but “private companies developing state-sponsored spyware have become even more dangerous.
“While these cybersecurity threats only impact a very small number of our customers, we take any attack on our users very seriously, and we’re constantly working to strengthen the security and privacy protections in iOS to keep all our users safe,” Federighi added.
NSO Group offered a statement to Healthcare IT News in response to requests for comment.
“Thousands of lives were saved around the world thanks to NSO Group’s technologies used by its customers,” said NSO Group representatives. “Pedophiles and terrorists can freely operate in technological safe-havens, and we provide governments the lawful tools to fight it. NSO Group will continue to advocate for the truth.”
WHY IT MATTERS
NSO Group says its surveillance technology is used by government intelligence and law enforcement agencies to track criminals.
But as Apple outlines in its complaint, the company’s spyware has reportedly been used against journalists, human rights activists, dissidents, public officials and others.
This month, the U.S. Department of Commerce included the NSO Group in its Entity List for “engaging in activities that are contrary to the national security or foreign policy interests of the United States.” Specifically, the agency said that NSO Group had enabled foreign governments, via its spyware, to “maliciously target” individuals such as embassy workers and academics and to “conduct transnational repression.”
In its complaint, Apple zeroed in on “FORCEDENTRY,” an exploit for a vulnerability used to break into a victim’s device and install NSO Group’s Pegasus spyware product.
The company accused attackers of creating Apple IDs to send malicious data to a victim’s device, which then allowed NSO Group or its clients to surreptitiously deliver Pegasus.
“On information and belief, Defendants provide consulting and expert services to their clients, assist them with their deployment and use of Pegasus, and participate in their attacks on Apple devices, servers and users,” according to the complaint. Although Apple has not observed any evidence of successful remote attacks against devices running iOS 15 or later, it said that each attack carries substantial costs for the company, including the necessity to redirect resources.
“In the meantime, on information and belief, Defendants continue with their pernicious efforts to target and harm Apple and its customers by infecting, exploiting, and misusing Apple devices and software,” said the complaint.
The company also announced that it would be contributing any damages from the lawsuit, plus an extra $10 million, to organizations pursuing cybersurveillance research and advocacy.
“At Apple, we are always working to defend our users against even the most complex cyberattacks,” said Ivan Krstic, head of Apple Security Engineering and Architecture, in a statement.
“The steps we’re taking today will send a clear message: In a free society, it is unacceptable to weaponize powerful state-sponsored spyware against those who seek to make the world a better place.”
THE LARGER TREND
Nation-states have increasingly relied on sophisticated software to carry out governmental objectives.
As Errol Weiss, H-ISAC chief security officer, pointed out in an interview with Healthcare IT News earlier this month, cyber-offensive capabilities have now become the norm, not the exception.
“A few years ago, you could count maybe a few dozen countries that had a decent, offensive cyber capability. And now it’s probably the opposite,” he said. The U.S. government has raised the alarm about these developments, most recently regarding an Iran-sponsored hacker group targeting healthcare.
ON THE RECORD
“Our threat intelligence and engineering teams work around the clock to analyze new threats, rapidly patch vulnerabilities, and develop industry-leading new protections in our software and silicon,” said Apple’s Krstic in a statement.
“Apple runs one of the most sophisticated security engineering operations in the world, and we will continue to work tirelessly to protect our users from abusive state-sponsored actors like NSO Group,” he said.
French Researchers Reveal Chatbot Skills to Override Vaccine Hesitancy
A team of French cognitive scientists has addressed the urgent issue of vaccine hesitancy within many EU countries and proposes a new approach. With a study published in October this year, the researchers successfully demonstrated that the reluctance to be vaccinated could be decreased by deploying chatbot technology.
WHY IT MATTERS
The chatbot study involved researchers from the Centre National de la Recherche Scientifique (CNRS), the French National Institute of Health and Medical Research INSERM and ENS-PSL.
The study, published in the Journal of Experimental Psychology: Applied, found that interaction with a chatbot developed by CNRS, ENS-PSL and INSERM was able to reduce vaccination refusal by 20 per cent within a test group of 338 participants.
In the control group, which received only brief information about the COVID-19 vaccination, there were no comparable results in terms of general views and willingness to vaccinate.
THE LARGER TREND
Although nearly three-quarters of all adult Europeans are now fully vaccinated against COVID-19, there remain huge disparities in vaccination rates across countries.
According to the vaccine tracker of the European Centre for Disease Prevention and Control (ECDC) as of 25 November 2021, individual EU countries such as Portugal (81.5 per cent), Ireland (76.2 per cent) and Denmark (76 per cent) have already made great progress in immunising their populations with a full COVID-19 vaccination, while the vaccination rate of other countries such as Germany, France or Austria continues to stagnate at below 70 per cent.
In other parts of Europe, especially in the south-west, the vaccination rates are significantly lower than 50 per cent. In Slovakia (45.7 per cent), Romania (37.3 per cent) and Bulgaria (24.7 per cent), very few people have received the double COVID-19 vaccine dose.
These vaccination backlogs are not only due to vaccine shortages, but in many cases a result of existing scepticism of many Europeans.
The researchers from France now hope that technology-based communication, such as chatbots, could have a positive impact on these figures in the future.
ON THE RECORD
“It remains to be shown whether the effects of chatbot interaction are lasting, and whether they are the same across age groups, and among those most resistant to vaccination”, emphasised the authors of the study with predominantly young and well-educated participants.
They added: “Half of the experimental group later tried to persuade others to get vaccinated, with three-quarters of them stating they drew information provided by the chatbot to do so.”
Roundup: Medanta Adopts Qure.ai’s X-ray Software, India to Open a Medical Cobotics Centre, and More Briefs
Medanta taps Qure.ai for AI-driven chest x-ray analysis
Medanta, a multi-speciality medical group in India, has partnered with Qure.ai to implement the latter’s artificial intelligence software to enhance chest x-ray analysis.
The hospital group will be adopting the qXR software which automatically analyses chest x-rays and spots findings for better diagnosis and treatment. The AI tool can detect 30 abnormalities of the lungs, pleura, heart, bones and diaphragm.
“Medanta strives to deliver world-class healthcare through its high-end medical equipment and superior infrastructure. State-of-the-art technology is an essential aspect of healthcare delivery,” Dr Naresh Trehan, chairman and managing director of Medanta, was quoted as saying in a news report.
The Qure.ai software has also been adopted by Fujifilm Corporation for its portable X-ray FDR Xair system. Through its recent partnership with AstraZeneca Malaysia, the startup has brought its x-ray software to some primary care clinics in Malaysia to support the early detection of lung cancer there.
Medical cobotics centre to be launched in India
The I-Hub Foundation for Cobotics at the Indian Institute of Technology – Delhi (IIT Delhi) and iHub Anubhuti at the Indraprastha Institute of Information Technology – Delhi (IIITD) have signed a memorandum of understanding to set up India’s first medical cobotics centre.
The two government-backed university technology hubs have been developing advanced technologies in robotics and collaborative robots (cobotics), digital health, sensing and computing technologies for robotic-assisted surgeries, training, and medical procedures.
According to a press statement, the Medical Cobotics Centre (MCC) at IIITD will be a tech-enabled medical simulation and training facility for young resident doctors, as well as other healthcare professionals, paramedical staff, technicians, engineers, and researchers.
It will also serve as a validation centre for research outcomes in the area of healthcare cobotics and digital health. This upcoming facility will establish partnerships with companies, undertake research, and work toward the commercialisation of technologies.
MMC’s training programmes will be at multiple levels and cohort-specific, such as urology, neurology, and laparoscopy, but will be initially limited to minimally invasive surgeries. Experts from All India Institute of Medical Sciences in New Delhi and other medical colleges will be consulted for these programmes and invited as guest faculty to conduct them.
The first batch of trainees is targeted to be inducted around April-May next year. They will be initially trained with basic training simulators while advanced surgical robots will come in the next phase.
Moreover, the centre will also be a place for various technology innovation hubs under the Indian government’s National Mission on Interdisciplinary Cyber-Physical Systems to “showcase their medical-related projects and products with applications,” according to IHFC CEO Ashutosh Dutt Sharm and IHFC Project Director Subir Kumar Saha.
Philips Foundation backs cardiac rehab programme in Singapore
Philips Foundation is funding one of the centres run by social service agency Singapore Heart Foundation that provides subsidised cardiac rehabilitation services.
The year-long project of Royal Philips’ non-profit organisation aims to reduce the mortality rate of cardiac incidences and help lower a patient’s risk of hospital readmission.
Specifically, it intends to close the gap in patients’ lack of participation in rehab programmes, which is considered a huge barrier in the secondary prevention of heart diseases. It was reported that only between 6%-15% of Singaporean patients attend cardiac rehabilitation programmes.
SHF-Philips Foundation Heart Wellness Centre is one of the social services’ three centres that provide cardiac patients and at-risk individuals with access to heart health.
Philips’ support, according to SHF Heart Wellness Centres Chairman Dr Tan Yong Seng, will provide SHF with the “resources required to continue providing affordable and quality support to the patients in need, as well as give our team the capacity to focus on raising awareness on the importance of cardiac rehab[ilitation] and drive higher participation in our programmes”.
Under the partnership, 20 sites in Singapore will be equipped with the Philips HeartStart automated external defibrillators (AED) and 500 persons will be trained in giving cardiopulmonary resuscitation (CPR) and AED over a year.
“Through the heart wellness centre’s education initiatives, the AED roll-out and the CPR training, we want to equip individuals and communities with the knowledge and resources to reduce the mortality rates of cardiac incidences in Singapore,” Philips Singapore Country Manager Ivy Lai said.
Original Source: healthcareitnews.com
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